Percutaneous transluminal angioplasty in arteriosclerosis

International Nuclear Information System (INIS)

Chung, Soo Young; Cha, In Ho

1984-01-01

Percutaneous transluminal angioplasty (PTA) is a non-operative therapeutic procedure to the dilation of stenosis or to the recanalization of occlusion in atherosclerotic arteries using of dilatation catheters. PTA was performed 37 times in 34 patients with arteriosclerotic for 1 year and 4 months from March, 1982 to June, 1983 at department of radiology, Klinikum Barmen/west Germany. The results were as follows; 1. The male to female ratio was 2 : 1 and peak age range was from 61 to 70. 2. The most common indication was clinical stage II b with 19 cases (51.3%). 3. PTA was performed most commonly in superficial femora artery in 25 cases (67.5%). 4. Acute major complication occurred in 2 cases (5.4%). PTA is a alternative or complementary therapeutic procedure to vascular surgery.

Percutaneous transluminal angioplasty (PTA) after kidney transplantation

International Nuclear Information System (INIS)

Fava, C.; Grosso, M.; Sandrone, M.; Malfi, B.; Segoloni, G.P.; Colla, L.

1988-01-01

Renal artery stenosis is a frequent complication of kidney transplantation (10%). Percutaneous transluminal angioplasty (PTA) has recently been proposed as a potential therapeutic procedure. Twelve transplant patients with arterial stenosis underwent PTA. The procedure was successful in 10 cases (83.3%). Restenosis occurred in 2 patients (16.7%); both of them underwent PTA successfully. No complications occurred. A considerable improvement in glomerular filtration rate and a reduction in high blood pressure were observed in all patients after successful PTA. The authors belive PTA to be the therapy of choice in the treatment of arterial stenoses in kidney transplant patients

Nuclear Techniques for Coronary Heart Disease Therapy after Percutaneous Transluminal Coronary Angioplasty

International Nuclear Information System (INIS)

Nurlaila-Z

2005-01-01

Nuclear techniques studies of the heart represent one of the fastest growing areas of research. Several years ago, nuclear medicine cardiac studies were limited for the evaluation and diagnosis of myocardial infarction. Development in radiopharmaceutical-chemistry and instrumentation have made possible advances in nuclear medicine for restenosis cardiovascular therapy after percutaneous transluminal coronary angioplasty.The radionuclide as radiation source can be delivered to the target basically by two techniques, those are catheter-based systems and radioactive stents. For this purpose,it can be use the γ and β emitter radionuclides, in which the β emitter radionuclides is an ideal radionuclide for endovascular therapy. Restenosis after percutaneous transluminal coronary angioplasty can be prevented by using the radioactive stent. This review discusses several techniques which could be used for restenosis cardiovascular therapy. Furthermore, several types of radiopharmaceutical and kinds of radionuclides as well as doses of the compounds for this purpose are also reviewed. (author)

Value of Duplex scanning in the selection of patients for percutaneous transluminal angioplasty

NARCIS (Netherlands)

van der Heijden, F. H.; Legemate, D. A.; van Leeuwen, M. S.; Mali, W. P.; Eikelboom, B. C.

1993-01-01

Duplex scanning is becoming increasingly important in the diagnosis and follow-up of arterial lesions, though most surgeons and radiologists currently still prefer diagnostic angiography prior to percutaneous transluminal angioplasty (PTA). We performed PTA based on Duplex scanning alone in 31

Short- and long-term functional effects of percutaneous transluminal angioplasty in hemodialysis vascular access

NARCIS (Netherlands)

J. van der Linden (Joke); J.H. Smits (Johannes); J.H. Assink (Jan Hendrik); D.W. Wolterbeek (Derk); J.J. Zijlstra (Jan); G.H.T. de Jong (Gijs); M.A. van den Dorpel (Marinus); P.J. Blankestijn (Peter)

2002-01-01

textabstractThe efficacy of percutaneous transluminal angioplasty (PTA) is usually expressed as the angiographic result. Access flow (Qa) measurements offer a means to quantify the functional effects. This study was performed to evaluate the short-term functional and

Long-term results of brachiocephalic artery percutaneous transluminal angioplasty

International Nuclear Information System (INIS)

Mc Namara, T.O.; Gardner, K.

1990-01-01

This paper establishes the ling-term and angiographic sequelae of percutaneous transluminal angioplasty (PTA) of stenoses of the origins of the brachycephalic arteries. From November of the proximal segments of the brachycephalic arteries. Clinical follow-up after PTA was 45 months. Two patients had recurrence of vertigo, after 16 and 75 months. There was no evidence of restenosis in the patient whose recurrence was after 16 months, but considerable restenosis was noted in the patient whose symptoms recurred after 75 months. That patient underwent successful repeated PTA

Renal artery blood flow assessed by video dilution technique before and after percutaneous transluminal angioplasty

International Nuclear Information System (INIS)

Lantz, B.M.T.; Link, D.P.; Lewis, E.L.; Foerster, J.M.; Lee, G.

1981-01-01

Successful percutaneous transluminal angioplasty was performed in 3 cases of renal artery stenosis where the effect upon renal blood flow was quantified by video dilution technique. This technique adds important information to pressure gradients and renin assays obtained during the dilatation procedure. (Auth.)

Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention

Energy Technology Data Exchange (ETDEWEB)

Escárcega, Ricardo O.; Baker, Nevin C.; Magalhaes, Marco A.; Lipinski, Michael J.; Minha, Sa’ar; Torguson, Rebecca; Satler, Lowell F.; Pichard, Augusto D.; Suddath, William O.; Waksman, Ron, E-mail: ron.waksman@medstar.net

2014-09-15

Objective: To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). Background: EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). Methods: A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. Results: EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p = 0.06 and 8.8% vs. 12.6%, respectively, p = 0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p = 0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome. Conclusion: While EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.

Ruptured Splenic Abscess following Percutaneous Transluminal Angioplasty in a 40-Year-Old Man

Directory of Open Access Journals (Sweden)

C. Rajasekharan

2012-05-01

Full Text Available The incidence of splenic abscesses is currently 0.14–0.7% with a reported mortality of 0–47%. The diagnosis of splenic abscess which has ruptured into the abdomen is often overlooked because of its rarity and its misleading clinical presentations. Percutaneous coronary interventions (PCIs and coronary stenting procedures increased from 184,000 to 885,000 (from 335 to 1,550 and from 3,000 to 770,000 (from 5 to 1,350 per one million inhabitants, respectively. A 40-year-old Asian male presented to our emergency department with upper abdominal pain 5 days after a percutaneous transluminal coronary angioplasty. Clinical examination raised the possibilities of acute pancreatitis and intraabdominal sepsis. An initial ultrasound of the abdomen and blood tests were negative. A computed tomography scan of the abdomen revealed a splenic abscess that had ruptured into the abdomen. Pus culture revealed a multidrug-resistant strain of Klebsiella pneumoniae that was sensitive to meropenem. The patient recovered quickly after open surgical drainage and antibiotic therapy. As this is the second case of splenic abscess and the first case report of a ruptured splenic abscess following a PCI, it will be rational to administer a short course of antibiotic prophylaxis for high-risk immunocompromised patients who are undergoing percutaneous transluminal coronary intervention.

Percutaneous transluminal angioplasty of an occluded surgical splenorenal shunt in a 4-year-old child after liver transplantation

Energy Technology Data Exchange (ETDEWEB)

Yussim, Ethan; Belenky, Alexander; Atar, Eli [Department of Diagnostic Radiology, Rabin Medical Center, Vascular and Interventional Radiology Unit, Petah Tikva (Israel); Shapiro, Rivka [Schneider Children' s Medical Center, Institute of Pediatric Gastroenterology and Nutrition, Petah Tikva (Israel); Mor, Eytan [Rabin Medical Center, Department of Organ Transplantation, Petah Tikva (Israel)

2005-07-01

Percutaneous transluminal angioplasty is increasingly used in children. We present a case of successful balloon angioplasty of an occluded surgical splenorenal shunt in a 4-year-old child who underwent liver transplantation because of biliary atresia. Percutaneous reopening of the shunt is a relatively safe procedure that may spare patients of surgical intervention. (orig.)

Percutaneous transluminal angioplasty of an occluded surgical splenorenal shunt in a 4-year-old child after liver transplantation

International Nuclear Information System (INIS)

Yussim, Ethan; Belenky, Alexander; Atar, Eli; Shapiro, Rivka; Mor, Eytan

2005-01-01

Percutaneous transluminal angioplasty is increasingly used in children. We present a case of successful balloon angioplasty of an occluded surgical splenorenal shunt in a 4-year-old child who underwent liver transplantation because of biliary atresia. Percutaneous reopening of the shunt is a relatively safe procedure that may spare patients of surgical intervention. (orig.)

Effect of sleep-inducing music on sleep in persons with percutaneous transluminal coronary angiography in the cardiac care unit.

Science.gov (United States)

Ryu, Min-Jung; Park, Jeong Sook; Park, Heeok

2012-03-01

The study compared the effect of earplug-delivered sleep-inducing music on sleep in persons with percutaneous transluminal coronary angiography in the cardiac care unit. Diverse types of music have been claimed to improve sleeping elsewhere, but relatively little is known in South Korea. Most studies investigating the effect of sleep-inducing music on sleep have involved persons with insomnia, even though many persons with cardiovascular disease in the intensive care unit suffer from sleeping problems. There is a need to investigate the effect of sleep-inducing music on sleep disorders in persons with percutaneous transluminal coronary angiography in the cardiac care unit. An experimental research design was used. Data collection was conducted in the cardiac care unit of K University Hospital in D city, from 3 September-4 October 2010. Fifty-eight subjects participated and were randomly assigned to the experimental group (earplug-delivered sleep-inducing music for 52 min beginning at 10:00 pm, while wearing an eyeshield, n = 29) and the control group (no music, but earplugs and eyeshield worn, n = 29). The quantity and quality of sleep were measured using questionnaires at 7 am the next morning for each group. Participants in the experimental group reported that the sleeping quantity and quality were significantly higher than control group (t = 3·181, p = 0·002, t = 5·269, p music significantly improved sleep in patients with percutaneous transluminal coronary angiography at a cardiac care unit. Offering earplugs and playing sleep-inducing music may be a meaningful and easily enacted nursing intervention to improve sleep for intensive care unit patients. Nurses working at cardiac care unit can use music to improve sleeping in clients with percutaneous transluminal coronary angiography. © 2011 Blackwell Publishing Ltd.

Percutaneous transluminal angioplasty (PTA) of supra-aortic arteries especially the internal carotid artery

Energy Technology Data Exchange (ETDEWEB)

Kachel, R.; Basche, S. (Medizinische Akademie, Erfurt (Germany, F.R.). Radiologische Klinik); Heerklotz, I.; Grossmann, K. (Medizinische Akademie, Erfurt (Germany, F.R.). Klinik fuer Innere Medizin); Endler, S. (Medizinische Akademie, Erfurt (Germany, F.R.). Klinik fuer Neurologie und Psychiatrie)

1991-06-01

We present our experience with 105 patients in whom percutaneous transluminal angioplasty was performed in 112 stenosed or occluded supra-aortic arteries. Symtoms of cerebrovascular and/or vertebrobasilar insufficiency were present in 104 of the 105 patients. The angioplasty was successful in 35 stenoses of the internal carotid artery, 2 stenoses of the common carotid artery, 1 stenosis of the external carotid artery, 15 stenoses of the vertebral artery, 3 stenoses of the innominate artery and 44 stenoses of the subclavian artery. There were only 4 minor-complications (2 haematomas, 1 transient ischemic attack, 1 small thrombus of the internal carotid artery which was detected by 111-indium platelet scintigraphy and treated by thrombendarterectomy before the appearance of neurological symptoms). All patients were symptom free after angioplasty. During the observations period of 3 to 109 months (average 58 months) there were only two cases with re-stenosis after subclavian angioplasty. The results of more than 700 personal and international published percutaneous transluminal angioplasties of supra-aortic arteries are presented. The results suggest that angioplasty of supra-aortic arteries is an effective method. On strict definition of the indications, the complication rate for angioplasty of the supra-aortic arteries is not likely to be higher than that for operative treatment. (orig.).

A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

Directory of Open Access Journals (Sweden)

Wehrenberg Scott

2010-01-01

Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry)

DEFF Research Database (Denmark)

Kaltoft, Anne; Jensen, Lisette Okkels; Maeng, Michael

2009-01-01

OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST...... databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1...

Short-, medium-, and long-term follow-up after percutaneous transluminal coronary angioplasty for stable and unstable angina pectoris

NARCIS (Netherlands)

O. Kamp (Otto); K.J. Beatt (Kevin); P.J. de Feyter (Pim); M.J.B.M. van den Brand (Marcel); H. Suryapranata (Harry); H.E. Luijten; P.W.J.C. Serruys (Patrick)

1989-01-01

textabstractThe first 840 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) performed in the same institution were retrospectively assessed at an average follow-up period of 25 months after the initial procedure. The study population consisted of 506 patients

A Systematic Review of Outcomes Following Percutaneous Transluminal Angioplasty and Stenting in the Treatment of Transplant Renal Artery Stenosis

NARCIS (Netherlands)

Ngo, A. T.; Markar, S. R.; de Lijster, M. S.; Duncan, N.; Taube, D.; Hamady, M. S.

2015-01-01

To evaluate outcomes following treatment of transplant renal artery stenosis by percutaneous transluminal angioplasty and stent insertion. A literature search was performed using Pubmed, MEDLINE, Embase, Wiley Interscience and the Cochrane Library databases. Outcome measures were glomerular

A perspective of percutaneous transluminal angioplasty.

Science.gov (United States)

Stanson, A W

1983-01-01

PTA is a relatively new procedure which is still evolving. More technical improvements are needed. Stiffer balloon plastics and devices to measure arterial wall compliance during balloon inflation are predicted to lead to better long-term success rates. Increasing case numbers provide greater expertise and subsequent refinements in performance and case selection. These factors will lead to improved statistics. Other features of overall patient care must be considered also. The procedure is easy for patients to tolerate, and they can return to activities and work in three or four days. The overall cost is much cheaper than surgery, even at a conservative success rate of 65 percent. There is minimal risk and morbidity, and virtually no mortality. PTA can be repeated if the lesion recurs. Severe complications are rare and almost always surgically treatable. If PTA fails to achieve success, a traditional surgical procedure can be performed. Percutaneous transluminal angioplasty is an important therapeutic alternative to traditional medical and surgical treatment for occlusive arterial disease. It can save legs, veins, time, and money. We need to refine and accurately record the use of this procedure. Total cooperation among clinicians, surgeons, and radiologists is essential for proper utilization of PTA.

Association Between Disruption of Fibrin Sheaths Using Percutaneous Transluminal Angioplasty Balloons and Late Onset of Central Venous Stenosis

International Nuclear Information System (INIS)

Ni, Nina; Mojibian, Hamid; Pollak, Jeffrey; Tal, Michael

2011-01-01

To compare the rates of central venous stenosis in patients undergoing hemodialysis who underwent disruption of fibrin sheath with percutaneous transluminal angioplasty balloons and those who underwent over-the-wire catheter exchange. This study is a retrospective review of 209 percutaneous transluminal angioplasty balloon disruption and 1304 over-the-wire catheter exchange procedures performed in 753 patients. Approval from the Human Investigations Committee was obtained for this study. Up to 10-year follow-up was performed. A χ 2 test was used to compare the rates of central venous stenosis after balloon disruption versus catheter exchange. A t-test was used to compare time to central venous stenosis development. Of the 753 patients in the study, 127 patients underwent balloon disruption of fibrin sheath and 626 had catheter exchange. Within the balloon disruption group, 18 (14.2%) of 127 patients subsequently developed central venous stenosis, compared with 44 (7.0%) of 626 in the catheter exchange group (P 2 test). Time to central venous stenosis development was approximately 3 years in both groups and not significantly different (1371 and 1010 days, P = 0.20). A total of 25.2% of patients in the balloon disruption group had four or more subsequent catheter exchanges, versus 12.6% in the catheter exchange group (P 2 test). In conclusions, there is a possible association between percutaneous transluminal angioplasty balloon disruption of fibrin sheath and late-onset central venous stenosis. Because venography was not routinely performed in catheter exchange patients, future randomized studies are necessary to confirm these findings.

Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

Science.gov (United States)

Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

2011-10-01

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the

Percutaneous Transluminal Angioplasty of Renal Artery Fibromuscular Dysplasia: Mid-term Results

International Nuclear Information System (INIS)

Kim, Hyo Jin; Do, Young Soo; Shin, Sung Wook; Park, Kwang Bo; Cho, Sung Ki; Choe, Yeon Hyeon; Choo, Sung Wook; Choo, In Wook; Kim, Duk Kyung

2008-01-01

To evaluate mid-term imaging, clinical follow-up, and restenosis rates from patients that had undergone percutaneous transluminal renal artery angioplasty (PTRA) for symptomatic renal artery fibromuscular dysplasia (FMD). Between March 1999 and July 2006, 16 consecutive renal artery FMD patients underwent PTRA for poorly controlled hypertension. The patients were enrolled into this retrospective study after receiving 19 primary and four secondary PTRAs in 19 renal artery segments. Follow-up monitoring of blood pressure, use of antihypertensive medication, and the serum creatinine level after PTRA were assessed at 1, 3, 6, 9, 12 months, and each following year. The degree of restenosis was evaluated with computed tomographic angiography (CTA) after PTRA at 6, 12 months, and every year if possible. Technical and clinical success rates for the treatment of FMD, and restenosis rates for the renal artery were evaluated. The technical success rate for primary PTRA was 79% (15/19) and the complication rate was 16% (3/19). Hypertension improved in 80% (12/15) of the patients after four weeks follow-up, and was finally cured or improved in 93% (14/15) during the mean follow-up period of 23.6 months. There was a cumulative 22% (4/18) restenosis rate during the follow-up period. All of the patients were treated with a second PTRA without complications and all of the patients were cured of hypertension after the second PTRA. Percutaneous transluminal renal artery angioplasty for clinically symptomatic renal FMD is technically and clinically successful and safe to perform. For all patients with restenosis, there was a good response after undergoing a second PTRA

Percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease using a transluminal endatherectomy catheter (TEC): Initial results and angiographic follow-up

International Nuclear Information System (INIS)

Rilinger, Norbert; Goerich, Johannes; Scharrer-Pamler, Reinhard; Vogel, Jochen; Tomczak, Reinhard; Merkle, Elmar; Sokiranski, Roman; Brambs, Hans-Juergen

1997-01-01

Purpose. To evaluate the clinical results of percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease. Methods. Rotational atherectomy was performed in 39 patients aged 39-87 years (mean 66.6 years). A total of 71 lesions (43 stenoses and 28 occlusions) were treated in 40 limbs. Additional balloon angioplasty was required in 54% of lesions. Fifteen patients (37.5%) presented in Fontaine stage II, 10 patients (25%) in Fontaine stage III and 15 patients (37.5%) in Fontaine stage IV. Rotational atherectomy at 750 rpm was carried out over a 0.014-inch guidewire with continuous aspiration into a vacuum, bottle. Follow-up angiography and color flow Doppler examinations were performed in 22 patients (23 limbs) after a mean period of 6 months (range 2-14 months). Results. There was one primary technical failure. In 36 of 40 lesions there was a good angiographic result with residual stenoses in less than 30%. In 70 lesions treated by rotational atherectomy, however, 54% showed residual stenoses of 30%-50% and these cases required additional balloon angioplasty. The mean ankle-brachial index improved significantly (p<0.001), from 0.49 before the procedure to 1.01 after the procedure. A single distal embolus, related to primary recanalization, occurred and there were two large inguinal hematomas. Cumulative clinical patency after 6 months was 83.8% and cumulative angiographic patency after 6 months was 79.1%. Conclusion. Percutaneous rotational atherectomy is a promising approach for the treatment of chronic peripheral vascular disease. Further prospective, randomized studies are necessary to compare percutaneous transluminal angioplasty with this new technical approach

Co-occurrence of diabetes and hopelessness predicts adverse prognosis following percutaneous coronary intervention

NARCIS (Netherlands)

S.S. Pedersen (Susanne); J. Denollet (Johan); R.A.M. Erdman (Ruud); P.W.J.C. Serruys (Patrick); R.T. van Domburg (Ron)

2009-01-01

textabstractWe examined the impact of co-occurring diabetes and hopelessness on 3-year prognosis in percutaneous coronary intervention patients. Consecutive patients (n = 534) treated with the paclitaxel-eluting stent completed a set of questionnaires at baseline and were followed up for 3-year

Cardiac troponin T and CK-MB mass release after visually successful percutaneous transluminal coronary angioplasty in stable angina pectoris

DEFF Research Database (Denmark)

Ravkilde, J; Nissen, H; Mickley, H

1994-01-01

The incidence of cardiac troponin T (Tn-T) and creatine kinase (CK) isoenzyme MB mass release was studied in 23 patients with stable angina pectoris undergoing visually successful percutaneous transluminal coronary angioplasty (PTCA). Serial blood samples were drawn for measurement of serum Tn...

[Effect of nattokinase on restenosis after percutaneous transluminal angioplasty of the abdominal artery in rabbits].

Science.gov (United States)

Gong, Min; Lin, Huan-bing; Wang, Qian; Xu, Jiang-ping

2008-08-01

To investigate the effect of nattokinase on intimal hyperplasia in rabbit abdominal artery after balloon injury and explore a novel strategy for the preventing restenosis after percutaneous transluminal angioplasty. Fifty-six New Zealand rabbits were randomly divided into 7 groups, namely the solvent control group, model group, natto extract lavage group, refined nattokinse lavage group, intravenous refined nattokinse injection group, clopidogrel group and clopidogrel-aspirin group. Balloon injury was induced by inserting the catheter through the femoral artery into the thoracic aorta of the rabbits. The platelet counts were notad and platelet aggregation was observed, and the abdominal artery was taken for pathological analysis. The expressions of MMP-2 and -9 in the abdominal artery were detected immunohistochemically. There was no significant difference in the platelet counts, platelet aggregation rate or MMP-2 and -9 expression between the model group and the nattokinse-treated groups (P>0.05). The stenosis index in each nattokinse-treated group was significantly greater and the neointimal proliferation index smaller than that of the model group (P<0.01 or 0.05). Nattokinse can inhibit restenosis of rabbit abdominal artery after percutaneous transluminal angioplasty, which is independent of its actions on the platelet or MMP-2 and -9 expressions.

Preparation of paclitaxel/chitosan co-assembled core-shell nanofibers for drug-eluting stent

Energy Technology Data Exchange (ETDEWEB)

Tang, Jing; Liu, Yongjia [Instrumental Analysis Center, Shanghai Jiao Tong University, 200240 Shanghai (China); State Key Laboratory of Metal Matrix Composites, School of Chemistry and Chemical Engineering, Shanghai Jiao Tong University, 200240 Shanghai (China); Zhu, Bangshang, E-mail: bshzhu@sjtu.edu.cn [Instrumental Analysis Center, Shanghai Jiao Tong University, 200240 Shanghai (China); State Key Laboratory for Modification of Chemical Fibers and Polymer Materials, Donghua University, 201620 Shanghai (China); Su, Yue; Zhu, Xinyuan [State Key Laboratory of Metal Matrix Composites, School of Chemistry and Chemical Engineering, Shanghai Jiao Tong University, 200240 Shanghai (China)

2017-01-30

Highlights: • The core-shell nanofibers (NFs) were made by the co-assembly of paclitaxel (PTX) and chitosan(CS). • The PTX/CS NFs have high PTX loading content, slow drug release and low adherence of platelets. • The PTX/CS NFs have low cytotoxicity and good haemocompatibility. • The PTX/CS NFs which could be easily coated on stents could have potential application for drug eluting stents. - Abstract: The paclitaxel/chitosan (PTX/CS) core-shell nanofibers (NFs) are easily prepared by co-assembly of PTX and CS and used in drug-eluting stent. The mixture solution of PTX (dissolved in ethanol) and CS (dissolved in 1% acetic acid water solution) under sonication will make the formation of NFs, in which small molecule PTX co-assembles with biomacromolecular CS through non-covalent interactions. The obtained NFs are tens to hundreds nanometers in diameter and millimeter level in length. Furthermore, the structure of PTX/CS NFs was characterized by confocal laser scanning microscopy (CLSM), zeta potential, X-ray photoelectron spectroscopy (XPS) and nanoscale infra-red (nanoIR), which provided evidences demonstrated that PTX/CS NFs are core-shell structures. The ‘shell’ of CS wrapped outside of the NFs, while PTX is located in the core. Thus it resulted in high drug loading content (>40 wt.%). The well-controlled drug release, low cytotoxicity and good haemocompatibility were also found in drug carrier system of PTX/CS NFs. In addition, the hydrophilic and flexible properties of NFs make them easily coating and filming on stent to prepare drug-eluting stent (DES). Therefore, this study provides a convenient method to prepare high PTX loaded NFs, which is a promising nano-drug carrier used for DES and other biomedical applications. The possible molecular mechanism of PTX and CS co-assembly and core-shell nanofiber formation is also explored. Statement of significance: We develop a convenient and efficient approach to fabricate core-shell nanofibers (NFs) through

Percutaneous transluminal angioplasty combining intraarterial drug perfusion for the treatment of chronic lower limb ischemia

International Nuclear Information System (INIS)

Liu Yuan; He Chunshui; Liao Huaqiang; Zeng Wei; Zhang Hongwei; Liu Yang; Mu Yan; Liao Huaqiang; Guan Yongsong

2008-01-01

Objective: To evaluate the clinical effects of balloon angioplasty in combination with intraarterial perfusion of vasoactive drugs in the treatment of chronic lower limb ischemia. Methods: A total of 21 patients were treated with percutaneous transfemoral or transaxillary approach of balloon dilatation of the occlusive arterial segments, and then followed by perfusion of urokinase, Lipo prostaglandin E 1 and ginkgo leaf injection, respectively, into the responsible arteries via the catheter. Postoperatively, some of the patients with tibioperoneal arteries occlusion were perfused with the same drugs into their diseased arterial segments, one time per day altogether 5-7 times, through the ipsilateral femoral arterial sheath reserved temporarily, and then followed by observation for improvement of ischemia, superficial ulceration and gangrenous change. Results: Of the 21 patients, 20 were successfully treated with percutaneous transluminal balloon dilation and arterial perfusion with a technical successful rate of 95.2% (20/21). Five of the total 20 were additionally treated with the same drugs perfusion 5-7 days through the retained sheath, showing well patency. No serious complications occurred and ischemic symptoms of limbs improved, such as rest pain, claudication and dermo temperature. During 2-7 months follow-up, healing of skin ulcer occurred in 4 patients and breakoff of necrotic digits in 2 with the surface wound healed. Necrotic toes in all patients were dehydrated with stopping of necrosis and without any amputation. Conclusions: Percutaneous transluminal angioplasty combining intraarterial drug perfusion is safe and effective for promoting blood circulation with healing of ulceration and ceasing the development of lesions; with furthermore of maintaining the arterial patency through the retained vascular sheath for sustaining the drug plerfusion. (authors)

[The usefullness of percutaneous transluminal balloon angioplasty in the management of budd-Chiari syndrome].

Science.gov (United States)

Kim, Se Hwan; Yu, Kyung Sool; Baek, Seung Min; Lee, Seung Yup; Kim, Hyun Su; Tak, Won Young; Kweon, Young Oh; Kim, Sung Kook; Choi, Yong Hwan; Chung, Joon Mo

2002-06-01

Membranous obstruction is the most common cause of Budd-Chiari syndrome in Orientals. Recently, percutaneous transluminal balloon angioplasty (PTBA) has been successfully applied as a treatment of membranous obstruction. We evaluated etiologies and clinical manifestations in our cases and the usefulness of PTBA. Twelve cases of Budd-Chiari syndrome were analyzed. 50.3 years was the average age of the cases (ranging from 37 to 67 years). Major symptoms or signs were superficial collateral vessels on the chest or the abdomen in 6 cases, ascites in 3, abdominal pain in 4, hepatomegaly in 4, splenomegaly in 3, melena or hematemesis in 2, and leg edema in 2. Upper gastrointestinal endoscopy showed esophageal varices in 6 cases and two of these 6 cases had gastric varices. Of 8 cases with liver cirrhosis, 4 were classified as Child-Pugh class A and 4 as B. Four patients with cirrhosis had concurrent hepatocellular carcinoma including 1 patient who was HBs Ag positive. Etiologies were membranous obstruction in 11 cases and protein C deficiency in 1 case. The main site of obstruction was IVC in 8 and hepatic vein in 4. PTBA was successfully performed in 8 cases of membranous obstruction. During the mean follow-up period of 27.6 months (12-40 months), there were no reobstructions except in 2 cases. The most common cause of Budd-Chiari syndrome in our cases was membranous obstruction of IVC. Percutaneous transluminal balloon angioplasty is a very useful treatment method.

Complications in percutaneous transluminal stenting for carotid artery stenosis

International Nuclear Information System (INIS)

Li Shenmao; Miao Zhongrong; Zhu Fengshui; Ji Xunming; Jiao Liqun; Qi Jianshu; Ling Feng

2007-01-01

Objective: To discuss the complications of endovascular stenting for carotid artery stenosis. Methods: Cerebral vascular angiography and cervical Doppler sonography were performed in 648 patients with carotid artery stenosis. Emboli-protected device was used in 365 patients and none in 283 patients. Results: All 648 patients were technically successful (100%). Symptoms disappeared or improved in 78.7% patients. Slow heart rate during operation existed in 26.4% patients. Embolism caused by dislodgment of emboli occurred in 5 patients, 3 of them recovered after treatment and 2 had unilateral dyskinesias. Intracranial hemorrhage occurred in 3 patients. Stroke or death within 30 days after operation occurred in 6 patients(1.24%). 322 patients (77.8%)were followed up. Restenosis occurred in 17 patients(3.3%). Conclusion: Percutaneous transluminal stenting is a safe option for carotid artery stenosis. Correct evaluation of clinical and angiographic data before operation, together with normative manipulation and nursing during and after operation are the key points to avoid complications. (authors)

The exposure of radiologists and patients to radiation during coronary angiography and percutaneous transluminal coronary angioplasty (PTCA)

International Nuclear Information System (INIS)

Karppinen, J.; Parviainen, T.

1993-03-01

The exposure of radiologists and patients to radiation during coronary angiography and percutaneous transluminal coronary angioplasty (PTCA) in Finland was studied using phantom measurements. Additional tests were made concerning the performance of TV fluoroscopy systems, cine fluorographic units and film processing. These tests include sensitometric quality control of film processing, automatic exposure control in fluoroscopy and cinefluorography, and contrast and resolution in a cine frame and TV image

Influence of paclitaxel-eluting expandable metallic stent on tissue hyperplasia: an experimental study in a canine tracheal model

International Nuclear Information System (INIS)

Shin, Ji Hoon; Kim, Jung Sun; Kim, Tae Hyung; Kim, Eun Young; Choi, Won Chan; Woo, Chul Woong; Di, Zhenhai; Song, Ho Young; Yuk, Soon Hong; Lee, Yong Seok

2005-01-01

To evaluate the efficacy of a paclitaxel-eluting expandable metallic stent in reducing tissue hyperplasia following stent placement in a canine tracheal model. Nine paclitaxel-eluting stents (drug stent, DS) consisting of a proximal bare part and a distal polyurethane-covered part were placed in the trachea of nine dogs and nine control stents (control stent, CS) were placed in the other nine dogs. The dogs were scheduled to be sacrificed 12 weeks after stent placement. Gross and histological factors, such as epithelial erosion/ulcer, granulation tissue thickness and inflammatory cell infiltration were evaluated after each dog was sacrificed. There were no procedure-related complications or malpositioning of any of the stents. One CS migrated less than eight weeks following stent placement. Four dogs (one DS and three CS dogs) died between three and five weeks following stent placement. Therefore, pathologic specimens were obtained from eight DS and five CS dogs. Epithelial erosion/ulcer or inflammatory cell infiltration was slightly more prominent in the DS cases than in the CS cases, in both the bare part and the covered part. However, the data was not statistically significant. Granulation tissue thickness was lower in the DS cases than in the CS cases in both the bare part (mean, 3.63-mm vs. 4.37-mm) and the covered part (mean, 1.75-mm vs. 2,78 mm), but the data was also statistically insignificant. Although the data was not statistically significant, placement of paclitaxel-eluting expandable metallic stent demonstrates a tendency toward a decrease in granulation tissue thickness in canine tracheal models

Influence of paclitaxel-eluting expandable metallic stent on tissue hyperplasia: an experimental study in a canine tracheal model

Energy Technology Data Exchange (ETDEWEB)

Shin, Ji Hoon; Kim, Jung Sun; Kim, Tae Hyung; Kim, Eun Young; Choi, Won Chan; Woo, Chul Woong; Di, Zhenhai; Song, Ho Young [Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Yuk, Soon Hong [Hannam University, College of Engineering, Daejeon (Korea, Republic of); Lee, Yong Seok [Wonkwang University College of Medicine, Iksan (Korea, Republic of)

2005-07-15

To evaluate the efficacy of a paclitaxel-eluting expandable metallic stent in reducing tissue hyperplasia following stent placement in a canine tracheal model. Nine paclitaxel-eluting stents (drug stent, DS) consisting of a proximal bare part and a distal polyurethane-covered part were placed in the trachea of nine dogs and nine control stents (control stent, CS) were placed in the other nine dogs. The dogs were scheduled to be sacrificed 12 weeks after stent placement. Gross and histological factors, such as epithelial erosion/ulcer, granulation tissue thickness and inflammatory cell infiltration were evaluated after each dog was sacrificed. There were no procedure-related complications or malpositioning of any of the stents. One CS migrated less than eight weeks following stent placement. Four dogs (one DS and three CS dogs) died between three and five weeks following stent placement. Therefore, pathologic specimens were obtained from eight DS and five CS dogs. Epithelial erosion/ulcer or inflammatory cell infiltration was slightly more prominent in the DS cases than in the CS cases, in both the bare part and the covered part. However, the data was not statistically significant. Granulation tissue thickness was lower in the DS cases than in the CS cases in both the bare part (mean, 3.63-mm vs. 4.37-mm) and the covered part (mean, 1.75-mm vs. 2,78 mm), but the data was also statistically insignificant. Although the data was not statistically significant, placement of paclitaxel-eluting expandable metallic stent demonstrates a tendency toward a decrease in granulation tissue thickness in canine tracheal models.

Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia

Czech Academy of Sciences Publication Activity Database

Dubský, M.; Jirkovská, A.; Bém, R.; Fejfarová, V.; Pagacová, L.; Němcová, A.; Sixta, B.; Chlupáč, J.; Peregrin, J. H.; Syková, Eva; Jude, E. B.

2014-01-01

Roč. 16, č. 12 (2014), s. 1733-1738 ISSN 1465-3249 Grant - others:GA MZd(CZ) 00023001IKEM Institutional support: RVO:68378041 Keywords : critical limb ischemia * stem cell therapy * percutaneous transluminal angioplasty Subject RIV: FH - Neurology Impact factor: 3.293, year: 2014

Randomized comparison between intracoronary β-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis

International Nuclear Information System (INIS)

Schukro, Christoph; Syeda, Bonni; Kirisits, Christian; Schmid, Rainer; Pichler, Philipp; Pokrajac, Boris; Lang, Irene; Poetter, Richard; Glogar, Dietmar

2007-01-01

Background and purpose: Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions >10 mm), β-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of β-brachytherapy with β-radioisotopes 90 Sr/ 90 Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. Material and methods: Thirty-seven patients with diffuse ISR were randomly assigned to β-brachytherapy after balloon angioplasty (Beta-Cath TM in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 TM in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. Results: Binary ISR (restenosis >50%) within target segment was observed in three patients treated with Beta-Cath TM , of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 TM (P = 0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P = NS). Stent implantation was the more time-saving (31 ± 11 min versus 60 ± 23 min, P TM arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to β-brachytherapy

Comparative vascular responses three months after paclitaxel and everolimus-eluting stent implantation in streptozotocin-induced diabetic porcine coronary arteries

Directory of Open Access Journals (Sweden)

Sheehy Alexander

2012-06-01

Full Text Available Abstract Background Diabetes remains a significant risk factor for restenosis/thrombosis following stenting. Although vascular healing responses following drug-eluting stent (DES treatment have been characterized previously in healthy animals, comparative assessments of different DES in a large animal model with isolated features of diabetes remains limited. We aimed to comparatively assess the vascular response to paclitaxel-eluting (PES and everolimus-eluting (EES stents in a porcine coronary model of streptozotocin (STZ-induced type I diabetes. Method Twelve Yucatan swine were induced hyperglycemic with a single STZ dose intravenously to ablate pancreatic β-cells. After two months, each animal received one XIENCE V® (EES and one Taxus Liberte (PES stent, respectively, in each coronary artery. After three months, vascular healing was assessed by angiography and histomorphometry. Comparative in vitro effects of everolimus and paclitaxel (10-5 M–10-12 M after 24 hours on carotid endothelial (EC and smooth muscle (SMC cell viability under hyperglycemic (42 mM conditions were assayed by ELISA. Caspase-3 fluorescent assay was used to quantify caspase-3 activity of EC treated with everolimus or paclitaxel (10-5 M, 10-7 M for 24 hours. Results After 3 months, EES reduced neointimal area (1.60 ± 0.41 mm, p vs. 0.08 ± 0.05, greater medial necrosis grade (0.52 ± 0.26 vs. 0.0 ± 0.0, and persistently elevated fibrin scores (1.60 ± 0.60 vs. 0.63 ± 0.41 with PES compared to EES (p In vitro, paclitaxel significantly increased (p -7 M, while everolimus did not affect EC/SMC apoptosis/necrosis within the dose range tested. In ECs, paclitaxel (10-5 M significantly increased caspase-3 activity (p  Conclusion After 3 months, both DES exhibited signs of delayed healing in a STZ-induced diabetic swine model. PES exhibited greater neointimal area, increased inflammation, greater medial necrosis, and

Is the Watanabe heritable hyperlipidemic rabbit a suitable experimental model for percutaneous transluminal coronary angioplasty in humans? A light microscopic, immunohistochemical and ultrastructural study

NARCIS (Netherlands)

Wanibuchi, H.; Dingemans, K. P.; Becker, A. E.; Ueda, M.; Naruko, T.; Tanizawa, S.; Nakamura, K.

1993-01-01

This study was designed to assess an experimental model for the study of mechanisms that underlie restenosis after percutaneous transluminal coronary angioplasty. The Watanabe heritable hyperlipidemic (WHHL) rabbit lacks the receptor for low density lipoproteins, produces atherosclerotic lesions

Flow motion waves with high and low frequency in severe ischaemia before and after percutaneous transluminal angioplasty

OpenAIRE

Hoffmann, Ulrich; Schneider, Ernst; Bollinger, Alfred

2017-01-01

Study of objective - The aim was to evaluate skin flux and prevalence of low and high frequency flow motion waves in patients with severe ischaemia due to peripheral arterial occlusive disease before and after percutaneous transluminal angioplasty (PTA) with and without local thrombolysis. Design - Flow motion was recorded by the laser Doppler technique at the dorsum of the foot before, one day, and one month after PTA. The results were separately analysed in patients with successful and unsu...

Percutaneous transluminal angioplasty of renal artery: therapeutic experience of 31 patients

International Nuclear Information System (INIS)

Kim, Seung Cheol; Park, Jae Hyung; Chung, Jin Wook; Han, Joon Koo; Kim, Hong Dae; Jeong, Yoong Ki; Kim, Seung Hoon; Yeon, Kyung Mo

1995-01-01

The purpose of this study is to introduce the experience of 31 patients who had renovascular hypertension and underwent percutaneous transluminal angioplasty of renal artery (PTA). The subjects were 31 patients with hypertension and stenotic renal artery or arteries on angiography. The criteria of stenosis is more than 50% narrowing of the artery. The technical results were considered to be successful if residual stenosis is less than 50%. The clinical results were classified as cure, improvement and fail. And clinical results were analyzed according to the follow-up duration, short term (≤6 mo) and long term (> 6 mo). Technical success rate was 90.2% (37/41) and clinical success rate were 82.8% (24/29) on short term follow-up and 84.2% (16/19) on long term follow-up. Recurred cases were 7 cases. PTA is a safe and effective therapeutic modality on renovascular hypertension

Review of the Latest Percutaneous Devices in Critical Limb Ischemia

Directory of Open Access Journals (Sweden)

Leila Haghighat

2018-04-01

Full Text Available Critical limb ischemia (CLI is a terminal stage of peripheral arterial disease that, in the absence of intervention, may lead to lower extremity amputation or death. Endovascular interventions have become a first-line approach to the management of CLI and have advanced considerably within the past decade. This review summarizes the types of percutaneous devices and the techniques that are available for the management of CLI and the data supporting their use. These include devices that establish and maintain vessel patency, including percutaneous transluminal angioplasty, drug-coated balloons, bare metal stents, drug-eluting stents, bioresorbable vascular scaffolds, and atherectomy; devices that provide protection from embolization; and, cell-based therapies. Additionally, ongoing trials with important implications for the field are discussed.

Review of the Latest Percutaneous Devices in Critical Limb Ischemia.

Science.gov (United States)

Haghighat, Leila; Altin, Sophia Elissa; Attaran, Robert R; Mena-Hurtado, Carlos; Regan, Christopher J

2018-04-14

Critical limb ischemia (CLI) is a terminal stage of peripheral arterial disease that, in the absence of intervention, may lead to lower extremity amputation or death. Endovascular interventions have become a first-line approach to the management of CLI and have advanced considerably within the past decade. This review summarizes the types of percutaneous devices and the techniques that are available for the management of CLI and the data supporting their use. These include devices that establish and maintain vessel patency, including percutaneous transluminal angioplasty, drug-coated balloons, bare metal stents, drug-eluting stents, bioresorbable vascular scaffolds, and atherectomy; devices that provide protection from embolization; and, cell-based therapies. Additionally, ongoing trials with important implications for the field are discussed.

Percutaneous Transluminal Angioplasty for Complete Membranous Obstruction of Suprahepatic Inferior Vena Cava: Long-Term Results

Energy Technology Data Exchange (ETDEWEB)

Kucukay, Fahrettin, E-mail: fkucukay@hotmail.com [Turkiye Yuksek Ihtisas Hospital, Department of Interventional Radiology (Turkey); Akdogan, Meral, E-mail: akdmeral@yahoo.com [Turkiye Yuksek Ihtisas Hospital, Department of Gastroenterology (Turkey); Bostanci, Erdal Birol, E-mail: ebbostanci@yahoo.com [Turkiye Yuksek Ihtisas Hospital, Department of Gastrointestinal Surgery (Turkey); Ulus, Ahmet Tulga, E-mail: uluss@yahoo.com [Hacettepe University, Department of Cardiovascular Surgery (Turkey); Kucukay, Murat Bulent, E-mail: dr-mbk@hotmail.com [Lokman Hekim Hospital, Department of Internal Medicine (Turkey)

2016-10-15

PurposeTo determine the long-term results of percutaneous transluminal angioplasty (PTA) for a complete membranous obstruction of the suprahepatic inferior vena cava.MethodsPatients (n = 65) who were referred to the interventional unit for PTA for a complete membranous obstruction of the suprahepatic inferior vena cava between January 2006 and October 2014 were included in the study. Thirty-two patients (18 males, 14 females, mean age 35 ± 10.7, range 20–42 years) were treated. The patients presented with symptoms of ascites (88 %), pleural effusion (53 %), varicose veins (94 %), hepatomegaly (97 %), abdominal pain (84 %), and splenomegaly (40 %). Transjugular liver access set and re-entry catheter were used to puncture and traverse the obstruction from the jugular side. PTA balloon dilations were performed. The mean follow-up period was 65.6 ± 24.5 months. The objective was to evaluate technical success, complications, primary patency, and clinical improvement in the symptoms of the patients.ResultsThe technical success rate was 94 %. In two patients, obstruction could not be traversed. These patients underwent cavoatrial graft bypass surgery. There were no procedure-related complications. Clinical improvements were achieved in all patients within 3 months. The primary patency rate at 4 years was 90 %. There was no primary assisted patency. There was no need for metallic stent deployment in the cohort. The secondary patency rate at 4 years was 100 %.ConclusionsPercutaneous transluminal angioplasty for a complete membranous obstruction of the suprahepatic inferior vena cava is safe and effective, and the long-term results are excellent.

Assessment of percutaneous transluminal coronary angioplasty with 123IODO-heptadecanoic acid

International Nuclear Information System (INIS)

Stoddart, P.G.P.; Wilde, P.; Papouchado, M.; Jones, J.V.

1987-01-01

Ten patients underwent myocardial scintigraphy with 123 I-iodo-heptadecanoic acid (HDA), which was injected in the last minute of maximal exercise testing. Six of the patients were rescanned following percutaneous transluminal coronary angioplasty. All ten patients underwent full coronary angiography. There were visible perfusion defects on the static images in 74% of the myocardial areas which were supplied by an artery with a stenosis greater than 75%. The mean half life recorded from areas distal to an arterial stenosis of at least 90% (35.69 min±41.25 min), was longer than the expected normal mean (18.85 min±3.35 min). However, the difference was not statistically significant. The static images changed in some patients following angioplasty, however there was no consistent alteration in the half-lives. It was concluded that HDA is a suitable agent for investigating myocardial perfusion, but that the half life cannot be measured adequately for clinical purposes with a planar imaging sytsem. (orig.)

Optimization and audit of radiation dose during percutaneous transluminal coronary angioplasty

International Nuclear Information System (INIS)

Livingstone, Roshan S.; Timothy Peace, B.S.; Chandy, Sunil; Gorge, Paul V.; Pati, Purendra

2007-01-01

The percutaneous transluminal coronary angioplasty (PTCA) is one of the interventional procedures which impart high radiation doses to patients compared to the other cardiologic procedures. This study intends to audit and optimize radiation dose imparted to patients undergoing PTCA. Forty-four patients who underwent PTCA involving single or multiple stent placement guided under cardiovascular X-ray machine were included in the study. Radiation doses were measured using dose area product (DAP) meter for patients undergoing single and multiple stent placements during PTCA. A dose reduction of 27-47% was achieved using copper filters and optimal exposure parameters. The mean DAP values before optimization were 66.16 and 122.68 Gy cm 2 for single and multiple stent placement respectively. These values were 48.67 and 65.44 Gy cm 2 respectively after optimization. In the present scenario, due to the increase in the number of PTCAs performed and the associated risk from radiation, periodical audit of radiation doses for interventional procedures are recommended. (author)

Percutaneous Transluminal Angioplasty and Enclosed Thrombolysis Versus Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Occlusions: Results of a Prospective Randomized Trial

International Nuclear Information System (INIS)

Nicholson, Tony

1998-01-01

Purpose: To determine whether percutaneous transluminal angioplasty (PTA) and enclosed thrombolysis (ET) is superior to PTA alone in the treatment of femoropopliteal occlusions. Methods: Twenty-five patients with 5-15-cm-long occlusions in the femoropopliteal segments, with otherwise normal run-in arteries and at least one normal tibioperoneal artery to the foot, were randomized to ET/PTA or PTA alone. Ankle brachial systolic index (ABI) was measured before the procedure and at 24 hr and 12 months after the procedure, when a duplex scan was also carried out. End points in the study were patency at, or repeat intervention before, 12 months. Results: Procedures were successful in 23 of 25 patients. There was one immediate occlusion of tibioperoneal arteries, and one early reocclusion of a reopened segment in the ET/PTA group. There was one early reocclusion in the PTA group. At 12 months patency was 70% and 69.2% in the ET/PTA and PTA groups respectively. Covariant analysis showed no significant difference in ABI between the two groups at any of the three measurement times. Conclusion: This trial demonstrated no difference between ET/PTA and PTA alone in femoropopliteal occlusions associated with normal proximal arteries and at least one normal tibioperoneal artery

Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial)

NARCIS (Netherlands)

A.J.J. IJsselmuiden (Alexander); C. Simsek (Cihan); Van Driel, A.G. (A. G.); Bouchez, D. (D.); G. Amoroso (Giovanni); P. Vermeersch (Paul); Karjalainen, P.P. (P. P.)

2018-01-01

textabstractAims To describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs). Methods and Results A randomised controlled trial was performed in four hospitals in three European countries between

Percutaneous transluminal angioplasty in the region of the renal artery: indications, technique and results

Energy Technology Data Exchange (ETDEWEB)

Olbert, F; Ogris, E; Muzika, N; Schlegl, A; Vacariu, O; Diez, W

1985-01-01

The paper reports the results obtained by percutaneous transluminal angioplasty (PTA) in the treatment of renal artery stenosis in 25 patients with secondary hypertension and discusses indications and the technique used. The follow-up period ranged from 0.5 to 12 months. All interventions were performed with the Olbert catheter system. Following PTA a significant decrease in systolic, diastolic and mean arterial pressure was observed in nearly all patients. The response of the plasma renin activity (PRA) to orthostatic stimulation and pharmacological stimulation by furosemide was determined in a subset of 15 patients before and after PTA. A significant decrease in both basal and stimulated PRA values was observed subsequent to PTA. The decrease in PRA values after successful PTA did not, however, correlate with the extent of the blood pressure changes. (Author).

Percutaneous transluminal angioplasty in the region of the renal artery: indications, technique and results

International Nuclear Information System (INIS)

Olbert, F.; Ogris, E.; Muzika, N.; Schlegl, A.; Vacariu, O.; Diez, W.

1985-01-01

The paper reports the results obtained by percutaneous transluminal angioplasty (PTA) in the treatment of renal artery stenosis in 25 patients with secondary hypertension and discusses indications and the technique used. The follow-up period ranged from 0.5 to 12 months. All interventions were performed with the Olbert catheter system. Following PTA a significant decrease in systolic, diastolic and mean arterial pressure was observed in nearly all patients. The response of the plasma renin activity (PRA) to orthostatic stimulation and pharmacological stimulation by furosemide was determined in a subset of 15 patients before and after PTA. A significant decrease in both basal and stimulated PRA values was observed subsequent to PTA. The decrease in PRA values after successful PTA did not, however, correlate with the extent of the blood pressure changes. (Author)

In-vitro release of anti-proliferative paclitaxel from novel balloon-expandable polycaprolactone stents

International Nuclear Information System (INIS)

Liu, Shih-Jung; Hsiao, Chao-Ying; Chen, Jan-Kan; Liu, Kuo-Sheng; Lee, Cheng-Hung

2011-01-01

This report investigated the in-vitro release characteristics of paclitaxel from novel balloon-expandable polycaprolactone stents. Polycaprolactone stents were first manufactured by a lab-made micro-injection molding machine. Paclitaxel and polylactide-polyglycolide (PLGA) copolymer were dissolved in acetonitrile and were coated onto the surface of the stents by a spray coating device, which was designed and built especially for this study. An elution method was utilized to characterize the in-vitro release characteristics of paclitaxel. The high performance liquid chromatography (HPLC) analysis showed that biodegradable stents could provide sustained release of paclitaxel for more than 70 days. Various process parameters that controlled the release rate of paclitaxel were studied. The experimental results suggested that the total period of drug release could be prolonged by adopting 75:25 PLGA copolymers, employing multi-layer coatings, and increasing the drug loading. In addition, the effectiveness of eluted paclitaxel on cell behavior was examined. The results showed that the eluted drug could effectively inhibit the proliferation of smooth muscle cells. - Research Highlights: → We investigate the in-vitro release characteristics of paclitaxel from polycaprolactone stents. → Biodegradable stents provide sustained release of paclitaxel for more than 70 days. → The eluted drug effectively inhibits the proliferation of smooth muscle cells.

Iatrogenic Subtotal Stenosis of the Right Subclavian Artery Treated With Percutaneous Transluminal Angioplasty

International Nuclear Information System (INIS)

Smeenk, Robert M.; Kock, Mark C. J. M.; Elgersma, Otto E. H.; Schnater, Marco J.

2011-01-01

This report describes a rare vascular complication of surgical placement of a marking clip and a possible approach to problem solving. A 55-year-old patient presented with loss of sensation in the fingers and loss of peripheral pulsations in the right arm 4 days after right upper lobectomy for a pT2N1 moderately differentiated adenocarcinoma of the lung. Duplex examination and computed tomography were performed the same day and showed a subtotal stenosis of the right subclavian artery, which was caused by the surgical placement of a metal clip to mark the surgical boundary. Selective angiography was subsequently performed. Percutaneous transluminal angioplasty (PTA) successfully dilated the stenosis and pushed the clip off. Flow in the right subclavian artery (RSA) was completely restored as were neurology and peripheral pulses. In conclusion, arterial stenosis by a surgical (marking) clip may be feasibly treated with PTA.

Clinical application of Inoue-balloon in percutaneous transluminal angioplasty for Budd-Chiari syndrome

International Nuclear Information System (INIS)

Mei Jian; Qu Jian; Zhu Yaoqing; Wang Lei; Liu Cheng

2007-01-01

Objective: To investigate the feasibility and effect of recanalization of inferior vena cava with percutaneous transluminal angioplasty(PTA)by Inoue-balloon. Methods: Eighty-nine patients with Budd-chiari syndrome (BCS )were treated with PTA by Inoue-balloon. Results: After PTA, the median (interquartile range)diameter of hepatic segment inferior vena cava increased from 0.00 (0.20-0.00) cm to 1.90 (2.00 1.47)cm; (P < 0.001), and the mean pressure of inferior vena cava reduced from (20.63 ± 7.22) mmHg to (12.13 ± 5.60) mmHg; (P < 0.001); with only less serious complications as rupture in two cases and without need of prior minor diameter balloon dilation in Inoue-balloon PTA. Conclusion: The advantages of Inoue- balloon PTA for BCS are more reliable and facile than those of polyethylene balloon, and may take the place in the foreseen future. (authors)

Aggressive nonsurgical management of acute coronary artery occlusions developing immediately after percutaneous transluminal coronary angioplasty (PTCA)

International Nuclear Information System (INIS)

Levin, D.C.; Meyerovitz, M.; Boxt, L.; Taus, R.; Ganz, P.; Friedman, P.; Selwyn, A.

1986-01-01

In 368 consecutive percutaneous transluminal coronary angiography (PTCA) procedures, acute occlusion of the dilated artery developed within the first hour after the procedure in 24 cases (6.5%). Four patients underwent emergency bypass surgery. In 17 of the remaining 20 patients, repeat balloon dilation was immediately attempted, and was successful in 11 instances (65%). Five of the six cases in which repeat balloon dilation was not successful responded well to surgical or medical therapy. The author conclude that acute occlusions of dilated coronary arteries shortly after PTCA do not automatically necessitate emergency bypass. Approximately two thirds of such cases can be managed by repeat dilation, converting a potential complication into a successful outcome

Exercise electrocardiography and myocardial scintigraphy in the serial evaluation of the results of percutaneous transluminal coronary angioplasty

International Nuclear Information System (INIS)

Schall, J.M.; Chaitman, B.R.; David, P.R.; Dupras, G.; Brevers, G; Val, P.G.; Crepeau, J.; Lesperance, J.; Bourassa, M.G.

1982-01-01

The diagnostic value of exercise electrocardiography using 14 leads and thallium-201 scintigraphy were evaluated in 54 of 70 patients who underwent percutaneous transluminal coronary angioplasty (PTCA), both in the initial assessment and serial follow-up of patients after PTCA. Of the 45 patients who had successful PTCA, 36 had complete noninvasive studies performed before and 1 month after PTCA. The use of clinical symptoms in conjunction with the physiologic data, ECG and myocardial scintigram acquired during exercise provide important short-term data on the angiographic evolution of PTCA results. The noninvasive tests may be useful in determining guidelines for repeat angiography in patients who have had PTCA

Close to Transplant Renal Artery Stenosis and Percutaneous Transluminal Treatment

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Leonardou Polytimi

2011-01-01

Full Text Available Purpose. To evaluate the efficacy of percutaneous transluminal angioplasty (PTA in the management of arterial stenosis located close to the allograft anastomosis (close-TRAS. Materials and Methods. 31 patients with renal transplants were admitted to our institution because of persistent hypertension and impairment of transplant renal function and underwent angiography for vascular investigation. 27 were diagnosed suffering from transplant renal artery stenosis (TRAS, whereas 4 had severe iliac artery stenosis proximal to the transplant anastomosis (Prox-TRAS. 3 cases of TRAS coexisted with segmental renal arterial stenosis, whereas 3 other cases of TRAS were caused by kinking and focal stenosis in the middle of the transplanted renal artery. Results. Angioplasty and stenting were successfully applied to all patients with iliac artery stenosis as well as to those with TRAS and segmental artery stenosis. Two of three patients with kinking were well treated with angioplasty and stenting, whereas one treated only with angioplasty necessitated surgery. No major procedure-related complications appeared, and the result was decrease of the serum creatinine level and of the blood pressure. Conclusions. PTA is the appropriate initial treatment of TRAS and close-TRAS, with low morbidity and mortality rates, achieving improvement of graft function and amelioration of hypertension.

Advantages of novel BioMimeTM Sirolimus Eluting Coronary Stent system. Moving towards biomimicry.

Science.gov (United States)

Upendra, K; Sanjeev, B

2012-02-01

Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advancements in interventional cardiology arena have been fast paced. Within the last ten years, these developments have been exponential. Developers & clinicians are fast adapting from the learning curve awarded by the time course of DES evolution. In that light BioMimeTM Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65 µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative - Sirolimus that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and low coating thickness of 2 µm. The resultant stent demonstrates almost 100% endothelialization at 30 days in preclinical model and zero percent MACE >18 months in the primary efficacy and safety clinical study.

Radiation dose to patients from the coronary angiography and percutaneous transluminal coronary angioplasty in interventional radiology procedures

International Nuclear Information System (INIS)

Zheng, Jun-Zheng; Bai, Mei; Liu, Bin

2008-01-01

Full text: Objective: To survey and assess radiation dose to patients from coronary angiography (CA) and percutaneous transluminal coronary angioplasty (PTCA) in Beijing Xuanwu Hospital of Capital University of Medical Sciences. Methods: The dose-area product (DAP) values to the patient and cumulative dose (CD) were recorded from 84 coronary angiographies and 51 percutaneous transluminal coronary angioplasty. A Monte-Carlo based program PCXMC was used to calculate the effective dose from DAP values for each patient. Organ doses were also measured by thermoluminescent dosimeters (TLD) using a human-shaped phantom to compare the calculated organ dose from DAP. Results: The difference between the organ doses measured by TLDs and those from PCXMC software (P>0.05) were tolerable. The DAP value ranged from 7611∼60538 mGy·cm 2 for CA and 16423∼161973 mGy·cm 2 for PTCA. The effective dose for all procedures was determined to be in the range of 1.1∼6.9 mSv for CA and 2.3∼20.1 mSv for PTCA. CD ranged from 120.0 to 1016.0 mGy for CA and 287 to 2883 mGy for PTCA. Conversion factors between effective dose and DAP were 0.114∼0.139 mSv·Gy - 1·cm -2 for CA and 0.124∼0.142 mSv·Gy -1 ·cm -2 for PTCA; Conversion factors between organ dose and CD were derived for CA and PTCA, respectively. Conclusions: DAP and CD can be used as the dose indicator to calculate the organ dose and effective dose of patient based on Monte Carlo simulation. Using this method can provide important information of patient absorbed dose and enhance the radiation protection of patient in interventional radiology procedures. (author)

Infrapopliteal Percutaneous Transluminal Balloon Angioplasty: Clinical Results and Influence Factors

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Song, Jang Hyeon; Lee, Seung Jin; Jung, Hye Doo; Lim, Jae Hoon; Chang, Nam Kyu; Yim, Nam Yeol; Kim, Jae Kyu [Dept. of Radiology, Chonnam National University Hospital, Gwangju (Korea, Republic of); Lee, Keun Bae [Dept. of Radiology, Chonnam National University Hospital, Gwangju (Korea, Republic of)

2011-09-15

To assess the efficacy of percutaneous transluminal angioplasty (PTA) in patients with infrapopliteal arterial disease, and to determine the influencing factor for prognosis. A total of 55 patients (60 limbs) with infrapopliteal arterial stenosis or occlusion underwent PTA. Atherosclerotic risk factors, clinical symptoms, TransAtlantic Inter-Society Consensus (TASC) classification, and vascular wall calcification were evaluated before PTA. The number of patent infrapopliteal arteries was estimated, and the outcome was evaluated by symptom relief and limb salvage. Technical success was achieved in 53/60 limbs (88.3%) and 81/93 arteries (87.1%), TASC classification (p = 0.038) and vascular calcification (p = 0.002) influenced on technical failure. During follow-up, 26 of 55 limbs (47%) achieved symptom relief and 42/55 limbs (76%) underwent limb salvage. Non-diabetic patients (9/12, 75%) were superior to diabetic patients (17/43, 40%) in terms of symptom relief (p = 0.024). TASC classification and vascular wall calcification influenced on symptom relief and limb salvage. The number of patent infrapopliteal arteries after PTA influenced symptom relief (p < 0.001) and limb amputation (p = 0.003). PTA in patients with chronic critical limb ischemia is worthwhile as a primary treatment. The influence factors should be considered before PTA, and PTA should be performed in as many involved arteries as possible.

Infrapopliteal Percutaneous Transluminal Balloon Angioplasty: Clinical Results and Influence Factors

International Nuclear Information System (INIS)

Song, Jang Hyeon; Lee, Seung Jin; Jung, Hye Doo; Lim, Jae Hoon; Chang, Nam Kyu; Yim, Nam Yeol; Kim, Jae Kyu; Lee, Keun Bae

2011-01-01

To assess the efficacy of percutaneous transluminal angioplasty (PTA) in patients with infrapopliteal arterial disease, and to determine the influencing factor for prognosis. A total of 55 patients (60 limbs) with infrapopliteal arterial stenosis or occlusion underwent PTA. Atherosclerotic risk factors, clinical symptoms, TransAtlantic Inter-Society Consensus (TASC) classification, and vascular wall calcification were evaluated before PTA. The number of patent infrapopliteal arteries was estimated, and the outcome was evaluated by symptom relief and limb salvage. Technical success was achieved in 53/60 limbs (88.3%) and 81/93 arteries (87.1%), TASC classification (p = 0.038) and vascular calcification (p = 0.002) influenced on technical failure. During follow-up, 26 of 55 limbs (47%) achieved symptom relief and 42/55 limbs (76%) underwent limb salvage. Non-diabetic patients (9/12, 75%) were superior to diabetic patients (17/43, 40%) in terms of symptom relief (p = 0.024). TASC classification and vascular wall calcification influenced on symptom relief and limb salvage. The number of patent infrapopliteal arteries after PTA influenced symptom relief (p < 0.001) and limb amputation (p = 0.003). PTA in patients with chronic critical limb ischemia is worthwhile as a primary treatment. The influence factors should be considered before PTA, and PTA should be performed in as many involved arteries as possible.

Percutaneous transluminal mitral commissurotomy for rheumatic mitral stenosis in a 5-year-old child.

Science.gov (United States)

Ullah, Maad; Sultan, Mehboob; Akbar, Hajira; Sadiq, Nadeem

2012-06-01

We report a 5-year-old boy weighing 11 kg, with severe mitral valve stenosis of rheumatic aetiology, who underwent successful percutaneous transluminal mitral commissurotomy (PTMC) with valvuloplasty balloon. Postprocedural mean pressure gradient across the mitral valve decreased to 6 mmHg from an initially recorded value of 22 mmHg. In addition to symptomatic improvement, the mitral valvular area increased from 0.4 to 0.8 cm(2) without significant change in mitral regurgitation. At 1- and 3-month follow up, transthoracic echocardiography revealed further improvement with an increase in mitral valve area to 1.0 cm(2), a decrease in pulmonary arterial pressure, and a mean mitral valve pressure gradient of 8 mmHg with trivial mitral regurgitation. To best of our knowledge, this is the first successful PTMC procedure performed in the youngest and smallest ever reported child with rheumatic mitral stenosis (MS). We conclude that PTMC with valvuloplasty balloon could be a logical alternative to surgery in young patients with rheumatic MS.

Percutaneous transluminal angioplasty and stent placement for iliofemoral arterial atherosclerotic occlusive disease

International Nuclear Information System (INIS)

Zheng Yanbo; Jiang Wenjin; Liu Sheng; Song Xuepeng; Sheng Qirui

2006-01-01

Objectives: To assess the safety and efficacy of percutaneous transluminal angioplasty (PTA) and stent placement for the treatment of iliofemoral arterial atherosclerotic occlusive diseases. Methods From April 1999 to August 2004, 13 cases of iliofemoral arterial occlusions were recanalized with contact thrombolytic therapy combined with guide wire mechanical recanalization method, followed by angioplasty and stent placement. A total of 25 self-expanding Wallstents were deployed. All patients were followed up by means of duplex ultrasound, angiography, or both. Results: All 13 cases were successfully recanalized, with technical successful rate of 100%. Available follow-up for all patients from 8 months-5 years (mean 26.2 months) included one patient undergoing again with successful contact thrombolysis because of early thrombosis; another patient with recurrent symptoms at 19 month after operation undertaking surgical bypass because of later reocclusion; all of the rest stents showing patency by the end of the study. Conclusions: Contact thrombolysis combined with guide wire mechanical recanalization for iliofemoral arterial occlusion is safe and effective, whereas PTA and stent placement would have the nearly same efficacy for the disease with mild injury and low restenosis. (authors)

Percutaneous transluminal forceps biopsy in patients suspected of having malignant biliary obstruction: factors influencing the outcomes of 271 patients

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Park, Jung Gu; Jung, Gyoo-Sik; Yun, Jong Hyouk [Kosin University College of Medicine, Department of Radiology, Seo-gu, Busan (Korea, Republic of); Yun, Byung Chul; Lee, Sang Uk; Han, Byung Hoon [Kosin University College of Medicine, Department of Internal Medicine, Busan (Korea, Republic of); Ko, Ji Ho [Busan Medical Center, Department of Radiology, Busan (Korea, Republic of)

2017-10-15

To evaluate predictive factors for false-negative diagnosis of percutaneous forceps biopsies in patients suspected of having a malignant biliary obstruction Two hundred seventy one consecutive patients with obstructive jaundice underwent percutaneous forceps biopsy. In each patient, three to five specimens (mean, 3.5 specimens) were collected from the lesion. The final diagnosis for each patient was confirmed with pathologic findings at surgery, additional histocytologic data, or clinical and radiologic follow-up. Univariate and multivariate logistic regression analysis was used to identify risk factors associated with false-negative diagnosis. One hundred ninety four of 271 biopsies resulted in correct diagnoses of malignancy, while 20 biopsy diagnoses were proved to be true-negative. There were 57 false-negative diagnoses and no false-positive diagnoses. The diagnostic performance of transluminal forceps biopsy in malignant biliary obstructions was as follows: sensitivity, 77.2%; specificity, 100%; and accuracy, 78.9%; positive predictive value, 100%, negative predictive value; 25.9%. Periampullary segment of common bile duct, intrahepatic bile duct and metastatic disease were the significant risk factors of false-negative diagnosis. Percutaneous forceps biopsy provides relatively high accuracy in the diagnosis of malignant biliary obstructions. The predictive factors of false-negative biopsy were determined to be biopsy site and origin of primary tumour. (orig.)

Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease.

Science.gov (United States)

Herten, Monika; Torsello, Giovanni B; Schönefeld, Eva; Stahlhoff, Stefan

2016-01-01

Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact

Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

International Nuclear Information System (INIS)

Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

2014-01-01

Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year

Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.

Science.gov (United States)

Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

2014-01-01

The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year. © 2014.

Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

Energy Technology Data Exchange (ETDEWEB)

Calderas, Carlos [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Condado, Jose Francisco; Condado, Jose Antonio [Hospital Centro Medico de Caracas y Hospital Miguel Perez Carreno, Caracas (Venezuela, Bolivarian Republic of); Flores, Alejandra [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Mueller, Amy; Thomas, Jack [Medlogics Device Corporation, Santa Rosa, CA (United States); Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa [Stanford University, Stanford, CA (United States); Fitzgerald, Peter, E-mail: crci-cvmed@stanford.edu [Stanford University, Stanford, CA (United States)

2014-01-15

Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.

The Timing and Frequency of Complications After Peripheral Percutaneous Transluminal Angioplasty and Iliac Stenting: Is a Change from Inpatient to Outpatient Therapy Feasible?

International Nuclear Information System (INIS)

Burns, Briony J.; Phillips, Andrea J.; Fox, Anthony; Boardman, Phillip; Phillips-Hughes, Jane

2000-01-01

Purpose: A prospective study was performed to assess the frequency and timing of complications after transluminal angioplasty and stent placement with a view to changing our practice and performing these procedures on an outpatient basis.Method: A total of 266 angioplasties and 51 stent deployments were attempted on 240 consecutive patients. Immediate complications were documented by the radiologists. The timing and nature of any complications during and beyond the first 24 hr were reported by the vascular surgeons.Results: There were 14 complications in 240 patients, giving a complication rate of 4.8% per vessel segment dilated. There were five major and nine minor complications. Eighty-six percent of complications were evident before the patient had left the angiography suite. All complications were evident within 4.5 hr of the procedure.Conclusion: The timing of complications suggests it would be reasonable to perform percutaneous transluminal angioplasties and iliac stenting on an outpatient basis in suitable patients

Duplex-guided percutaneous transluminal angioplasty in iliac arterial occlusive disease.

Science.gov (United States)

Krasznai, A G; Sigterman, T A; Welten, R J; Heijboer, R; Sikkink, C J J M; van de Akker, L H J M; Bouwman, L H

2013-11-01

Chronic renal insufficiency (CRI) is a growing global problem. PTA can be performed without nephrotoxic contrast, utilizing Doppler-ultrasound (Duplex) guidance. Duplex-guided infra-inguinal interventions and access-related interventions have been reported. Duplex-guided iliac interventions have not been performed to any extent because of the anatomic location. In our study we evaluated the safety and efficacy of Duplex-guided percutaneous transluminal angioplasty (DuPTA) in iliac arteries. From June 2012 until February 2013, 31 patients (35 iliac lesions), underwent DuPTA. Indications ranged from Rutherford 3 to 5. Preoperative evaluation included Ankle Brachial Index (ABI), Duplex and MRA. Procedural success was defined as crossing the lesion with a guidewire and dilating or stenting the lesion. Clinical success was defined as 50% reduction in peak systolic velocity (PSV) or clinical improvement. PSV was evaluated after PTA, then at 2 weeks. Clinical results were assessed 2 weeks after the procedure. Procedural success was achieved in 94% of patients (33/35), all of whom also had clinical success. Post-procedural PSV reduction showed an average improvement of 63% (431 cm/s to 153 cm/s). Mean preoperative ABI was 0.72 and improved to 0.88 postoperatively. PTA using Duplex-guidance in significant iliac stenosis is a safe method with major advantages in patients at high risk for developing contrast-induced nephropathy. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

DEFF Research Database (Denmark)

Giustino, Gennaro; Mastoris, Ioannis; Baber, Usman

2016-01-01

OBJECTIVES: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). BACKGROUND: The clinical correlates and the prognostic significance of CAC...

Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

Science.gov (United States)

Kaul, Upendra; Bhagwat, Ajit; Pinto, Brian; Goel, Praveen K; Jagtap, Prashant; Sathe, Shireesh; Wander, Gurpreet S; Arambam, Priyadarshini; Bangalore, Sripal

2017-11-20

The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

Usefulness of percutaneous transluminal coronary angioplasty in silent myocardial ischemia

International Nuclear Information System (INIS)

Hou, Mami

1996-01-01

The usefulness of percutaneous transluminal coronary angioplasty (PTCA) was assessed in patients with exercise-induced asymptomatic myocardial ischemia (silent ischemia) and compared with exercise-induced symptomatic myocardial ischemia (symptomatic ischemia). Patients with single vessel coronary artery disease (51 with angina pectoris, 40 with old myocardial infarction) and evidence of stress-induced ischemia on thallium-201 single photon emission computed tomography (SPECT) underwent successful PTCA. Thirty-seven percent of angina patients and 60% of infarction patients showed asymptomatic exercise-induced ischemia. There was no significant difference in population characteristics between silent and symptomatic patients. Patients with silent angina had significantly higher percentage thallium uptake and washout rate than symptomatic patients. After PTCA, both percentage diameter stenosis and percentage thallium uptake were improved in all patients with angina irrespective of the presence or absence of symptoms. There were no significant differences in percentage thallium uptake and washout rate between patients with silent and symptomatic infarction. After PTCA, percentage diameter stenosis, percentage thallium uptake, and washout rate improved in all infarction patients irrespective of the symptoms. Zero percent of silent angina patients, 12% of symptomatic angina patients, 12% of silent infarction patients, 19% of symptomatic infarction patients had cardiac events during about 4.5 years after PTCA. The incidence of cardiac events did not significantly differ in any patient group. PTCA improved myocardial perfusion in all patients, and the incidence of cardiac events did not differ between the silent and symptomatic groups. Revascularization with PTCA is suitable for patients with silent as well as symptomatic ischemia. (author)

Type D personality predicts chronic anxiety following percutaneous coronary intervention in the drug-eluting stent era

DEFF Research Database (Denmark)

Spindler, Helle; Pedersen, Susanne S.; Serruys, Patrick W.

2007-01-01

  Background: Anxiety is an often overlooked risk factor in coronary artery disease (CAD). Hence, little is known about predictors of unremitting chronic anxiety in CAD patients. This study examined whether the distressed personality (Type D) predicts chronic anxiety post percutaneous coronary...... months post-PCI. Results: Of 167 patients anxious at 6 months, 108 (65%) were still anxious 12 months post-PCI. Significant univariable predictors of chronic anxiety were Type D personality (OR:3.17: 95% CI:1.64-6.14) and sirolimus-eluting stents (OR:0.51; 95% CI:0.27-0.98), with sirolimus-eluting stents...... showing a protective effect. In multivariable analyses, Type D personality (OR:3.31; 95% CI:1.59-6.87) and sirolimus-eluting stents (OR:0.44; 95% CI:0.21-0.92) remained significant independent predictors of chronic anxiety adjusting for depressive symptoms at 6 months, and demographic and clinical risk...

XIENCE V everolimus-eluting coronary stent system: a novel second generation drug-eluting stent

NARCIS (Netherlands)

Beijk, Marcel A. M.; Piek, Jon J.

2007-01-01

Drug-eluting stents (DES) have been shown to be safe and significantly reduce clinical events and angiographic restenosis in the percutaneous treatment of coronary artery disease. Currently, three DES have been approved in Europe and Northern America: the sirolimus-eluting stent (SES), the

Second generation drug-eluting stents versus bare-metal stents for percutaneous coronary intervention of the proximal left anterior descending artery

DEFF Research Database (Denmark)

Mangione, Fernanda Marinho; Biering-Sørensen, Tor; Nochioka, Kotaro

2017-01-01

OBJECTIVES: To compare mid-term outcomes between patients undergoing proximal left anterior descending artery (LAD) percutaneous coronary intervention (PCI) with second generation drug-eluting stent (DES) or bare-metal stent (BMS). BACKGROUND: PCI with BMS and first-generation DES have shown to b...

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

DEFF Research Database (Denmark)

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

2011-01-01

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).......We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

Angiographic Characteristics of Symptomatic Recurrent Disease After Infrainguinal Percutaneous Transluminal Angioplasty

International Nuclear Information System (INIS)

Soeder, Heini K.; Manninen, Hannu I.; Matsi, Pekka J.

1999-01-01

Purpose: To evaluate the angiographic patterns of clinically manifest recurrent disease after infrainguinal percutaneous transluminal angioplasty (PTA) of stenoses and total occlusions. Methods: Among 326 infrainguinal PTAs on 263 consecutive patients, selective angiography was performed on 61 limbs of 52 patients 1-60 months after the primary intervention because of clinically suspected recurrent disease. Lesion-specific and patient-related factors were analyzed for 75 angiographically confirmed recurrent lesions in 57 limbs of 48 patients. Results: Recurrent disease was more frequently a stenosis when the original target lesion was a stenosis (92%, 44/48) than when the original lesion was a total occlusion (59%, 16/27; p < 0.001). When the original target lesion was a stenosis, the total length of the recurrent disease was longer than that of the original lesion [3.9 ± 3.9 cm (mean ± standard deviation) vs 2.8 ± 2.7 cm; p= 0.03], while in the subgroup of original total occlusions the length of the recurrent lesion was shorter than that of the original occlusion (7.1 ± 5.0 cm vs 9.9 ± 6.9 cm; p0.02). Half the restenoses (22/44) extended beyond one or both ends of the original stenosis and 38% (6/16) of the reocclusions extended beyond the distal end of the original occlusion. Conclusions: The type of recurrent disease depends on the original lesion type and the restenotic lesion frequently extends beyond one or both ends of the original target lesion

[Synchronized anterograde perfusion during percutaneous transluminal coronary angioplasty: preliminary clinical study].

Science.gov (United States)

Farcot, J C; Berland, J; Derumeaux, G; Letac, B; Bourdarias, J P

1995-03-01

A new circulatory system, "physiologic anteroperfusion system", has been developed and tested in 6 patients with significant proximal coronary artery stenosis. Prolonged and safe balloon inflation was possible without any ischemic signs. The system consists of an electronic cardiac synchroperfusor which, by activating a pulsatile unit, permits increased diastolic anteroperfusion of autologous blood under physiologic pressure through low-profile standard angioplasty catheters. This study reports the results obtained in 6 patients during proximal prolonged percutaneous transluminal coronary angioplasty. Four men and two women suffering from severe exertional angina pectoris, with normal resting left ventricular function, no collaterals and excellent apical two-dimensional four-chamber echocardiographic views were studied. After a 90 +/- 10 seconds of control occlusion under continuous monitoring of hemodynamics, electrocardiograms (3 to 4 leads), two-dimensional echo and chest pain grading, a second balloon inflation protected by the physiologic anteroperfusion system at a flow rate of 44 +/- 12 ml/min was performed for fifteen minutes. The ischemic signs present in the myocardium depending on the occluded artery were totally abolished during prolonged inflation protected by physiologic anteroperfusion system. All the patients were successfully dilated and were discharged from hospital the following morning without cardiac enzyme elevation or signs of central or peripheral hemolysis. Conclusion, in 6 patients with severe proximal coronary artery stenosis, safe prolonged proximal angioplasty without signs of ischemia was performed using a new simple physiologic anteroperfusion system, which allows active diastolic flow-pressure controlled autologous arterial blood perfusion, through standard low profile catheters.

Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention

OpenAIRE

Baschet, Louise; Bourguignon, Sandrine; Marque, S?bastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

2016-01-01

Objective To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. Methods A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117?762 patient-years with 76 randomised trials. The main effectiveness criterion was major c...

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study.

Science.gov (United States)

Parsa, Ehsan; Saroukhani, Sepideh; Majlessi, Fereshteh; Poorhosseini, Hamidreza; Lofti-Tokaldany, Masoumeh; Jalali, Arash; Salarifar, Mojtaba; Nematipour, Ebrahim; Alidoosti, Mohammad; Aghajani, Hassan; Amirzadegan, Alireza; Kassaian, Seyed Ebrahim

2016-04-01

We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents. At Tehran Heart Center, we performed a retrospective analysis of the data from January 2007 through December 2011 on 3,270 consecutive patients with coronary artery disease who underwent percutaneous coronary intervention with the biodegradable-polymer biolimus-eluting stent or the durable-polymer everolimus-eluting stent. We excluded patients with histories of coronary artery bypass grafting or percutaneous coronary intervention, acute ST-segment-elevation myocardial infarction, or the implantation of 2 different stent types. Patients were monitored for 12 months. The primary endpoint was a major adverse cardiac event, defined as a composite of death, nonfatal myocardial infarction, and target-vessel and target-lesion revascularization. Durable-polymer everolimus-eluting stents were implanted in 2,648 (81%) and biodegradable-polymer biolimus-eluting stents in 622 (19%) of the study population. There was no significant difference between the 2 groups (2.7% vs 2.7%; P=0.984) in the incidence of major adverse cardiac events. The cumulative adjusted probability of major adverse cardiac events in the biodegradable-polymer biolimus-eluting stent group did not differ from that of such events in the durable-polymer everolimus-eluting stent group (hazard ratio=0.768; 95% confidence interval, 0.421-1.44; P=0.388). We conclude that in our patients the biodegradable-polymer biolimus-eluting stent was as effective and safe, during the 12-month follow-up period, as was the durable-polymer everolimus-eluting stent.

Selection of patients with infrainguinal arterial occlusive disease for percutaneous transluminal angioplasty with duplex scanning

International Nuclear Information System (INIS)

Bostroem Ardin, A.; Hellberg, A.; Ljungman, C.; Logason, K.; Karacagil, S.; Loefberg, A.M.; Andren, B.

2002-01-01

Aim: To evaluate the role of duplex scanning in the selection of patients with infrainguinal arterial occlusive disease for percutaneous transluminal angioplasty (PTA). Material and Methods: From January 1995 through May 2000, 702 patients (952 limbs), with chronic lower extremity ischemia due to infrainguinal atherosclerotic disease diagnosed by duplex scanning, were retrospectively studied. Diagnostic angiography (130 limbs) or infrainguinal PTA (108 limbs) was performed in 238 limbs. Two investigators retrospectively analyzed the duplex examinations and angiographies in a blinded manner and used similar criteria for the interpretation of lesions suitable or not suitable for PTA. Results: The superficial femoral, popliteal and crural artery lesions were correctly selected for PTA in 85%, 66% and 32%, respectively. The accuracy, sensitivity, specificity, negative predictive value and positive predictive value of duplex scanning to appropriately categorize femoropopliteal lesions as suitable or unsuitable for PTA were 89%, 83%, 92%, 94% and 78%, respectively. The accuracy of duplex scanning for predicting the performance of infrainguinal PTA was 83%. Conclusion: Duplex scanning has an important impact on the selection of treatment modalities in limbs with infrainguinal arterial occlusive disease. Femoropopliteal lesions can be reliably selected to PTA according to duplex scan findings

Percutaneous transluminal angioplasty with stenting for treatment of superior vena cava obstructive syndrome

International Nuclear Information System (INIS)

Chen Shiwei; Qiao Delin

2004-01-01

Objective: To evaluate the clinical value of percutaneous transluminal angioplasty with stenting (PTAS) for the treatment of superior vana cava obstructive syndrome (SVCOS). Methods: 15 cases of SVCOS including 10 cases of lung cancer with mediastinal lymphatic metastasis, 3 cases as malignant lymphoma and 2 cases of esophageal cancer with mediastinal lymphadenopathy, were undergone right subclavian vein or elbow vein catheterization for pressure measurement and DSA imaging of SVC with displaying the obstructive characteristics. A self-expanding stent was then implanted through right femoral vein catheterization. Results: 15 cases were all successfully under-taken angioplasty and stenting, except 1 case with a long stricture over 10 cm requiring 2 stents. After successful stent placement, DSA revealed smooth flow of contrast with almost normal diameter of SVC lumen, together with disappearance or relief of SVCOS. The SVC pressure decreased from 30.5±2.3 cmH 2 O down to 8.8 ± 1.5 cmH 2 O after recanalization, with a significant difference in statistics (P<0.01). All the patients were followed up for 6 months and obstructive symptom did not reappear except one case complicated with thrombosis which was treated by regional thrombolysis and balloon dilation leading to obviously improved symptom. Conclusion: PTAS for the treatment of SVCOS is effective, safe, simple and of less complications. (authors)

Treatment of renovascular hypertension by transluminal angioplasty

DEFF Research Database (Denmark)

Øvrehus, Kristian A; Andersen, Poul E; Jacobsen, Ib A

2007-01-01

: with improved control of blood pressure; group III: unchanged blood pressure control. Grouping was performed immediately after treatment, at 1 month, 6 months and at the latest follow-up. One hundred-and-twenty-two patients (124 atherosclerotic and 12 fibromuscular lesions) were treated during 13 years......OBJECTIVE: The study is a follow-up on treatment of renovascular hypertension (RVH) with percutaneous transluminal renal angioplasty (PTRA). METHODS: Patients were screened on the basis of clinical criteria of increased probability of RVH with renography and in selected cases with renal vein renin...

Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation

DEFF Research Database (Denmark)

Yamaji, Kyohei; Brugaletta, Salvatore; Sabaté, Manel

2017-01-01

OBJECTIVES: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EE...

[Meta-analysis of percutaneous transluminal atherectomy in the treatment for in-stent restenosis of lower extremity peripheral artery disease].

Science.gov (United States)

Li, Weihao; Zhang, Tao; Liu, Yunfeng; Zhang, Yongbao; Li, Qingle; Zhang, Xiaoming; Shen, Chenyang

2015-11-24

To evaluate the clinical safety and efficacy of percutaneous transluminal atherectomy for in-stent restenosis (ISR) in patients with low extremity peripheral arterial diseases (PAD). PubMed, Elsevier, EBSCO, Spring databases and Cochrane Library were searched for relevant articles. Based on the different mechanisms of atherectomy, the patients were divided into mechanic atherectomy group and laser atherectomy group. The safety end points included the rate of distal embolism and severe arterial wall injuries. And the efficacy end points included primary patency rate and freedom from target vessel revascularization (TVR-free) 6 months and 12 months after surgery. A total of 9 studies and 620 patients (published between 2006 and 2014) were accepted. The rate of distal embolism was 4.2% (95% confidence interval (CI): 1.7%-6.7%), while that of severe arterial wall injuries was 1.9% (95%CI: 0.9%-3.0%), respectively. Laser atherectomy was responsible for more distal embolism (6.8%) compared to mechanic atherectomy (2.0%), which was significantly different (Q=21.66, P=0.010). At 6-month follow-up, primary patency rate and rate of TVR-free were 63.0% (95% CI: 55.5%-70.6%) and 80.4% (95% CI: 70.5%-90.3%), while at 12-month follow-up were 43.5% (95%CI: 32.2%-54.9%) and 58.0% (95% CI: 52.1%-63.9%), respectively. The free-TVR rate at 6 months follow-up in mechanical atherectomy group was 77.9%, and was inferior to that in laser atherectomy group (80.8%, Q=13.49, P=0.009). Published bias was discovered at the analysis of 12-month TVR-free rate by means of Begg Test (P=0.039). Meta analysis concerned about the 3 randomized controlled trials demonstrated that there was no significant improvement using atherectomy for ISR comparing to standard balloon at 6-month TVR-free rate (OR=1.34, 95% CI: 0.86-2.07, P=0.196). To treat ISR lesion in lower extremities, laser atherectomy has a lower free-TVR rate in the middle term follow-up.A higher rate of distal embolism is noted though. On

Patients' feelings and experiences during and after peripheral percutaneous transluminal angioplasty

International Nuclear Information System (INIS)

Lundén, Maud; Lundgren, Solveig M.; Persson, Lars-Olof; Lepp, Margret

2015-01-01

Background: Peripheral Arterial Disease (PAD) often caused by atherosclerosis is a major health care issue worldwide. Percutaneous Transluminal Angioplasty (PTA) on the lower limb is a common procedure used to enhance peripheral circulation. With an increasing number of individuals acquiring peripheral PTA treatment and with an increased focus on patient centred care, there is a need to find out more about patients' feelings and thoughts of undergoing PTA. Aim: The aim was to identify patients who are predominantly anxious or calm during and after peripheral PTA and to explore reasons for these feelings. Method: The study includes 51 patients who received PTA treatment in western Sweden. Findings: Seventy-eight percent of the patients rated themselves as calm after the PTA. The analysed interviews resulted in two themes: reasons for feelings of calmness and reasons for feelings of anxiety. Conclusion: In order to feel calm during and after the PTA, information given prior to the PTA needs to be comprehensive and consistent with the actual situation at the angiography suite. The dialogue with the physician and the radiographers was considered valuable, as was the ability to follow the procedure on the image screen. It is concluded that a thorough dialogue with the physician in a calm setting after the PTA is important for the patients' ability to foresee and plan for the future. Moreover, there is a need to find ways to improve analgesic routines regarding assessment and evaluation in connection with PTA treatment as pain is shown to increase anxiety

Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era

DEFF Research Database (Denmark)

Pedersen, Susanne S.; Ong, Andrew T L; Lemos, Pedro A

2006-01-01

In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men....

Effect of percutaneous transluminal angioplasty on the stenosis of autogenous radiocephalic ateriovenous fistula for hemodialysis

Energy Technology Data Exchange (ETDEWEB)

Jeong, Sun Min; Kim, Jeong Ho; Byun, Sung Su; Kang, Jin MMo; Choi, Sang Tae; Kim, Jong Woo; Kim, Hyung Sik; Choi, Hye Young [Gachon University Gil Medical Center, Incheon (Korea, Republic of); Park, Jae Hyung [Dept. of Radiology, Seonam University College of Medicine, Myongji Hospital, Goyang (Korea, Republic of)

2016-02-15

The purpose of this study was to evaluate the effectiveness of percutaneous transluminal angioplasty (PTA) on stenosis of autogenous radiocephalic arteriovenous fistula (RCF) for hemodialysis and to determine the factors influencing patency. This retrospective study included 136 patients referred for PTA of RCF stenosis between March 2005 and July 2014. The technical success rate, complications, and patency rate were evaluated. The following factors were analyzed as they might influence patency: age, gender, site and duration of arteriovenous fistula, underlying disease, body mass index, hypercholesterolemia, smoking, peripheral artery or coronary artery occlusive disease, stenosis length/grade, cutting balloon, and balloon size. The initial technical success rate was 91.9% (125/136). Complications included vessel rupture (n = 2) and vessel dissection (n = 2). The patency rates at 6, 12, 24, and 48 months after PTA were 81.9, 67.1, 52.7, and 42.3%, respectively. The patency rate was higher in cases with longer (> 3 cm) stenosis (p = 0.04). Use of cutting balloon and larger size of balloon catheter made the patency longer, but this difference was not statistically significant (p = 0.637, 0.258). PTA is a safe and effective way to manage stenosis in RCF. The length of stenosis was the only factor which affected the patency rate in this study.

Efficacy of 24-Hour Blood Pressure Monitoring in Evaluating Response to Percutaneous Transluminal Renal Angioplasty.

Science.gov (United States)

Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Furuki, Yuho; Ouchi, Taisuke; Kim, Ahsung; Suzuki, Yuki; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

2016-08-25

Percutaneous transluminal renal angioplasty (PTRA) improves patency in atherosclerotic renal artery stenosis (ARAS), but improvement in clinic blood pressure (BP) is seen in only 20-40% of patients who undergo PTRA. This study investigated the effects of PTRA on BP lowering, assessed on 24-h ambulatory BP monitoring (ABPM), and identified preoperative features predictive of satisfactory BP improvement after PTRA. Of 1,753 consecutive patients undergoing coronary angiography, 31 patients with angiographically significant ARAS and translesional pressure gradient (TLPG) >20 mmHg underwent PTRA. ABPM was performed before, at 1 month and at 1 year after PTRA; patients with average systolic ABPM-BP decrease >10 mmHg at 1 month from baseline were categorized as responders. There was no obvious relationship between clinic BP and ABPM-BP at baseline. ABPM-BP was significantly higher in responders at baseline (SBP: 148 vs. 126 mmHg, PABPM-BP achieved a larger decrease in ABPM-BP, but the severity of stenosis reflected by TLPG; renal duplex findings; and neurohumoral parameters other than baseline renal function, did not differ between the groups. Clinic BP does not represent daily hemodynamic status, whereas high ABPM-BP is a potent predictor of satisfactory BP response to PTRA. (Circ J 2016; 80: 1922-1930).

New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease

Directory of Open Access Journals (Sweden)

Naghi J

2016-06-01

Full Text Available Jesse Naghi, Ethan A Yalvac, Ali Pourdjabbar, Lawrence Ang, John Bahadorani, Ryan R Reeves, Ehtisham Mahmud, Mitul Patel Division of Cardiovascular Medicine, Sulpizio Cardiovascular Center, University of California, San Diego, CA, USA Abstract: Peripheral arterial disease (PAD involving the lower extremity is a major source of morbidity and mortality. Clinical manifestations of PAD span the spectrum from lifestyle limiting claudication to ulceration and gangrene leading to amputation. Advancements including balloon angioplasty, self-expanding stents, drug-eluting stents, and atherectomy have resulted in high technical success rates for endovascular therapy in patients with PAD. However, these advances have been limited by somewhat high rates of clinical restenosis and clinically driven target lesion revascularization. The recent introduction of drug-coated balloon technology shows promise in limiting neointimal hyperplasia induced by vascular injury after endovascular therapies. This review summarizes the contemporary clinical data in the emerging area of drug-coated balloons. Keywords: drug-coated balloons, endovascular, percutaneous transluminal angioplasty, paclitaxel, peripheral arterial disease

Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention

DEFF Research Database (Denmark)

Jakobsen, Lars; Christiansen, Evald H; Maeng, Michael

2018-01-01

Background: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have...... designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention. Methods: The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro...... stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion...

High-Flow Nasal Cannula Therapy in a Patient with Reperfusion Pulmonary Edema following Percutaneous Transluminal Pulmonary Angioplasty

Directory of Open Access Journals (Sweden)

Kiyoshi Moriyama

2014-01-01

Full Text Available A 62-year-old woman with Wolff-Parkinson-White syndrome was with recent worsening of dyspnea to New York Heart Association functional status Class III. The patient was diagnosed as having central type chronic thromboembolic pulmonary hypertension. By cardiac catheterization, her mean pulmonary artery pressure was 53 mmHg with total pulmonary resistance 2238 dynes·sec·cm−5. After medical therapies with tadalafil, furosemide, ambrisentan, beraprost, and warfarin were initiated, percutaneous transluminal pulmonary angioplasty (PTPA was performed. Following PTPA, life-threating hypoxemia resulting from postoperative reperfusion pulmonary edema developed. High-flow nasal cannula therapy (HFNC was applied, and 100% oxygen at 50 L/min of flow was required to keep oxygenation. HFNC was continued for 3 days, and the patient was discharged on 8th postoperative day with SpO2 of 97% on 3 L/min of oxygen inhalation. Because of the simplicity of the technique, the lower cost of equipment, and remarkable patient tolerance to the treatment, we speculate that HFNC can take over the post of noninvasive ventilation as first-line therapy for patients with acute respiratory failure.

The Use of Below-Knee Percutaneous Transluminal Angioplasty in Arterial Occlusive Disease Causing Chronic Critical Limb Ischemia

International Nuclear Information System (INIS)

Loefberg, Ann-Marie; Loerelius, Lars-Erik; Karacagil, Sadettin; Westman, Bo; Almgren, Bo; Berqgvist, David

1996-01-01

Purpose: To determine the efficacy, safety and long-term results of crural artery percutaneous transluminal angioplasty (PTA) in limbs with chronic critical limb ischemia (CLI). Methods: Patients undergoing crural artery PTA due to CLI were followed at regular clinic visits with ankle brachial pressure index (ABPI) measurements. PTA of the crural arteries was attempted either alone (n= 39) or in combination with PTA of the superficial and/or popliteal artery (n= 55) in 86 limbs (82 patients and 94 procedures) presenting with CLI. The ages of patients ranged from 37 to 94 years (mean 72 years). The indications for PTA were rest pain in 10 and ulcer/gangrene in 84 limbs.Results: A technically successful PTA with at least one crural level was achieved in 88% of cases (n= 83). Cumulative primary clinical success rates at 6, 12, 24, and 36 months were 55%, 51%, 36%, and 36%, respectively. Cumulative secondary clinical success and limb salvage rates at 36 months were 44% and 72%, respectively. Conclusion: PTA of the crural arteries might be considered the primary choice of treatment in patients with CLI and distal lesions with localized stenosis or segmental short occlusions

Clinical application of hepatic vein percutaneous transluminal angioplasty and stent after stent placement in inferior vena cava

International Nuclear Information System (INIS)

Xu Hao; Zu Maoheng; Gu Yuming; Li Guojun; Zhang Qingqiao; Wei Ning; Xu Wei; Liu Hongtao

2005-01-01

Objective: To investigate the feasibility and effect of recanalization of hepatic vein with percutaneous transluminal angioplasty (PTA) and stent after stent placement in inferior vena cava (IVC). Methods: Eleven patients with Budd-Chiari syndrome (BCS)were once performed metal stent placement in IVC at other hospital, but ascites was not subsided in 9 patients after the stent placement and occurred again in 2 patients in 3 months after the procedure. PTA and metal stent placement were used to treat the occlusion of the hepatic vein (HV) via stent in IVC. Results: Recanalization of occlusive HV was successful in all 11 patients, and symptoms disappeared or were obviously improved. The mean blood pressure in HV dropped from pre-operation (45.12 ± 1.57) cm H 2 O (1 cm H 2 O=0.098 kPa) to post-operation (17.53 ± 0.68) cm H 2 O (P<0.01). In a period of 4-30 months (mean: 13.6 months) following-up, no patient reoccurred symptoms. Conclusion: Recanalization of HV via stent in IVC is a feasible and effective method for occlusive HV, but it is difficult. (authors)

Obstructive jaundice: a comparative study of forceps and brush biopsy under percutaneous transhepatic cholangiography

International Nuclear Information System (INIS)

Li Yongdong; Han Xinwei; Wu Gang; Ma Bo; Xing Gusheng

2004-01-01

Objective: To compare the sensitivity between forceps biopsy and brushing, and to explore a feasible approach to pathological diagnosis of the obstructive jaundice. Methods: 92 consecutive patients with obstructive jaundice underwent transluminal forceps biopsy and brushing during percutaneous transhepatic cholangiography and percutaneous transhepatic cholangiodrainage. The technique was performed through a preexisting percutaneous transhepatic tract with multiple specimens obtained after passing the forceps biopsy or brush into a 8-French sheath. Finally the specimens were fixed with formalin for pathologic or cytologic diagnosis. Results: The histopathologic diagnosis was acquired in 81 out of 92 patients with forceps biopsy reaching the successful rate of 97.83%. Sensitivity of forceps biopsy in 92 patients was higher than that of brush in 84 patients (88.04% vs 76.19% χ 2 =4.251, P= <0.05). Conclusions: Percutaneous transhepatic cholangiobiopsy is a simple technique with minimal invasion, high sensitivity and worthy to be used spread extensively. Percutaneous transluminal brush cytology is also an useful method for establishing a diagnosis of cholangiocarcinoma. (authors)

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Directory of Open Access Journals (Sweden)

Herten M

2016-08-01

Full Text Available Monika Herten,1 Giovanni B Torsello,1,2 Eva Schönefeld,3 Stefan Stahlhoff2 1Department of Vascular and Endovascular Surgery, University Hospital Münster, 2Department of Vascular Surgery, St Franziskus Hospital, Münster, 3Institute for Education and Student Affairs, University Hospital Münster, Münster, Germany Abstract: Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1 medical journals (ie, MEDLINE, 2 international registers for clinical studies (ie, www.clinicaltrials.gov, and 3 abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been

The role of percutaneous transluminal coronary angioplasty in heart transplant recipients.

Science.gov (United States)

Schnetzler, B; Drobinski, G; Dorent, R; Camproux, A C; Ghossoub, J; Thomas, D; Gandjbakhch, I

2000-06-01

Review the acute and late results of percutaneous transluminal coronary angioplasty (PTCA) in heart transplant recipients and examine the factors predictive of restenosis. Coronary graft disease (CGD) is the main factor responsible for late graft loss. Medical treatment, surgical revascularization, or retransplantation gives only suboptimal results in this regard. Therefore, PTCA has been attempted in this situation. More than 332 heart transplantations in our institution have been performed since 1992, the date of the first PTCA in our patients. We are currently in charge of 450 patients. All the characteristics, procedure-related information, and clinical outcome of patients needing PTCA were assessed by review of each patient's clinical records. All coronary angiograms were reviewed by an independent cardiologist. Since 1992, 53 coronary sites have been dilated in the course of 39 procedures in 29 patients. Indication for PTCA was asymptomatic angiographic coronary graft disease in 35 sites (64.8%), angina in 9 (16.6%), silent ischemia in 2 (3.7%), acute myocardial infarction in 1 (1.8%), and CHF in 7 (12.9%). Primary success ( 50%) was 32.5% (14/43). Mean follow-up was 1.27 year +/- 1.2 (SD). Five deaths (17. 2%) occurred in follow-up and were all in relation to coronary graft disease. Mean time separating PTCA from death was 0.9 year +/- 1.3 (SD). We also sought to look at factors predictive of restenosis. By multivariate analysis, a positive recipient's serology for cytomegalovirus (CMV) before the graft was the only factor found protective against restenosis (odds ratio 22.4; confidence interval 1.1 to 443.4). PTCA in heart transplant recipients allows a high level of primary success with a low periprocedural-complication rate. Restenosis rate seems equivalent to restenosis rate in native coronary arteries. Mortality during follow-up is increased in this population and is the consequence of a high level of coronary events. Recipient positivity for CMV before

From drug eluting stents to bioresorbable scaffolds; to new horizons in PCI

NARCIS (Netherlands)

Tenekecioglu, Erhan; Bourantas, Christos; Abdelghani, Mohammad; Zeng, Yaping; Silva, Rafael Cavalcante; Tateishi, Hiroki; Sotomi, Yohei; Onuma, Yoshinobu; Yılmaz, Mustafa; Serruys, Patrick W.

2016-01-01

Drug eluting stents and particularly the fully bioresorbable drug-eluting scaffolds herald a new era in percutaneous treatment of coronary artery disease. There has been tremendous progress in drug eluting stents with fully biodegradable coating polymers and polymer-free devices with reservoir

Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

Science.gov (United States)

Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

2016-06-27

This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by

The usefulness of percutaneous transluminal angioplasty of the middle cerebral artery stenosis in patients with transient ischemic attack

Energy Technology Data Exchange (ETDEWEB)

Lee, Young Chul; Lim, Hyo Soon; Kim, Jae Kyu; Seo, Jeong Jin; Jeong, Gwang Woo; Kang, Heoung Keun [Chonnam National Univ. Medical School, Kwangju (Korea, Republic of)

2001-06-01

To determine the effectiveness of percutaneous transluminal angioplasty(PTA) of atherosclerotic middle cerebral artery(MCA) stenosis in patients with transient ischemic attack (TIA). Ten patients with TIA who had undergone PTA were retrospectively investigated. In all ten, angiography revealed stenosis of the MCA. Mechanical dilatation was performed at the stenotic portion, and the angiographic findings after PTA, as well as peri/post-angioplastic complications, were evaluated. Four to 64 (mean, 23.5) months later, neurologic symptoms and the nature and timing of recurrent attacks were also assessed. The degree of stenosis before PTA was 50-75% in six patients and greater than 75% in four. Complete or partial angiographic recanalization of the stenotic segment occurred in nine patients (90%). During follow-up, seven patients recovered without recurrent TIA or cerebral stroke; one reported a tingling sensation and one experienced vertebrobasilar insufficiency. Motor aphasia developed in one patient after PTA, but after systemic heparinization, improved within 24 hours. One patient who suffered intracranial hemorrhage due to vascular rupture during PTA did three days later. PTA for atherosclerotic MCA stenosis in patients with TIA is an effective therapeutic method.

Membranous obstruction of inferior vena cava(MOIVC): treatment with percutaneous transluminal angioplasty(PTA) and self expandable metallic stent

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Lee, Ki Yeol; Kim, Baek Hyun; Cha, In Ho; Lee, Nam Joon; Kim, Yun Hwan; Kim, Jung Hyuk [College of Medicine, Korea University, Seoul (Korea, Republic of)

1994-03-15

Percutaneous transluminal angioplasty(PTA) with a balloon catheter is a standard method of treatment for membranous obstruction of inferior vena cava(MOIVC). But, correct therapeutic approach has not been established for MOIVC patients whose lesion is associated with extensive thrombotic IVC occlusion. We tried to treat MOIVC associated with or without thrombus. We treated 13 cases of MOIVC(associated with thrombus in 7 cases, no thrombus in 6 cases) with PTA, thrombolysis and self-expandable metallic stents. PTA was successful in 8 cases, but failed in 5 cases. The recurred cases were retreated with PTA, but follow-up study revealed recoiling restenosis in 4 cases and intimal hyperplasia in 1 case at previous PTA site which could be overcome with a self-expandable metallic stent. The complication were occurred in 3 cases which were hemothorax, hemopericardium, and hemoperitoneum respectively. However, those were resolved by conservative treatment only. Recanalization and dilatation could be done in MOIVC patients with or without thrombosis for improvement of patient's symptom. Gianturco self-expandable metallic stent is useful in treatment of recurred MOIVC after balloon dilatation and preventing reocclusion of the IVC after PTA.

The usefulness of percutaneous transluminal angioplasty of the middle cerebral artery stenosis in patients with transient ischemic attack

International Nuclear Information System (INIS)

Lee, Young Chul; Lim, Hyo Soon; Kim, Jae Kyu; Seo, Jeong Jin; Jeong, Gwang Woo; Kang, Heoung Keun

2001-01-01

To determine the effectiveness of percutaneous transluminal angioplasty(PTA) of atherosclerotic middle cerebral artery(MCA) stenosis in patients with transient ischemic attack (TIA). Ten patients with TIA who had undergone PTA were retrospectively investigated. In all ten, angiography revealed stenosis of the MCA. Mechanical dilatation was performed at the stenotic portion, and the angiographic findings after PTA, as well as peri/post-angioplastic complications, were evaluated. Four to 64 (mean, 23.5) months later, neurologic symptoms and the nature and timing of recurrent attacks were also assessed. The degree of stenosis before PTA was 50-75% in six patients and greater than 75% in four. Complete or partial angiographic recanalization of the stenotic segment occurred in nine patients (90%). During follow-up, seven patients recovered without recurrent TIA or cerebral stroke; one reported a tingling sensation and one experienced vertebrobasilar insufficiency. Motor aphasia developed in one patient after PTA, but after systemic heparinization, improved within 24 hours. One patient who suffered intracranial hemorrhage due to vascular rupture during PTA did three days later. PTA for atherosclerotic MCA stenosis in patients with TIA is an effective therapeutic method

Quantitative exercise thallium-201 scintigraphy for predicting angina recurrence after percutaneous transluminal coronary angioplasty

International Nuclear Information System (INIS)

Stuckey, T.D.; Burwell, L.R.; Nygaard, T.W.; Gibson, R.S.; Watson, D.D.; Beller, G.A.

1989-01-01

The aim of this prospective study was to determine the value of quantitative exercise thallium-201 scintigraphy for predicting short-term outcome in patients after percutaneous transluminal coronary angioplasty (PTCA). Quantitative exercise thallium-201 scintigraphy was performed 2.2 +/- 1.2 weeks after successful PTCA in 68 asymptomatic patients, 64 (94%) of whom had class III or IV angina before the procedure. Clinical follow-up was obtained in all patients at a mean of 10 +/- 2 months and all were followed for at least 6 months; 45 patients (66%) remained asymptomatic during follow-up and 23 (34%) developed recurrent class III or IV angina at a mean of 2.6 +/- 1.2 months. Multivariate analysis of 22 clinical, angiographic and exercise test variables revealed that thallium-201 redistribution, any thallium scan abnormality, presence of a distal stenosis and treadmill time were the only significant predictors of recurrent angina after PTCA. Using a stepwise discriminant function model, thallium-201 redistribution was the only significant independent predictor. Despite its prognostic value relative to other variables as a predictor, thallium redistribution at 2 weeks after PTCA was only detected in 9 of the 23 patients (39%) who subsequently developed recurrent angina, although only 2 of the 45 patients (9%) who remained asymptomatic during follow-up demonstrated thallium-201 redistribution at the time of early testing. After repeat angiography was performed in 17 of the 23 patients with recurrent angina, 14 (82%) demonstrated restenosis and 3 (18%) had worse narrowing distal to or remote from the site of dilatation

Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

Science.gov (United States)

Park, Duk-Woo; Park, Seung-Jung

2017-06-01

For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

Diabetes insipidus-like state complicating percutaneous transluminal renal stenting for transplant renal artery stenosis.

Science.gov (United States)

Tian, Lu; He, Yangyan; Zhang, Hongkun; Wu, Ziheng; Li, Donglin; Chen, Shanwen

2014-07-01

To report the incidence, etiology, and treatments of diabetes insipidus-like state that complicate percutaneous transluminal renal stenting (PTRS) for transplant renal artery stenosis (TRAS). Data from 7 patients on whom PTRS for TRAS was performed between October 2008 and March 2012 were reviewed retrospectively. The parameters investigated included blood flow velocity, blood pressure, and creatinine levels before and after the intervention. The procedural success rate was 100%. Three cases developed a diabetes insipidus-like state in the immediate postprocedural period. Urine output returned to normal within 2 weeks after treatment. The median blood flow velocity was significantly reduced from 4.51 m/sec (4.31-4.61 m/sec) at the time of TRAS diagnosis to 1.33 m/sec (1.31-1.51 m/sec) at the most recent follow-up of the group with a diabetes insipidus-like state. The ratio of median blood flow velocity before and after stenting in the group with a diabetes insipidus-like state was significantly higher than that in the group without a diabetes insipidus-like state (3.39 vs. 1.93). Diabetes insipidus-like state that complicates PTRS for TRAS is not an uncommon event, but appears to be underreported in the medical literature. A high ratio of pre- and poststenting median blood flow velocity may be a predictor for a postprocedural diabetes insipidus-like state. The most probable cause may be the marked increase in renal arterial flow. Early recognition of the condition is essential to avoid dehydration and electrolyte imbalance. Copyright © 2014 Elsevier Inc. All rights reserved.

Long-Term Safety of Drug-Eluting and Bare-Metal Stents

DEFF Research Database (Denmark)

Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

2015-01-01

BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

Femoral artery recanalisation with percutaneous angioplasty and segmentally enclosed plasminogen activator

DEFF Research Database (Denmark)

Jørgensen, B; Tønnesen, K H; Bülow, J

1989-01-01

To establish whether re-occlusion of the femoral artery could be prevented, in 6 consecutive patients undergoing percutaneous transluminal angioplasty (PTA) for superficial femoral artery occlusion the recanalised segment was isolated, with a 7-French double-balloon catheter. 5 mg recombined huma...

Efficacy of Ultrasound-Guided Axillary Brachial Plexus Block for Analgesia During Percutaneous Transluminal Angioplasty for Dialysis Access

International Nuclear Information System (INIS)

Chiba, Emiko; Hamamoto, Kohei; Nagashima, Michio; Matsuura, Katsuhiko; Okochi, Tomohisa; Tanno, Keisuke; Tanaka, Osamu

2016-01-01

PurposeTo evaluate the efficacy and safety of ultrasound (US)-guided axillary brachial plexus block (ABPB) for analgesia during percutaneous transluminal angioplasty (PTA) for dialysis access.Subjects and MethodsTwenty-one patients who underwent PTA for stenotic dialysis access shunts and who had previous experience of PTA without sedation, analgesia, and anesthesia were included. The access type in all patients was native arteriovenous fistulae in the forearm. Two radiologists performed US-guided ABPB for the radial and musculocutaneous nerves before PTA. The patients’ pain scores were evaluated using a visual analog scale (VAS) after PTA, and these were compared with previous sessions without US-guided ABPB. The patient’s motor/sensory paralysis after PTA was also examined.ResultsThe mean time required to achieve US-guided ABPB was 8 min. The success rate of this procedure was 100 %, and there were no significant complications. All 21 patients reported lower VAS with US-guided ABPB as compared to without the block (p < 0.01). All patients expressed the desire for an ABPB for future PTA sessions, if required. Transient motor paralysis occurred in 8 patients, but resolved in all after 60 min.ConclusionUS-guided ABPB is feasible and effective for analgesia in patients undergoing PTA for stenotic dialysis access sites.Level of EvidenceLevel 4 (case series).

Percutaneous transluminal angioplasty of malfunctioning Brescia-Cimino arteriovenous fistula: analysis of factors adversely affecting long-term patency

International Nuclear Information System (INIS)

Sugimoto, Koji; Hirota, Shozo; Sugimura, Kazuro; Higashino, Takanori; Kuwata, Yoichiro; Imanaka, Kazufumi

2003-01-01

Our objective was to identify the factors adversely affecting long-term patency after percutaneous transluminal angioplasty (PTA) for hemodialysis Brescia-Cimino arteriovenous fistulas. Between November 1995 and March 2000, 91 PTA procedures were performed on 50 patients with 57 Brescia-Cimino fistulas. A retrospective study based on the chart review was performed. The initial technical success rate for all procedures and the primary and secondary patency rates for all fistulas were calculated. Regarding fistulas successfully maintained by the primary PTA, the primary and secondary patency rates were compared using the Kaplan-Meier method between two patient groups. They were classified on the basis of several factors, including age (older, over 70 years, and younger group), age of the fistulas (older, over 6 months, and younger group), with or without diabetes mellitus (DM), solitary or multiple lesions, long or short segment lesion, stenosis or occlusion, and with or without arterial and/or anastomotic lesions. Initial technical success rates for all procedures and fistulas were 91.2 and 89.5%, respectively. Cumulative primary and secondary patency rates at 1 year were 47.3 and 67.3%, respectively. In the comparative study, the secondary patency rate for the older group was lower than that of the younger group with statistical significance (p =0.029). The higher age is the only factor that reduces the long-term patency rate after PTA. (orig.)

Efficacy of Ultrasound-Guided Axillary Brachial Plexus Block for Analgesia During Percutaneous Transluminal Angioplasty for Dialysis Access

Energy Technology Data Exchange (ETDEWEB)

Chiba, Emiko, E-mail: chibaemi23@comet.ocn.ne.jp; Hamamoto, Kohei, E-mail: hkouhei917@gmail.com [Jichi Medical University, Department of Radiology, Saitama Medical Center (Japan); Nagashima, Michio, E-mail: nagamic00@gmail.com [Asahikawa Medical University, Department of Emergency Medicine (Japan); Matsuura, Katsuhiko, E-mail: kmatsur@gmail.com; Okochi, Tomohisa, E-mail: t-shachi@dj8.so-net.ne.jp; Tanno, Keisuke, E-mail: tankichi1974@gmail.com; Tanaka, Osamu, E-mail: otanaka@omiya.jichi.ac.jp [Jichi Medical University, Department of Radiology, Saitama Medical Center (Japan)

2016-10-15

PurposeTo evaluate the efficacy and safety of ultrasound (US)-guided axillary brachial plexus block (ABPB) for analgesia during percutaneous transluminal angioplasty (PTA) for dialysis access.Subjects and MethodsTwenty-one patients who underwent PTA for stenotic dialysis access shunts and who had previous experience of PTA without sedation, analgesia, and anesthesia were included. The access type in all patients was native arteriovenous fistulae in the forearm. Two radiologists performed US-guided ABPB for the radial and musculocutaneous nerves before PTA. The patients’ pain scores were evaluated using a visual analog scale (VAS) after PTA, and these were compared with previous sessions without US-guided ABPB. The patient’s motor/sensory paralysis after PTA was also examined.ResultsThe mean time required to achieve US-guided ABPB was 8 min. The success rate of this procedure was 100 %, and there were no significant complications. All 21 patients reported lower VAS with US-guided ABPB as compared to without the block (p < 0.01). All patients expressed the desire for an ABPB for future PTA sessions, if required. Transient motor paralysis occurred in 8 patients, but resolved in all after 60 min.ConclusionUS-guided ABPB is feasible and effective for analgesia in patients undergoing PTA for stenotic dialysis access sites.Level of EvidenceLevel 4 (case series).

Early detection of restenosis after successful percutaneous transluminal coronary angioplasty by exercise-redistribution Thallium scintigraphy

NARCIS (Netherlands)

W. Wijns (William); P.W.J.C. Serruys (Patrick); J.H.C. Reiber (Johan); P.J. de Feyter (Pim); M.J.B.M. van den Brand (Marcel); M.L. Simoons (Maarten); P.G. Hugenholtz (Paul)

1985-01-01

textabstractThe value of exercise testing and thallium scintigraphy in predicting recurrence of angina pectoris and restenosis after a primary successful transluminal coronary angioplasty (PTCA) was prospectively evaluated. In 89 patients, a symptom-limited exercise electrocardiogram (ECG) and

Co-occurrence of diabetes and hopelessness predicts adverse prognosis following percutaneous coronary intervention

DEFF Research Database (Denmark)

Pedersen, Susanne S.; Denollet, Johan; Erdman, Ruud A M

2009-01-01

We examined the impact of co-occurring diabetes and hopelessness on 3-year prognosis in percutaneous coronary intervention patients. Consecutive patients (n = 534) treated with the paclitaxel-eluting stent completed a set of questionnaires at baseline and were followed up for 3-year adverse...... clinical events. The incidence of 3-year death/non-fatal myocardial infarction was 3.5% in patients with no risk factors (neither hopelessness nor diabetes), 8.2% in patients with diabetes, 11.2% in patients with high hopelessness, and 15.9% in patients with both factors (p = 0.001). Patients...... with hopelessness (HR: 3.28; 95% CI: 1.49-7.23) and co-occurring diabetes and hopelessness (HR: 4.89; 95% CI: 1.86-12.85) were at increased risk of 3-year adverse clinical events compared to patients with no risk factors, whereas patients with diabetes were at a clinically relevant but not statistically significant...

Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

DEFF Research Database (Denmark)

Maeng, Michael; Tilsted, Hans Henrik; Jensen, Lisette Okkels

2014-01-01

received two different types of drug-eluting stents. METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug......-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...

The Use of Color-Coded Duplex Scanning in the Selection of Patients with Lower Extremity Arterial Disease for Percutaneous Transluminal Angioplasty: A Prospective Study

International Nuclear Information System (INIS)

Elsman, Bernard H.P.; Legemate, Dink A.; Heyden, Frank W.H.M. van der; Vos, Henk de; Mali, Willem P.T.M.; Eikelboom, Bert C.

1996-01-01

Purpose: To exploit the potential benefits of percutaneous transluminal angioplasty (PTA) in patients with short obstructive lesions in the lower extremity, it is preferable to select patients suitable for PTA before proceeding to hospital admission and angiography. The aim of this prospective study was to evaluate the role of color-coded duplex scanning in the correct selection of patients for PTA and its influence on planning the approach to the lesion. Methods: On the basis of clinical history, physical examination, pressure indices, and ultrasound duplex scanning, 109 patients were scheduled for PTA. Results: The indication for PTA was correct in 103 patients (94%), while the procedure was performed successfully in 98 patients (90%). The approach to the lesion was planned successfully in the majority of patients. Conclusion: This study shows that it is justifiable to plan PTA on the basis of information obtained by duplex scanning. Results of the duplex scan may guide the catheterization route

The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

DEFF Research Database (Denmark)

Garg, Scot; Serruys, Patrick W; Silber, Sigmund

2011-01-01

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.......This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

The predictive value of angiographic results for the outcome of percutaneous transluminal angioplasty in stenosed femoral bypass grafts

International Nuclear Information System (INIS)

Spijkerboer, Anje M.; Beek, Frederik J. A.; Graaf, Yolanda van der; Eikelboom, Bert C.; Mali, Willem P. T. M.

1997-01-01

Purpose. To assess the predictive value of immediate angiographic results after percutaneous transluminal angioplasty (PTA) for stenoses in femoral bypass grafts using duplex ultrasound (DUS) criteria. Methods. A 1-year follow-up with DUS was performed in 38 patients with 50 stenoses in 41 grafts, treated with PTA for a graft stenosis. The indication for PTA according to DUS criteria was a severe stenosis in 43 lesions, and a moderate stenosis in 7 lesions. In the moderate stenosis group 3 patients showed claudication and 1 patient had a nonhealing ulcer. For the purposes of statistical evaluation, primary patency was considered present if the graft was not occluded. The graft was considered to have failed when it was found to be occluded on DUS, or when secondary interventions (surgery, repeat PTA) were performed. Results. After 1 year the cumulative primary patency rate was 44$ [95% confidence interval (CI) 27.8-59.8]. Stenoses with initially good angiographic results after PTA (<30% residual stenosis) were 2.9 times more likely to be patent at 1 year than stenoses with initially poor or moderate angiographic results (hazard ratio 2.9, 95% CI 1.3-6.4,p=0.007). Conclusion. A poor or moderate angiographic result immediately following PTA was prognostic for poor long-term results and may indicate a requirement for earlier surgical intervention

Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients the randomized diabetes and drug-eluting stent (DiabeDES) IV intravascular ultrasound trial

DEFF Research Database (Denmark)

Antonsen, Lisbeth; Maeng, Michael; Thayssen, Per

2013-01-01

OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients. BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent...... implantation due to intimal hyperplasia (IH). METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available...... in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0...

First-Generation Versus Second-Generation Drug-Eluting Stents in Coronary Chronic Total Occlusions: Two-Year Results of a Multicenter Registry.

Directory of Open Access Journals (Sweden)

Jong-Hwa Ahn

Full Text Available Limited data are available regarding the long-term clinical outcomes of second-generation drug-eluting stents (DES versus first-generation DES in patients with coronary chronic total occlusion (CTO who undergo percutaneous coronary intervention (PCI. The aim of this study was to compare the clinical outcomes of second-generation DES with those of first-generation DES for the treatment of CTO.Between March 2003 and February 2012, 1,006 consecutive patients with CTO who underwent successful PCI using either first-generation DES (n = 557 or second-generation DES (n = 449 were enrolled in a multicenter, observational registry. Propensity-score matching was also performed. The primary outcome was cardiac death over a 2-year follow-up period. No significant differences were observed between the two groups regarding the incidence of cardiac death (first-generation DES versus second-generation DES; 2.5% vs 2.0%; hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.37 to 1.98; p = 0.72 or major adverse cardiac events (MACE, 11.8% vs 11.4%; HR: 1.00; 95% CI: 0.67 to 1.50; p = 0.99. After propensity score matching, the incidences of cardiac death (HR: 0.86; 95% CI: 0.35 to 2.06; p = 0.86 and MACE (HR: 0.93; 95% CI: 0.63 to 1.37; p = 0.71 were still similar in both groups. Furthermore, no significant differences were observed between sirolimus-eluting, paclitaxel-eluting, zotarolimus-eluting, and everolimus-eluting stents regarding the incidence of cardiac death or MACE.This study shows that the efficacy of second-generation DES is comparable to that of first-generation DES for treatment of CTO over 2 years of follow-up.

Pressure-wire-guided percutaneous transluminal pulmonary angioplasty: a breakthrough in catheter-interventional therapy for chronic thromboembolic pulmonary hypertension.

Science.gov (United States)

Inami, Takumi; Kataoka, Masaharu; Shimura, Nobuhiko; Ishiguro, Haruhisa; Yanagisawa, Ryoji; Fukuda, Keiichi; Yoshino, Hideaki; Satoh, Toru

2014-11-01

This study sought to prove the safety and effectiveness of pressure-wire-guided percutaneous transluminal pulmonary angioplasty (PTPA). PTPA has been demonstrated to be effective for treatment of chronic thromboembolic pulmonary hypertension. However, a major and occasionally fatal complication after PTPA is reperfusion pulmonary edema. To avoid this, we developed the PEPSI (Pulmonary Edema Predictive Scoring Index). The pressure wire has been used to detect insufficiency of flow in a vessel. We included 350 consecutive PTPA sessions in 103 patients with chronic thromboembolic pulmonary hypertension from January 1, 2009 to December 31, 2013. During these 5 years, 140 PTPA sessions were performed without guidance, 65 with guidance of PEPSI alone, and 145 with both PEPSI and pressure-wire guidance. Each PTPA session was finished after achieving PEPSI scores of PEPSI guidance and each target lesion achieving distal mean pulmonary arterial pressure PEPSI (0% and 6.9%, respectively). Furthermore, the group guided by pressure wire and PEPSI accomplished the same hemodynamic improvements with fewer numbers of target lesions treated and sessions performed. The combined approach using pressure wire and PEPSI produced more efficient clinical results and greatly reduced reperfusion pulmonary edema and vessel complications. This is further evidence that PTPA is an alternative strategy for treating chronic thromboembolic pulmonary hypertension. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Successful intestinal ischemia treatment by percutaneus transluminal angioplasty of visceral arteries in a patient with abdominal angina

Directory of Open Access Journals (Sweden)

Nenezić Dragoslav

2011-01-01

Full Text Available Introduction. Abdominal angina, also known as chronic mesenteric ischemia or intestinal angina, is a rare disease caused by intestinal flow reduction due to stenosis or occlusion of mesenteric arteries. A case of successful treatment of a patient with abdominal angina by percutaneous transuliminal angioplasty of high-grade superior mesenteric artery and coeliac trunk stenosis was presented. Case Outline. A 77-year-old male patient was admitted at our Clinic for severe postprandial abdominal pains followed by frequent diarrhoeas. Extensive gastrointestinal investigations were performed and all results were normal. Multislice computerized (MSCT arteriography was indicated which revealed ostial celiac trunk and superior mesenteric artery subocclusion. Percutaneous transluminal angioplasty of the superior mesenteric artery and coeliac trunk was done with two stents implantation. Just a few hours following the intervention, after food ingestion, there were no abdominal pains. Six months later, the patient described a significant feeling of relief after food ingestion and no arduousness at all. Conclusion. High-grade visceral arteries stenoses in patients with intestinal ischemia symptoms can be treated by either surgical procedures or percutaneus transluminal angioplasty. In cases when a low operative risk is anticipated, surgical treatment is recommended due to a better anatomical outcome, while percutaneus angioplasty is advised to elderly patients in whom increased operative risks can be expected.

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

Science.gov (United States)

de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

2018-02-03

MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction

DEFF Research Database (Denmark)

Holmvang, Lene; Kelbæk, Henning; Kaltoft, Anne Kjer

2013-01-01

This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.......This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention....

Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention

DEFF Research Database (Denmark)

Versteeg, Henneke; Pedersen, Susanne S.; Erdman, Ruud A M

2009-01-01

We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents.......We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents....

Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction

DEFF Research Database (Denmark)

Räber, Lorenz; Kelbæk, Henning; Ostojic, Miodrag

2012-01-01

The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).......The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)....

The Role of Duplex Scanning in the Selection of Patients with Critical Lower-Limb Ischemia for Infrainguinal Percutaneous Transluminal Angioplasty

International Nuclear Information System (INIS)

Loefberg, Anne-Marie; Karacagil, Sadettin; Hellberg, Anders; Bostroem, Annika; Ljungman, Christer; Ostholm, Goerel

2001-01-01

Purpose: To investigate the role of duplex scanning in the selection of patients with critical lower-limb ischemia (CLI) for infrainguinal percutaneous transluminal angioplasty (PTA).Methods: One hundred and sixty-two limbs with CLI (150 patients) that underwent duplex scanning within 3 months prior to conventional diagnostic angiography (n = 88) or infrainguinal PTA (n = 74) were retrospectively studied. The findings obtained from duplex scanning and angiography were analyzed in a masked fashion by two different investigators.Results: The accuracy, sensitivity, specificity, and negative and positive predictive values of duplex scanning in the selection of patients for infrainguinal PTA were 86%, 84%, 89%, 86%, and 87% respectively. Forty-two procedures (57%) were performed at multiple arterial segments. The accuracy of duplex scanning in the selection of femoropopliteal and crural lesions for PTA was over 85%. However, the sensitivity of duplex scanning in the selection of popliteal and crural lesions for PTA was 49% and 38% respectively, compared with 80% for superior femoral artery lesions. In 39% of patients who were correctly selected for PTA, duplex scanning misdiagnosed one of the multiple lesions treated by PTA.Conclusion: Duplex scanning can safely be used for the selection of patients for infrainguinal PTA. The sensitivity of duplex scanning in the selection of lesions for PTA was less satisfactory in the popliteal and crural arteries compared with the femoropopliteal arteries

Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

International Nuclear Information System (INIS)

Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

2013-01-01

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

Energy Technology Data Exchange (ETDEWEB)

Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

2013-02-15

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

Science.gov (United States)

Poerner, Tudor C; Otto, Sylvia; Gassdorf, Johannes; Nitsche, Kristina; Janiak, Florian; Scheller, Bruno; Goebel, Björn; Jung, Christian; Figulla, Hans R

2014-12-01

In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744. © 2014 American Heart Association, Inc.

Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

Science.gov (United States)

Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

2017-06-26

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

Long-term clinical outcome in STEMI patients treated with primary PCI and drug-eluting or bare-metal stents: insights from a high-volume single-center registry

DEFF Research Database (Denmark)

Pedersen, Sune; Galatius, Soren; Mogelvang, Rasmus

2011-01-01

Use of drug-eluting stents (DES) in patients with ST-elevation myocardial infarction (STEMI) during routine primary percutaneous coronary intervention (pPCI) is controversial.......Use of drug-eluting stents (DES) in patients with ST-elevation myocardial infarction (STEMI) during routine primary percutaneous coronary intervention (pPCI) is controversial....

Indirect evidence for a role of a subpopulation of activated neutrophils in the remodelling process after percutaneous coronary intervention

NARCIS (Netherlands)

Costa, MA; de Wit, LEA; de Valk, V.; Serrano, P; Wardeh, AJ; Serruys, PW; Sluiter, W

Aim Leukocytes have been implicated in restenosis following percutaneous transluminal coronary angioplasty. We investigated the link between the activated status of circulating neutrophils and restenosis after angioplasty. Methods and Results The population of 108 patients with single, de novo

Evaluation and percutaneous management of atherosclerotic peripheral vascular disease

International Nuclear Information System (INIS)

Widlus, D.M.; Osterman, F.A. Jr.

1989-01-01

Atherosclerotic peripheral vascular disease (PVD) of the lower extremities deprives a person of the ability to exercise to their satisfaction, later of the ability to perform the activities of their daily life, and finally of their legs themselves. Peripheral vascular disease has long been managed by the vascular surgeon utilizing endarterectomy and peripheral arterial bypass. Patient acceptance of nonsurgical, percutaneous procedures such as percutaneous transluminal balloon angioplasty (PTA) is high. Increased utilization of these procedures has led to improved techniques and adjuncts to therapy, as well as more critical review of long-term results. This article will review the evaluation and nonoperative management of PVD, with an emphasis on the newer modalities of management presently being investigated

Transcutaneous oximetry compared to ankle-brachial-index measurement in the evaluation of percutaneous transluminal angioplasty

International Nuclear Information System (INIS)

Wildgruber, Moritz; Wolf, Oliver; Weiss, Wolfgang; Berger, Hermann; Lutzenberger, Werner; Eckstein, Hans-Henning; Heider, Peter

2007-01-01

Objective: To investigate transcutaneous oximetry as parameter of the microcirculation is correlated to ankle-brachial-index as parameter of the macrocirculation after peripheral angioplasty procedures. Design: Prospective study. Materials and methods: 60 patients suffering from intermittent claudication were scheduled for angioplasty treatment. 45 patients were considered as eligible for angioplasty after angiographic evaluation, 15 patients underwent angiography only. Transcutaneous oximetry measurements were performed before the procedure, at the end of intervention, 24 h as well as 2 and 4 weeks after percutaneous transluminal angioplasty. Ankle-brachial-indices were obtained before intervention, 24 h as well as 2 and 4 weeks later. Results: Ankle-brachial-indices increased significantly at 24 h after angioplasty in patients being treated with angioplasty. Transcutaneous oximetry values dropped significantly at the end of the procedure and returned close to the baseline levels at 2 and 4 weeks after angioplasty. Ankle-brachial-indices and transcutaneous oximetry were positively correlated before (r = 0.3833, p = 0.009) as well as 4 weeks after angioplasty (r = 0.4596, p = 0.001). Immediately after radiological interventions, ankle-brachial-indices and transcutaneous oximetry are not positively correlated. In patients undergoing angiography only, transcutaneous oximetry levels drop significantly immediately after angiography and remain at decreased levels even at 4 weeks after intervention. Conclusion: Transcutaneous oximetry as parameter of the microcirculation is positively correlated with ankle-brachial-index as parameter of the macrocirculation before and at 4 weeks after angioplasty. Intraarterial angiography leads to a sudden decrease in skin microcirculation without affecting macrocirculation. As indicated by a lack of recovery in transcutaneous oximetry levels after 4 weeks, angiography alone results in a prolonged impaired microcirculation which may

Stent underexpansion in angiographic guided percutaneous coronary intervention, despite adjunctive balloon post-dilatation, in drug eluting stent era

Directory of Open Access Journals (Sweden)

Mehrdad Taherioun

2014-01-01

Full Text Available BACKGROUND: Stent underexpansion is the most powerful predictor of long-term stent patency and clinical outcome. The purpose of this study was to evaluate the incidence and predictors of stent underexpansion despite adjunctive post-dilatation with non-compliant balloon. METHODS: After elective coronary stent implantation and adjunctive post-dilatation with non-compliant balloon and optimal angiographic result confirmed by the operator, intravascular ultrasound (IVUS was performed for all the treated lesions. If the treated lesions fulfilled the IVUS criteria, they are considered as the optimal stent group; if not, they are considered as the suboptimal group. RESULTS: From 50 patients enrolled in this study 39 (78% had optimal stent deployment and 11 (22% had suboptimal stent deployment. In the suboptimal group 7 (14% had underexpansion, 2 (4% malposition, and 2 (4% had asymmetry. There were no stent edge dissections detected by IVUS. We did not find any correlation between lesion calcification, ostial lesions, stent length, and stent underexpansion. Stent diameter ≤ 2.75 mm had a strong correlation with stent underexpansion. CONCLUSION: Despite adjunctive post-dilatation with noncompliant balloon, using a relatively small stent diameter was a strong predictor for underexpansion. IVUS guided percutaneous coronary intervention (PCI may be considered for drug eluting stent (DES implantation in relatively small vessels.   Keywords: Stent, Percutaneous Coronary Intervention, Ultrasound, Post-dilatation 

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V)

DEFF Research Database (Denmark)

Christiansen, Evald Høj; Jensen, Lisette Okkels; Thayssen, Per

2013-01-01

Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer......-coated sirolimus-eluting stent in a population-based setting....

Drug-eluting versus bare-metal stents in large coronary arteries

DEFF Research Database (Denmark)

Kaiser, Christoph; Galatius, Soeren; Erne, Paul

2010-01-01

Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether...

Comparing Percutaneous Transluminal Angioplasty and Stent Placement for Treatment of Subclavian Arterial Occlusive Disease: A Systematic Review and Meta-Analysis

International Nuclear Information System (INIS)

Ahmed, Ahmed T.; Mohammed, Khaled; Chehab, Monzer; Brinjikji, Waleed; Hassan Murad, M.; Cloft, Harry; Bjarnason, Haraldur

2016-01-01

Background and PurposeSubclavian artery occlusive disease (SAOD) is often associated with cerebrovascular symptoms such as subclavian steal syndrome and stroke. We conducted a systematic review and meta-analysis to compare percutaneous transluminal angioplasty (PTA) and stent placement for the treatment of SAOD.Materials and MethodsWe searched Medline, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through October 16, 2014. From each study, we abstracted baseline patient characteristics, study design variables, and outcome data including rates of technical success, primary patency (≤2 and >2 years follow-up), symptom resolution, and complications. Meta-analysis was performed using a random-effects model.ResultsA total of 35 non-comparative studies with 1726 patients were included. Technical success rate was significantly higher in the stent group than the PTA group (92.8 vs 86.8 %, p = 0.007). Long-term primary patency rates (76.9 vs 79.6 %, p = 0.729) and symptom resolution rates (82.2 vs 73.0 %, p = 0.327) were not statistically different. There was no statistically significant difference in the rates of stroke or death.ConclusionStent placement for treatment of SAOD may be associated with higher rates of technical success but similar rates of symptom resolution and long-term outcomes. The confidence in the available estimates is low. Further comparative studies are needed to guide patients and clinicians in shared decision making.

Comparing Percutaneous Transluminal Angioplasty and Stent Placement for Treatment of Subclavian Arterial Occlusive Disease: A Systematic Review and Meta-Analysis

Energy Technology Data Exchange (ETDEWEB)

Ahmed, Ahmed T., E-mail: Ahmed.Ahmed1@mayo.edu; Mohammed, Khaled, E-mail: Mohammed.Khaled@mayo.edu [Mayo Clinic, Evidence-Based Practice Research Program (United States); Chehab, Monzer, E-mail: moe.chehab@beumont.edu [Oakland University William Beaumont School of Medicine, Department of Diagnostic Radiology and Molecular Imaging (United States); Brinjikji, Waleed, E-mail: Brinjikji.Waleed@mayo.edu [Mayo Clinic, Department of Radiology (United States); Hassan Murad, M., E-mail: Murad.Mohammad@mayo.edu [Mayo Clinic, Evidence-Based Practice Research Program (United States); Cloft, Harry, E-mail: Cloft.Harry@mayo.edu; Bjarnason, Haraldur, E-mail: Bjarnason.Haraldur@mayo.edu [Mayo Clinic, Department of Radiology (United States)

2016-05-15

Background and PurposeSubclavian artery occlusive disease (SAOD) is often associated with cerebrovascular symptoms such as subclavian steal syndrome and stroke. We conducted a systematic review and meta-analysis to compare percutaneous transluminal angioplasty (PTA) and stent placement for the treatment of SAOD.Materials and MethodsWe searched Medline, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through October 16, 2014. From each study, we abstracted baseline patient characteristics, study design variables, and outcome data including rates of technical success, primary patency (≤2 and >2 years follow-up), symptom resolution, and complications. Meta-analysis was performed using a random-effects model.ResultsA total of 35 non-comparative studies with 1726 patients were included. Technical success rate was significantly higher in the stent group than the PTA group (92.8 vs 86.8 %, p = 0.007). Long-term primary patency rates (76.9 vs 79.6 %, p = 0.729) and symptom resolution rates (82.2 vs 73.0 %, p = 0.327) were not statistically different. There was no statistically significant difference in the rates of stroke or death.ConclusionStent placement for treatment of SAOD may be associated with higher rates of technical success but similar rates of symptom resolution and long-term outcomes. The confidence in the available estimates is low. Further comparative studies are needed to guide patients and clinicians in shared decision making.

Efficacy of percutaneous transluminal renal angioplasty with stent in elderly male patients with atherosclerotic renal artery stenosis

Directory of Open Access Journals (Sweden)

Zhao J

2012-10-01

Full Text Available Jiahui Zhao, Qingli Cheng, Xiaoying Zhang, Meihua Li, Sheng Liu, Xiaodan WangDepartment of Geriatric Nephrology, Chinese PLA General Hospital, Beijing, ChinaObjectives: Percutaneous transluminal renal angioplasty with stent implantation (PTRAS has become the treatment of choice for atherosclerotic renal artery stenosis (ARAS. This study evaluates the long-term effects of PTRAS on hypertension and renal function in elderly patients with ARAS.Methods: We conducted a retrospective cohort study of all patients who underwent PTRAS in the geriatric division of a tertiary medical center during the period 2003–2010. The clinical data were extracted from the medical records of each patient. Changes in blood pressure, antihypertensive treatment, and estimated glomerular filtration rate were analyzed before and after PTRAS.Results: Eighty-six stents in 81 elderly patients were placed successfully. The average age of the patients was 76.2 years (65–89 years. Mean follow-up was 31.3 months (range 12 –49 months. There was a significant decrease in both systolic and diastolic blood pressure at the third day after the PTRAS procedure and the reduction in blood pressure was constant throughout the follow-up period until 36 months after PTRAS. However, there was no marked benefit to renal function outcome during the follow-up period. The incidence of contrast-induced nephropathy was 9.9% in this study group. The rate of renal artery restenosis was 14.8%. The survival rate was 96.3% for 4 years after the procedure.Conclusion: It is beneficial to control blood pressure in elderly patients with ARAS up to 36 months after a PTRAS procedure. However, their renal function improvement is limited.Keywords: angioplasty, hypertension, renal function, elderly, renal artery stenosis

Flow motion waves with high and low frequency in severe ischaemia before and after percutaneous transluminal angioplasty.

Science.gov (United States)

Hoffmann, U; Schneider, E; Bollinger, A

1990-09-01

STUDY OF OBJECTIVE: The aim was to evaluate skin flux and prevalence of low and high frequency flow motion waves in patients with severe ischaemia due to peripheral arterial occlusive disease before and after percutaneous transluminal angioplasty (PTA) with and without local thrombolysis. Flow motion was recorded by the laser Doppler technique at the dorsum of the foot before, one day, and one month after PTA. The results were separately analysed in patients with successful and unsuccessful treatment. 18 patients with rest pain or incipient gangrene were included. Mean pretreatment systolic ankle pressure was 55.8(SD 25.5) mm Hg, and mean transcutaneous PO2 at 43 degrees C was 5.2(9.4) mm Hg. Arteriography revealed relevant stenoses or occlusions of the femoropopliteal and calf arteries. Before treatment two patterns of flow motion with characteristic frequency ranges were observed at the foot dorsum and at a probe temperature of 32 degrees C: low frequency (LF) waves with a mean frequency of 2.2(0.5) cycles.min-1 and a mean amplitude of 0.73(0.42) arbitrary units (AU) and high frequency (HF) waves with a mean frequency of 22.6(4.2) cycles.min-1 and a mean amplitude of 0.39(0.33) AU. PTA was successful in 11 of the 18 patients. After successful treatment, prevalence of HF waves decreased from 10/11 to 4/11 cases (p less than 0.001), but remained nearly unchanged after failed procedure. Prevalence of LF waves before and after PTA did not differ significantly. Our data support the hypothesis that HF waves represent a reaction of skin microcirculation to severe ischaemia. With reference to animal studies it is proposed that HF waves originate from terminal arterioles. They may function as a compensatory mechanism of flow regulation involved in pathophysiology of ischaemia.

Nanoparticle albumin-bound paclitaxel: a novel Cremphor-EL-free formulation of paclitaxel.

Science.gov (United States)

Stinchcombe, Thomas E

2007-08-01

Standard formulation paclitaxel requires the use of solvents, such as Cremphor-EL, which contribute to some of the toxicities commonly associated with paclitaxel-based therapy. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel. The formulation is prepared by high-pressure homogenization of paclitaxel in the presence of serum albumin into a nanoparticle colloidal suspension. The human albumin-stabilized paclitaxel particles have an average size of 130 nm. Nab-paclitaxel has several practical advantages over Cremphor-EL-paclitaxel, including a shorter infusion time (30 min) and no need for premedications for hypersensitivity reactions. The nab-paclitaxel formulation eliminates the impact of Cremphor-EL on paclitaxel pharmacokinetics and utilizes the endogenous albumin transport mechanisms to concentrate nab-paclitaxel within the tumor. A recent Phase III trial compared nab- and Cremphor-EL-paclitaxel in patients with metastatic breast cancer. Patients treated with nab-paclitaxel experienced a higher response, longer time to tumor progression and, in patients receiving second-line or greater therapy, a longer median survival. Patients treated with nab-paclitaxel had a significantly lower rate of severe neutropenia and a higher rate of sensory neuropathy. The preclinical and clinical data indicate that the nab-paclitaxel formulation has significant advantages over Cremphor-EL-paclitaxel.

Stability of multilead ST-segment "fingerprints" over time after percutaneous transluminal coronary angioplasty and its usefulness in detecting reocclusion.

Science.gov (United States)

Krucoff, M W; Parente, A R; Bottner, R K; Renzi, R H; Stark, K S; Shugoll, R A; Ahmed, S W; DeMichele, J; Stroming, S L; Green, C E

1988-06-01

Multilead ST-segment recordings taken during percutaneous transluminal coronary angioplasty (PTCA) could function as an individualized noninvasive template or "fingerprint," useful in evaluating transient ischemic episodes after leaving the catheterization laboratory. To evaluate the reproducibility of such ST-segment patterns over time, these changes were analyzed in patients grouped according to the time between occlusion and reocclusion. For the patients in group 1, the study required comparing their "fingerprints" in repeat balloon inflation during PTCA (reocclusion in less than 1 hour), for those in group 2, comparing ST "fingerprints" during PTCA with ST changes during spontaneous early myocardial infarction (reocclusion in 24 hours) and in group 3, comparing ST "fingerprints" with ST changes during repeat PTCA for restenosis greater than 1 month after the initial PTCA. The ST "fingerprints" among the 20 patients in group 1 were identical in 14 cases (70%) and clearly related in another 4 (20%). Of the 23 patients in group 2, 12 (52%) had the same and 8 (35%) had related patterns. Of 19 patients in group 3, 8 (42% had the same pattern and 8 (42%) had related patterns. Thus, ST fingerprints were the same or clearly related with reocclusion in the same patient from less than 1 hour to greater than 1 month after initial occlusion in 87% of patients overall, in 90% in less than 1 hour, in 87% in less than 24 hours and in 84% greater than 1 month later. Multilead pattern ST-segment "fingerprints" may serve as a noninvasive marker for detecting site-specific reocclusion.

Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

Science.gov (United States)

Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

2013-02-01

Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Percutaneous angioscopy

International Nuclear Information System (INIS)

Beck, A.

1987-01-01

In dogs and 11 patients a new endoscopic method for arteries has been developed. The approach is transfemoral, and endoscopy is combined with angiography, percutaneous transluminal angioplasty (PTA), and local lysis. An ultrathin endoscope with a diameter of 2.4 mm is used, which also provides a working channel with a diameter of 0.4 mm. Guide wires, contrast media, and drugs for local lysis can be inserted through this channel. Under fluoroscopic control, the endoscope is placed in the region of interest, followed by a special method for decreasing blood flow. Endoscopy is documented by video or by a high-speed camera. No complications have occurred. In all patients, it was possible to demonstrate the results of dilatation, recanalization, or local lysis before and after the interventional procedure. (orig.) [de

Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

Science.gov (United States)

Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

2006-01-01

To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

Science.gov (United States)

Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

2012-04-14

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions

DEFF Research Database (Denmark)

Richelsen, Rasmus Kapalu Broge; Overvad, Thure Filskov; Jensen, Svend Eggert

2016-01-01

Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used...

Peroxisome proliferator-activated receptor-gamma agonists suppress tissue factor overexpression in rat balloon injury model with paclitaxel infusion.

Directory of Open Access Journals (Sweden)

Jun-Bean Park

Full Text Available The role and underlying mechanisms of rosiglitazone, a peroxisome proliferator-activated receptor-gamma (PPAR-γ agonist, on myocardial infarction are poorly understood. We investigated the effects of this PPAR-γ agonist on the expression of tissue factor (TF, a primary molecule for thrombosis, and elucidated its underlying mechanisms. The PPAR-γ agonist inhibited TF expression in response to TNF-α in human umbilical vein endothelial cells, human monocytic leukemia cell line, and human umbilical arterial smooth muscle cells. The overexpression of TF was mediated by increased phosphorylation of mitogen-activated protein kinase (MAPK, which was blocked by the PPAR-γ agonist. The effective MAPK differed depending on each cell type. Luciferase and ChIP assays showed that transcription factor, activator protein-1 (AP-1, was a pivotal target of the PPAR-γ agonist to lower TF transcription. Intriguingly, two main drugs for drug-eluting stent, paclitaxel or rapamycin, significantly exaggerated thrombin-induced TF expression, which was also effectively blocked by the PPAR-γ agonist in all cell types. This PPAR-γ agonist did not impair TF pathway inhibitor (TFPI in three cell types. In rat balloon injury model (Sprague-Dawley rats, n = 10/group with continuous paclitaxel infusion, the PPAR-γ agonist attenuated TF expression by 70±5% (n = 4; P<0.0001 in injured vasculature. Taken together, rosiglitazone reduced TF expression in three critical cell types involved in vascular thrombus formation via MAPK and AP-1 inhibitions. Also, this PPAR-γ agonist reversed the paclitaxel-induced aggravation of TF expression, which suggests a possibility that the benefits might outweigh its risks in a group of patients with paclitaxel-eluting stent implanted.

A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial

NARCIS (Netherlands)

Serruys, Patrick W.; Ruygrok, Peter; Neuzner, Jörg; Piek, Jan J.; Seth, Ashok; Schofer, Joachim J.; Richardt, Gert; Wiemer, Marcus; Carrié, Didier; Thuesen, Leif; Boone, Els; Miquel-Herbert, Karine; Daemen, Joost

2006-01-01

Background: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.Methods: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting

In vitro haematic proteins adsorption and cytocompatibility study on acrylic copolymer to realise coatings for drug-eluting stents

International Nuclear Information System (INIS)

Gagliardi, Mariacristina

2012-01-01

In the present paper, a preliminary in vitro analysis of biocompatibility of newly-synthesised acrylic copolymers is reported. In particular, with the aim to obtain coatings for drug-eluting stents, blood protein absorption and cytocompatibility were studied. For protein absorption tests, bovine serum albumin and bovine plasma fibrinogen were considered. Cytocompatibility was tested using C2C12 cell line as model, analysing the behaviour of polymeric matrices and of drug-eluting systems, obtained loading polymeric matrices with paclitaxel, an anti-mitotic drug, in order to evaluate the efficacy of a pharmacological treatment locally administered from these materials. Results showed that the amount of albumin absorbed was greater than the amount of fibrinogen (comprised in the range of 70%–85% and 10%–22% respectively) and it is a good behaviour in terms of haemocompatibility. Cell culture tests showed good adhesion properties and a relative poor proliferation. In addition, a strong effect related to drug elution and a correlation with the macromolecular composition were detected. In this preliminary analysis, tested materials showed good characteristics and can be considered possible candidates to obtain coatings for drug-eluting stents. Highlights: ► Preliminary evaluation of haemo- and cytocompatibility of newly-synthesised acrylic copolymers ► Materials adsorb higher amounts of albumin and with a faster rate than fibrinogen. ► Protein adsorption depended on the macromolecular composition and surface properties. ► Cell viability on pure samples and efficacy of paclitaxel release were verified in C2C12 cultures.

In vitro haematic proteins adsorption and cytocompatibility study on acrylic copolymer to realise coatings for drug-eluting stents

Energy Technology Data Exchange (ETDEWEB)

Gagliardi, Mariacristina, E-mail: mariacristina.gagliardi@iit.it

2012-12-01

In the present paper, a preliminary in vitro analysis of biocompatibility of newly-synthesised acrylic copolymers is reported. In particular, with the aim to obtain coatings for drug-eluting stents, blood protein absorption and cytocompatibility were studied. For protein absorption tests, bovine serum albumin and bovine plasma fibrinogen were considered. Cytocompatibility was tested using C2C12 cell line as model, analysing the behaviour of polymeric matrices and of drug-eluting systems, obtained loading polymeric matrices with paclitaxel, an anti-mitotic drug, in order to evaluate the efficacy of a pharmacological treatment locally administered from these materials. Results showed that the amount of albumin absorbed was greater than the amount of fibrinogen (comprised in the range of 70%-85% and 10%-22% respectively) and it is a good behaviour in terms of haemocompatibility. Cell culture tests showed good adhesion properties and a relative poor proliferation. In addition, a strong effect related to drug elution and a correlation with the macromolecular composition were detected. In this preliminary analysis, tested materials showed good characteristics and can be considered possible candidates to obtain coatings for drug-eluting stents. Highlights: Black-Right-Pointing-Pointer Preliminary evaluation of haemo- and cytocompatibility of newly-synthesised acrylic copolymers Black-Right-Pointing-Pointer Materials adsorb higher amounts of albumin and with a faster rate than fibrinogen. Black-Right-Pointing-Pointer Protein adsorption depended on the macromolecular composition and surface properties. Black-Right-Pointing-Pointer Cell viability on pure samples and efficacy of paclitaxel release were verified in C2C12 cultures.

Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

Science.gov (United States)

Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

2013-06-01

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All

Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

DEFF Research Database (Denmark)

Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik

2015-01-01

BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety...... and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent. METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All......-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat...

Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

Science.gov (United States)

Baron, Suzanne J; Lei, Yang; Chinnakondepalli, Khaja; Vilain, Katherine; Magnuson, Elizabeth A; Kereiakes, Dean J; Ellis, Stephen G; Stone, Gregg W; Cohen, David J

2017-04-24

The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906). Copyright © 2017

Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents.

Science.gov (United States)

Yazdani, Saami K; Sheehy, Alexander; Pacetti, Stephen; Rittlemeyer, Brandon; Kolodgie, Frank D; Virmani, Renu

2016-10-01

Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo. © 2016, Wiley Periodicals, Inc.

Increased Plasma Cathepsin S at the Time of Percutaneous Transluminal Angioplasty is Associated with 6-Months’ Restenosis of the Femoropopliteal Artery

Directory of Open Access Journals (Sweden)

Mijovski Mojca Bozic

2018-01-01

Full Text Available Background: We tested the hypothesis that increased levels of cathepsin S and decreased levels of cystatin C in plasma at the time of percutaneous transluminal angioplasty (PTA are associated with the occurrence of 6-months’ restenosis of the femoropopliteal artery (FPA. Methods: 20 patients with restenosis and 24 matched patients with patent FPA after a 6-months follow-up were in - cluded in this study. They all exhibited disabling claudication or critical limb ischemia and had undergone technically successful PTA. They were all receiving statins and ACE in hi - bitors (or angiotensin II receptor antagonist before the PTA and the therapy did not change throughout the observational period. Plasma concentrations of C-reactive protein were < 10 mg/L and of creatinine within the reference range at the time of the PTA. Plasma concentration and activity of cathepsin S, together with its potent inhibitor cystatin C, were measured the day before and the day after the PTA. Results: The increased plasma concentration and activity of cathepsin S at the time of PTA was associated with the occurrence of 6-months’ restenosis of FPA, independently of established risk factors (lesion complexity, infrapopliteal run-off vessels, type of PTA, age, gender, smoking, diabetes, lipids and of cystatin C. Plasma cystatin C concentration was not associated with restenosis and did not correlate with cathepsin S activity and concentration in the plasma. Conclusion: Increased level of plasma cathepsin S at the time of PTA is associated with 6-months’ restenosis of PTA, independently of established risk factors.

Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

Science.gov (United States)

Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

2013-10-10

Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

An Italian cost-effectiveness analysis of paclitaxel albumin (nab-paclitaxel) versus conventional paclitaxel for metastatic breast cancer patients: the COSTANza study

Science.gov (United States)

Lazzaro, Carlo; Bordonaro, Roberto; Cognetti, Francesco; Fabi, Alessandra; De Placido, Sabino; Arpino, Grazia; Marchetti, Paolo; Botticelli, Andrea; Pronzato, Paolo; Martelli, Elisa

2013-01-01

Purpose Paclitaxel albumin (nab-paclitaxel) is a nanoparticle albumin-bound paclitaxel formulation aimed at increasing therapeutic index in metastatic breast cancer. When compared to conventional paclitaxel, nab-paclitaxel has a reported longer time to progression, higher response, lower incidence of neutropenia, no need for premedication, shorter time of administration, and in pretreated metastatic breast cancer patients, extended overall survival. This study investigates the cost-effectiveness of nab-paclitaxel versus conventional paclitaxel for pretreated metastatic breast cancer patients in Italy. Materials and methods A Markov model with progression-free, progressed, and dead states was developed to estimate costs, outcomes, and quality adjusted life years over 5 years from the Italian National Health Service viewpoint. Patients were assumed to receive nab-paclitaxel 260 mg/m2 three times weekly or conventional paclitaxel 175 mg/m2 three times weekly. Data on health care resource consumption was collected from a convenience sample of five Italian centers. Resources were valued at Euro (€) 2011. Published utility weights were applied to health states to estimate the impact of response, disease progression, and adverse events on quality adjusted life years. Three sensitivity analyses tested the robustness of the base case incremental cost-effectiveness ratio (ICER). Results and conclusion Compared to conventional paclitaxel, nab-paclitaxel gains an extra 0.165 quality adjusted life years (0.265 life years saved) and incurs additional costs of €2506 per patient treated. This translates to an ICER of €15,189 (95% confidence interval: €11,891–€28,415). One-way sensitivity analysis underscores that ICER for nab-paclitaxel remains stable despite varying taxanes cost. Threshold analysis shows that ICER for nab-paclitaxel exceeds €40,000 only if cost per mg of conventional paclitaxel is set to zero. Probabilistic sensitivity analysis highlights that nab-paclitaxel

Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

Science.gov (United States)

de Waha, Suzanne; Allali, Abdelhakim; Büttner, Heinz-Joachim; Toelg, Ralph; Geist, Volker; Neumann, Franz-Josef; Khattab, Ahmed A; Richardt, Gert; Abdel-Wahab, Mohamed

2016-03-01

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis

Science.gov (United States)

Stortecky, Stefan; Stefanini, Giulio G; daCosta, Bruno R; Rutjes, Anne Wilhelmina; Di Nisio, Marcello; Siletta, Maria G; Maione, Ausilia; Alfonso, Fernando; Clemmensen, Peter M; Collet, Jean-Philippe; Cremer, Jochen; Falk, Volkmar; Filippatos, Gerasimos; Hamm, Christian; Head, Stuart; Kappetein, Arie Pieter; Kastrati, Adnan; Knuuti, Juhani; Landmesser, Ulf; Laufer, Günther; Neumann, Franz-Joseph; Richter, Dimitri; Schauerte, Patrick; Sousa Uva, Miguel; Taggart, David P; Torracca, Lucia; Valgimigli, Marco; Wijns, William; Witkowski, Adam; Kolh, Philippe; Juni, Peter

2014-01-01

Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease. Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation. Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease. Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation. Main outcome measure All cause mortality. Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably

Feasibility study of natural orifice transluminal endoscopic surgery inguinal hernia repair.

Science.gov (United States)

Sherwinter, Danny A; Eckstein, Jeremy G

2009-07-01

A potentially less-invasive technique, transluminal surgery, may reduce or eliminate pain and decrease time to full return of activities after abdominal operations. Inguinal hernia repair is perfectly suited to the transgastric endoscopic approach and has not been previously reported. Our purpose was to evaluate the feasibility of transgastric bilateral inguinal herniorrhaphy (BIH). Feasibility study with a nonsurvival canine model. Under general anesthesia, male mongrel dogs weighing 20 to 30 kg had a dual-channel endoscope introduced into the peritoneal cavity over a percutaneously placed guidewire. An overtube with an insufflation channel was used. Peritoneoscopy was performed, and bilateral deep and superficial inguinal rings were identified. The endoscope was removed, premounted with a 4 x 6 cm acellular human dermal implant and then readvanced intraperitoneally through the overtube. The implant was then deployed across the entire myopectineal orifice and draped over the cord structures. Bioglue was then applied endoscopically, and the implant was attached to the peritoneum. After completion of bilateral repairs, the animals were killed and necropsy performed. Five dogs underwent pure natural orifice transluminal endoscopic surgery (NOTES) intraperitoneal onlay mesh (IPOM) BIH. Accurate placement and adequate myopectineal coverage was accomplished in all subjects. At necropsy no injuries to the major structures were noted but Bioglue misapplication with contamination of unintended sites did occur. Our study involved only a small number of subjects in nonsurvival experiments, and no gastric closure was used. Many of the characteristics of inguinal hernia repair are especially well suited to the transgastric approach. The repair is in line with the transgastric endoscope vector, bilateral defects are adjacent, and the IPOM technique does not require significant manipulation or novel instrumentation.

Nickel elution properties of contemporary interatrial shunt closure devices.

Science.gov (United States)

Verma, Divya Ratan; Khan, Muhammad F; Tandar, Anwar; Rajasekaran, Namakkal S; Neuharth, Renée; Patel, Amit N; Muhlestein, Joseph B; Badger, Rodney S

2015-02-01

We sought to compare nickel elution properties of contemporary interatrial shunt closure devices in vitro. There are two United States Food and Drug Administration (FDA)-approved devices for percutaneous closure of secundum atrial septal defect: the Amplatzer septal occluder (ASO; St Jude Medical Corporation) and Gore Helex septal occluder (HSO; W.L. Gore & Associates). The new Gore septal occluder (GSO) device is in clinical trials. These are also used off-label for patent foramen ovale closure in highly selected patients. These devices have high nickel content. Nickel allergy is the most common reason for surgical device explantation. Nickel elution properties of contemporary devices remain unknown. We compared nickel elution properties of 4 devices - ASO, GSO, HSO, and sternal wire (SW) - while Dulbecco's phosphate-buffered saline (DPBS) served as control. Three samples of each device were submerged in DPBS. Nickel content was measured at 14 intervals over 90 days. Nickel elution at 24 hours, compared to control (0.005 ± 0.0 mg/L), was significantly higher for ASO (2.98 ± 1.65 mg/L; P=.04) and SW (0.03 ± 0.014 mg/L; P=.03). Nickel levels at 90 days, compared to control (0.005 ± 0.0 mg/L) and adjusting for multiple comparisons, were significantly higher for ASO (19.80 ± 2.30 mg/L; P=.01) and similar for HSO (P=.34), GSO (P=.34), and SW (P=.34). ASO had significantly higher nickel elution compared to HSO, GSO, and SW (P=.01). There is substantial variability in nickel elution; devices with less exposed nickel (HSO and GSO) have minimal elution. The safety of low nickel elution devices in patients with nickel allergy needs to be evaluated in prospective trials.

[Drug-eluting stent thrombosis and its pharmacological prevention].

Science.gov (United States)

Pershukov, I V; Batyraliev, T A

2007-01-01

The problem of drug eluting stents (DES) safety has been actively discussed throughout 2006 because of increase of frequency of development of late stent thromboses which were noted during almost 2 years after stenting. In December 2006 US Food and Drug Administration (FDA) advisory panel acknowledged increase of development of late stent thrombosis. At the same time FDA accepted new definition of stent-thrombosis suggested by the Academic Research Consortium. According to this definition thrombosis can be definite, probable and possible. Any unexplained death before end of follow-up in a trial should be considered thrombosis related. Recalculation of thrombosis rate using this definition caused pronounced increase of this parameter in previously conducted trials. Thrombosis rate rose from 0,6 to 3,3% for bare metal stents, from 0,8 to 3,6% for sirolimus eluting stents and from 1,3 to 3,5% for paclitaxel eluting stents. Professional cardiological and angiographical societies (ACC, AHA, SCAI) responding to FDA advisory panel published their proofs and vision of the problem of stent thrombosis. In February 2007 ACC, AHA, SCAI, American College of Surgeons and Association of Dentists published scientific bulletin in which described preventive measures aimed at lowering of risk of thrombosis development. This document contains strict recommendation to continue double antithrombotic therapy with aspirin and clopidogrel for 12 months after implantation of DES or abandonment of the use of this type of stents when long term double antithrombotic therapy is not possible.

Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial

DEFF Research Database (Denmark)

Galløe, Anders M; Thuesen, Leif; Kelbaek, Henning

2008-01-01

Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.......Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients....

Evaluation of In-111 DTPA-paclitaxel scintigraphy to predict response on murine tumors to paclitaxel

International Nuclear Information System (INIS)

Inoue, Tomio; Li, C.; Yang, D.J.

1999-01-01

Our goal was to determine whether scintigraphy with 111 In-DTPA-paclitaxel could predict the response to chemotherapy with paclitaxel. Ovarian carcinoma (OCA 1), mammary carcinoma (MCA-4), fibrosarcoma (FSA) and squamous cell carcinoma (SCC VII) were inoculated into the thighs of female C3Hf/Kam mice. Mice bearing 8 mm tumors were treated with paclitaxel (40 mg/kg). The growth delay, which was defined as the time in days for tumors in the treated groups to grow from 8 to 12 mm in diameter minus the time in days for tumors in the untreated control group to reach the same size, was measured to determine the effect of paclitaxel on the tumors. Sequential scintigraphy in mice bearing 10 to 14 mm tumors was conducted at 5, 30, 60, 120, 240 min and 24 hrs postinjection of 111 In-DTPA-paclitaxel (3.7 MBq) or 111 In-DTPA as a control tracer. The tumor uptakes (% injection dose/pixel) were determined. The growth delay of OCA 1, MCA-4, FSA and SCC VII tumors was 13.6, 4.0, -0.02 and -0.28 days, respectively. In other words, OCA 1 and MCA-4 were paclitaxel-sensitive tumors, whereas FSA and SCC VII were paclitaxel-resistant tumors. The tumor uptakes at 24 hrs postinjection of In-111 DTPA paclitaxel of OCA 1, MCA-4, FSA and SCC VII were 1.0 x 10 -3 , 1.6 x 10 -3 , 2.2 x 10 -3 and 9.0 x 10 -3 % injection dose/pixel, respectively. There was no correlation between the response to chemotherapy with paclitaxel and the tumor uptakes of 111 In-DTPA-paclitaxel. Scintigraphy with 111 In-DTPA-paclitaxel could not predict the response to paclitaxel chemotherapy. Although there was significant accumulation of the paclitaxel in the tumor cells, additional mechanisms must be operative for the agent to be effective against the neoplasm. 111 In-DTPA-paclitaxel activity is apparently different from that of paclitaxel with Cremophor. (author)

Novel paclitaxel-coated angioplasty balloon catheter based on cetylpyridinium salicylate: Preparation, characterization and simulated use in an in vitro vessel model

Energy Technology Data Exchange (ETDEWEB)

Petersen, Svea, E-mail: svea.petersen@uni-rostock.de [Institute for Biomedical Engineering, University of Rostock, Friedrich-Barnewitz-Straße 4, 18119 Rostock (Germany); Kaule, Sebastian [Institute for Biomedical Engineering, University of Rostock, Friedrich-Barnewitz-Straße 4, 18119 Rostock (Germany); Stein, Florian [Institute for Chemistry, Analytical and Technical Chemistry University of Rostock, Albert-Einstein-Straße 3a, 18059 Rostock (Germany); Minrath, Ingo; Schmitz, Klaus-Peter [Institute for Biomedical Engineering, University of Rostock, Friedrich-Barnewitz-Straße 4, 18119 Rostock (Germany); Kragl, Udo [Institute for Chemistry, Analytical and Technical Chemistry University of Rostock, Albert-Einstein-Straße 3a, 18059 Rostock (Germany); Sternberg, Katrin [Institute for Biomedical Engineering, University of Rostock, Friedrich-Barnewitz-Straße 4, 18119 Rostock (Germany)

2013-10-15

Drug-coated balloons (DCB), which have emerged as therapeutic alternative to drug-eluting stents in percutaneous cardiovascular intervention, are well described with regard to clinical efficiency and safety within a number of clinical studies. In vitro studies elucidating the correlation of coating method and composition with DCB performance are however rare but considered important for the understanding of DCB requirements and the improvement of established DCB. In this context, we evaluated the applicability of a pipetting, dip-coating, and spray-coating process for the establishment of DCB based on paclitaxel (PTX) and the ionic liquid cetylpyridinium salicylate (Cetpyrsal) as novel innovative additive in three different compositions. Among tested methods and compositions, the pipetting process with 50 wt.% PTX resulted in most promising coatings as drug load was less controllable by the other processes and higher PTX contents led to considerable drug crystallization, as visualized by electron microscopy, accelerating PTX loss during short-term elution. Applying these conditions, homogeneous coatings could be applied on balloon catheter, whose simulated use in an in vitro vessel model revealed percental drug losses of 36 and 28% during transit and percental drug transfers of 12 and 40% under expansion for coatings applied in expanded and folded balloon condition, respectively. In comparison to literature values, these results support the high potential of Cetpyrsal as novel DCB matrix regarding low drug loss and efficient drug transfer. - Highlights: • We provide detailed in vitro data for definition of DCB coating requirements. • An in vitro vessel model for evaluating drug delivery from DCB is presented. • Innovative ionic liquid-based coatings for DCB are developed. • The coating shows low drug loss and efficient drug transfer.

Novel paclitaxel-coated angioplasty balloon catheter based on cetylpyridinium salicylate: Preparation, characterization and simulated use in an in vitro vessel model

International Nuclear Information System (INIS)

Petersen, Svea; Kaule, Sebastian; Stein, Florian; Minrath, Ingo; Schmitz, Klaus-Peter; Kragl, Udo; Sternberg, Katrin

2013-01-01

Drug-coated balloons (DCB), which have emerged as therapeutic alternative to drug-eluting stents in percutaneous cardiovascular intervention, are well described with regard to clinical efficiency and safety within a number of clinical studies. In vitro studies elucidating the correlation of coating method and composition with DCB performance are however rare but considered important for the understanding of DCB requirements and the improvement of established DCB. In this context, we evaluated the applicability of a pipetting, dip-coating, and spray-coating process for the establishment of DCB based on paclitaxel (PTX) and the ionic liquid cetylpyridinium salicylate (Cetpyrsal) as novel innovative additive in three different compositions. Among tested methods and compositions, the pipetting process with 50 wt.% PTX resulted in most promising coatings as drug load was less controllable by the other processes and higher PTX contents led to considerable drug crystallization, as visualized by electron microscopy, accelerating PTX loss during short-term elution. Applying these conditions, homogeneous coatings could be applied on balloon catheter, whose simulated use in an in vitro vessel model revealed percental drug losses of 36 and 28% during transit and percental drug transfers of 12 and 40% under expansion for coatings applied in expanded and folded balloon condition, respectively. In comparison to literature values, these results support the high potential of Cetpyrsal as novel DCB matrix regarding low drug loss and efficient drug transfer. - Highlights: • We provide detailed in vitro data for definition of DCB coating requirements. • An in vitro vessel model for evaluating drug delivery from DCB is presented. • Innovative ionic liquid-based coatings for DCB are developed. • The coating shows low drug loss and efficient drug transfer

Evaluation of the restenosis of coronary artery after percutaneous transluminal coronary angioplasty by three-dimensional coronary magnetic resonance angiography

International Nuclear Information System (INIS)

Arisaka, Hiraku

2000-01-01

Coronary magnetic resonance angiography (MRA) has been recently brought into clinical use, however, there has not been reports on the comparison with MRA and conventional contrast coronary angiography (CAG) in the detection of the localization and characteristics of coronary restenosis after percutaneous transluminal coronary angioplasty (PTCA). To assess the restenosis of coronary artery after PTCA, this study compared three-dimensional (3D) coronary MRA and CAG. One hundred three patients (76 males and 27 females, average age of 64.6±9.3 years old) were performed coronary MRA at 3-6 months after PTCA. The right coronary artery (RCA) group consist of 21 patients, the left anterior descending branch (LAD) 63 patients and the left circumflex branch (LCX) 19 patients. Coronary MRA was performed with the patients in supine position on a 1.5 T whole body scanner (MAGNETOM VISION, Siemens AG, Germany) using body array coil. The imaging technique used a 3-D gradient echo sequence with respiratory gating and fat suppression. The slice thickness was 2 mm, slab thickness 32 mm, a field of view of 300 mm and a matrix of 128 x 256. Other parameters were an echo time of 2.7 ms and a repetition time of 600 to 1100 msec. The measurement time of 1 imaging slab took 15 to 20 minutes depending on the patient's heart rate. The coronary arteries were reconstructed from the 3-D data set using a multiplanar reconstruction (MPR) technique. According to previous coronary MRA studies, a significant stenosis with a luminal reduction of ≥50% was assumed if a marked signal reduction or signal loss of a vessel segment was visible. In CAG, 57 of 103 patients showed restenosis. In coronary MRA, 37 of 103 patients demonstrated restenosis. The sensitivity, specificity, positive and negative predictive values were 64.9%, 100%, 100% and 69.6%, respectively. Predictive accuracy was 79.6%. Three-dimensional coronary MRA is useful in a noninvasive diagnostic method to evaluate the coronary

Herbal Medicine Goshajinkigan Prevents Paclitaxel-Induced Mechanical Allodynia without Impairing Antitumor Activity of Paclitaxel

Directory of Open Access Journals (Sweden)

Muh. Akbar Bahar

2013-01-01

Full Text Available Chemotherapy-induced peripheral neuropathy is a major dose-limiting side effect of commonly used chemotherapeutic agents. However, there are no effective strategies to treat the neuropathy. We examined whether Goshajinkigan, a herbal medicine, would prevent paclitaxel-induced allodynia without affecting the anticancer action in mice. Murine breast cancer 4T1 cells were inoculated into the mammary fat pad. Paclitaxel (10 and 20 mg/kg, intraperitoneal, alternate day from day 7 postinoculation inhibited the tumor growth, and Goshajinkigan (1 g/kg, oral, daily from day 2 postinoculation did not affect the antitumor action of paclitaxel. Mechanical allodynia developed in the inoculated region due to tumor growth and in the hind paw due to paclitaxel-induced neuropathy. Paclitaxel-induced allodynia was markedly prevented by Goshajinkigan, although tumor-associated allodynia was not inhibited by Goshajinkigan. These results suggest that Goshajinkigan prevents paclitaxel-induced peripheral neuropathy without interfering with the anti-cancer action of paclitaxel.

Paclitaxel Injection

Science.gov (United States)

(pak'' li tax' el)Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell ...

77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2012-06-14

... Paclitaxel- February 22, 2012. Corp. Eluting Coronary Stent System (Monorail and Over- The-Wire Delivery...] February 22, 2012. Corp. Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery.... Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). P110023, FDA-2012-M...

Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty.

Science.gov (United States)

Inami, Takumi; Kataoka, Masaharu; Shimura, Nobuhiko; Ishiguro, Haruhisa; Yanagisawa, Ryoji; Taguchi, Hiroki; Fukuda, Keiichi; Yoshino, Hideaki; Satoh, Toru

2013-07-01

This study sought to identify useful predictors for hemodynamic improvement and risk of reperfusion pulmonary edema (RPE), a major complication of this procedure. Percutaneous transluminal pulmonary angioplasty (PTPA) has been reported to be effective for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). PTPA has not been widespread because RPE has not been well predicted. We included 140 consecutive procedures in 54 patients with CTEPH. The flow appearance of the target vessels was graded into 4 groups (Pulmonary Flow Grade), and we proposed PEPSI (Pulmonary Edema Predictive Scoring Index) = (sum total change of Pulmonary Flow Grade scores) × (baseline pulmonary vascular resistance). Correlations between occurrence of RPE and 11 variables, including hemodynamic parameters, number of target vessels, and PEPSI, were analyzed. Hemodynamic parameters significantly improved after median observation period of 6.4 months, and the sum total changes in Pulmonary Flow Grade scores were significantly correlated with the improvement in hemodynamics. Multivariate analysis revealed that PEPSI was the strongest factor correlated with the occurrence of RPE (p PEPSI to be a useful marker of the risk of RPE (cutoff value 35.4, negative predictive value 92.3%). Pulmonary Flow Grade score is useful in determining therapeutic efficacy, and PEPSI is highly supportive to reduce the risk of RPE after PTPA. Using these 2 indexes, PTPA could become a safe and common therapeutic strategy for CTEPH. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Type D personality predicts death or myocardial infarction after bare metal stent or sirolimus-eluting stent implantation

DEFF Research Database (Denmark)

Pedersen, Susanne S.; Lemos, Pedro A; van Vooren, Priya R

2004-01-01

We investigated the effect of Type D personality on the occurrence of adverse events at nine months in patients with ischemic heart disease (IHD) after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SESs) or bare stents. Type D patients experience increased negative...

Optimization of Drug Delivery by Drug-Eluting Stents.

Directory of Open Access Journals (Sweden)

Franz Bozsak

Full Text Available Drug-eluting stents (DES, which release anti-proliferative drugs into the arterial wall in a controlled manner, have drastically reduced the rate of in-stent restenosis and revolutionized the treatment of atherosclerosis. However, late stent thrombosis remains a safety concern in DES, mainly due to delayed healing of the endothelial wound inflicted during DES implantation. We present a framework to optimize DES design such that restenosis is inhibited without affecting the endothelial healing process. To this end, we have developed a computational model of fluid flow and drug transport in stented arteries and have used this model to establish a metric for quantifying DES performance. The model takes into account the multi-layered structure of the arterial wall and incorporates a reversible binding model to describe drug interaction with the cells of the arterial wall. The model is coupled to a novel optimization algorithm that allows identification of optimal DES designs. We show that optimizing the period of drug release from DES and the initial drug concentration within the coating has a drastic effect on DES performance. Paclitaxel-eluting stents perform optimally by releasing their drug either very rapidly (within a few hours or very slowly (over periods of several months up to one year at concentrations considerably lower than current DES. In contrast, sirolimus-eluting stents perform optimally only when drug release is slow. The results offer explanations for recent trends in the development of DES and demonstrate the potential for large improvements in DES design relative to the current state of commercial devices.

Percutaneous treatment of transplant renal artery stenosis in children.

Science.gov (United States)

Repetto, Horacio A; Rodríguez-Rilo, Laila; Mendaro, Esteban; Basso, Laura; Galvez, Hugo; Morrone, Gabriela; Vazquez, Luis A

2004-12-01

Percutaneous treatment of renal artery stenosis (RAS) is an accepted procedure and numerous reports have been published. However, experience with its use in RAS in the transplanted kidney in children is scarce. Since 1994 we have diagnosed RAS in seven children with the use of Doppler ultrasonography (US), confirming it with percutaneous angiography (PAG). In six of the seven patients percutaneous transluminal angioplasty (PTA) was performed. In one patient a metallic stent was placed due to the extension of the arterial lesion, and a second stent was placed in another child when a re-stenosis was diagnosed 1 month after the PTA. All patients presented with hypertension (de novo or 30% increase over previous values). After ruling out acute rejection, calcineurin inhibitor toxicity, and urinary obstruction, US was performed and, when an increase in arterial flux velocity was registered, PAG was also performed. Six children showed an increase in serum creatinine (Cr) and proteinuria. Blood pressure decreased after the procedure and Cr returned to previous levels in all children. One of the grafts was lost due to chronic transplant rejection 7 years later. The other children have a functioning kidney. Although this is a small group of patients, the consistently good results and the lack of reported experience prompted us to communicate our preliminary observation.

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

Science.gov (United States)

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

2016-06-27

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Clinical effectiveness of percutaneous angioplasty for acute and chronic mesenteric ischemia: a six case series.

Science.gov (United States)

Jung, Yu Min; Jo, Yun Ju; Ahn, Sang Bong; Son, Byoung Kwan; Kim, Seong Hwan; Park, Young Sook; Bae, June Ho; Cho, Young Kwon

2011-04-01

Intestinal ischemia is divided into three categories, namely, acute mesenteric ischemia (AMI), chronic mesenteric ischemia (CMI), and colonic ischemia. AMI can result from arterial or venous thrombi, emboli, and vasoconstriction secondary to low-flow states. It is an urgent condition which can result in high mortality rate. The predominant causative factor of CMI is stenosis or occlusion of the mesenteric arterial circulation, and it is characterized by postprandial abdominal pain and weight loss. Surgery is the treatment of choice for intestinal ischemia. However, it has been recently reported that percutaneous transluminal angioplasty with stent placement and/or thrombolysis is an effective therapy in various types of mesenteric ischemia. We report six cases of mesenteric ischemia which were successfully treated by percutaneous angioplasty, and review the literature from South Korea.

Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention.

Science.gov (United States)

Baschet, Louise; Bourguignon, Sandrine; Marque, Sébastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

2016-01-01

To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117 762 patient-years with 76 randomised trials. The main effectiveness criterion was major cardiac event-free survival. Effectiveness and costs were modelled over a 5-year horizon using a three-state Markov model. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were calculated for a range of thresholds for willingness to pay per year without major cardiac event gain. Deterministic and probabilistic sensitivity analyses were performed. Base case results demonstrated that DES are dominant over BMS, with an increase in event-free survival and a cost-reduction of €184, primarily due to a diminution of second revascularisations, and an absence of myocardial infarction and stent thrombosis. These results are robust for uncertainty on one-way deterministic and probabilistic sensitivity analyses. Using a cost-effectiveness threshold of €7000 per major cardiac event-free year gained, DES has a >95% probability of being cost-effective versus BMS. Following DES price decrease, new-generation DES development and taking into account recent meta-analyses results, the DES can now be considered cost-effective regardless of selective indication in France, according to European recommendations.

Coated stents to prevent restenosis in coronary heart disease

Directory of Open Access Journals (Sweden)

Hagen, Anja

2005-11-01

Full Text Available Background: In-stent-restenosis (ISR is considered to be an essential limiting factor of stenting in coronary heart disease (CHD. The development of coated stents has raised expectations on substantial lowering restenosis after stenting with decreasing the rate of restenosis and a reduction in the rate of clinical events. Objectives: The present analysis addresses the questions on medical effectiveness and cost-effectiveness of the use of various coated stent types in CHD. Methods: The literature was searched in December 2004 in the most relevant medical and economic databases. The medical evaluation was conducted on the basis of published RCT. The data from the studies regarding various angiographic, sonographic and clinical endpoints were checked for methodical quality and summarised in meta-analyses. Within the scope of economic evaluation the primary studies were analysed and modelling was performed, applying clinical effect estimates from the meta-analyses of the medical evaluation and current estimates of German costs. Results: Medical evaluation: Ten different stenttypes were used in the included 26 RCT. The results for heparin, silicon-carbide, carbon and PTFE coated stenttypes could not reveal any significant differences between the medical effectiveness of coated and uncoated stents. The application of sirolimus, paclitaxel, everolimus and 7-hexanoyltaxol eluting stents showed a significant lower restenosis at 6-9 months with decrease in the rate of restenosis for polymer-based sirolimus, paclitaxel and 7-hexanoyltaxol eluting stents. In contrast, the use of gold-coated and actinomycin-D eluting stents was associated with a significantly higher restenosis. The polymer-based sirolimus and paclitaxel eluting stents also showed a significant and considerable reduction in the rate of repeated percutaneous revascularisations at 6-12 months (3.5% vs. 19.7%; p<0.0001, RR=0.19 [95%CI: 0.11; 0.33] and 3.5% vs. 12.2%; p<0.0001, RR=0.30 [95%CI: 0

Histologic Assessment of Drug-Eluting Grafts Related to Implantation Site

Directory of Open Access Journals (Sweden)

Jean-Christophe Tille

2016-02-01

Full Text Available Drug-eluting vascular prostheses represent a new direction in vascular surgery to reduce early thrombosis and late intimal hyperplasia for small calibre grafts. Subcutaneous implantation in rats is a rapid and cost-effective screening model to assess the drug-elution effect and could, to some extent, be useful to forecast results for vascular prostheses. We compared biological and histological responses to scaffolds in different implantation sites. Polycaprolactone (PCL, paclitaxel-loaded PCL (PCL-PTX and dexamethasone-loaded PCL (PCL-DXM electrospun scaffolds were implanted subcutaneously and in an infrarenal abdominal aortic model in rats for up to 12 weeks. At the conclusion of the study, a histological analysis was performed. Cellular graft invasion revealed differences in the progression of cellular infiltration between PCL-PTX and PCL/PCL-DXM groups in both models. Cell infiltration increased over time in the aortic model compared to the subcutaneous model for all groups. Cell counting revealed major differences in fibroblast, macrophage and giant cell graft colonisation in all groups and models over time. Macrophages and giant cells increased in the PCL aortic model; whereas in the subcutaneous model these cell types increased only after three weeks or even decreased in the drug-eluting PCL groups. Other major findings were observed only in the aortic replacement such as extracellular matrix deposition and neo-angiogenesis. The subcutaneous implant model can be used for screening, especially when drug-eluting effects are studied. However, major histological differences were observed in cell type reaction and depth of cell penetration compared to the aortic model. Our results demonstrate that the implantation site is a critical determinant of the biological response.

Long-Term Outcomes and Toxicity of Concurrent Paclitaxel and Radiotherapy for Locally Advanced Head-and-Neck Cancer

International Nuclear Information System (INIS)

Citrin, Deborah; Mansueti, John; Likhacheva, Anna; Sciuto, Linda; Albert, Paul S.; Rudy, Susan F.; Cooley-Zgela, Theresa; Cotrim, Ana; Solomon, Beth; Colevas, A. Dimitrios; Russo, Angelo; Morris, John C.; Herscher, Laurie; Smith, Sharon

2009-01-01

Purpose: To report the long-term outcomes and toxicity of a regimen of infusion paclitaxel delivered concurrently with radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck. Patients and Methods: Between 1995 and 1999, 35 patients with nonmetastatic, Stage III or IV squamous cell carcinoma of the head and neck were treated with three cycles of paclitaxel as a 120-h continuous infusion beginning on Days 1, 21, and 42, concurrent with radiotherapy. The initial 16 patients received 105 mg/m 2 /cycle, and the subsequent 19 patients received 120 mg/m 2 /cycle. External beam radiotherapy was delivered to a dose of 70.2-72 Gy at five fractions weekly. Patients were followed to evaluate the disease outcomes and late toxicity of this regimen. Results: The median follow-up for all patients was 56.5 months. The median survival was 56.5 months, and the median time to local recurrence was not reached. Of the 35 patients, 15 (43%) developed hypothyroidism. Of the 33 patients who underwent percutaneous endoscopic gastrostomy tube placement, 11 were percutaneous endoscopic gastrostomy tube dependent until death or their last follow-up visit. Also, 5 patients (14%) required a tracheostomy until death, and 3 (9%) developed a severe esophageal stricture. All evaluated long-term survivors exhibited salivary hypofunction. Fibrosis in the radiation field occurred in 24 patients (69%). Conclusion: The results of our study have shown that concurrent chemoradiotherapy with a 120-h infusion of paclitaxel provides long-term local control and survival in patients with squamous cell carcinoma of the head and neck. Xerostomia, hypothyroidism, esophageal and pharyngeal complications, and subcutaneous fibrosis were common long-term toxicities; however, the vast majority of toxicities were grade 1 or 2.

Clinical Pharmacokinetics of Paclitaxel Monotherapy

DEFF Research Database (Denmark)

Stage, Tore B; Bergmann, Troels K; Kroetz, Deanna L

2018-01-01

Paclitaxel is an anticancer agent efficacious in the treatment of ovarian, breast, and lung cancer. Due to a strong link between the pharmacokinetics and therapeutic efficacy of paclitaxel, we reviewed the literature on paclitaxel pharmacokinetics. Systematic data mining was performed to extract ...

Clopidogrel paclitaxel drug-drug interaction

DEFF Research Database (Denmark)

Agergaard, K; Mau-Sørensen, M; Stage, T B

2017-01-01

register. Peripheral sensory neuropathy was retrospectively evaluated from medical charts and compared to that of 88 age and sex matched controls treated with paclitaxel and low dose aspirin. By a cumulative dose of 1500 mg paclitaxel, 35% of the patients had developed severe neuropathy. The overall hazard...... ratio between clopidogrel use and severe paclitaxel neuropathy was 1.7 (95% CI, 0.9-3.0). Among those receiving a high dose paclitaxel regimen, the hazard ratio was 2.3 (95% CI, 1.1-4.5). Our study indicates that clopidogrel is associated with a clinically relevant increased risk of neuropathy......Paclitaxel is mainly eliminated by CYP2C8 in the liver. CYP2C8 is strongly inhibited by the clopidogrel metabolite acyl-β-D-glucuronide. To determine if this interaction has clinical relevance, we identified 48 patients treated with clopidogrel and paclitaxel using databases and a prescription...

Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

Science.gov (United States)

Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

2016-02-08

This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease

NARCIS (Netherlands)

P.W.J.C. Serruys (Patrick); M-C. Morice (Marie-Claude); A.P. Kappetein (Arie Pieter); A. Colombo (Antonio); D.R. Holmes Jr (David); M.J. Mack (Michael); E. Stahle (Elisabeth); T.E. Feldman (Ted); M.J.B.M. van den Brand (Marcel); E.J. Bass (Eric); N. van Dyck (Nic); K. Leadly (Katrin); K.D. Dawkins (Keith); F.W. Mohr (Friedrich)

2009-01-01

textabstractBACKGROUND Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating

Impaired health status in Type D patients following PCI in the drug-eluting stent era

DEFF Research Database (Denmark)

Pedersen, Susanne S.; Denollet, Johan; Ong, Andrew T L

2007-01-01

Drug-eluting stenting reduces restenosis post-percutaneous coronary intervention (PCI), but subgroups of patients may not benefit optimally from this procedure. We examined the impact of Type D personality on health status over time and the clinical relevance of Type D as a predictor of impaired...... health status at 12 months in unselected post-PCI patients....

Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

Science.gov (United States)

Lee, Pil Hyung; Lee, Jong-Young; Lee, Cheol Whan; Kim, Seon-Ok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

2018-01-01

The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation. © 2018 American Heart Association, Inc.

Progress in the study of drug-eluting intra-stent thrombosis

International Nuclear Information System (INIS)

Guo Zhifu; Zheng Xing; Qin Yongwen

2007-01-01

Durg-eluting stent has been regarded as the milestone in the history of PCI for their efficiency in the prevention of coronary arterial restenosis after percutaneous coronary intervention. But unfortunately intra-stent thrombosis continues to be a serious complication of contemporary DES use. The incidence of drug-eluting stents thrombosis is at least not lower than that of bare metal stents at present. The clinical consequences of stent thrombosis are frequently catastrophic, including death in 40% to 50% of the cases or major myocardial infarction in 60% to 70%. Premature discontinuation of standard antiplatelet therapy is by far the most important predictor of stent thrombosis with DES and other predictors included renal failure, diabetes, bifurcation lesions, multiple lesions or multivessel disease, long stents, female, advanced age, stent underexpansion and residual stenosis etc. The delayed endothelialization may be the underling mechanism of DES thrombosis. (authors)

Endothelial cell repopulation after stenting determines in-stent neointima formation: effects of bare-metal vs. drug-eluting stents and genetic endothelial cell modification.

Science.gov (United States)

Douglas, Gillian; Van Kampen, Erik; Hale, Ashley B; McNeill, Eileen; Patel, Jyoti; Crabtree, Mark J; Ali, Ziad; Hoerr, Robert A; Alp, Nicholas J; Channon, Keith M

2013-11-01

Understanding endothelial cell repopulation post-stenting and how this modulates in-stent restenosis is critical to improving arterial healing post-stenting. We used a novel murine stent model to investigate endothelial cell repopulation post-stenting, comparing the response of drug-eluting stents with a primary genetic modification to improve endothelial cell function. Endothelial cell repopulation was assessed en face in stented arteries in ApoE(-/-) mice with endothelial-specific LacZ expression. Stent deployment resulted in near-complete denudation of endothelium, but was followed by endothelial cell repopulation, by cells originating from both bone marrow-derived endothelial progenitor cells and from the adjacent vasculature. Paclitaxel-eluting stents reduced neointima formation (0.423 ± 0.065 vs. 0.240 ± 0.040 mm(2), P = 0.038), but decreased endothelial cell repopulation (238 ± 17 vs. 154 ± 22 nuclei/mm(2), P = 0.018), despite complete strut coverage. To test the effects of selectively improving endothelial cell function, we used transgenic mice with endothelial-specific overexpression of GTP-cyclohydrolase 1 (GCH-Tg) as a model of enhanced endothelial cell function and increased NO production. GCH-Tg ApoE(-/-) mice had less neointima formation compared with ApoE(-/-) littermates (0.52 ± 0.08 vs. 0.26 ± 0.09 mm(2), P = 0.039). In contrast to paclitaxel-eluting stents, reduced neointima formation in GCH-Tg mice was accompanied by increased endothelial cell coverage (156 ± 17 vs. 209 ± 23 nuclei/mm(2), P = 0.043). Drug-eluting stents reduce not only neointima formation but also endothelial cell repopulation, independent of strut coverage. In contrast, selective targeting of endothelial cell function is sufficient to improve endothelial cell repopulation and reduce neointima formation. Targeting endothelial cell function is a rational therapeutic strategy to improve vascular healing and decrease neointima formation after stenting.

Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

DEFF Research Database (Denmark)

Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

2008-01-01

BACKGROUND: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis...... Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very...... late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted...

77 FR 11120 - Scientific Information Request on Treatment Strategies for Patients With Peripheral Artery...

Science.gov (United States)

2012-02-24

... transluminal angioplasty, atherectomy, or stents), and/or surgical revascularization (endarterectomy, bypass... endovascular intervention (percutaneous transluminal angioplasty, atherectomy, or stents) and surgical...

Incidence of vascular complications in patients submitted to percutaneous transluminal coronary angioplasty by transradial and transfemoral arterial approach Incidencia de complicaciones vasculares en pacientes sometidos a angioplastía coronaria transluminal percutánea por vía arterial transradial y transfemoral Incidência de complicações vasculares em pacientes submetidos a angioplastia coronariana transluminal percutânea por via arterial transradial e transfemoral

Directory of Open Access Journals (Sweden)

Marinez Kellermann Armendaris

2008-03-01

Full Text Available OBJECTIVE: To describe the vascular complications of transradial and transfemoral artery punctures in patients submitted to percutaneous transluminal coronary angioplasty (PTCA. METHODS: Prospective cohort study including patients submitted to PTCA. An interview was performed and an instrument applied to collect risk factors/predictors of complications. After the procedure, a physical examination was performed, vital signs were measured and the puncture site was assessed. RESULTS: 199 patients were included, age 64±10 years. Complications found for the radial and femoral approach were respectively: ecchymosis (18.29%, (17.14%; bruising (17.66%, (14.27%; urinary retention (2.43%, (25.71%; loss of vessel permeability (8.53%, (0%. CONCLUSION: The complications found were considered minor or secondary, depending on the classification found in literature. A higher rate of vascular complications related to transradial artery punctures compared to the interventions performed by transfemoral approach.OBJETIVO: Describir complicaciones vasculares relacionadas a punciones arteriales transradial y transfemoral en pacientes sometidos a angioplastía coronaria transluminal percutánea (ACTP. MÉTODOS: Se trata de un estudio de cohorte prospectivo realizado con pacientes sometidos a ACTP. Se llevó a cabo una entrevista y aplicó un instrumento para obtener factores de riesgo/predictores. Fue realizado un examen físico, medición de signos vitales y se evaluó el lugar de punción. RESULTADOS: Fueron incluidos 199 pacientes, edad 64±10 años. Las complicaciones encontradas para vía radial y femoral respectivamente, fueron: esquimosis (18,29%, (17,14%; hematoma (17,66%, (14,27%; retención urinaria (2,43%, (25,71%; pérdida de permeabilidad de vaso (8,53%, (0%. CONCLUSIÓN: Las complicaciones fueron consideradas menores o secundarias conforme clasificación literaria. Existe una mayor incidencia de complicaciones vasculares relacionadas a punciones

Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention

DEFF Research Database (Denmark)

De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

2013-01-01

revascularization (hazard ratio 0.42, 95% confidence interval 0.29 to 0.59, p 1 year) with DES. In conclusion, this meta-analysis, based on individual patients' data from 11 randomized trials, showed that among patients with diabetes with STEMIs who undergo primary percutaneous coronary intervention, sirolimus...... with high rates of target vessel revascularization after bare-metal stent (BMS) implantation but also higher rates of ST after DES implantation. Therefore, the aim of this study was to perform a meta-analysis of individual patients' data to evaluate the long-term safety and effectiveness of DES compared......Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated...

gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease--sub-analysis of the Japan TAXUS Express2 post-marketing survey.

Science.gov (United States)

Okura, Hiroyuki; Nakamura, Masato; Kotani, Jun-Ichi; Kozuma, Ken

2013-01-01

 Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome.  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, Ptarget lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05).  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year. 

Prodrug Strategies for Paclitaxel

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Ziyuan Meng

2016-05-01

Full Text Available Paclitaxel is an anti-tumor agent with remarkable anti-tumor activity and wide clinical uses. However, it is also faced with various challenges especially for its poor water solubility and low selectivity for the target. To overcome these disadvantages of paclitaxel, approaches using small molecule modifications and macromolecule modifications have been developed by many research groups from all over the world. In this review, we discuss the different strategies especially prodrug strategies that are currently used to make paclitaxel more effective.

Improved left ventricular function and perfusion at rest after successful transluminal coronary angioplasty

International Nuclear Information System (INIS)

Klepzig, H.; Kaltenbach, M.; Standke, R.; Maul, F.D.; Hoer, G.

1991-01-01

The purpose of this study was to evaluate left ventricular function and perfusion at rest before and after percutaneous transluminal coronary angioplasty. In consecutive 69 patients in whom coronary stenoses were dilated, the radionuclide left ventricular ejection fraction at rest increased significantly. In 26 of these patients, the ejection fraction increased by at least 4%. In these patients, exercise-induced ischemic ST depression had been more pronounced than in the others. 36 other patients underwent 201 Tl myocardial scintigraphy before and after angioplasty. Twelve patients in whom pre-PTCA images had revealed regions with irreversible 201 Tl uptake defects, showed normal 201 Tl distribution patterns on post-PTCA scintigrams. Post-exercise 201 Tl uptake (representing myocardial perfusion and metabolic activity) during pre-PTCA exercise stress tests was significantly lower in these cases. It is concluded that PTCA can improve left ventricular function and perfusion at rest. This improvement is most obvious in patients with pronounced exercise-induced myocardial ischemia as diagnosed by typical ST segment depression and reduced thallium uptake. (orig.) [de

Curcumin increases the sensitivity of Paclitaxel-resistant NSCLC cells to Paclitaxel through microRNA-30c-mediated MTA1 reduction.

Science.gov (United States)

Lu, Yimin; Wang, Jun; Liu, Lei; Yu, Lequn; Zhao, Nian; Zhou, Xingju; Lu, Xudong

2017-04-01

Non-small-cell lung cancer is one of the most lethal cancers in the worldwide. Although Paclitaxel-based combinational therapies have long been used as a standard treatment in aggressive non-small-cell lung cancers, Paclitaxel resistance emerges as a major clinical problem. It has been demonstrated that Curcumin from Curcuma longa as a traditional Chinese medicine can inhibit cancer cell proliferation. However, the role of Curcumin in Paclitaxel-resistant non-small-cell lung cancer cells is not clear. In this study, we investigated the effect of Curcumin on the Paclitaxel-resistant non-small-cell lung cancer cells and found that Curcumin treatment markedly increased the sensitivity of Paclitaxel-resistant non-small-cell lung cancer cells to Paclitaxel. Mechanically, the study revealed that Curcumin could reduce the expression of metastasis-associated gene 1 (MTA1) gene through upregulation of microRNA-30c in Paclitaxel-resistant non-small-cell lung cancer cells. During the course, MTA1 reduction sensitized Paclitaxel-resistant non-small-cell lung cancer cells and enhanced the effect of Paclitaxel. Taken together, our studies indicate that Curcumin increases the sensitivity of Paclitaxel-resistant non-small-cell lung cancer cells to Paclitaxel through microRNA-30c-mediated MTA1 reduction. Curcumin might be a potential adjuvant for non-small-cell lung cancer patients during Paclitaxel treatment.

Interventional treatment of renal artery stenosis: a mid-term evaluation of clinical efficacy

International Nuclear Information System (INIS)

Liu Jing; Zhang Xitong

2009-01-01

Objective: To assess the clinical efficacy of interventional management for the treatment of renal artery stenosis. Methods: Percutaneous transluminal balloon renal angioplasty and / or percutaneous transluminal renal artery stenting were performed in 47 patients with renal artery stenosis (55 stenosed arteries in total). A follow-up study on the blood pressure and renal function was conducted and the results were statistically analyzed. Results: Fifty-four stenosed renal arteries were successfully reopened, of which only percutaneous transluminal balloon angioplasty was adopted in 17 and percutaneous transluminal renal artery stenting in 37. One patient died during the procedure. A follow-up for a mean period of (2.5 ± 0.6) years was carried out. The blood pressure determined at one (n = 46), 6 (n = 46), 12 (n = 33) and 24 (n = 29) months after the treatment was significantly decreased when compared to that determined before the treatment (P < 0.01). The clinical effective rate was 89.13% (41 / 46), 72.73% (24 / 33) and 62.07% (18 / 29), respectively. After the therapy,the renal function was improved in 5, remained unchanged in 33 and became worse in 3 patients. The comparison of the post-operative renograms (obtained within 2 months) with the pre-operative ones showed that in eight patients there was an increase in renal blood flow with an improvement in renal function impairment, which took a turn from severe degree to mild or moderate degree. Nevertheless, severe impairment in renal blood flow remained in 3 patients. Conclusion: Percutaneous transluminal balloon renal angioplasty and percutaneous transluminal renal artery stenting are safe and effective treatments for the renal artery stenosis, which also has a beneficial effect on the related renal hypertension and renal insufficiency. (authors)

Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention

DEFF Research Database (Denmark)

Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

2015-01-01

BACKGROUND: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide......-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. DESIGN: The multicenter SORT OUT VII trial (NCT01879358...... will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N...

Survival and sudden cardiac death after septal ablation for hypertrophic obstructive cardiomyopathy

DEFF Research Database (Denmark)

Jensen, Morten Kvistholm; Havndrup, Ole; Hassager, Christian

2011-01-01

Reports of long-term survival and the risk of sudden cardiac death (SCD) after percutaneous transluminal septal myocardial ablation (PTSMA) in patients with hypertrophic obstructive cardiomyopathy (HOCM) are sparse.......Reports of long-term survival and the risk of sudden cardiac death (SCD) after percutaneous transluminal septal myocardial ablation (PTSMA) in patients with hypertrophic obstructive cardiomyopathy (HOCM) are sparse....

Ototoxicity of paclitaxel in rat cochlear organotypic cultures

International Nuclear Information System (INIS)

Dong, Yang; Ding, Dalian; Jiang, Haiyan; Shi, Jian-rong; Salvi, Richard; Roth, Jerome A.

2014-01-01

Paclitaxel (taxol) is a widely used antineoplastic drug employed alone or in combination to treat many forms of cancer. Paclitaxel blocks microtubule depolymerization thereby stabilizing microtubules and suppressing cell proliferation and other cellular processes. Previous reports indicate that paclitaxel can cause mild to moderate sensorineural hearing loss and some histopathologic changes in the mouse cochlea; however, damage to the neurons and the underlying cell death mechanisms are poorly understood. To evaluate the ototoxicity of paclitaxel in more detail, cochlear organotypic cultures from postnatal day 3 rats were treated with paclitaxel for 24 or 48 h with doses ranging from 1 to 30 μM. No obvious histopathologies were observed after 24 h treatment with any of the paclitaxel doses employed, but with 48 h treatment, paclitaxel damaged cochlear hair cells in a dose-dependent manner and also damaged auditory nerve fibers and spiral ganglion neurons (SGN) near the base of the cochlea. TUNEL labeling was negative in the organ of Corti, but positive in SGN with karyorrhexis 48 h after 30 μM paclitaxel treatment. In addition, caspase-6, caspase-8 and caspase-9 labeling was present in SGN treated with 30 μM paclitaxel for 48 h. These results suggest that caspase-dependent apoptotic pathways are involved in paclitaxel-induced damage of SGN, but not hair cells in cochlea. - Highlights: • Paclitaxel was toxic to cochlear hair cells and spiral ganglion neurons. • Paclitaxel-induced spiral ganglion degeneration was apoptotic. • Paclitaxel activated caspase-6, -8 and -8 in spiral ganglion neurons

Ototoxicity of paclitaxel in rat cochlear organotypic cultures

Energy Technology Data Exchange (ETDEWEB)

Dong, Yang [Shanghai University of Traditional Chinese Medicine, Shanghai 201203 (China); Center for Hearing and Deafness, University at Buffalo, NY 14214 (United States); Ding, Dalian; Jiang, Haiyan [Center for Hearing and Deafness, University at Buffalo, NY 14214 (United States); Shi, Jian-rong [Shanghai University of Traditional Chinese Medicine, Shanghai 201203 (China); Salvi, Richard [Center for Hearing and Deafness, University at Buffalo, NY 14214 (United States); Roth, Jerome A., E-mail: jaroth@buffalo.edu [Department of Pharmacology and Toxicology, University at Buffalo, NY 14214 (United States)

2014-11-01

Paclitaxel (taxol) is a widely used antineoplastic drug employed alone or in combination to treat many forms of cancer. Paclitaxel blocks microtubule depolymerization thereby stabilizing microtubules and suppressing cell proliferation and other cellular processes. Previous reports indicate that paclitaxel can cause mild to moderate sensorineural hearing loss and some histopathologic changes in the mouse cochlea; however, damage to the neurons and the underlying cell death mechanisms are poorly understood. To evaluate the ototoxicity of paclitaxel in more detail, cochlear organotypic cultures from postnatal day 3 rats were treated with paclitaxel for 24 or 48 h with doses ranging from 1 to 30 μM. No obvious histopathologies were observed after 24 h treatment with any of the paclitaxel doses employed, but with 48 h treatment, paclitaxel damaged cochlear hair cells in a dose-dependent manner and also damaged auditory nerve fibers and spiral ganglion neurons (SGN) near the base of the cochlea. TUNEL labeling was negative in the organ of Corti, but positive in SGN with karyorrhexis 48 h after 30 μM paclitaxel treatment. In addition, caspase-6, caspase-8 and caspase-9 labeling was present in SGN treated with 30 μM paclitaxel for 48 h. These results suggest that caspase-dependent apoptotic pathways are involved in paclitaxel-induced damage of SGN, but not hair cells in cochlea. - Highlights: • Paclitaxel was toxic to cochlear hair cells and spiral ganglion neurons. • Paclitaxel-induced spiral ganglion degeneration was apoptotic. • Paclitaxel activated caspase-6, -8 and -8 in spiral ganglion neurons.

Successful drug-eluting stent implantation in a male patient with dextrocardia: a case report

Directory of Open Access Journals (Sweden)

Long Wenjie

2017-12-01

Full Text Available Situs inversus with dextrocardia is a rare condition, with complete transposition of all the body organs, including the heart. Percutaneous coronary intervention (PCI in these patients is technically difficult because of the mirror image of organs. Here, we describe a 56-year-old man with coronary heart disease with known situs inversus with dextrocardia and coronary percutaneous intervention was performed for stenosis in the right coronary artery. A drug eluting stent was implanted at this site successfully. This case suggested that the interventional management of such patients follows the same general rules as for non-dextrocardia patients, but the manipulation of the catheter and projection position choices need to be taken into consideration to obtain optimal benefits for the patient.

Natural orifice transluminal endoscopic surgery for patients with perforated peptic ulcer.

Science.gov (United States)

Bonin, Eduardo A; Moran, Erica; Gostout, Christopher J; McConico, Andrea L; Zielinski, Martin; Bingener, Juliane

2012-06-01

Perforation accounts for 70% of deaths attributed to peptic ulcers. Laparoscopic repair is effective but infrequently used. Our aim was to assess how many patients with perforated peptic ulcer could be candidates for a transluminal endoscopic omental patch closure. This retrospective study reviewed patients with perforated peptic ulcer from 2005 to 2010. Demographics, ulcer characteristics, operative procedure, and outcomes were recorded. Candidates for endoscopic transluminal repair were defined as those having undergone omental patch closure of an ulcer of appropriate size and no contraindications to laparoscopy or endoscopy. In the retrospective review, a total of 104 patients were identified; 62% female, mean age = 68 years, mean ASA of 3, and 63% medication-related ulcers. Fifty-nine (63%) had an omental patch (80% open), and 35 (37%) had other procedures. Ten patients had nonoperative management. Thirty-day mortality was 14% and 1 year mortality was 35%. Forty-nine patients (52%) were considered potential candidates for transluminal repair. Sixty-three percent of our patients sustained a medication-related perforation with 1 year mortality of 35%. The majority of patients were treated using open omental patch repair. Transluminal endoscopic repair may provide an additional situation for a minimally invasive approach for a number of these patients.

Concurrent paclitaxel and radiotherapy. Treatment feasibility studies

International Nuclear Information System (INIS)

Vogt, H.G.; Martin, T.; Kolotas, C.; Hey, S.; Schneider, L.; Templin, T.; Zamboglou, N.; Dornoff, W.; Kettner, H.

1997-01-01

Background: The anti-neoplastic effect of paclitaxel has been demonstrated in various clinical studies in different malignant diseases. Clinical studies have also demonstrated a greater efficacy for simultaneous radio-chemotherapy compared with radiotherapy alone when using radiosensitizing drugs. Based on these clinical and in-vitro data we initiated several pilot studies using paclitaxel as a radiosensitizing agent and we now present our initial experience in its use in a combined modality protocol, radiation and simultaneous chemotherapy with paclitaxel. Methods: I. Concurrent paclitaxel and radiation for locally advanced non-small-cell lung cancer (NSCLC): In a phase-I-study we applicated paclitaxel (45 to 65 mg/m 2 ) as a 3-hour infusion weekly for 3 to 7 weeks simultaneously with primary radiotherapy in shrinking field technique with 5x1.8 Gy/week up to 59.4 Gy. - II. Concurrent paclitaxel and radiation for breast cancer as neoadjuvant or palliative: 50 mg/m 2 paclitaxel as a 3-hour infusion weekly for 6 weeks simultaneous with neoadjuvant or palliative radiotherapy of the breast/chest wall with 5x1.8 Gy/week up to 54.0 Gy. - III./IV. Concurrent paclitaxel/carboplatin and combined radiation (EBRT+brachytherapy) for locally advanced inoperable cancer of the cervix: 50 mg/m 2 paclitaxel as a 3-hour infusion weekly for 5 weeks, 50 mg/m 2 carboplatin at day 1 to 5 in week 1 and 5 simultaneously with external beam radiotherapy of the pelvis with 5x1.8 Gy/week up to 54.0 Gy and endocavitary LDR-brachytherapy (4x5 Gy). - V. Concurrent paclitaxel and radiation for locally advanced inoperable cancer of the bladder: 50 mg/m 2 paclitaxel as a 3-hour infusion weekly for 5 weeks simultaneous with radiotherapy of the pelvis with 5x1.8 Gy/week up to 50.4 Gy. VI. Concurrent paclitaxel and radiation in locally advanced inoperable head and neck cancer: 50 mg/m 2 paclitaxel as a 3-hour infusion weekly for 7 to 8 weeks simultaneous with radiotherapy in shrinking field technique

Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention

NARCIS (Netherlands)

H. Versteeg (Henneke); S.S. Pedersen (Susanne); R.A.M. Erdman (Ruud); J.W.I. van Nierop; P.P.T. de Jaegere (Peter); R.T. van Domburg (Ron)

2009-01-01

textabstractPurpose: We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents. Methods: Consecutive PCI patients (n = 562) completed the Global Mood Scale at baseline to

[Natural Orifice Transluminal Endoscopic Surgery (NOTES)].

Science.gov (United States)

Kim, Yong Sik; Kim, Chul Young; Chun, Hoon Jai

2008-03-01

Recently, the field of gastrointestinal endoscopy is developing rapidly. Once limited to the gastroinstestinal lumen, the endoscopic technology is now breaking the barriers and extending its boundary to peritoneal and pleural space. In 2004, Dr. Kalloo, a gastroenterologist, observed intraperitoneal organs of a pig using a conventional endoscope through the stomach wall. Since then, new endoscopic technique of intraperitoneal intervention with transluminal approach named the Natural Orifice Transluminal Endoscopic Surgery or NOTES has been introduced. NOTES reaches the target organ by inserting the endoscope through a natural orifice (e.g. mouth, anus, vagina, urethra) and entering the peritoneal lumen by means of making an incision on the luminal wall. After a series of successful experiences in animal studies, NOTES are now being tried on human subjects. There are still many obstacles to overcome, but bright future for this new technology is expected because of its proposed advantages of less pain, lower complication rate, short recovery time, and scarless access. In this review, we plan to learn about NOTES.

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

NARCIS (Netherlands)

de Winter, Robbert J.; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P.; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A. J.; Koch, Karel T.; Troquay, Roland P. T.; Hamer, Bas J. B.; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H.; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E. Karin; Noutsias, Michel; Ferrari, Markus W.; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W.

2018-01-01

Background MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical

Percutaneous transhepatic cholangiographic forceps biopsy in pathologic diagnosis for obstructive jaundice

International Nuclear Information System (INIS)

Han Xinwei; Li Yongdong; Ma Bo; Xing Gusheng; Wu Gang; Gao Xuemei; Ma Nan

2004-01-01

Objective: To evaluate the technical feasibility and sensitivity of percutaneous transhepatic cholangiographic forceps biopsy in bile duct diseases. Methods: Between April 2001 and March 2003, 65 consecutive patients (36 men and 29 women; age range 33-88 years, mean 54 years) with obstructive jaundice underwent transluminal forceps biopsy or/and brush during percutaneous transhepatic cholangiography, percutaneous transhepatic cholangiography and drainage, or placement of stents. The technique was performed through an existing percutaneous transhepatic tract. Multiple specimens were obtained after passing the biopsy forceps or brush into a long 8-French sheath, and the specimens were fixed with formalin for pathologic or cytologic diagnosis. Statistical analysis was performed with the χ 2 test or Fisher exact probability, and P 2 =5.919, P=0.015). The cyctologic diagnosis was acquired in 43 of 58 patients with brush biopsy. Pathologic reports included cholangioadenocarcinoma (n=36), cholangiosquam-ocarcinoma (n=1), pancreatic adenocarcinoma (n=1), hepatocellular carcinoma (n=2), metastatic carcinoma (n=2), zoogloea aggregation (n=1), and negative results (n=15). The sensitivity rate of brush biopsy was 74.14%. Sensitivity of brush in the 45 patients with cholangiocarcinoma was higher than in the 11 patients with malignant tumors other than cholangiocarcinoma (82.22% vs 45.45%, χ 2 =4.563, P=0.033). Sensitivity of forceps biopsy in the 65 patients was higher than that of brush in the 58 patients (χ 2 =4.754, P=0.029). Conclusion: Percutaneous transhepatic cholangiobiopsy is a safe and minimal invasive procedure with no pain and low complication that is easy to perform with no addition trauma through a transhepatic biliary drainage tract. It is an effective, economic, accurate, and reliable new approach, which is safe and easy to perform in acquiring the pathologic diagnosis worthy to spread extensively. (authors)

Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease.

Science.gov (United States)

Javaid, Aamir; Steinberg, Daniel H; Buch, Ashesh N; Corso, Paul J; Boyce, Steven W; Pinto Slottow, Tina L; Roy, Probal K; Hill, Peter; Okabe, Teruo; Torguson, Rebecca; Smith, Kimberly A; Xue, Zhenyi; Gevorkian, Natalie; Suddath, William O; Kent, Kenneth M; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2007-09-11

Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a "real-world" evaluation of current technology in the treatment of multivessel coronary artery disease. A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes

Red blood cell distribution width and long-term outcome in patients undergoing percutaneous coronary intervention in the drug-eluting stenting era: a two-year cohort study.

Science.gov (United States)

Yao, Hai-Mu; Sun, Tong-Wen; Zhang, Xiao-Juan; Shen, De-Liang; Du, You-You; Wan, You-Dong; Zhang, Jin-Ying; Li, Ling; Zhao, Luo-Sha

2014-01-01

Previous studies suggest the higher the red blood cell distribution width (RDW) the greater the risk of mortality in patients with coronary artery disease (CAD). However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD. In total of 2169 non-anemic patients (1468 men, mean age 60.2 ± 10.9 years) with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%), Quartile 2 (12.27% ≤ RDW <13%), Quartile 3 (13% ≤ RDW<13.5%), and Quartile 4 (RDW ≥ 13.5). The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05). After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05). The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05). Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR) = 1.37, 95% confidence interval (CI) = 1.15-1.62, P<0.001) and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04-1.39, P = 0.013). The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05). High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.

Red blood cell distribution width and long-term outcome in patients undergoing percutaneous coronary intervention in the drug-eluting stenting era: a two-year cohort study.

Directory of Open Access Journals (Sweden)

Hai-Mu Yao

Full Text Available BACKGROUND: Previous studies suggest the higher the red blood cell distribution width (RDW the greater the risk of mortality in patients with coronary artery disease (CAD. However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI with a drug-eluting stent (DES remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD. METHODS: In total of 2169 non-anemic patients (1468 men, mean age 60.2 ± 10.9 years with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%, Quartile 2 (12.27% ≤ RDW <13%, Quartile 3 (13% ≤ RDW<13.5%, and Quartile 4 (RDW ≥ 13.5. RESULTS: The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05. After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05. The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05. Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR = 1.37, 95% confidence interval (CI = 1.15-1.62, P<0.001 and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04-1.39, P = 0.013. The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05. CONCLUSION: High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.

Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease A Meta-Analysis of Individual Patient Data

NARCIS (Netherlands)

Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

2016-01-01

OBJECTIVES The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD).

Percutaneous treatment of critical lower limb ischemia in patients with obstruction of the crural arteries

International Nuclear Information System (INIS)

Falkowski, A.; Rutkowski, D.; Poncyliusz, W.; Sienko, J.

2006-01-01

This article describes the application of percutaneous transluminal angioplasty (PTA) in the treatment of crural artery obstruction in patients with critical lower limb ischemia. In 17 patients, 24 PTAs of crural artery obstructions were performed. The clinical material consisted of 9 men and 8 women, whose mean age was 72 years (range 54-85 years). 11 patients were classified in clinical stage Fontaine IV, and 6 in stage III. The obstructions were from 3 to 21 cm (mean 6 cm). In 8 cases, PTA of the femoropopliteal segment was also carried out. The risk factors and comorbidities included diabetes 10 cases (58.8%), hypertension 9 cases (56%), ischemic heart disease 8 cases (50%), hyperlipidaemia 7 cases (43.8%), cerebrovascular diseases 3 cases (18.8%), and cigarette smoking 6 cases (37.5%). Technical success was defined as restoration of the artery along its whole length to the foot. Pain relief at rest and healing of trophic lesions at 30-day follow-up were recognized as a good outcome. Technical success was achieved in 12 patients (70.6%). In 2 cases the patency was only restored in the proximal part of the artery (12.5%). In 3 cases (17.6%) the procedure failed. In one case acute occlusion of the artery occurred. In 2 cases the obstruction was not successfully passed with a guidewire. In 4 cases hematoma was found at the puncture site, without clinical consequences. In 13 patients (76.4%) clinical success was achieved. Percutaneous transluminal angioplasty is an effective and relatively safe method of treatment of patients with critical limb ischemia caused by obstruction of the crural arteries. (author)

Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives

OpenAIRE

Rapetto, Claudio; Leoncini, Massimo

2017-01-01

Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the firs...

Propensity score matched lesion-based comparison of long-term clinical and angiographic outcomes after placement of sirolimus (Cypher Bx Velocity) and paclitaxel (TAXUS Express)-eluting stents for de novo native coronary stenosis.

Science.gov (United States)

Nakano, Yosuke; Ishikawa, Tetsuya; Hino, Shoryoku; Mutoh, Makoto

2014-04-01

Long-term clinical and angiographic outcomes after sirolimus (SES: Cypher Bx Velocity) and paclitaxel (PES: TAXUS Express)-eluting stent implantation were firstly compared in Japan. During PES-available period from May 2007 to February 2009, 1068 nonrandomized consecutive de novo native coronary lesions treated either with a PES (682 lesions) or SES were enrolled in this study, and a retrospective examination was conducted in April 2013. During that interval, the use ratio of drug-eluting stent (i.e. SES plus PES) was 94.2 %. By adjusting the baselines with a propensity score matching analysis produced 383 lesions in each arm, the incidence of the clinical endpoint (1500-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of SES (2.1 %; mean follow-up, 1400 ± 290 days) was not significantly different from that in the PES group (2.6 %; 1394 ± 325 days, p = 0.637). SES did not relate to the clinical endpoint (hazard ratio 1.04; 95 % CI 0.29-3.76; p = 0.949). In the baseline-adjusted angiographic followed up lesions (n = 234 in each arm), the incidence of binary restenosis (percent diameter stenosis [%DS] >50 %) in the SES group (12.0 %; mean follow-up, 477 ± 281 days) was not significantly different from that in the PES group (14.5 %; 497 ± 341 days, p = 0.431). SES did not relate to binary restenosis (Odds ratio 0.73; 95 % CI 0.40-1.32; p = 0.295). In conclusion, the present propensity score matched lesion-based analysis firstly showed the statistical equivalent long-term clinical and angiographic outcomes after either SES or PES placement for de novo native coronary lesion in Japanese patients in a daily practice environment.

Balloon angioplasty in acute and chronic coronary artery disease

International Nuclear Information System (INIS)

Holmes, D.R. Jr.; Vlietstra, R.E.

1989-01-01

Percutaneous transluminal coronary angioplasty has grown exponentially since its introduction. Currently, selection criteria include single-vessel and multivessel disease, stable and unstable angina, and acute infarction. The outcome depends on specific patient and antiographic characteristics. In ideal lesions, success rates should be greater than 90%, with low morbidity and mortality. With more severe and diffuse multivessel disease, success rates are lower and complication rates are higher. In these cases, percutaneous transluminal coronary angioplasty still offers a reasonable option, provided complete revascularization can be achieved or the angina-producing lesion dilated. Numerous issues remain unresolved, including (1) the role of percutaneous transluminal coronary angioplasty vs coronary surgery (currently being tested), (2) restenosis, which occurs in approximately 30% of treated lesions, and (3) organizational adjustments such as training and certification to maintain high standards of care

Angioplasty: MedlinePlus Health Topic

Science.gov (United States)

... segment (Medical Encyclopedia) Also in Spanish Directional coronary atherectomy (DCA) (Medical Encyclopedia) Also in Spanish Percutaneous transluminal ... segment Coronary artery balloon angioplasty - slideshow Directional coronary atherectomy ... transluminal coronary angioplasty (PTCA) Stent Related ...

Comparative effectiveness of early-line nab-paclitaxel vs. paclitaxel in patients with metastatic breast cancer: a US community-based real-world analysis

Directory of Open Access Journals (Sweden)

Mahtani RL

2018-02-01

Full Text Available Reshma L Mahtani,1 Monika Parisi,2 Stefan Glück,3 Quanhong Ni,2 Siyeon Park,4 Corey Pelletier,2 Claudio Faria,2 Fadi Braiteh5,6 1Division of Hematology/Oncology, University of Miami, Miami, FL, 2Health Economics and Outcomes Research, Celgene Corporation, Summit, NJ, 3Global Medical Affairs, Celgene Corporation, Summit, NJ, 4School of Pharmacy, The Ohio State University, Columbus, OH, 5Department of Hematology/Oncology, University of Nevada School of Medicine, Las Vegas, NV, 6Department of Hematology/Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA Background: Real-world analyses of treatments for patients with metastatic breast cancer are limited. We evaluated the comparative effectiveness of nab-paclitaxel vs. paclitaxel in patients with metastatic breast cancer using data from an electronic medical record database from community practices across the USA.Methods: We performed a retrospective cohort study using fully de-identified data from an independent US electronic medical record platform of patients with metastatic breast cancer initiating single-agent nab-paclitaxel or paclitaxel as a first- or second-line treatment from December 1, 2010 to October 6, 2014. The clinical efficacy objectives were time to treatment discontinuation (TTD and time to next treatment (TTNT. Subgroup analyses were performed in patients with 2 types of metastatic breast cancer as follows: 1 hormone receptor-positive and human epidermal growth factor receptor 2 negative, and 2 triple-negative disease. Results: This analysis included 925 patients. Patients receiving nab-paclitaxel vs. paclitaxel had significantly longer TTD (median 4.2 vs. 2.8 months, P<0.0001 and TTNT (median 6.0 vs. 4.2 months, P<0.0001; similar outcomes were observed for patients with hormone receptor-positive/human epidermal growth factor receptor 2 negative disease. Compared with paclitaxel, nab-paclitaxel was associated with significantly longer TTD in patients with triple

Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis. From western denmark heart registry

DEFF Research Database (Denmark)

Jensen, Jesper; Jensen, Lisette Okkels; Terkelsen, Christian Juhl

2012-01-01

There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis...

Nab-paclitaxel, docetaxel, or solvent-based paclitaxel in metastatic breast cancer: a cost-utility analysis from a Chinese health care perspective

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Dranitsaris G

2015-05-01

Full Text Available George Dranitsaris,1 Bo Yu,2 Jennifer King,3 Satyin Kaura,3 Adams Zhang3 1Augmentium Pharma Consulting Inc., Toronto, ON, Canada; 2Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China; 3Celgene Corporation, Summit, NJ, USA Background: Paclitaxel and docetaxel are commonly used for metastatic breast cancer in the People’s Republic of China. To improve the safety and efficacy of paclitaxel, an albumin-bound formulation (nab is now available in the People's Republic of China (Abraxane®. To provide health economic data for the key stakeholders, a cost-utility analysis comparing nab-paclitaxel to docetaxel, both as alternatives to paclitaxel, was conducted. Methods: A meta-analysis of clinical outcomes Phase III trials comparing nab-paclitaxel (260 mg/m2 every [q] 3 weeks or branded docetaxel (100 mg/m2 q 3 weeks, to solvent-based branded paclitaxel (175 mg/m2 q 3 weeks was undertaken to provide safety and clinical data. Resource use data for the delivery of anticancer therapy and for the treatment of grade 3/4 toxicity was collected from a time and motion study conducted in three Chinese cancer centers and from a survey of clinicians. Using the Time Trade-Off technique, health utility estimates were derived from interviewing 28 breast cancer patients from one cancer center in the People's Republic of China. All costs were reported in 2014 US dollars. Results: Nab-paclitaxel had the most favorable safety profile, characterized with the lowest incidence of grade 3/4 neutropenia, febrile neutropenia, anemia, and stomatitis. When the median number of cycles delivered from the clinical trials was applied, nab-paclitaxel had a cost per course of $19,752 compared with $8,940 and $13,741 for paclitaxel and docetaxel, respectively. As an alternative to paclitaxel, the cost per quality-adjusted life-year (QALY gained with nab-paclitaxel suggested better value than with docetaxel ($57,900 vs $130,600. Conclusion: Nab-paclitaxel

Trabectome-Initiated Gonioscopy-Assisted Transluminal Trabeculotomy.

Science.gov (United States)

Smith, Brett L; Ellyson, Austin C; Kim, Won I

2018-03-01

To introduce a trabectome-initiated gonioscopy-assisted transluminal trabeculotomy (TIGATT) procedure and to report preliminary results. A preliminary case series of eight patients who have undergone the newly proposed TIGATT procedure is presented. TIGATT is a new concept that modifies established techniques by replacing the initial goniotomy incision of gonioscopy-assisted transluminal trabeculotomy (GATT) with an ab interno trabeculectomy ablation utilizing the trabectome. All surgeries were performed by a single surgeon (W.I.K.) between November 2014 and October 2015 in adults with primary open-angle glaucoma. Recorded outcome measures were intraocular pressure (IOP), number of medications, and complications. Eight patients with an age range of 63-93 yr underwent TIGATT with at least 3 mo of follow-up. Five of the eight initial patients had follow-up to 2 yr. The mean pre-operative IOP was 25 mmHg (standard deviation [SD] 7.0) on four medications (SD 1.1). The mean post-operative IOP at 3 mo was 14 mmHg (SD 1.8) on two medications (SD 1.3). The average decrease in IOP was 9.9 mmHg (SD 7.5) with an average decrease in medications of two (SD 1.4) at 3 mo. At 2 yr, the mean post-operative IOP was 14 mmHg (SD 3.2) on one medication (SD 1.1). The average decrease in IOP was 7.8 mmHg (SD 3.1) with an average decrease in medications of two (SD 1.8). There were two treatment failures that required further glaucoma surgery and one patient was lost to follow-up. The preliminary results and safety profile for TIGATT are promising and appear at least comparable with previously published results for both GATT and trabectome. Initiating the transluminal trabeculotomy with trabectome clearly exposes Schlemm's canal and facilitates threading the microcatheter into the canal. Additionally, if the 360-degree trabeculotomy cannot be completed because of an incompletely patent Schlemm's canal, the patient will at least have a trabectome ablation that can serve as their glaucoma

Transluminal laser angioplasty

Science.gov (United States)

Otto, Wlodzimierz

1996-03-01

Twenty seven patients with femoral artery occlusion were treated by transluminal Nd:YAG laser angioplasty, in 16 patients the procedure was combined with intraarterial infusion of rTPA (actilyse-Boehringer Ing). In 5 out of 11 patients from the initial group recanalization was not successful. In 16 patients from the rTPA group satisfactory immediate results were achieved in all cases. In long time observations ranging from 9 to 24 months all patients remained free from symptoms, although in 4 of them angiography and Doppler ultrasound examination reveal no flow in the femoral artery. In the remaining 12 patients (75%), the previously occluded artery is patent. No complications of laser angioplasty nor intraarterial infusion of rTPA were noted in this series.

Transluminal Angioplasty of Peroneal Artery Branches in Diabetics: Initial Technical Experience

International Nuclear Information System (INIS)

Graziani, Lanfroi; Silvestro, Antonio; Monge, Luca; Boffano, Gian Mario; Kokaly, Francesco; Casadidio, Ilaria; Giannini, Francesco

2008-01-01

The present study aimed to report the technical feasibility of percutaneous transluminal angioplasty (PTA) of obstructed or insufficient collateral branches (anterior and posterior perforating branches) from distal peroneal to foot arteries in diabetic patients with chronic critical limb ischemia (CLI) and chronic noncrossable occlusion of the anterior and posterior tibial arteries. Twenty-four diabetic CLI patients (age, 67 ± 8 years; 87% males) undergoing collateral PTA were included. Baseline clinical angiographic and follow-up data were retrospectively reviewed. Collateral PTA was associated with a concomitant PTA of other sites in 21 (83%) cases. In 15 cases the treated collateral linked the peroneal with the plantaris communis; in 9 cases, the peroneal with the dorsalis pedis. Angiographic results of collateral PTA were good in 13 cases (<30% residual stenosis), whereas the result was considered moderate (30%-49% residual stenosis) in the remaining cases. Neither perforation nor acute occlusion of the treated collaterals or other relevant complications were observed. Mean follow-up was 32 ± 17 months. Major amputation was necessary for two (8.3%) patients. Cumulative limb salvage rates at 2 and 4 years were 96% and 87%, respectively. In conclusion, this initial experience shows that PTA of the collateral branches from distal peroneal to foot arteries is a feasible technique. Future studies are required to define the clinical role of this novel approach

Albumin-bound paclitaxel in solid tumors: clinical development and future directions.

Science.gov (United States)

Kundranda, Madappa N; Niu, Jiaxin

2015-01-01

Albumin-bound paclitaxel (nab-paclitaxel) is a solvent-free formulation of paclitaxel that was initially developed more than a decade ago to overcome toxicities associated with the solvents used in the formulation of standard paclitaxel and to potentially improve efficacy. Nab-paclitaxel has demonstrated an advantage over solvent-based paclitaxel by being able to deliver a higher dose of paclitaxel to tumors and decrease the incidence of serious toxicities, including severe allergic reactions. To date, nab-paclitaxel has been indicated for the treatment of three solid tumors in the USA. It was first approved for the treatment of metastatic breast cancer in 2005, followed by locally advanced or metastatic non-small-cell lung cancer in 2012, and most recently for metastatic pancreatic cancer in 2013. Nab-paclitaxel is also under investigation for the treatment of a number of other solid tumors. This review highlights key clinical efficacy and safety outcomes of nab-paclitaxel in the solid tumors for which it is currently indicated, discusses ongoing trials that may provide new data for the expansion of nab-paclitaxel's indications into other solid tumors, and provides a clinical perspective on the use of nab-paclitaxel in practice.

Proinflammatory Factors Mediate Paclitaxel-Induced Impairment of Learning and Memory

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Zhao Li

2018-01-01

Full Text Available The chemotherapeutic agent paclitaxel is widely used for cancer treatment. Paclitaxel treatment impairs learning and memory function, a side effect that reduces the quality of life of cancer survivors. However, the neural mechanisms underlying paclitaxel-induced impairment of learning and memory remain unclear. Paclitaxel treatment leads to proinflammatory factor release and neuronal apoptosis. Thus, we hypothesized that paclitaxel impairs learning and memory function through proinflammatory factor-induced neuronal apoptosis. Neuronal apoptosis was assessed by TUNEL assay in the hippocampus. Protein expression levels of tumor necrosis factor-α (TNF-α and interleukin-1β (IL-1β in the hippocampus tissue were analyzed by Western blot assay. Spatial learning and memory function were determined by using the Morris water maze (MWM test. Paclitaxel treatment significantly increased the escape latencies and decreased the number of crossing in the MWM test. Furthermore, paclitaxel significantly increased the number of TUNEL-positive neurons in the hippocampus. Also, paclitaxel treatment increased the expression levels of TNF-α and IL-1β in the hippocampus tissue. In addition, the TNF-α synthesis inhibitor thalidomide significantly attenuated the number of paclitaxel-induced TUNEL-positive neurons in the hippocampus and restored the impaired spatial learning and memory function in paclitaxel-treated rats. These data suggest that TNF-α is critically involved in the paclitaxel-induced impairment of learning and memory function.

Next generation drug-eluting stents: focus on bioabsorbable platforms and polymers

Directory of Open Access Journals (Sweden)

Brendan Doyle

2009-11-01

Full Text Available Brendan Doyle, David R Holmes JrDivision of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, USAAbstract: The success of drug-eluting stents in preventing restenosis has shifted the focus of new stent development toward enhancing long term safety and efficacy of these devices, while simultaneously eliminating the need for indefinite dual antiplatelet therapy. A technical advance fulfilling these aims would hold tremendous potential to reduce morbidity, mortality and economic costs associated with the percutaneous treatment of coronary artery disease. An attractive approach is the use of bioabsorbable stent designs. These may include stents with different bioabsorbable drugs, bioabsorbable polymers or even bioabsorbable metallic backbones. A device that could achieve excellent acute and long-term results, but disappear completely within months (thereby avoiding the need for prolonged dual antiplatelet therapy, would be a tremendous advance. Too good to be true? We explore here the scientific rationale and prospects for success with this exciting concept.Keywords: percutaneous coronary intervention, biodegradable, bioabsorbable, polymer, stent

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

Science.gov (United States)

Ott, Ilka; Cassese, Salvatore; Groha, Philipp; Steppich, Birgit; Hadamitzky, Martin; Ibrahim, Tareq; Kufner, Sebastian; Dewitz, Karl; Hiendlmayer, Regina; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Fusaro, Massimiliano

2017-06-06

Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion

Pioneers of invasive cardiovascular medicine - Charles Theodore dotter and colleagues: Short historical review

Directory of Open Access Journals (Sweden)

Kostić Jelena

2014-01-01

Full Text Available Within modern medicine at the beginning of 21st century, we are witnessing a revolutionary development of the invasive diagnostics and therapy of cardiovascular system diseases. With the discovery of X-rays at the end of 19th century by Wilhelm Roentgen, it is appropriate to reflect on the gifted individuals whose efforts drastically altered radiology and cardiology. The early techniques used in peripheral percutaneous transluminal angioplasty form the basis for subsequent percutaneous intervention both in the peripheral and coronary arteries and are largely the contribution of Charles Dotter. The main goal of his work was the use of catheters for diagnosis and treatment in an attempt to replace the scalpel. He was 20 years ahead of his time, especially with percutaneous transluminal angioplasty. The first percutaneous transluminal angioplasty marked a new era in the treatment of peripheral atherosclerotic lesions. This practical genius dedicated his considerable energy to the belief that there is always a better way to treat disease. His personal contributions to clinical medicine, research, and teaching have saved millions of limbs and lives all over the world. European physicians, who were more open to unproven techniques, almost immediately embraced percutaneous transluminal angioplasty. Without the contribution and help of his colleagues, Forssmann, Sones and Gruntzig, all of them pioneers, nothing would be done. They were all ahead of there time and opened completely new chapter in medicine.

Percutaneous angioplasty of carotid artery stenoses

Energy Technology Data Exchange (ETDEWEB)

Freitag, G.; Freitag, J.; Koch, R.D.; Wagemann, W.

1986-03-01

Percutaneous transluminal angioplasty (PTA) is a well-established method to remedy stenoses and short occlusions in the femoro-popliteal region and has also proved worthwhile in dilating stenoses of pelvic, renal and coronary arteries. Following successful experiments in animals, Mathias et al. employed angioplasty to treat carotid artery stenoses in the same way. To date, successful treatment of carotid artery stenoses has been described only in isolated recent reports. For fear of embolism, angioplasty has not yet become standard practice in this region. Because of the limited number of carotid artery stenoses treated so far, the risk involved cannot be reliably assessed. It is remarkable that no embolism has been reported for the greater number of dilated stenoses of the subclavian artery. Moreover, the report by Mathias et al. indicated that for 350 angioplasties of pelvifemoral arteries 1.1% embolisms occured after artery occlusions only, while no embolism was observed after stenoses. Having gained experience of applying PTA to the treatment of vascular obstructions of extremities, we have adopted this technique in the carotid area as well.

Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up

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Pellegrini, Denise Oliveira, E-mail: dennizmo@yahoo.com.br; Gomes, Vitor Osório; Lasevitch, Ricardo; Smidt, Luis; Azeredo, Marco Aurélio; Ledur, Priscila; Bodanese, Rodrigo; Sinnott, Leonardo; Moriguchi, Emílio; Caramori, Paulo [Hospital São Lucas PUC, Porto Alegre, RS (Brazil)

2014-09-15

Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. To evaluate the efficacy and safety of drug-eluting stents in the real world. We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the 'real world' may benefit from drug-eluting stenting with excellent, long-term results.

To vigorously and safely develop the interventional therapy for diabetic peripheral vascular diseases

International Nuclear Information System (INIS)

Zhao Jungong; Cheng Yongde

2011-01-01

Diabetic critical limb ischemia is one of the most severe complications caused by diabetes mellitus, which carries significant morbidity and mortality. The symptoms related to limb ischemia include intermittent claudication, rest pain, refractory ulcers, infections or even gangrene of the foot or toes. Percutaneous transluminal angioplasty (PTA) can be used to treat arterial stenosis or occlusive disease of the iliac and femoropopliteal arteries. However, PTA has a relatively poor outcome for the treatment of infrapopliteal arteries with conventional short coronary balloons. In the past 10 years, infrapopliteal angioplasty with a long over-the-wire (OTW) balloon, subintimal technique, retrograde transdorsal-to-plantar loop, Excimer laser ablation, local delivery of paclitaxel, etc. have been continually developed. The clinical practise has proved that these techniques and devices are feasible and effective for the treatment of severe limb ischemia in diabetic patients. The midterm outcomes seem to be satisfactory and encouraging. (authors)

Synthesis and characterization of a fluorescent water-soluble paclitaxel prodrug.

Science.gov (United States)

Sohn, Jeong-Sun; Choi, Eun-Sun; Jo, Byung-Wook; Hess, Michael; Han, Song-Hee

2010-05-01

A fluorescence susceptible water-soluble paclitaxel was synthesized by a condensation reaction between PEGylated paclitaxel (namely, PP7) and 1-pyrene butyric acid (PBA) in order to obtain a better understanding of the mechanism of action of paclitaxel as well as of the environment of the paclitaxel-binding site. The reaction was performed successfully and the resulting paclitaxel was characterized by FT-NMR, analytical-HPLC, UV spectro photometry, and fluorescence spectrometry. The synthesized paclitaxel analogue showed a high susceptibility to fluorescence in both excitation and emission spectra. And we have investigated the time-resolved fluorescence behavior of them in different solvents and at different excitation wavelengths.

Improved Accuracy of Percutaneous Biopsy Using “Cross and Push” Technique for Patients Suspected with Malignant Biliary Strictures

Energy Technology Data Exchange (ETDEWEB)

Patel, Prashant, E-mail: p.patel@bham.ac.uk [University of Birmingham, School of Cancer Sciences, Vincent Drive (United Kingdom); Rangarajan, Balaji; Mangat, Kamarjit, E-mail: kamarjit.mangat@uhb.nhs.uk, E-mail: kamarjit.mangat@nhs.net [University Hospital Birmingham NHS Trust, Department of Radiology (United Kingdom)

2015-08-15

PurposeVarious methods have been used to sample biliary strictures, including percutaneous fine-needle aspiration biopsy, intraluminal biliary washings, and cytological analysis of drained bile. However, none of these methods has proven to be particularly sensitive in the diagnosis of biliary tract malignancy. We report improved diagnostic accuracy using a modified technique for percutaneous transluminal biopsy in patients with this disease.Materials and MethodsFifty-two patients with obstructive jaundice due to a biliary stricture underwent transluminal forceps biopsy with a modified “cross and push” technique with the use of a flexible biopsy forceps kit commonly used for cardiac biopsies. The modification entailed crossing the stricture with a 0.038-in. wire leading all the way down into the duodenum. A standard or long sheath was subsequently advanced up to the stricture over the wire. A Cook 5.2-Fr biopsy forceps was introduced alongside the wire and the cup was opened upon exiting the sheath. With the biopsy forceps open, within the stricture the sheath was used to push and advance the biopsy cup into the stricture before the cup was closed and the sample obtained. The data were analysed retrospectively.ResultsWe report the outcomes of this modified technique used on 52 consecutive patients with obstructive jaundice secondary to a biliary stricture. The sensitivity and accuracy were 93.3 and 94.2 %, respectively. There was one procedure-related late complication.ConclusionWe propose that the modified “cross and push” technique is a feasible, safe, and more accurate option over the standard technique for sampling strictures of the biliary tree.

Improved Accuracy of Percutaneous Biopsy Using “Cross and Push” Technique for Patients Suspected with Malignant Biliary Strictures

International Nuclear Information System (INIS)

Patel, Prashant; Rangarajan, Balaji; Mangat, Kamarjit

2015-01-01

PurposeVarious methods have been used to sample biliary strictures, including percutaneous fine-needle aspiration biopsy, intraluminal biliary washings, and cytological analysis of drained bile. However, none of these methods has proven to be particularly sensitive in the diagnosis of biliary tract malignancy. We report improved diagnostic accuracy using a modified technique for percutaneous transluminal biopsy in patients with this disease.Materials and MethodsFifty-two patients with obstructive jaundice due to a biliary stricture underwent transluminal forceps biopsy with a modified “cross and push” technique with the use of a flexible biopsy forceps kit commonly used for cardiac biopsies. The modification entailed crossing the stricture with a 0.038-in. wire leading all the way down into the duodenum. A standard or long sheath was subsequently advanced up to the stricture over the wire. A Cook 5.2-Fr biopsy forceps was introduced alongside the wire and the cup was opened upon exiting the sheath. With the biopsy forceps open, within the stricture the sheath was used to push and advance the biopsy cup into the stricture before the cup was closed and the sample obtained. The data were analysed retrospectively.ResultsWe report the outcomes of this modified technique used on 52 consecutive patients with obstructive jaundice secondary to a biliary stricture. The sensitivity and accuracy were 93.3 and 94.2 %, respectively. There was one procedure-related late complication.ConclusionWe propose that the modified “cross and push” technique is a feasible, safe, and more accurate option over the standard technique for sampling strictures of the biliary tree

Percutaneous reconstruction of the innominate bifurcation using the retrograde 'kissing stents' technique

International Nuclear Information System (INIS)

Nagata, Shun-ichi; Kazekawa, Kiyoshi; Matsubara, Shuko; Sugata, Sei

2006-01-01

Obstructions of the supraaortic vessels are an important cause of morbidity associated with a variety of symptoms. Percutaneous transluminal angioplasty has evolved as an effective and safe treatment modality for occlusive lesions of the supraaortic vessels. However, the endovascular management of an innominate bifurcation has not previously been reported. A 53-year-old female with a history of systematic hypertension, diabetes mellitus and hypercholesterolemia presented with left hemiparesis and dysarthria. Angiography of the innominate artery showed a stenosis of the innominate bifurcation. The lesion was successfully treated using the retrograde kissing stent technique via a brachial approach and an exposed direct carotid approach. The retrograde kissing stent technique for the treatment of a stenosis of the innominate bifurcation was found to be a safe and effective alternative to conventional surgery. (orig.)

Novel free paclitaxel-loaded poly(L-γ-glutamylglutamine–paclitaxel nanoparticles

Directory of Open Access Journals (Sweden)

Danbo Yang

2011-01-01

Full Text Available Danbo Yang1, Sang Van2, Xinguo Jiang3, Lei Yu1,21Biomedical Engineering and Technology Institute, Institutes for Advanced Interdisciplinary Research, East China Normal University, Shanghai, People's Republic of China; 2Biomedical Group, Nitto Denko Technical Corporation, Oceanside, CA, USA; 3School of Pharmacy, Fudan University, Shanghai, People's Republic of ChinaAbstract: The purpose of this study was to develop a novel formulation of paclitaxel (PTX that would improve its therapeutic index. Here, we combined a concept of polymer–PTX drug conjugate with a concept of polymeric micelle drug delivery to form novel free PTX-loaded poly(L-γ-glutamylglutamine (PGG–PTX conjugate nanoparticles. The significance of this drug formulation emphasizes the simplicity, novelty, and flexibility of the method of forming nanoparticles that contain free PTX and conjugated PTX in the same drug delivery system. The results of effectively inhibiting tumor growth in mouse models demonstrated the feasibility of the nanoparticle formulation. The versatility and potential of this dual PTX drug delivery system can be explored with different drugs for different indications. Novel and simple formulations of PTX-loaded PGG–PTX nanoparticles could have important implications in translational medicines.Keywords: paclitaxel, polymeric micelle, poly(L-γ-glutamylglutamine–paclitaxel, nanoconjugate, nanoparticles

Outcome of Sirolimus-Eluting Versus Zotarolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus (a SORT OUT III Substudy)

DEFF Research Database (Denmark)

Maeng, Michael; Jensen, Lisette O; Tilsted, Hans-Henrik

2011-01-01

Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first...... cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated.......90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated...

Excel-Based Tool for Pharmacokinetically Guided Dose Adjustment of Paclitaxel.

Science.gov (United States)

Kraff, Stefanie; Lindauer, Andreas; Joerger, Markus; Salamone, Salvatore J; Jaehde, Ulrich

2015-12-01

Neutropenia is a frequent and severe adverse event in patients receiving paclitaxel chemotherapy. The time above a paclitaxel threshold concentration of 0.05 μmol/L (Tc > 0.05 μmol/L) is a strong predictor for paclitaxel-associated neutropenia and has been proposed as a target pharmacokinetic (PK) parameter for paclitaxel therapeutic drug monitoring and dose adaptation. Up to now, individual Tc > 0.05 μmol/L values are estimated based on a published PK model of paclitaxel by using the software NONMEM. Because many clinicians are not familiar with the use of NONMEM, an Excel-based dosing tool was developed to allow calculation of paclitaxel Tc > 0.05 μmol/L and give clinicians an easy-to-use tool. Population PK parameters of paclitaxel were taken from a published PK model. An Alglib VBA code was implemented in Excel 2007 to compute differential equations for the paclitaxel PK model. Maximum a posteriori Bayesian estimates of the PK parameters were determined with the Excel Solver using individual drug concentrations. Concentrations from 250 patients were simulated receiving 1 cycle of paclitaxel chemotherapy. Predictions of paclitaxel Tc > 0.05 μmol/L as calculated by the Excel tool were compared with NONMEM, whereby maximum a posteriori Bayesian estimates were obtained using the POSTHOC function. There was a good concordance and comparable predictive performance between Excel and NONMEM regarding predicted paclitaxel plasma concentrations and Tc > 0.05 μmol/L values. Tc > 0.05 μmol/L had a maximum bias of 3% and an error on precision of 0.05 μmol/L values between both programs was 1%. The Excel-based tool can estimate the time above a paclitaxel threshold concentration of 0.05 μmol/L with acceptable accuracy and precision. The presented Excel tool allows reliable calculation of paclitaxel Tc > 0.05 μmol/L and thus allows target concentration intervention to improve the benefit-risk ratio of the drug. The easy use facilitates therapeutic drug monitoring in

Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial.

Science.gov (United States)

Awada, Ahmad; Colomer, Ramon; Inoue, Kenichi; Bondarenko, Igor; Badwe, Rajendra A; Demetriou, Georgia; Lee, Soo-Chin; Mehta, Ajay O; Kim, Sung-Bae; Bachelot, Thomas; Goswami, Chanchal; Deo, Suryanarayan; Bose, Ron; Wong, Alvin; Xu, Feng; Yao, Bin; Bryce, Richard; Carey, Lisa A

2016-12-01

Efficacious ERBB2 (formerly HER2 or HER2/neu)-directed treatments, in addition to trastuzumab and lapatinib, are needed. To determine whether neratinib, an irreversible pan-ERBB tyrosine kinase inhibitor, plus paclitaxel improves progression-free survival compared with trastuzumab plus paclitaxel in the first-line treatment of recurrent and/or metastatic ERBB2-positive breast cancer. In the randomized, controlled, open-label NEfERT-T trial conducted from August 2009 to December 2014 at 188 centers in 34 countries in Europe, Asia, Africa, and North America, 479 women with previously untreated recurrent and/or metastatic ERBB2-positive breast cancer were randomized to 1 of 2 treatment arms (neratinib-paclitaxel [n = 242] or trastuzumab-paclitaxel [n = 237]). Women with asymptomatic central nervous system metastases were eligible, and randomization was stratified by prior trastuzumab and lapatinib exposure, hormone-receptor status, and region. Women received neratinib (240 mg/d orally) or trastuzumab (4 mg/kg then 2 mg/kg weekly), each combined with paclitaxel (80 mg/m2 on days 1, 8, and 15 every 28 days). Primary prophylaxis for diarrhea was not mandatory. The primary outcome was progression-free survival. Secondary end points were response rate, clinical benefit rate, duration of response, frequency, and time to symptomatic and/or progressive central nervous system lesions, and safety. The intent-to-treat population comprised 479 women 18 years or older (neratinib-paclitaxel, n = 242; trastuzumab-paclitaxel, n = 237) randomized and stratified in their respective treatment arms by prior trastuzumab and lapatinib exposure, hormone-receptor status, and region. Median progression-free survival was 12.9 months (95% CI, 11.1-14.9) with neratinib-paclitaxel and 12.9 months (95% CI, 11.1-14.8) with trastuzumab-paclitaxel (hazard ratio [HR], 1.02; 95% CI, 0.81-1.27; P =.89). With neratinib-paclitaxel, the incidence of central nervous system recurrences was

Herbal Medicine Goshajinkigan Prevents Paclitaxel-Induced Mechanical Allodynia without Impairing Antitumor Activity of Paclitaxel

OpenAIRE

Bahar, Muh. Akbar; Andoh, Tsugunobu; Ogura, Keisuke; Hayakawa, Yoshihiro; Saiki, Ikuo; Kuraishi, Yasushi

2013-01-01

Chemotherapy-induced peripheral neuropathy is a major dose-limiting side effect of commonly used chemotherapeutic agents. However, there are no effective strategies to treat the neuropathy. We examined whether Goshajinkigan, a herbal medicine, would prevent paclitaxel-induced allodynia without affecting the anticancer action in mice. Murine breast cancer 4T1 cells were inoculated into the mammary fat pad. Paclitaxel (10 and 20 mg/kg, intraperitoneal, alternate day from day 7 postinoculation) ...

Nano-particle nab-paclitaxel in treatment of metastatic breast cancer

International Nuclear Information System (INIS)

Barilla, R.; Dolinsky, J.

2011-01-01

Taxanes, paclitaxel and docetaxel, are together with anthracyclines the cornerstone of treatment of both early and advanced breast cancer. They are established as the standard of care either as monotherapy or in combination with other cytostatic agents and targeted therapies. However, despite their significant clinical activity in many cancer types, the use of taxanes is often limited by significant toxicities, including hypersensitivity reactions, which complicate treatment and diminish quality of life. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a 130 nm particle cremophor free formulation. Due to its special properties it allows to reach higher intratumoral concentrations of paclitaxel. In randomized phase II and phase III trials has been shown a superior efficacy and safety of nab-paclitaxel over paclitaxel or docetaxel. This new therapeutic formulation of paclitaxel may be therefore an adequate alternative to classic formulation of taxanes in the treatment of metastatic breast cancer. (author)

Covalent linkage of nanodiamond-paclitaxel for drug delivery and cancer therapy

Energy Technology Data Exchange (ETDEWEB)

Liu, Kuang-Kai; Wang, Chi-Ching; Chao, Jui-I [Department of Biological Science and Technology, National Chiao Tung University, Hsinchu 30013, Taiwan (China); Zheng, Wen-Wei; Lo, Yu-Shiu; Chen, Chinpiao [Department of Chemistry, National Dong Hwa University, Hualien 97401, Taiwan (China); Chiu, Yu-Chung; Cheng, Chia-Liang, E-mail: clcheng@mail.ndhu.edu.tw, E-mail: chinpiao@mail.ndhu.edu.tw, E-mail: jichao@faculty.nctu.edu.tw [Department of Physics, National Dong Hwa University, Hualien 97401, Taiwan (China)

2010-08-06

A nanoparticle-conjugated cancer drug provides a novel strategy for cancer therapy. In this study, we manipulated nanodiamond (ND), a carbon nanomaterial, to covalently link paclitaxel for cancer drug delivery and therapy. Paclitaxel was bound to the surface of 3-5 nm sized ND through a succession of chemical modifications. The ND-paclitaxel conjugation was measured by atomic force microscope and nuclear magnetic resonance spectroscopy, and confirmed with infrared spectroscopy by the detection of deuterated paclitaxel. Treatment with 0.1-50 {mu}g ml{sup -1} ND-paclitaxel for 48 h significantly reduced the cell viability in the A549 human lung carcinoma cells. ND-paclitaxel induced both mitotic arrest and apoptosis in A549 cells. However, ND alone or denatured ND-paclitaxel (after treatment with strong alkaline solution, 1 M NaOH) did not induce the damage effects on A549 cells. ND-paclitaxel was taken into lung cancer cells in a concentration-dependent manner using flow cytometer analysis. The ND-paclitaxel particles were located in the microtubules and cytoplasm of A549 cells observed by confocal microscopy. Furthermore, ND-paclitaxel markedly blocked the tumor growth and formation of lung cancer cells in xenograft SCID mice. Together, we provide a functional covalent conjugation of ND-paclitaxel, which can be delivered into lung carcinoma cells and preserves the anticancer activities on the induction of mitotic blockage, apoptosis and anti-tumorigenesis.

Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

Science.gov (United States)

Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

2017-10-03

The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http

Paclitaxel and concurrent radiation for gastric cancer

International Nuclear Information System (INIS)

Safran, Howard; Wanebo, Harry J.; Hesketh, Paul J.; Akerman, Paul; Ianitti, David; Cioffi, William; Di Petrillo, Thomas; Wolf, Brian; Koness, James; McAnaw, Robert; Moore, Todd; Chen, M.-H.; Radie-Keane, Kathy

2000-01-01

Purpose: To determine the activity and toxicity of paclitaxel and concurrent radiation for gastric cancer. Methods and Materials: Twenty-seven patients were studied. Twenty-five had proximal gastric cancers, two had distal cancers. Eight had esophageal extension, 6 had celiac adenopathy, and 7 had retroperitoneal adenopathy. Patients received paclitaxel, 50 mg/m 2 by 3-hour intravenous (IV) infusion, weekly, on days 1, 8, 15, 22, and 29. Radiation was administered concurrently to a total dose of 45.0 Gy, in 1.80 Gy fractions, for 25 treatments. Patients who were medically or surgically inoperable received a sixth week of paclitaxel with a radiation boost to 50.4 Gy. Results: Esophagitis and gastritis were the most important toxicities, Grade 3 in four patients (15%), and Grade 4 in three patients (11%). Five patients (19%) had Grade 3 nausea. The overall response rate was 56%, including three patients (11%) with a complete response. The 2-year progression-free and overall survival rates were 29% and 31%, respectively. Conclusion: Concurrent paclitaxel and radiation demonstrates substantial local-regional activity in gastric cancer. Future investigations combining paclitaxel and radiation with other local-regional and systemic treatments are warranted

Cirugía endoscópica transluminal por orificios naturales: NOTES Natural orifice transluminal endoscopic surgery: NOTES

Directory of Open Access Journals (Sweden)

M. J. Varas Lorenzo

2009-04-01

Full Text Available Se presenta una revisión actual, puesta al día, y punto de vista de los autores sobre un tema sumamente novedoso y atractivo, como es la Cirugía Endoscópica Transluminal por Orificios Naturales (NOTES: Natural Orifice Translumenal Endoscopic Surgery. La mayoría de los trabajos revisados se han realizado en animales de experimentación, pero la publicación de la colecistectomía por vía transvaginal, y la aparición de editoriales y artículos de revisión sobre el tema, nos llevan a realizar una serie de preguntas no resueltas actualmente sobre este tipo de cirugía, que representa un avance potencial para conseguir "una cirugía endoscópica sin cicatrices, sin infecciones, con mínimos requerimientos de anestesia y una inmediata recuperación".A current review and update of an exceedingly novel and appealing topic, namely natural orifice transluminal endoscopic surgery (NOTES, is discussed, as well as the authors' viewpoint thereon. Most reviewed studies were performed in laboratory animals, but reports on transvaginal cholecystectomy and the emergence of editorials and review articles on this topic pose a number of as yet unanswered questions on this type of surgery, which represents a potential advance towards "endoscopic surgery with no scars, no infection, minimal anesthesia requirements, and immediate recovery".

Relationship between the total length of the stents and patients' quality of life after percutaneous coronary intervention.

Science.gov (United States)

Liu, Wei; Yang, Xuming; Dong, Pingshuan; Li, Zhijuan

2015-01-01

The aim of this study was to examine the relationship between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who undergo percutaneous coronary intervention (PCI). Using the short-form health survey (SF-36) items, we analyzed the data on the postoperative life quality of 166 patients with multi-vessel coronary artery disease who underwent percutaneous transluminal coronary intervention in the Department of Cardiology of the First Affiliated Hospital of Henan University of Science and Technology from September 2011 to September 2013. Follow-up was performed 6 months later. All of the dimensionalities, except general health and mental health, showed significantly higher scores after PCI. No significant relationships were observed between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who underwent PCI. PCI can effectively improve the postoperative life quality of patients; however, there was no significant relationship between the total length of the stents and postoperative life quality of patients.

Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

DEFF Research Database (Denmark)

Giustino, Gennaro; Baber, Usman; Stefanini, Giulio Giuseppe

2015-01-01

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11......,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST......-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p clinical...

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction.

Science.gov (United States)

Pilgrim, Thomas; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Tüller, David; Vuilliomenet, André; Muller, Olivier; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Khattab, Ahmed A; Taniwaki, Masanori; Rigamonti, Fabio; Nietlispach, Fabian; Blöchlinger, Stefan; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

2016-12-10

Our aim was to compare the safety and efficacy of a novel, ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) with a thin strut, durable polymer everolimus-eluting stent (DP-EES) in a pre-specified subgroup of patients with acute ST-segment elevation myocardial infarction (STEMI) enrolled in the BIOSCIENCE trial. The BIOSCIENCE trial is an investigator-initiated, single-blind, multicentre, randomised non-inferiority trial (NCT01443104). Randomisation was stratified according to the presence or absence of STEMI. The primary endpoint, target lesion failure (TLF), is a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Between February 2012 and May 2013, 407 STEMI patients were randomly assigned to treatment with BP-SES or DP-EES. At one year, TLF occurred in seven (3.4%) patients treated with BP-SES and 17 (8.8%) patients treated with DP-EES (RR 0.38, 95% CI: 0.16-0.91, p=0.024). Rates of cardiac death were 1.5% in the BP-SES group and 4.7% in the DP-EES group (RR 0.31, 95% CI: 0.08-1.14, p=0.062); rates of target vessel myocardial infarction were 0.5% and 2.6% (RR 0.18, 95% CI: 0.02-1.57, p=0.082), respectively, and rates of clinically indicated target lesion revascularisation were 1.5% in the BP-SES group versus 2.1% in the DP-EES group (RR 0.69, 95% CI: 0.16-3.10, p=0.631). There was no difference in the risk of definite stent thrombosis. In this pre-specified subgroup analysis, BP-SES was associated with a lower rate of target lesion failure at one year compared to DP-EES in STEMI patients. These findings require confirmation in a dedicated STEMI trial.

ASSOCIATION OF HIGH LIPOPROTEIN(a LEVELS WITH CORONARY ARTERY PATENCY DURING THE FIRST YEAR AFTER PERCUTANEOUS CORONARY INTERVENTIONS

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M. V. Ezhov

2011-01-01

Full Text Available Objective: to study an association of high lipoprotein(a [Lp(a] levels with the development of restenosis and the progression of coronaryatherosclerosis after percutaneous coronary interventions (PCI in patients with chronic coronary heart disease (CHD.Subjects and methods. From 502 enrolled patients (mean age 54.7 ± 8.9 years, 92 underwent routine percutaneous transluminal coronary angioplasty (PTCA, 270 had PTCA with the bare metal stent (BMS being implantation, 140 had PTCA using drug-eluting stents (DES. Functionalclasses III and IV angina have been registered in 337 (67 % patients; history of one myocardial infarction (MI was noted in 234 (47 % cases, 171 (34 % had experienced 2 or more MIs. Blood samples for lipid and Lp(a measurements were taken in all the patients. Restenosis was defined as at least 50 % lumen narrowing of the coronary artery segment after angioplasty. Coronary atherosclerosis progression was established in cases of the new occlusion occurring, as well as identifying a 10 % decrease in lumen diameter in comparison with baseline angiograms.Results. Repeated coronary angiography revealed the signs of restenosis in 103 of 243 patients. Dividing patients into 3 groups according to the type of intervention demonstrated that the level of Lp(a (median 25–75 % quartiles was significantly higher in the restenosis group after implantation of BMS (33; 11–62 and 16; 6–39 mg/dl, respectively; p = 0.014 versus those who had undergone DES implantation (23; 10–30 and 20; 6–60 mg/dl; p = 0.7 or balloon angioplasty (17; 4–48 and 9; 4–36 mg/dl; p = 0.3. Patients with progression of coronary atherosclerosis had difference only in Lp(a levels compared to the group without progression (36; 13–62 versus 12; 4–26 mg/dl, p < 0,001.Conclusion. During the first year after elective PCI Lp(a concentration determined the severity of coronary atherosclerosis in non-culprit lesionsand associated with the risk of in

ASSOCIATION OF HIGH LIPOPROTEIN(a LEVELS WITH CORONARY ARTERY PATENCY DURING THE FIRST YEAR AFTER PERCUTANEOUS CORONARY INTERVENTIONS

Directory of Open Access Journals (Sweden)

M. V. Ezhov

2014-07-01

Full Text Available Objective: to study an association of high lipoprotein(a [Lp(a] levels with the development of restenosis and the progression of coronaryatherosclerosis after percutaneous coronary interventions (PCI in patients with chronic coronary heart disease (CHD.Subjects and methods. From 502 enrolled patients (mean age 54.7 ± 8.9 years, 92 underwent routine percutaneous transluminal coronary angioplasty (PTCA, 270 had PTCA with the bare metal stent (BMS being implantation, 140 had PTCA using drug-eluting stents (DES. Functionalclasses III and IV angina have been registered in 337 (67 % patients; history of one myocardial infarction (MI was noted in 234 (47 % cases, 171 (34 % had experienced 2 or more MIs. Blood samples for lipid and Lp(a measurements were taken in all the patients. Restenosis was defined as at least 50 % lumen narrowing of the coronary artery segment after angioplasty. Coronary atherosclerosis progression was established in cases of the new occlusion occurring, as well as identifying a 10 % decrease in lumen diameter in comparison with baseline angiograms.Results. Repeated coronary angiography revealed the signs of restenosis in 103 of 243 patients. Dividing patients into 3 groups according to the type of intervention demonstrated that the level of Lp(a (median 25–75 % quartiles was significantly higher in the restenosis group after implantation of BMS (33; 11–62 and 16; 6–39 mg/dl, respectively; p = 0.014 versus those who had undergone DES implantation (23; 10–30 and 20; 6–60 mg/dl; p = 0.7 or balloon angioplasty (17; 4–48 and 9; 4–36 mg/dl; p = 0.3. Patients with progression of coronary atherosclerosis had difference only in Lp(a levels compared to the group without progression (36; 13–62 versus 12; 4–26 mg/dl, p < 0,001.Conclusion. During the first year after elective PCI Lp(a concentration determined the severity of coronary atherosclerosis in non-culprit lesionsand associated with the risk of in

Nab-paclitaxel for the treatment of breast cancer: efficacy, safety, and approval

Directory of Open Access Journals (Sweden)

Iwase H

2011-07-01

Full Text Available Yutaka Yamamoto1, Ichiro Kawano2, Hirotaka Iwase11Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; 2Department of Surgery, Asahino General Hospital, Kumamoto, JapanAbstract: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel is a novel formulation of paclitaxel that does not require solvents such as polyoxyethylated castor oil and ethanol. Use of these solvents has been associated with toxic response, including hypersensitivity reactions and prolonged sensory neuropathy, as well as a negative impact in relation to the therapeutic index of paclitaxel. nab-paclitaxel displays greater antitumor activity and less toxicity than solvent-base paclitaxel. In a phase I trial of single nab-paclitaxel, the maximum tolerated dose was 300 mg/m2 with the dose limiting toxicities being sensory neuropathy, stomatitis, and superficial keratopathy. In the metastatic setting, a pivotal comparative randomized phase III study demonstrated that nab-paclitaxel (at 260 mg/m2 over 30 minutes infusion without premedication every 3 weeks mediated a superior objective response rate and prolonged time to progression compared with solvent-based paclitaxel (at 175 mg/m2 over a 3-hour injection with standard premedication. The nab-paclitaxel-treated group showed a higher incidence of sensory neuropathy than the solvent-based paclitaxel group. However, these adverse side effects rapidly resolved after interruption of treatment and dose reduction. Weekly administration of nab-paclitaxel was also more active and displayed less toxicity compared with 100 mg/m2 docetaxel given triweekly. Nab-paclitaxel has already been approved in 42 countries for the treatment of metastatic breast cancer previously treated with anthracycline, based on confirmation of the efficacy and manageable toxicity in the metastatic setting. This review summarizes the most relevant knowledge on nab-paclitaxel for treating breast cancer

EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).

Science.gov (United States)

Khashab, Mouen A; Valeshabad, Ali Kord; Modayil, Rani; Widmer, Jessica; Saxena, Payal; Idrees, Mehak; Iqbal, Shahzad; Kalloo, Anthony N; Stavropoulos, Stavros N

2013-11-01

EUS-guided biliary drainage (EGBD) can be performed via direct transluminal or rendezvous techniques. It is unknown how both techniques compare in terms of efficacy and adverse events. To describe outcomes of EGBD performed by using a standardized approach and compare outcomes of rendezvous and transluminal techniques. Retrospective analysis of prospectively collected data. Two tertiary-care centers. Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EGBD after failed ERCP between July 2006 and December 2012 were included. EGBD by using a standardized algorithm. Technical success, clinical success, and adverse events. During the study period, 35 patients underwent EGBD (rendezvous n = 13, transluminal n = 20). Technical success was achieved in 33 patients (94%), and clinical success was attained in 32 of 33 patients (97.0%). The mean postprocedure bilirubin level was 1.38 mg/dL in the rendezvous group and 1.33 mg/dL in the transluminal group (P = .88). Similarly, length of hospital stay was not different between groups (P = .23). There was no significant difference in adverse event rate between rendezvous and transluminal groups (15.4% vs 10%; P = .64). Long-term outcomes were comparable between groups, with 1 stent migration in the rendezvous group at 62 days and 1 stent occlusion in the transluminal group at 42 days after EGBD. Retrospective analysis, small number of patients, and selection bias. EGBD is safe and effective when the described standardized approach is used. Stent occlusion is not common during long-term follow-up. Both rendezvous and direct transluminal techniques seem to be equally effective and safe. The latter approach is a reasonable alternative to rendezvous EGBD. Copyright © 2013. Published by Mosby, Inc.

Percutaneous reconstruction of the innominate bifurcation using the retrograde 'kissing stents' technique

Energy Technology Data Exchange (ETDEWEB)

Nagata, Shun-ichi; Kazekawa, Kiyoshi; Matsubara, Shuko [Fukuoka University Chikushi Hospital, Department of Neurosurgery, Chikushino, Fukuoka (Japan); Sugata, Sei [Bironoki Neurosurgical Hospital, Shibushi, Kagoshima (Japan)

2006-08-15

Obstructions of the supraaortic vessels are an important cause of morbidity associated with a variety of symptoms. Percutaneous transluminal angioplasty has evolved as an effective and safe treatment modality for occlusive lesions of the supraaortic vessels. However, the endovascular management of an innominate bifurcation has not previously been reported. A 53-year-old female with a history of systematic hypertension, diabetes mellitus and hypercholesterolemia presented with left hemiparesis and dysarthria. Angiography of the innominate artery showed a stenosis of the innominate bifurcation. The lesion was successfully treated using the retrograde kissing stent technique via a brachial approach and an exposed direct carotid approach. The retrograde kissing stent technique for the treatment of a stenosis of the innominate bifurcation was found to be a safe and effective alternative to conventional surgery. (orig.)

A study of concurrent radiochemotherapy with paclitaxel in glioblastoma multiforme

International Nuclear Information System (INIS)

Julka, P.K.; Awasthy, B.S.; Rath, G.K.; Agarwal, S.; Varna, T.; Mahapatra, A.K.; Singh, R.

2000-01-01

Despite advances in neurosurgery and radiotherapy, the prognosis of patients with glioblastoma multiforme remains poor. Reports in the literature about the radiosensitizing properties of paclitaxel stimulated the authors to conduct a study using paclitaxel concurrently with radiation in a group of 18 patients who had residual disease postoperatively. Paclitaxel was delivered weekly as an intravenous infusion in a dose of 60 mg/m 2 along with radiation to the primary lesion. A total of 108 cycles of paclitaxel was given. All the patients tolerated the treatment well. The main side effects were haematological, and neuropathy which was self-limiting. The overall 1-year survival rate was 70%, with 12 patients alive at 13 months. The median survival has not yet been reached although it is more than 13 months. Thus, paclitaxel can be safely delivered concomitantly with radiation in patients with glioblastoma multiforme. Larger, randomized trials are required to establish the comparative efficacy of paclitaxel as a radiosensitizer in glioblastoma multiforme. Copyright (1999) Blackwell Science Pty Ltd

Kronisk tarmiskæmi hos en yngre patient

DEFF Research Database (Denmark)

Hansen, Lars Koch; Kammerlander, Heidi; Cecere, Stefano

2012-01-01

A 46 year-old woman presented with classic symptoms. Computed tomography-angiography and duplex ultrasonography showed stenosis of the aa. mesenteria superior et inferior. The patient was moved to a university hospital and a percutaneous transluminal angioplasty with insertion of stents was perfo......A 46 year-old woman presented with classic symptoms. Computed tomography-angiography and duplex ultrasonography showed stenosis of the aa. mesenteria superior et inferior. The patient was moved to a university hospital and a percutaneous transluminal angioplasty with insertion of stents...... was performed. She was discharged shortly after feeling well....

Novel management strategy for coronary steal syndrome: case report of occlusion of a LIMA graft side branch with a combination of drug-eluting and covered-stent deployment.

LENUS (Irish Health Repository)

Hynes, Brian G

2009-11-01

We report a novel percutaneous therapeutic approach to the management of suspected coronary artery steal syndrome resulting from a large side branch of the left internal mammary artery bypass graft, using a combination of coated and drug-eluting stents. We demonstrate the feasibility and long-term efficacy of this strategy in a case report.

Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes

DEFF Research Database (Denmark)

Thim, Troels; Maeng, Michael; Kaltoft, Anne Kjer

2012-01-01

To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial.......To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial....

Patient and physician perception of natural orifice transluminal endoscopic appendectomy

Czech Academy of Sciences Publication Activity Database

Hucl, T.; Saglová, A.; Beneš, M.; Kocík, M.; Oliverius, M.; Valenta, Zdeněk; Špičák, J.

2012-01-01

Roč. 18, č. 15 (2012), s. 1800-1805 ISSN 1007-9327 Institutional research plan: CEZ:AV0Z10300504 Keywords : natural orifice transluminal endoscopic surgery * patient perception * physician perception * appendectomy * laparoscopy Subject RIV: FJ - Surgery incl. Transplants Impact factor: 2.547, year: 2012

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

Science.gov (United States)

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

Science.gov (United States)

Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

2017-01-01

To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

An initial experience using concurrent paclitaxel and radiation in the treatment of head and neck malignancies

International Nuclear Information System (INIS)

Tishler, Roy B.; Busse, Paul M.; Norris, Charles M.; Rossi, Rene; Poulin, Mark; Thornhill, Lee; Costello, Rosemary; Peters, Edward S.; Colevas, A. Dimitrios; Posner, Marshall R.

1999-01-01

Background: Combined modality therapy plays a central role in the management of head and neck malignancies. This study examined the feasibility and preliminary results of treating a group of patients using concurrent bolus paclitaxel (Taxol TM ) and radiation therapy. Methods: Fourteen patients with a median age of 56 years (range 42-81) were treated. Paclitaxel was given every 3 weeks at a dose of 100 mg/m 2 concurrently with external beam radiation. The patients treated included those who had failed to achieve a complete response (CR) to induction chemotherapy with cisplatin, 5-fluorouracil, and leucovorin (PFL), or who had locally advanced disease not previously treated. Results: Median follow-up from the initiation of treatment is 40 months (range 23-48). The majority of patients (13/14) achieved clinical CRs at the primary site. The development of responses was characterized by a long time course. Three patients who were nonresponders (NRs) to induction PFL chemotherapy were treated. One was a clinical CR at the primary site, one did not achieve a CR, and the other had residual disease in the neck. Four patients have failed, one with local-regional disease, one with a marginal failure, one with distant metastases, and one was not rendered disease-free by the treatment. As expected, significant local toxicity was observed. Most patients were managed with the aid of a percutaneous endoscopic gastrostomy (PEG). Two patients experienced significant moist desquamation and required treatment breaks of greater than 1 week. Conclusion: Paclitaxel can be given on a 3-week schedule at 100 mg/m 2 concurrently with radiation. The preliminary results indicate good local responses and acceptable toxicity. This treatment approach merits further study in the treatment of head and neck malignancies, and should be considered as an option in other sites

Mechanisms and Patterns of Intravascular Ultrasound In-Stent Restenosis Among Bare Metal Stents and First- and Second-Generation Drug-Eluting Stents.

Science.gov (United States)

Goto, Kosaku; Zhao, Zhijing; Matsumura, Mitsuaki; Dohi, Tomotaka; Kobayashi, Nobuaki; Kirtane, Ajay J; Rabbani, LeRoy E; Collins, Michael B; Parikh, Manish A; Kodali, Susheel K; Leon, Martin B; Moses, Jeffrey W; Mintz, Gary S; Maehara, Akiko

2015-11-01

The most common causes of in-stent restenosis (ISR) are intimal hyperplasia and stent under expansion. The purpose of this study was to use intravascular ultrasound (IVUS) to compare the ISR mechanisms of bare metal stents (BMS), first-generation drug-eluting stents (DES), and second-generation DES. There were 298 ISR lesions including 52 BMS, 73 sirolimus-eluting stents, 52 paclitaxel-eluting stents, 16 zotarolimus-eluting stents, and 105 everolimus-eluting stent. Mean patient age was 66.6 ± 1.1 years, 74.2% were men, and 48.3% had diabetes mellitus. BMS restenosis presented later (70.0 ± 66.7 months) with more intimal hyperplasia compared with DES (BMS 58.6 ± 15.5%, first-generation DES 52.6 ± 20.9%, second-generation DES 48.2 ± 22.2%, p = 0.02). Although reference lumen areas were similar in BMS and first- and second-generation DES, restenotic DES were longer (BMS 21.8 ± 13.5 mm, first-generation DES 29.4 ± 16.1 mm, second-generation DES 32.1 ± 18.7 mm, p = 0.003), and stent areas were smaller (BMS 7.2 ± 2.4 mm(2), first-generation DES 6.1 ± 2.1 mm(2), second-generation DES 5.7 ± 2.0 mm(2), p Stent fracture was seen only in DES (first-generation DES 7 [5.0%], second-generation DES 8 [7.4%], p = 0.13). In conclusion, restenotic first- and second-generation DES were characterized by less neointimal hyperplasia, smaller stent areas, longer stent lengths, and more stent fractures than restenotic BMS. Copyright © 2015 Elsevier Inc. All rights reserved.

Formulation and pharmacokinetic evaluation of a paclitaxel nanosuspension for intravenous delivery

Directory of Open Access Journals (Sweden)

Wang YL

2011-07-01

Full Text Available Yonglu Wang1,4, Xueming Li1,2*, Liyao Wang3, Yuanlong Xu1, Xiaodan Cheng1, Ping Wei41College of Pharmacy, Nanjing University of Technology, Nanjing; 2State Key Laboratory of Materials-Oriented Chemical Engineering, Nanjing University of Technology, Nanjing; 3College of Life Science, Anhui Agricultural University, Hefei; 4College of Biotechnology and Pharmaceutical Engineering, Nanjing University of Technology, Nanjing, People’s Republic of China *These authors contributed equally to this work.Abstract: Paclitaxel is a diterpenoid isolated from Taxus brevifolia. It is effective for various cancers, especially ovarian and breast cancer. Due to its aqueous insolubility, it is administered dissolved in ethanol and Cremophor® EL (BASF, Ludwigshafen, Germany, which can cause serious allergic reactions. In order to eliminate Cremophor EL, paclitaxel was formulated as a nanosuspension by high-pressure homogenization. The nanosuspension was lyophilized to obtain the dry paclitaxel nanoparticles (average size, 214.4 ± 15.03 nm, which enhanced both the physical and chemical stability of paclitaxel nanoparticles. Paclitaxel dissolution was also enhanced by the nanosuspension. Differential scanning calorimetry showed that the crystallinity of paclitaxel was preserved during the high-pressure homogenization process. The pharmacokinetics and tissue distribution of paclitaxel were compared after intravenous administration of paclitaxel nanosuspension and paclitaxel injection. In rat plasma, paclitaxel nanosuspension exhibited a significantly (P < 0.01 reduced area under the concentration curve (AUC0–∞ (20.343 ± 9.119 µg · h · mL−1 vs 5.196 ± 1.426 µg · h · mL−1, greater clearance (2.050 ± 0.616 L · kg−1 · h−1 vs 0.556 ± 0.190 L · kg−1 · h−1, and shorter elimination half-life (5.646 ± 2.941 vs 3.774 ± 1.352 hours compared with the paclitaxel solution. In contrast, the paclitaxel nanosuspension resulted in a

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.

Science.gov (United States)

Mok, Tony S; Wu, Yi-Long; Thongprasert, Sumitra; Yang, Chih-Hsin; Chu, Da-Tong; Saijo, Nagahiro; Sunpaweravong, Patrapim; Han, Baohui; Margono, Benjamin; Ichinose, Yukito; Nishiwaki, Yutaka; Ohe, Yuichiro; Yang, Jin-Ji; Chewaskulyong, Busyamas; Jiang, Haiyi; Duffield, Emma L; Watkins, Claire L; Armour, Alison A; Fukuoka, Masahiro

2009-09-03

Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group. Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for

Efficacy and toxicological studies of cremophor EL free alternative paclitaxel formulation.

Science.gov (United States)

Utreja, Puneet; Jain, Subheet; Yadav, Subodh; Khandhuja, K L; Tiwary, A K

2011-11-01

In the present study, Cremophor EL free paclitaxel elastic liposomal formulation consisting of soya phosphatidylcholine and biosurfactant sodium deoxycholate was developed and optimized. The toxicological profile, antitumor efficacy and hemolytic toxicity of paclitaxel elastic liposomal formulation in comparison to Cremophor EL based marketed formulation were evaluated. Paclitaxel elastic liposomal formulations were prepared and characterized in vitro, ex-vivo and in vivo. Single dose toxicity study of paclitaxel elastic liposomal and marketed formulation was carried out in dose range of 10, 20, 40, 80, 120, 160 and 200 mg/kg. Cytotoxicity of developed formulation was evaluated using small cell lung cancer cell line (A549). Antitumor activity of developed formulation was compared with the marketed formulation using Cytoselect™ 96-well cell transformation assay. In vivo administration of paclitaxel elastic liposomal formulation into mice showed 6 fold increase in Maximum Tolerated Dose (MTD) in comparison to the marketed formulation. Similarly, LD50 (141.6 mg/kg) was also found to increase significantly than the marketed formulation (16.7 mg/kg). Result of antitumor assay revealed a high reduction of tumor density with paclitaxel elastic liposomal formulation. Reduction in hemolytic toxicity was also observed with paclitaxel elastic liposomal formulation in comparison to the marketed formulation. The carrier based approach for paclitaxel delivery demonstrated significant reduction in toxicity as compared to the Cremophor EL based marketed formulation following intra-peritoneal administration in mice model. The reduced toxicity and enhanced anti-cancer activity of elastic liposomal formulation strongly indicate its potential for safe and effective delivery of paclitaxel.

Frequency of Cardiac Death and Stent Thrombosis in Patients With Chronic Obstructive Pulmonary Disease Undergoing Percutaneous Coronary Intervention (from the BASKET-PROVE I and II Trials)

DEFF Research Database (Denmark)

Jatene, Tannas; Biering-Sørensen, Tor; Nochioka, Kotaro

2017-01-01

Chronic obstructive pulmonary disease (COPD) is associated with long-term all-cause death after percutaneous coronary intervention with bare-metal stents. Regarding other outcomes, previous studies have shown conflicting results and the impact of drug-eluting stent (DES) in this population is not...

Acoustically active lipospheres containing paclitaxel: a new therapeutic ultrasound contrast agent.

Science.gov (United States)

Unger, E C; McCreery, T P; Sweitzer, R H; Caldwell, V E; Wu, Y

1998-12-01

Paclitaxel-carrying lipospheres (MRX-552) were developed and evaluated as a new ultrasound contrast agent for chemotherapeutic drug delivery. Paclitaxel was suspended in soybean oil and added to an aqueous suspension of phospholipids in vials. The headspace of the vials was replaced with perfluorobutane gas; the vials were sealed, and they were agitated at 4200 rpm on a shaking device. The resulting lipospheres containing paclitaxel were studied for concentration, size, acute toxicity in mice, and acoustic activity and drug release with ultrasound. Lipospheres containing sudan black dye were produced to demonstrate the acoustically active liposphere (AAL)-ultrasound release concept. Acoustically active lipospheres containing paclitaxel had a mean particle count of approximately 1 x 10(9) particles per mL and a mean size of 2.9 microns. Acute toxicity studies in mice showed a 10-fold reduction in toxicity for paclitaxel in AALs compared with free paclitaxel. The AALs reflected ultrasound as a contrast agent. Increasing amounts of ultrasound energy selectively ruptured the AALs and released the paclitaxel. Acoustically active lipospheres represent a new class of acoustically active drug delivery vehicles. Future studies will assess efficacy of AALs for ultrasound-mediated drug delivery.

Left main percutaneous coronary intervention.

Science.gov (United States)

Teirstein, Paul S; Price, Matthew J

2012-10-23

The introduction of drug-eluting stents and advances in catheter techniques have led to increasing acceptance of percutaneous coronary intervention (PCI) as a viable alternative to coronary artery bypass graft (CABG) for unprotected left main disease. Current guidelines state that it is reasonable to consider unprotected left main PCI in patients with low to intermediate anatomic complexity who are at increased surgical risk. Data from randomized trials involving patients who are candidates for either treatment strategy provide novel insight into the relative safety and efficacy of PCI for this lesion subset. Herein, we review the current data comparing PCI with CABG for left main disease, summarize recent guideline recommendations, and provide an update on technical considerations that may optimize clinical outcomes in left main PCI. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Polaprezinc reduces paclitaxel-induced peripheral neuropathy in rats without affecting anti-tumor activity

Directory of Open Access Journals (Sweden)

Kuniaki Tsutsumi

2016-06-01

Full Text Available Paclitaxel, an anticancer drug, frequently causes painful peripheral neuropathy. In this study, we investigated the preventive effect of polaprezinc on paclitaxel-induced peripheral neuropathy in rats. Polaprezinc (3 mg/kg, p.o., once daily inhibited the development of mechanical allodynia induced by paclitaxel (4 mg/kg, i.p., on days 1, 3, 5 and 7 and suppressed the paclitaxel-induced increase in macrophage migration in dorsal root ganglion cells. In addition, polaprezinc did not affect the anti-tumor activity of paclitaxel in cultured cell lines or tumor-bearing mice. These results suggest a clinical indication for polaprezinc in the prevention of paclitaxel-induced neuropathy.

Role of cytochrome P450 2C8*3 (CYP2C8*3) in paclitaxel metabolism and paclitaxel-induced neurotoxicity

DEFF Research Database (Denmark)

Lee, Mi-Young; Apellániz-Ruiz, María; Johansson, Inger

2015-01-01

AIM: The CYP2C8*3 allele has been suggested as a risk factor for paclitaxel-induced neuropathy but the data hitherto published are conflicting. MATERIALS & METHODS: In total 435 patients were investigated with respect to maximum neuropathy grade and accumulated paclitaxel dose. The enzymatic prop...

Cost-Benefit Analysis of Nanoparticle Albumin-Bound Paclitaxel versus Solvent-Based Paclitaxel for the Treatment of Metastatic Breast Cancer in the United States

Science.gov (United States)

Vichansavakul, Kittaya

Breast cancer is the second leading cause of death among women in the US. Although early detection and treatment help to increase survival rates, some unfortunate patients develop metastatic breast cancer that has no cure. Palliative treatment is the main objective in this group of patients in order to prolong life and reduce toxicities from interventions. In the advancement of treatment for metastatic breast cancer, solvent-based paclitaxel has been widely used. However, solvent-based paclitaxel often causes adverse reactions. Therefore, researchers have developed a new chemotherapy based on nanotechnology. One of these drugs is the Nanoparticle albumin-bound Paclitaxel. This nanodrug aims to increase therapeutic index by reducing adverse reactions from solvents and to improve efficacy of conventional cytotoxic chemotherapy. Breast cancer is a disease with high epidemiological and economic burden. The treatment of metastatic breast cancer has not only high direct costs but also high indirect costs. Breast cancer affects mass populations, especially women younger than 50 years of age. It relates to high indirect costs due to lost productivity and premature death because the majority of these patients are in the workforce. Because of the high cost of breast cancer therapies and short survival rates, the question is raised whether the costs and benefits are worth paying or not. Due to the rising costs in healthcare and new financing policies that have been developed to address this issue, economic evaluation is an important aspect of the development and use of any new interventions. To guide policy makers on how to allocate limited healthcare resources in the most efficient and effective manner, many economic evaluation methods can be used to measure the costs, benefits, and impacts of healthcare innovations. Currently, economic evaluation and health outcomes studies have focused greatly on cost-effectiveness and cost-utility analysis. However, the previous studies

Milrinone infusion: A therapeutic option in coronary vasospasm after primary percutaneous transluminal coronary angioplasty

Directory of Open Access Journals (Sweden)

Singh Amarpal

2009-01-01

Full Text Available A 42-year-old male presented to the emergency department with acute chest pain. The electrocardiogram revealed inferior wall myocardial infarction. Emergency coronary angiography revealed total occlusion of the distal right coronary artery with thrombus. Patient was taken up for primary percutaneous coronary angioplasty with stenting of distal right coronary artery. Six hours following the procedure, the patient developed re-elevation of ST-segment in inferior leads of electrocardiogram and subsequent haemodynamic instability. Repeat coronary angiography revealed patent stent and coronary artery spasm in proximal part, which was relieved by intracoronary injection of nitroglycerine. After an hour, the patient re-developed symptoms of chest pain along with bradycardia, hypotension and ST segment elevation. Intravenous infusion of nitroglycerine did not improve the condition but produced persistent hypotension. Infusion of milrinone was then started. Over time, normalisation of electrocardiogram occurred. The patient was discharged in stable condition. This case suggests that milrinone may be effective in alleviating coronary artery spasm when the use of other agents fails

Coronary Stents in Diabetic Patients: State of the Knowledge.

Science.gov (United States)

Codner, Pablo; Gurm, Hitinder Singh; Motivala, Apurva

2017-04-01

This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions

DEFF Research Database (Denmark)

Jensen, Lisette Okkels; Maeng, Michael; Kaltoft, Anne

2007-01-01

OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002...... through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from...... within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents. Udgivelsesdato: 2007-Jul-31...

Neurotoxic 1-deoxysphingolipids and paclitaxel-induced peripheral neuropathy

Science.gov (United States)

Kramer, Rita; Bielawski, Jacek; Kistner-Griffin, Emily; Othman, Alaa; Alecu, Irina; Ernst, Daniela; Kornhauser, Drew; Hornemann, Thorsten; Spassieva, Stefka

2015-01-01

Peripheral neuropathy is a major dose-limiting side effect of paclitaxel and cisplatin chemotherapy. In the current study, we tested the involvement of a novel class of neurotoxic sphingolipids, the 1-deoxysphingolipids. 1-Deoxysphingolipids are produced when the enzyme serine palmitoyltransferase uses l-alanine instead of l-serine as its amino acid substrate. We tested whether treatment of cells with paclitaxel (250 nM, 1 µM) and cisplatin (250 nM, 1 µM) would result in elevated cellular levels of 1-deoxysphingolipids. Our results revealed that paclitaxel, but not cisplatin treatment, caused a dose-dependent elevation of 1-deoxysphingolipids levels and an increase in the message and activity of serine palmitoyltransferase (P peripheral neuropathy symptoms [evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-chemotherapy-induced peripheral neuropathy-20 (CIPN20) instrument] and the 1-deoxysphingolipid plasma levels (measured by mass spectrometry) in 27 patients with breast cancer who were treated with paclitaxel chemotherapy. Our results showed that there was an association between the incidence and severity of neuropathy and the levels of very-long-chain 1-deoxyceramides such as C24 (P neuropathy (P peripheral neuropathy.—Kramer, R., Bielawski, J., Kistner-Griffin, E., Othman, A., Alecu, I., Ernst, D., Kornhauser, D., Hornemann, T., Spassieva, S. Neurotoxic 1-deoxysphingolipids and paclitaxel-induced peripheral neuropathy. PMID:26198449

The Combination Process for Preparative Separation and Purification of Paclitaxel and 10-Deacetylbaccatin III Using Diaion® Hp-20 Followed by Hydrophilic Interaction Based Solid Phase Extraction.

Science.gov (United States)

Shirshekanb, Mahsa; Rezadoost, Hassan; Javanbakht, Mehran; Ghassempour, Ali Reza

2017-01-01

There is no other naturally occurring defense agent against cancer that has a stronger effect than paclitaxel, commonly known under the brand name of Taxol ® . The major drawback for the more widespread use of paclitaxel and its precious precursor, 10-deacetylbaccatin III (10-DAB III), is that they require large-scale extraction from different parts of yew trees ( Taxus species), cell cultures, taxane-producing endophytic fungi, and Corylus species. In our previous work, a novel online two-dimensional heart-cut liquid chromatography process using hydrophilic interaction/ reversed-phase chromatography was used to introduce a semi-preparative treatment for the separation of polar (10-deacetylbaccatin III) and non-polar (paclitaxel) taxanes from Taxus baccata L. In this work, a combination of the absorbent (Diaion ®  HP-20) and a silica based solid phase extraction is utilized as a new, efficient, and cost effective method for large-scale production of taxanes. This process avoids the technical problem of two-dimensional preparative liquid chromatography. The first stage of the process involves discarding co-extractive polar compounds including chlorophylls and pigments using a non-polar synthetic hydrophobic absorbent, Diaion ®  HP-20. Extract was then loaded on to a silica based hydrophilic interaction solid phase extraction (silica 40-60 micron). Taxanes was eluted using a mixture of water and methanol at the optimized ratio of 70:30. Finally, the fraction containing taxanes was applied to semi-preparative reversed phase HPLC. The results revealed that using this procedure, paclitaxel and 10-DAB III could be obtained at 8 and 3 times more, respectively than by the traditional method of extraction.

The Combination Process for Preparative Separation and Purification of Paclitaxel and 10-Deacetylbaccatin III Using Diaion® Hp-20 Followed by Hydrophilic Interaction Based Solid Phase Extraction

Science.gov (United States)

Shirshekanb, Mahsa; Rezadoost, Hassan; Javanbakht, Mehran; Ghassempour, Ali Reza

2017-01-01

There is no other naturally occurring defense agent against cancer that has a stronger effect than paclitaxel, commonly known under the brand name of Taxol®. The major drawback for the more widespread use of paclitaxel and its precious precursor, 10-deacetylbaccatin III (10-DAB III), is that they require large-scale extraction from different parts of yew trees (Taxus species), cell cultures, taxane-producing endophytic fungi, and Corylus species. In our previous work, a novel online two-dimensional heart-cut liquid chromatography process using hydrophilic interaction/ reversed-phase chromatography was used to introduce a semi-preparative treatment for the separation of polar (10-deacetylbaccatin III) and non-polar (paclitaxel) taxanes from Taxus baccata L. In this work, a combination of the absorbent (Diaion® HP-20) and a silica based solid phase extraction is utilized as a new, efficient, and cost effective method for large-scale production of taxanes. This process avoids the technical problem of two-dimensional preparative liquid chromatography. The first stage of the process involves discarding co-extractive polar compounds including chlorophylls and pigments using a non-polar synthetic hydrophobic absorbent, Diaion® HP-20. Extract was then loaded on to a silica based hydrophilic interaction solid phase extraction (silica 40-60 micron). Taxanes was eluted using a mixture of water and methanol at the optimized ratio of 70:30. Finally, the fraction containing taxanes was applied to semi-preparative reversed phase HPLC. The results revealed that using this procedure, paclitaxel and 10-DAB III could be obtained at 8 and 3 times more, respectively than by the traditional method of extraction. PMID:29552048

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Full Text Available ... breast Macular degeneration Nerve conduction Osteoarthritis Osteoporosis Ovulation Parkinson disease Percutaneous transluminal coronary angioplasty (PTCA) Peristalsis Phagocytosis ...

Social inhibition modulates the effect of negative emotions on cardiac prognosis following percutaneous coronary intervention in the drug-eluting stent era

DEFF Research Database (Denmark)

Denollet, Johan; Pedersen, Susanne S.; Ong, Andrew T L

2006-01-01

Negative emotions have an adverse effect on cardiac prognosis. We investigated whether social inhibition (inhibited self-expression in social interaction) modulates the effect of negative emotions on clinical outcome following percutaneous coronary intervention (PCI).......Negative emotions have an adverse effect on cardiac prognosis. We investigated whether social inhibition (inhibited self-expression in social interaction) modulates the effect of negative emotions on clinical outcome following percutaneous coronary intervention (PCI)....

Phase I/II dose-finding study of nanoparticle albumin-bound paclitaxel (nab®-Paclitaxel) plus Cisplatin as Treatment for Metastatic Nasopharyngeal Carcinoma.

Science.gov (United States)

Huang, Yan; Liang, Wenhua; Yang, Yunpeng; Zhao, Liping; Zhao, Hongyun; Wu, Xuan; Zhao, Yuanyuan; Zhang, Yang; Zhang, Li

2016-07-13

This phase I/II study aimed to determine the maximum tolerated dose (MTD) of nanoparticle albumin-bound paclitaxel (nab (®)-paclitaxel) plus cisplatin as treatment for metastatic nasopharyngeal carcinoma (NPC). Patients were enrolled into 1 of 3 dose cohorts, each with 21-day treatment cycles: 1) intravenous (IV) nab-paclitaxel 260 mg/m(2) on day 1; 2) IV nab-paclitaxel 140 mg/m(2) on days 1 and 8; 3) IV nab-paclitaxel 100 mg/m(2) on days 1, 8, and 15. All patients received IV cisplatin 75 mg/m(2) on day 1. Treatment continued for 4-6 cycles, or until progression or unacceptable toxicity. If more than one-third of the patients in a cohort experienced a dose-limiting toxicity (DLT), the dose used in the previous cohort would be designated the MTD. Secreted protein acidic and rich in cysteine (SPARC) expression was detected by immunohistochemistry staining. Sixty-nine patients were enrolled, of whom 64 and 67 were eligible for efficacy and safety analysis, respectively. Two DLTs occurred in cohort 1 (grade 4 febrile neutropenia, grade 3 myalgia), none occurred in cohort 2, and 2 occurred in cohort 3 (both grade 3 fatigue). The MTD was not reached. Partial responses were achieved by 42 patients, 15 had stable disease, and 7 had progressive disease, giving an overall response rate of 66 %. Median progression-free survival was 9 months (95 % CI, 6-12 months). Grade ≥ 3 adverse events were mainly hematologic. There was no significant difference between the 3 cohorts with respect to efficacy or safety. Biomarker analyses indicated that stromal, rather than tumoral, SPARC may predict the response to nab-paclitaxel in NPC. Our findings suggest that nab-paclitaxel plus cisplatin is a highly active regimen with moderate toxicity for the treatment of metastatic NPC, which warrants further investigation in a phase III study. ClinicalTrials.gov ID: NCT01735409 . The trial was registered on November 20th, 2012.

Medline Plus

Full Text Available ... breast Macular degeneration Nerve conduction Osteoarthritis Osteoporosis Ovulation Parkinson disease Percutaneous transluminal coronary angioplasty (PTCA) Peristalsis Phagocytosis Pituitary ...

Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

NARCIS (Netherlands)

Drenth, Derk Jan

2005-01-01

This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

Natural orifice transluminal endoscopic surgery vs laparoscopic ovariectomy: Complications and inflammatory response

Czech Academy of Sciences Publication Activity Database

Martínek, J.; Ryska, O.; Filípková, T.; Doležel, R.; Juhás, Štefan; Motlík, Jan; Holubová, Monika; Nosek, V.; Rotnáglová, B.; Zavoral, M.; Ryska, M.

2012-01-01

Roč. 18, č. 27 (2012), s. 3558-3564 ISSN 1007-9327 Institutional research plan: CEZ:AV0Z50450515 Keywords : Natural orifice transluminal endoscopic surgery * Laparoscopy * Ovariectomy Subject RIV: FP - Other Medical Disciplines Impact factor: 2.547, year: 2012

Low doses of Paclitaxel repress breast cancer invasion through DJ-1/KLF17 signalling pathway.

Science.gov (United States)

Ismail, Ismail Ahmed; El-Sokkary, Gamal H; Saber, Saber H

2018-04-27

Paclitaxel (taxol) is an important agent against many tumours, including breast cancer. Ample data documents that paclitaxel inhibits breast cancer metastasis while others prove that paclitaxel enhances breast cancer metastasis. The mechanisms by which paclitaxel exerts its action are not well established. This study focuses on the effect of paclitaxel, particularly the low doses on breast cancer metastasis and the mechanisms that regulate it. Current results show that, paclitaxel exerts significant cytotoxicity even at low doses in both MCF-7 and MDA-MB-231 cells. Interestingly, paclitaxel significantly inhibits cell invasion and migration, decreases Snail and increases E-cadherin mRNA expression levels at the indicated low doses. Furthermore, paclitaxel-inhibiting breast cancer metastasis is associated with down-regulation of DJ-1 and ID-1 mRNA expression level with a concurrent increase in KLF17 expression. Under the same experimental conditions, paclitaxel induces KLF17 and concurrently represses ID-1 protein levels. Our results show for the first time that paclitaxel inhibits breast cancer metastasis through regulating DJ-1/KLF17/ID-1 signalling pathway; repressed DJ-1 and ID-1 and enhanced KLF17 expression. © 2018 John Wiley & Sons Australia, Ltd.

Safety and efficacy of everolimus-eluting stents for bare-metal in-stent restenosis

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Ota, Hideaki [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Mahmoudi, Michael [University of Surrey, Guildford Road, Surrey, GU2-7XH (United Kingdom); Torguson, Rebecca; Satler, Lowell F.; Suddath, William O.; Pichard, Augusto D. [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Waksman, Ron, E-mail: ron.waksman@medstar.net [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States)

2015-04-15

Objective: The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. Background: The optimal treatment for bare-metal in-stent restenosis remains controversial. Methods: The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year. Results: The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES = 3.5%, PES = 4.6%, SES = 4.2%; p = 0.94), MI (EES = 3.5%, PES = 6.3%, SES = 2.1%; p = 0.31), TLR (EES = 9.8%, PES = 9.5%, SES = 5.7%; p = 0.42), TVR (EES = 14.3%, PES = 11.1%, SES = 11.3%; p = 0.74), definite ST (EES = 0.9%, PES = 3.1%, SES = 3.5%; p = 0.38) and MACE (EES = 14.0%, PES = 15.4%, SES = 10.5%; p = 0.54). Male gender (hazard ratio = 0.47; 95% confidence interval = 0.25–0.88) and number of treated lesions (hazard ratio = 1.47; 95% confidence interval = 1.06–2.05) were found to be independent predictors of MACE. Conclusion: The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.

Therapeutic potential of paclitaxel-radiation treatment of a murine ovarian carcinoma

International Nuclear Information System (INIS)

Milas, Luka; Saito, Yoshihiro; Hunter, Nancy; Milross, Christopher G.; Mason, Kathryn A.

1996-01-01

Background. Paclitaxel has been shown to radiosensitize tumor cells in culture by arresting them in the most radiosensitive G 2 and M cell cycle phases. In vivo preclinical studies are now necessary to obtain full insight into the radiopotentiating potential of this drug and its ability to increase the therapeutic gain of radiotherapy. We tested its ability to enhance the tumor radioresponse of an ovarian carcinoma and to influence the normal tissue radioresponse of recipient mice. Methods. Mice bearing 8-mm isotransplants of a syngeneic ovarian carcinoma, designated OCA-I, in their legs were treated with 40 mg/kg paclitaxel i.v., 14-60 Gy single-dose local tumor irradiation, or both; radiation was given under ambient conditions 1-96 h after paclitaxel. Tumor growth delay, tumor cure rate (TCD 50 assay), and delay in tumor recurrences were measured. Normal tissue radioresponse was determined using jejunal crypt cell survival at 3.5 days after exposure of mice to 9-14 Gy single dose of total body irradiation; the mice were untreated or treated with 40 mg/kg i.v. paclitaxel 4-96 h before irradiation. Results. Paclitaxel alone was effective against OCA-I, but its combination with irradiation produced supra-additive tumor growth delay. It also reduced TCD 50 values and delayed tumor recurrences. The enhancement of tumor radioresponse ranged from 1.33 to 1.96; the value increased as the time between paclitaxel administration and tumor irradiation increased up to 48 h, but then decreased again at 96 h. In contrast, paclitaxel protected jejunum against radiation damage by factors of 1.03 to 1.07 when given 24-96 h before irradiation. It showed some potentiation of damage (by a factor of 1.07), but only when given 4 h before irradiation. Conclusions. Paclitaxel potentiated tumor radioresponse if given within 4 days before irradiation, whereas it caused radioprotection of normal tissue (jejunum) at that time. Therefore, paclitaxel significantly increased therapeutic gain

Biocatalysis of a Paclitaxel Analogue: Conversion of Baccatin III to N-Debenzoyl-N-(2-furoyl)paclitaxel and Characterization of an Amino Phenylpropanoyl CoA Transferase.

Science.gov (United States)

Thornburg, Chelsea K; Walter, Tyler; Walker, Kevin D

2017-11-07

In this study, we demonstrate an enzyme cascade reaction using a benzoate CoA ligase (BadA), a modified nonribosomal peptide synthase (PheAT), a phenylpropanoyltransferase (BAPT), and a benzoyltransferase (NDTNBT) to produce an anticancer paclitaxel analogue and its precursor from the commercially available biosynthetic intermediate baccatin III. BAPT and NDTNBT are acyltransferases on the biosynthetic pathway to the antineoplastic drug paclitaxel in Taxus plants. For this study, we addressed the recalcitrant expression of BAPT by expressing it as a soluble maltose binding protein fusion (MBP-BAPT). Further, the preparative-scale in vitro biocatalysis of phenylisoserinyl CoA using PheAT enabled thorough kinetic analysis of MBP-BAPT, for the first time, with the cosubstrate baccatin III. The turnover rate of MBP-BAPT was calculated for the product N-debenzoylpaclitaxel, a key intermediate to various bioactive paclitaxel analogues. MBP-BAPT also converted, albeit more slowly, 10-deacetylbaccatin III to N-deacyldocetaxel, a precursor of the pharmaceutical docetaxel. With PheAT available to make phenylisoserinyl CoA and kinetic characterization of MBP-BAPT, we used Michaelis-Menten parameters of the four enzymes to adjust catalyst and substrate loads in a 200-μL one-pot reaction. This multienzyme network produced a paclitaxel analogue N-debenzoyl-N-(2-furoyl)paclitaxel (230 ng) that is more cytotoxic than paclitaxel against certain macrophage cell types. Also in this pilot reaction, the versatile N-debenzoylpaclitaxel intermediate was made at an amount 20-fold greater than the N-(2-furoyl) product. This reaction network has great potential for optimization to scale-up production and is attractive in its regioselective O- and N-acylation steps that remove protecting group manipulations used in paclitaxel analogue synthesis.

Development of New Lipid-Based Paclitaxel Nanoparticles Using Sequential Simplex Optimization

Science.gov (United States)

Dong, Xiaowei; Mattingly, Cynthia A.; Tseng, Michael; Cho, Moo; Adams, Val R.; Mumper, Russell J.

2008-01-01

The objective of these studies was to develop Cremophor-free lipid-based paclitaxel (PX) nanoparticle formulations prepared from warm microemulsion precursors. To identify and optimize new nanoparticles, experimental design was performed combining Taguchi array and sequential simplex optimization. The combination of Taguchi array and sequential simplex optimization efficiently directed the design of paclitaxel nanoparticles. Two optimized paclitaxel nanoparticles (NPs) were obtained: G78 NPs composed of glyceryl tridodecanoate (GT) and polyoxyethylene 20-stearyl ether (Brij 78), and BTM NPs composed of Miglyol 812, Brij 78 and D-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS). Both nanoparticles successfully entrapped paclitaxel at a final concentration of 150 μg/ml (over 6% drug loading) with particle sizes less than 200 nm and over 85% of entrapment efficiency. These novel paclitaxel nanoparticles were stable at 4°C over three months and in PBS at 37°C over 102 hours as measured by physical stability. Release of paclitaxel was slow and sustained without initial burst release. Cytotoxicity studies in MDA-MB-231 cancer cells showed that both nanoparticles have similar anticancer activities compared to Taxol®. Interestingly, PX BTM nanocapsules could be lyophilized without cryoprotectants. The lyophilized powder comprised only of PX BTM NPs in water could be rapidly rehydrated with complete retention of original physicochemical properties, in-vitro release properties, and cytotoxicity profile. Sequential Simplex Optimization has been utilized to identify promising new lipid-based paclitaxel nanoparticles having useful attributes. PMID:19111929

Effect of Paclitaxel (Taxol) alone and in combination with radiation on the gastrointestinal mucosa

International Nuclear Information System (INIS)

Mason, Kathryn Ann; Milas, Luka; Peters, Lester J.

1995-01-01

Purpose: Paclitaxel is a potentially useful drug for augmenting the cytotoxic action of radiotherapy because it has independent cytotoxic activity against certain cancers and blocks cells in the radiosensitive mitotic phase of the cell cycle. However, all rapidly proliferating tissues, both normal and neoplastic, may be affected by this therapeutic strategy. The aim of this study was to define the in vivo response of rapidly dividing cells of the small bowel mucosa to paclitaxel given alone and in combination with radiation. Methods and Materials: Mice were given single IV doses of 10 or 40 mg/kg paclitaxel or four doses of 10 mg/kg paclitaxel at 6, 12, or 24 h intervals. The kinetics of mitotic arrest and apoptosis in jejunal crypts of mice at 1-24 h after treatment were defined histologically. An in vivo stem cell microcolony assay was used to assess the radiosensitizing potential of paclitaxel when radiation was delivered at the peak of mitosis and at 24 h after drug treatment. Results: Paclitaxel blocked jejunal crypt cells in mitosis and induced apoptosis in a dose-dependent manner. Fractionating the paclitaxel dose over 1-4 days did not result in any greater accumulation of mitotically blocked cells than did a single dose. Mitosis peaked 2-4 h after paclitaxel and returned to near normal by 24 h. Apoptosis lagged several hours behind mitosis and peaked about 6 h later than mitosis. Despite these kinetic perturbations, there was little or no enhancement of radiation effect when single doses were delivered 2-4 h after paclitaxel administration. The maximum sensitizer enhancement ratio of 1.07 observed after a single paclitaxel dose of 40 mg/kg is consistent with independent crypt cell killing. Conversely, when radiation was given 24 h after paclitaxel, a significant protective effect of the drug (SER 0.89-0.92), most probably due to a regenerative overshoot induced by paclitaxel, was observed. Conclusion: Stem cells of the jejunal mucosa determining radiation

Effectiveness of selective intracoronary thrombolysis in acute myocardial infarction

Energy Technology Data Exchange (ETDEWEB)

Yamaguchi, Hiroshi; Nosaka, Hideyuki; Saitoh, Taroh

1984-10-01

Protective effects of percutaneous transluminal coronary recanalization (PTCR) on the myocardium were investigated by creatine phosphokinase levels, regional left ventricular wall motion in chronic stage and /sup 201/Tl myocardial single photon emission computed tomography. Recanalization of the occlusive coronary artery at the early stage of myocardial infarction was effective for the protection of the myocardium and heart functions. This effect depended largely on the degree of occlusion at the time of the first imaging, the final degree of occlusion after recanalization, and the time required for the recanalization. Cases in which percutaneous transluminal coronary angiography was performed following PTCR are also presented and examined. (Namekawa, K.).

Effectiveness of selective intracoronary thrombolysis in acute myocardial infarction

International Nuclear Information System (INIS)

Yamaguchi, Hiroshi; Nosaka, Hideyuki; Saitoh, Taroh

1984-01-01

Protective effects of percutaneous transluminal coronary recanalization (PTCR) on the myocardium were investigated by creatine phospho kinase levels, regional left ventricular wall motion in chronic stage and 201 Tl myocardial single photon emission computed tomography. Recanalization of the occlusive coronary artery at the early stage of myocardial infarction was effective for the protection of the myocardium and heart functions. This effect depended largely on the degree of occlusion at the time of the first imaging, the final degree of occlusion after recanalization, and the time required for the recanalization. Cases in which percutaneous transluminal coronary angiography was performed following PTCR are also presented and examined. (Namekawa, K.)

Paclitaxel-induced apoptosis is BAK-dependent, but BAX and BIM-independent in breast tumor.

Directory of Open Access Journals (Sweden)

Anna V Miller

Full Text Available Paclitaxel (Taxol-induced cell death requires the intrinsic cell death pathway, but the specific participants and the precise mechanisms are poorly understood. Previous studies indicate that a BH3-only protein BIM (BCL-2 Interacting Mediator of cell death plays a role in paclitaxel-induced apoptosis. We show here that BIM is dispensable in apoptosis with paclitaxel treatment using bim(-/- MEFs (mouse embryonic fibroblasts, the bim(-/- mouse breast tumor model, and shRNA-mediated down-regulation of BIM in human breast cancer cells. In contrast, both bak (-/- MEFs and human breast cancer cells in which BAK was down-regulated by shRNA were more resistant to paclitaxel. However, paclitaxel sensitivity was not affected in bax(-/- MEFs or in human breast cancer cells in which BAX was down-regulated, suggesting that paclitaxel-induced apoptosis is BAK-dependent, but BAX-independent. In human breast cancer cells, paclitaxel treatment resulted in MCL-1 degradation which was prevented by a proteasome inhibitor, MG132. A Cdk inhibitor, roscovitine, blocked paclitaxel-induced MCL-1 degradation and apoptosis, suggesting that Cdk activation at mitotic arrest could induce subsequent MCL-1 degradation in a proteasome-dependent manner. BAK was associated with MCL-1 in untreated cells and became activated in concert with loss of MCL-1 expression and its release from the complex. Our data suggest that BAK is the mediator of paclitaxel-induced apoptosis and could be an alternative target for overcoming paclitaxel resistance.

Paclitaxel: a pharmacoeconomic review of its use in the treatment of ovarian cancer.

Science.gov (United States)

Young, M; Plosker, G L

2001-01-01

Paclitaxel belongs to the group of antitumour agents called the taxanes. Its efficacy in advanced ovarian cancer has been established in large, randomised phase III clinical trials. When used in combination with cisplatin for first-line treatment of advanced ovarian cancer, it is superior to cyclophosphamide/cisplatin, with gains in median survival of around 1 year. Paclitaxel plus carboplatin has similar efficacy to paclitaxel plus cisplatin. There is now consensus that paclitaxel plus either carboplatin or cisplatin is the recommended first-line therapy for patients with advanced ovarian cancer. The particular combination employed may vary between institutions and geographical regions, although paclitaxel plus carboplatin is generally better tolerated (i.e. lower incidence of non-haematological adverse events) than paclitaxel plus cisplatin and is widely used in many countries. Paclitaxel is also used as monotherapy in second-line (salvage) treatment of ovarian cancer. Pharmacoeconomic analyses performed to date have primarily focused on first-line therapy comparing the combination of paclitaxel/cisplatin with cyclophosphamide/cisplatin. All studies incorporated clinical outcomes data, most commonly from the Gynecologic Oncology Group (GOG) 111 trial, showing a survival advantage for paclitaxel/cisplatin. These studies report incremental cost-effectiveness ratios (ICERs) ranging from $US 6395 per additional life-year gained (LYG) in Spain (1995/96 values) to $US 44,690 per additional progression-free LYG in France (year of costs not reported). Five studies were based in the US and Canada and these reported very similar ICERs of $US 13,135 (year of costs not reported) to $US 25,131 (1993 costs) per additional LYG. In all of these studies the incremental costs of paclitaxel/cisplatin therapy fall well within the commonly cited threshold limit of $US 50,000 for new therapies and compare well with incremental costs reported for other oncological and life

Pharmacological Modulation of the Mitochondrial Electron Transport Chain in Paclitaxel-Induced Painful Peripheral Neuropathy.

Science.gov (United States)

Griffiths, Lisa A; Flatters, Sarah J L

2015-10-01

Paclitaxel is an effective first-line chemotherapeutic with the major dose-limiting side effect of painful neuropathy. Mitochondrial dysfunction and oxidative stress have been implicated in paclitaxel-induced painful neuropathy. Here we show the effects of pharmacological modulation of mitochondrial sites that produce reactive oxygen species using systemic rotenone (complex I inhibitor) or antimycin A (complex III inhibitor) on the maintenance and development of paclitaxel-induced mechanical hypersensitivity in adult male Sprague Dawley rats. The maximally tolerated dose (5 mg/kg) of rotenone inhibited established paclitaxel-induced mechanical hypersensitivity. However, some of these inhibitory effects coincided with decreased motor coordination; 3 mg/kg rotenone also significantly attenuated established paclitaxel-induced mechanical hypersensitivity without any motor impairment. The maximally tolerated dose (.6 mg/kg) of antimycin A reversed established paclitaxel-induced mechanical hypersensitivity without any motor impairment. Seven daily doses of systemic rotenone or antimycin A were given either after paclitaxel administration or before and during paclitaxel administration. Rotenone had no significant effect on the development of paclitaxel-induced mechanical hypersensitivity. However, antimycin A significantly inhibited the development of paclitaxel-induced mechanical hypersensitivity when given before and during paclitaxel administration but had no effect when given after paclitaxel administration. These studies provide further evidence of paclitaxel-evoked mitochondrial dysfunction in vivo, suggesting that complex III activity is instrumental in paclitaxel-induced pain. This study provides further in vivo evidence that mitochondrial dysfunction is a key contributor to the development and maintenance of chemotherapy-induced painful neuropathy. This work also indicates that selective modulation of the electron transport chain can induce antinociceptive

Polaprezinc reduces paclitaxel-induced peripheral neuropathy in rats without affecting anti-tumor activity

OpenAIRE

Kuniaki Tsutsumi; Takanori Kaname; Haruka Shiraishi; Takehiro Kawashiri; Nobuaki Egashira

2016-01-01

Paclitaxel, an anticancer drug, frequently causes painful peripheral neuropathy. In this study, we investigated the preventive effect of polaprezinc on paclitaxel-induced peripheral neuropathy in rats. Polaprezinc (3 mg/kg, p.o., once daily) inhibited the development of mechanical allodynia induced by paclitaxel (4 mg/kg, i.p., on days 1, 3, 5 and 7) and suppressed the paclitaxel-induced increase in macrophage migration in dorsal root ganglion cells. In addition, polaprezinc did not affect th...

Global inhibition of reactive oxygen species (ROS inhibits paclitaxel-induced painful peripheral neuropathy.

Directory of Open Access Journals (Sweden)

Mehmet Fidanboylu

Full Text Available Paclitaxel (Taxol® is a widely used chemotherapeutic agent that has a major dose limiting side-effect of painful peripheral neuropathy. Currently there is no effective therapy for the prevention or treatment of chemotherapy-induced painful peripheral neuropathies. Evidence for mitochondrial dysfunction during paclitaxel-induced pain was previously indicated with the presence of swollen and vacuolated neuronal mitochondria. As mitochondria are a major source of reactive oxygen species (ROS, the aim of this study was to examine whether pharmacological inhibition of ROS could reverse established paclitaxel-induced pain or prevent the development of paclitaxel-induced pain. Using a rat model of paclitaxel-induced pain (intraperitoneal 2 mg/kg paclitaxel on days 0, 2, 4 & 6, the effects of a non-specific ROS scavenger, N-tert-Butyl-α-phenylnitrone (PBN and a superoxide selective scavenger, 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl (TEMPOL were compared. Systemic 100 mg/kg PBN administration markedly inhibited established paclitaxel-induced mechanical hypersensitivity to von Frey 8 g and 15 g stimulation and cold hypersensitivity to plantar acetone application. Daily systemic administration of 50 mg/kg PBN (days -1 to 13 completely prevented mechanical hypersensitivity to von Frey 4 g and 8 g stimulation and significantly attenuated mechanical hypersensitivity to von Frey 15 g. Systemic 100 mg/kg TEMPOL had no effect on established paclitaxel-induced mechanical or cold hypersensitivity. High dose (250 mg/kg systemic TEMPOL significantly inhibited mechanical hypersensitivity to von Frey 8 g & 15 g, but to a lesser extent than PBN. Daily systemic administration of 100 mg/kg TEMPOL (day -1 to 12 did not affect the development of paclitaxel-induced mechanical hypersensitivity. These data suggest that ROS play a causal role in the development and maintenance of paclitaxel-induced pain, but such effects cannot be attributed to superoxide radicals

Bioequivalence of Liposome-Entrapped Paclitaxel Easy-To-Use (LEP-ETU) formulation and paclitaxel in polyethoxylated castor oil: a randomized, two-period crossover study in patients with advanced cancer.

Science.gov (United States)

Slingerland, Marije; Guchelaar, Henk-Jan; Rosing, Hilde; Scheulen, Max E; van Warmerdam, Laurence J C; Beijnen, Jos H; Gelderblom, Hans

2013-12-01

Preclinical studies comparing paclitaxel formulated with polyethoxylated castor oil with the sonicated formulation of liposome-entrapped paclitaxel (LEP) have demonstrated that LEP was associated with reduced toxicity while maintaining similar efficacy. Preliminary studies on the pharmacokinetics in patients support earlier preclinical data, which suggested that the LEP Easy-to-Use (LEP-ETU) formulation and paclitaxel formulated with castor oil may have comparable pharmacokinetic properties. Our objectives were: (1) to determine bioequivalence of paclitaxel pharmaceutically formulated as LEP-ETU (test) and paclitaxel formulated with castor oil (reference); and (2) to assess the tolerability of LEP-ETU following intravenous administration. Patients with advanced cancer were studied in a randomized, 2-period crossover bioequivalence study. Patients received paclitaxel 175 mg/m(2) administered as an intravenous infusion over 180 minutes, either as a single-treatment cycle of the test formulation followed by a single-treatment cycle of the reference formulation, or vice versa. Thirty-two of 58 patients were evaluable and were included in the analysis for bioequivalence. Mean total paclitaxel Cmax values for the test and reference formulations were 4955.0 and 5108.8 ng/mL, respectively. Corresponding AUC0-∞ values were 15,853.8 and 18,550.8 ng·h/mL, respectively. Treatment ratios of the geometric means were 97% (90% CI, 91%-103%) for Cmax and 84% (90% CI, 80%-90%) for AUC0-∞. These results met the required 80% to 125% bioequivalence criteria. The most frequently reported adverse events after LEP-ETU administration were fatigue, alopecia, and myalgia. At the studied dose regimen, LEP-ETU showed bioequivalence with paclitaxel formulated with polyethoxylated castor oil. © 2013 Elsevier HS Journals, Inc. All rights reserved.

Phase I/II dose-finding study of nanoparticle albumin-bound paclitaxel (nab®-Paclitaxel) plus Cisplatin as Treatment for Metastatic Nasopharyngeal Carcinoma

International Nuclear Information System (INIS)

Huang, Yan; Liang, Wenhua; Yang, Yunpeng; Zhao, Liping; Zhao, Hongyun; Wu, Xuan; Zhao, Yuanyuan; Zhang, Yang; Zhang, Li

2016-01-01

This phase I/II study aimed to determine the maximum tolerated dose (MTD) of nanoparticle albumin-bound paclitaxel (nab ® -paclitaxel) plus cisplatin as treatment for metastatic nasopharyngeal carcinoma (NPC). Patients were enrolled into 1 of 3 dose cohorts, each with 21-day treatment cycles: 1) intravenous (IV) nab-paclitaxel 260 mg/m 2 on day 1; 2) IV nab-paclitaxel 140 mg/m 2 on days 1 and 8; 3) IV nab-paclitaxel 100 mg/m 2 on days 1, 8, and 15. All patients received IV cisplatin 75 mg/m 2 on day 1. Treatment continued for 4–6 cycles, or until progression or unacceptable toxicity. If more than one-third of the patients in a cohort experienced a dose-limiting toxicity (DLT), the dose used in the previous cohort would be designated the MTD. Secreted protein acidic and rich in cysteine (SPARC) expression was detected by immunohistochemistry staining. Sixty-nine patients were enrolled, of whom 64 and 67 were eligible for efficacy and safety analysis, respectively. Two DLTs occurred in cohort 1 (grade 4 febrile neutropenia, grade 3 myalgia), none occurred in cohort 2, and 2 occurred in cohort 3 (both grade 3 fatigue). The MTD was not reached. Partial responses were achieved by 42 patients, 15 had stable disease, and 7 had progressive disease, giving an overall response rate of 66 %. Median progression-free survival was 9 months (95 % CI, 6–12 months). Grade ≥ 3 adverse events were mainly hematologic. There was no significant difference between the 3 cohorts with respect to efficacy or safety. Biomarker analyses indicated that stromal, rather than tumoral, SPARC may predict the response to nab-paclitaxel in NPC. Our findings suggest that nab-paclitaxel plus cisplatin is a highly active regimen with moderate toxicity for the treatment of metastatic NPC, which warrants further investigation in a phase III study. ClinicalTrials.gov ID: NCT01735409. The trial was registered on November 20th, 2012. The online version of this article (doi:10.1186/s12885

Evaluation of electrochemical ion exchange for cesium elution

International Nuclear Information System (INIS)

Bontha, J.D.; Kurath, D.E.; Surma, J.E.; Buehler, M.F.

1996-04-01

Electrochemical elution was investigated as an alternative method to acid elution for the desorption of cesium from loaded ion exchange resins. The approach was found to have several potential advantages over existing technologies, in particular, electrochemical elution eliminates the need for addition of chemicals to elute cesium from the ion exchange resin. Also, since, in the electrochemical elution process the eluting solution is not in direct contact with the ion exchange material, very small volumes of the eluting solution can be used in a complete recycle mode in order to minimize the total volume of the cesium elute. In addition, the cesium is eluted as an alkaline solution that does not require neutralization with caustic to meet the tank farm specifications. Other advantages include easy incorporation of the electrochemical elution process into the present cesium recovery schemes

New Treatments for Infrapopliteal Disease: Devices, Techniques, and Outcomes So Far

International Nuclear Information System (INIS)

Bernstein, Ondina; Chalmers, Nicholas

2012-01-01

The use of endovascular treatment of infrapopliteal disease has increased in popularity in recent years. An improvement in technical success rates due to the availability of newer devices has fuelled an increased interest in the subject. The pathogenesis, indications for treatment, and outcome measures of infrapopliteal disease differ from larger vessel intervention. Diabetes and renal failure are prevalent. Neuropathy and venous disease contribute to the etiology of ulceration. Most interventions are undertaken for critical limb ischemia rather than claudication. Therefore, a range of conservative, pharmacological, and invasive therapies are provided. Conventional percutaneous transluminal angioplasty (PTA) using modern low-profile systems is associated with high technical success rates. However, initial data from recent randomized, controlled trials suggest that drug-eluting stents are consistently achieving improved patency over PTA alone or over bare metal stents. This review summarizes recent advances in the treatment of infrapopliteal disease.

Paclitaxel: new uses for an old drug

Directory of Open Access Journals (Sweden)

Zhang D

2014-02-01

Full Text Available Dongshan Zhang,1,2 Ruhao Yang,1 Shixuan Wang,2 Zheng Dong1,2 1Departments of Emergency Medicine and Nephrology, Second Xiangya Hospital, Central South University, Changsha, Hunan, People’s Republic of China; 2Department of Cellular Biology and Anatomy, Medical College of Georgia, Georgia Regents University and Charlie Norwood VA Medical Center, Augusta, GA, USA Abstract: Paclitaxel (Taxol, one of the most important anticancer drugs, has been used for therapy of different types of cancers. Mechanistically, paclitaxel arrests cell cycle and induces cell death by stabilizing microtubules and interfering with microtubule disassembly in cell division. Recently, it has been found that low-dose paclitaxel seems promising in treating non-cancer diseases, such as skin disorders, renal and hepatic fibrosis, inflammation, axon regeneration, limb salvage, and coronary artery restenosis. Future studies need to understand the mechanisms underlying these effects in order to design therapies with specificity. Keywords: taxol inflammation, fibrosis, coronary artery restenosis, limb salvage, kidney

Effect of paclitaxel (TAXOL) alone and in combination with radiation on the gastrointestinal mucosa

International Nuclear Information System (INIS)

Mason, K.A.; Milas, L.; Peters, L.J.

1995-01-01

Paclitaxel is a potentially useful drug for augmenting the cytotoxic action of radiotherapy because it has independent cytotoxic activity against certain cancers and blocks cells in the radiosensitive mitotic phase of the cell cycle. However, all rapidly proliferating tissues, both normal and neoplastic, may be affected by this therapeutic strategy. The aim of this study was to define the in vivo response of rapidly dividing cells of the small bowel mucosa in mice to paclitaxel given alone and in combination with radiation. Paclitaxel blocked jejunal crypt cells in mitosis and induced apoptosis in a dose-dependent manner. Fractionating the paclitaxel dose over 1-4 days did not result in any greater accumulation of mitotically blocked cells than did a single dose. Mitosis peaked 2-4 h after paclitaxel and returned to near normal by 24 h. Apoptosis lagged several hours behind mitosis and peaked about 6 h later than mitosis. Despite these kinetic perturbations, there was little or no enhancement of radiation effect when single doses were delivered 2-4 h after paclitaxel administration. The maximum sensitizer enhancement ratio of 1.07 observed after a single paclitaxel dose of 40 mg/kg is consistent with independent crypt cell killing. Conversely, when radiation was given 24 h after paclitaxel, a significant protective effect of the drug (SER 0.89-0.92), most probably due to a regenerative overshoot induced by paclitaxel, was observed. Stem cells of the jejunal mucosa determining radiation response were not radiosensitized by paclitaxel with the drug concentrations and dose deliver schedules used, although additive cytotoxicity was observed with the highest drug dose. A radioprotective effect was observed when radiation was given 24 h after paclitaxel administration. 33 refs., 4 figs., 3 tabs

The co-solvent Cremophor EL limits absorption of orally administered paclitaxel in cancer patients.

Science.gov (United States)

Malingré, M M; Schellens, J H; Van Tellingen, O; Ouwehand, M; Bardelmeijer, H A; Rosing, H; Koopman, F J; Schot, M E; Ten Bokkel Huinink, W W; Beijnen, J H

2001-11-16

The purpose of this study was to investigate the effect of the co-solvents Cremophor EL and polysorbate 80 on the absorption of orally administered paclitaxel. 6 patients received in a randomized setting, one week apart oral paclitaxel 60 mg m(-2) dissolved in polysorbate 80 or Cremophor EL. For 3 patients the amount of Cremophor EL was 5 ml m(-2), for the other three 15 ml m(-2). Prior to paclitaxel administration patients received 15 mg kg(-1) oral cyclosporin A to enhance the oral absorption of the drug. Paclitaxel formulated in polysorbate 80 resulted in a significant increase in the maximal concentration (C(max)) and area under the concentration-time curve (AUC) of paclitaxel in comparison with the Cremophor EL formulations (P = 0.046 for both parameters). When formulated in Cremophor EL 15 ml m(-2), paclitaxel C(max) and AUC values were 0.10 +/- 0.06 microM and 1.29 +/- 0.99 microM h(-1), respectively, whereas these values were 0.31 +/- 0.06 microM and 2.61 +/- 1.54 microM h(-1), respectively, when formulated in polysorbate 80. Faecal data revealed a decrease in excretion of unchanged paclitaxel for the polysorbate 80 formulation compared to the Cremophor EL formulations. The amount of paclitaxel excreted in faeces was significantly correlated with the amount of Cremophor EL excreted in faeces (P = 0.019). When formulated in Cremophor EL 15 ml m(-2), paclitaxel excretion in faeces was 38.8 +/- 13.0% of the administered dose, whereas this value was 18.3 +/-15.5% for the polysorbate 80 formulation. The results show that the co-solvent Cremophor EL is an important factor limiting the absorption of orally administered paclitaxel from the intestinal lumen. They highlight the need for designing a better drug formulation in order to increase the usefulness of the oral route of paclitaxel

Paclitaxel: a pharmacoeconomic review of its use in non-small cell lung cancer.

Science.gov (United States)

Plosker, G L; Hurst, M

2001-01-01

A number of first-line chemotherapy options for patients with advanced non-small cell lung cancer (NSCLC) are advocated in treatment guidelines and/or by various clinical investigators. Platinum-based chemotherapy has clearly demonstrated efficacy in patients with advanced NSCLC and is generally recommended as first-line therapy, although there is increasing interest in the use of non-platinum chemotherapy regimens. Among the platinum-based combinations currently used in clinical practice are regimens such as cisplatin or carboplatin combined with paclitaxel, vinorelbine, gemcitabine, docetaxel or irinotecan. The particular combinations employed may vary between institutions and geographical regions. Several pharmacoeconomic analyses have been conducted on paclitaxel in NSCLC and most have focused on its use in combination with cisplatin. In terms of clinical efficacy, paclitaxel-cisplatin combinations achieved significantly higher response rates than teniposide plus cisplatin or etoposide plus cisplatin (previously thought to be among the more effective regimens available) in two large randomised trials. One of these studies showed a survival advantage for paclitaxel plus cisplatin [with or without a granulocyte colony-stimulating factor (G-CSF)] compared with etoposide plus cisplatin. A Canadian cost-effectiveness analysis incorporated data from one of the large randomised comparative trials and showed that the incremental cost per life-year saved for outpatient administration of paclitaxel plus cisplatin versus etoposide plus cisplatin was $US 22181 (30619 Canadian dollars; $Can) [1997 costs]. A European analysis incorporated data from the other large randomised study and showed slightly higher costs per responder for paclitaxel plus cisplatin than for teniposide plus cisplatin in The Netherlands ($US 30769 vs $US 29592) and Spain ($US 19 923 vs $US 19724) but lower costs per responder in Belgium ($US 22852 vs $US 25000) and France ($US28 080 vs $US 34747) [1995

Characterization of acquired paclitaxel resistance of breast cancer cells and involvement of ABC transporters

International Nuclear Information System (INIS)

Němcová-Fürstová, Vlasta; Kopperová, Dana; Balušíková, Kamila; Ehrlichová, Marie; Brynychová, Veronika; Václavíková, Radka; Daniel, Petr; Souček, Pavel; Kovář, Jan

2016-01-01

Development of taxane resistance has become clinically very important issue. The molecular mechanisms underlying the resistance are still unclear. To address this issue, we established paclitaxel-resistant sublines of the SK-BR-3 and MCF-7 breast cancer cell lines that are capable of long-term proliferation in 100 nM and 300 nM paclitaxel, respectively. Application of these concentrations leads to cell death in the original counterpart cells. Both sublines are cross-resistant to doxorubicin, indicating the presence of the MDR phenotype. Interestingly, resistance in both paclitaxel-resistant sublines is circumvented by the second-generation taxane SB-T-1216. Moreover, we demonstrated that it was not possible to establish sublines of SK-BR-3 and MCF-7 cells resistant to this taxane. It means that at least the tested breast cancer cells are unable to develop resistance to some taxanes. Employing mRNA expression profiling of all known human ABC transporters and subsequent Western blot analysis of the expression of selected transporters, we demonstrated that only the ABCB1/PgP and ABCC3/MRP3 proteins were up-regulated in both paclitaxel-resistant sublines. We found up-regulation of ABCG2/BCRP and ABCC4 proteins only in paclitaxel-resistant SK-BR-3 cells. In paclitaxel-resistant MCF-7 cells, ABCB4/MDR3 and ABCC2/MRP2 proteins were up-regulated. Silencing of ABCB1 expression using specific siRNA increased significantly, but did not completely restore full sensitivity to both paclitaxel and doxorubicin. Thus we showed a key, but not exclusive, role for ABCB1 in mechanisms of paclitaxel resistance. It suggests the involvement of multiple mechanisms in paclitaxel resistance in tested breast cancer cells. - Highlights: • Expression of all ABC transporters in paclitaxel-resistant sublines of SK-BR-3 and MCF-7 cells was analyzed. • SK-BR-3 and MCF-7 cells are unable to develop resistance to some taxanes. • Some taxanes are able to overcome developed resistance to

Characterization of acquired paclitaxel resistance of breast cancer cells and involvement of ABC transporters

Energy Technology Data Exchange (ETDEWEB)

Němcová-Fürstová, Vlasta, E-mail: vlasta.furstova@lf3.cuni.cz [Division of Cell and Molecular Biology, Third Faculty of Medicine, Charles University, Prague (Czech Republic); Kopperová, Dana; Balušíková, Kamila [Division of Cell and Molecular Biology, Third Faculty of Medicine, Charles University, Prague (Czech Republic); Ehrlichová, Marie; Brynychová, Veronika; Václavíková, Radka [Toxicogenomics Unit, National Institute of Public Health, Prague (Czech Republic); Daniel, Petr [Division of Cell and Molecular Biology, Third Faculty of Medicine, Charles University, Prague (Czech Republic); Souček, Pavel [Toxicogenomics Unit, National Institute of Public Health, Prague (Czech Republic); Kovář, Jan [Division of Cell and Molecular Biology, Third Faculty of Medicine, Charles University, Prague (Czech Republic)

2016-11-01

Development of taxane resistance has become clinically very important issue. The molecular mechanisms underlying the resistance are still unclear. To address this issue, we established paclitaxel-resistant sublines of the SK-BR-3 and MCF-7 breast cancer cell lines that are capable of long-term proliferation in 100 nM and 300 nM paclitaxel, respectively. Application of these concentrations leads to cell death in the original counterpart cells. Both sublines are cross-resistant to doxorubicin, indicating the presence of the MDR phenotype. Interestingly, resistance in both paclitaxel-resistant sublines is circumvented by the second-generation taxane SB-T-1216. Moreover, we demonstrated that it was not possible to establish sublines of SK-BR-3 and MCF-7 cells resistant to this taxane. It means that at least the tested breast cancer cells are unable to develop resistance to some taxanes. Employing mRNA expression profiling of all known human ABC transporters and subsequent Western blot analysis of the expression of selected transporters, we demonstrated that only the ABCB1/PgP and ABCC3/MRP3 proteins were up-regulated in both paclitaxel-resistant sublines. We found up-regulation of ABCG2/BCRP and ABCC4 proteins only in paclitaxel-resistant SK-BR-3 cells. In paclitaxel-resistant MCF-7 cells, ABCB4/MDR3 and ABCC2/MRP2 proteins were up-regulated. Silencing of ABCB1 expression using specific siRNA increased significantly, but did not completely restore full sensitivity to both paclitaxel and doxorubicin. Thus we showed a key, but not exclusive, role for ABCB1 in mechanisms of paclitaxel resistance. It suggests the involvement of multiple mechanisms in paclitaxel resistance in tested breast cancer cells. - Highlights: • Expression of all ABC transporters in paclitaxel-resistant sublines of SK-BR-3 and MCF-7 cells was analyzed. • SK-BR-3 and MCF-7 cells are unable to develop resistance to some taxanes. • Some taxanes are able to overcome developed resistance to

Paclitaxel Albumin-stabilized Nanoparticle Formulation

Science.gov (United States)

This page contains brief information about paclitaxel albumin-stabilized nanoparticle formulation and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials.

Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.

Science.gov (United States)

Bangalore, Sripal; Pencina, Michael J; Kleiman, Neal S; Cohen, David J

2014-06-01

The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy. Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use

First line treatment of advanced non-small-cell lung cancer – specific focus on albumin bound paclitaxel

Directory of Open Access Journals (Sweden)

Gupta N

2013-12-01

Full Text Available Neha Gupta, Hassan Hatoum, Grace K DyDepartment of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USAAbstract: Lung cancer is the leading cause of cancer mortality worldwide in both men and women. Non-small-cell lung cancer (NSCLC is the most common type of lung cancer, accounting for more than 80% of cases. Paclitaxel has a broad spectrum of activity against various malignancies, including NSCLC. Paclitaxel is poorly soluble in water and thus, until recently, its commercially available preparations contained a non-ionic solvent Cremophor EL®. Cremophor EL® improves the solubility of paclitaxel and allows its intravenous administration. However, certain side-effects associated with paclitaxel, such as hypersensitivity reactions, myelosuppression, and peripheral neuropathy, are known to be worsened by Cremophor®. Nanoparticle albumin-bound paclitaxel ([nab-paclitaxel] ABRAXANE® ABI-007 is a new generation formulation of paclitaxel that obviates the need for Cremophor®, resulting in a safer and faster infusion without requiring the use of premedications to avoid hypersensitivity. Albumin-binding receptor-mediated delivery and lack of sequestering Cremophor® micelles allow higher intratumoral concentration of pharmacologically active paclitaxel. Multiple clinical trials have demonstrated a superior tolerability profile of nab-paclitaxel in comparison to solvent-bound paclitaxel (sb-paclitaxel. A recent Phase III trial compared the effects of weekly nab-paclitaxel in combination with carboplatin versus sb-paclitaxel in combination with carboplatin given every 3 weeks for first line treatment of NSCLC. This trial highlights the weekly nab-paclitaxel combination as an alternate treatment option for NSCLC, with higher response rate in squamous cell NSCLC and longer survival in elderly patients. This review will focus on the properties of nab-paclitaxel and its use in the first line treatment of NSCLC.Keywords: ABI-007, Abraxane, nab-paclitaxel

A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

International Nuclear Information System (INIS)

De Cock, Erwin; Sapoval, Marc; Julia, Pierre; Lissovoy, Greg de; Lopes, Sandra

2013-01-01

The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of €6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

Energy Technology Data Exchange (ETDEWEB)

De Cock, Erwin, E-mail: erwin.decock@unitedbiosource.com [United BioSource Corporation, Peri- and Post-Approval Services (Spain); Sapoval, Marc, E-mail: Marc.sapoval2@egp.aphp.fr [Hopital Europeen Georges Pompidou, Universite Rene Descartes, Department of Cardiovascular and Interventional Radiology (France); Julia, Pierre, E-mail: pierre.julia@egp.aphp.fr [Hopital Europeen Georges Pompidou, Universite Rene Descartes, Cardiovascular Surgery Department (France); Lissovoy, Greg de, E-mail: gdelisso@jhsph.edu [Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management (United States); Lopes, Sandra, E-mail: Sandra.Lopes@CookMedical.com [Cook Medical, Health Economics and Reimbursement (Denmark)

2013-04-15

The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of Euro-Sign 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

Directory of Open Access Journals (Sweden)

Danbo Yang

2010-12-01

Full Text Available The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(L-g-glutamylglutamine-paclitaxel nano-conjugate (PGG-PTX. PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic.

Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

International Nuclear Information System (INIS)

Yang, Danbo; Yu, Lei; Van, Sang

2010-01-01

The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(l-γ-glutamylglutamine)-paclitaxel nano-conjugate (PGG-PTX). PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic

Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

Energy Technology Data Exchange (ETDEWEB)

Yang, Danbo [Biomedical Engineering and Technology Institute, Institutes for Advanced Interdisciplinary Research, East China Normal University, 3663 North Zhongshan Road, Shanghai, 200062 (China); Yu, Lei, E-mail: yu-lei@gg.nitto.co.jp [Biomedical Engineering and Technology Institute, Institutes for Advanced Interdisciplinary Research, East China Normal University, 3663 North Zhongshan Road, Shanghai, 200062 (China); Biomedical Group, Nitto Denko Technical Corporation, 501 Via Del Monte, Oceanside, CA 92058 (United States); Van, Sang [Biomedical Group, Nitto Denko Technical Corporation, 501 Via Del Monte, Oceanside, CA 92058 (United States)

2010-12-23

The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(l-γ-glutamylglutamine)-paclitaxel nano-conjugate (PGG-PTX). PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic.

Construction of hydroxypropyl-{beta}-cyclodextrin copolymer nanoparticles and targeting delivery of paclitaxel

Energy Technology Data Exchange (ETDEWEB)

Miao Qinghua; Li Suping; Han Siyuan [National Center for Nanoscience and Technology of China, CAS Key Laboratory for Biological Effects of Nanomaterials and Nanosafety (China); Wang Zhi, E-mail: wangzhi@jlu.edu.cn [Jilin University, Key Laboratory for Molecular Enzymology and Engineering, Ministry of Education (China); Wu Yan, E-mail: wuy@nanoctr.cn; Nie Guangjun, E-mail: niegj@nanoctr.cn [National Center for Nanoscience and Technology of China, CAS Key Laboratory for Biological Effects of Nanomaterials and Nanosafety (China)

2012-08-15

A novel amphiphilic copolymer with p-maleimidophenyl isocyanate-hydroxypropyl-{beta}-cyclodextrin-polylactide-1, 2-dipalmitoyl-sn-glycero-3-phosphoethanolamine to generate copolymer nanoparticles (NPs) has been designed. In order to develop an active targeting system, integrin {alpha}{sub v}{beta}{sub 3}-specific targeting peptide cyclo(Arg-Gly-Asp-D-Phe-Cys), cRGD, was conjugated to the surface of NPs (NPs-RGD). These NPs were used to encapsulate anti-tumor drug, paclitaxel. The resulting NPs exhibited high drug-loading capacity and controlled drug release in vitro at acidic pH. In vitro cytotoxicity assay demonstrates that paclitaxel-loaded NPs-RGD significantly inhibited B16 tumor cell (high {alpha}{sub v}{beta}{sub 3}) proliferation relative to free paclitaxel and paclitaxel-loaded NPs at high concentrations. Paclitaxel-loaded NPs-RGD localized mainly in lysosomes in B16 cells as revealed by confocal microscopy. These results suggest a novel strategy for fabrication-functionalizing hydroxypropyl-{beta}-cyclodextrin copolymer nanoparticles for targeting delivery of paclitaxel to integrin {alpha}{sub v}{beta}{sub 3}-rich tumor cells. These nanocarriers can be readily extended to couple other bioactive molecules for active targeting and delivery of various chemotherapeutic drugs.

Management of paclitaxel-induced neurotoxicity

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Manisha Bhutani

2011-12-01

Full Text Available Paclitaxel exerts its antitumor activity by promoting microtubule assembly and stabilizing microtubules. Microtubules are important for the development and maintenance of neurons. As a consequence, neurotoxicity is one of the drug’s major side effects. The risk of neurotoxicity depends on dose, duration and schedule of paclitaxel. Risk increases for patients with pre-existing conditions that may cause neuropathy (such as alcohol consumption, diabetes, or renal disease or with simultaneous or prior exposure to other neurotoxic chemotherapy such as platinum-based drugs, vinca alkaloids, immunomodulators, proteasome inhibitors, and epothilones. Patients with paclitaxel-induced neurotoxicity (PINT experience a constellation of symptoms over the course of treatment and beyond, ranging from mild to severe. Typically, the clinical presentation reflects an axonal peripheral neuropathy with glove-and-stocking distribution sensory loss, combined with features suggestive of nerve hyperexcitability including paresthesia, dysesthesia, and pain. Proprioceptive and motor effects become apparent as neuropathy becomes more advanced. These symptoms may be prolonged, severe, disabling, relatively resistant to intervention and adversely affect activities of daily living and thereby quality of life. Management is mainly symptomatic and supportive. Despite attempts to minimize PINT with changes in dose, vehicle, delivery systems, infusion schedule and premedication or co-treatment with neuroprotective agents, PINT remains dose-limiting in many instances and is a barrier to achieving the desired clinical response.

Paclitaxel-induced epithelial damage and ectopic MMP-13 expression promotes neurotoxicity in zebrafish.

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Lisse, Thomas S; Middleton, Leah J; Pellegrini, Adriana D; Martin, Paige B; Spaulding, Emily L; Lopes, Olivia; Brochu, Elizabeth A; Carter, Erin V; Waldron, Ashley; Rieger, Sandra

2016-04-12

Paclitaxel is a microtubule-stabilizing chemotherapeutic agent that is widely used in cancer treatment and in a number of curative and palliative regimens. Despite its beneficial effects on cancer, paclitaxel also damages healthy tissues, most prominently the peripheral sensory nervous system. The mechanisms leading to paclitaxel-induced peripheral neuropathy remain elusive, and therapies that prevent or alleviate this condition are not available. We established a zebrafish in vivo model to study the underlying mechanisms and to identify pharmacological agents that may be developed into therapeutics. Both adult and larval zebrafish displayed signs of paclitaxel neurotoxicity, including sensory axon degeneration and the loss of touch response in the distal caudal fin. Intriguingly, studies in zebrafish larvae showed that paclitaxel rapidly promotes epithelial damage and decreased mechanical stress resistance of the skin before induction of axon degeneration. Moreover, injured paclitaxel-treated zebrafish skin and scratch-wounded human keratinocytes (HEK001) display reduced healing capacity. Epithelial damage correlated with rapid accumulation of fluorescein-conjugated paclitaxel in epidermal basal keratinocytes, but not axons, and up-regulation of matrix-metalloproteinase 13 (MMP-13, collagenase 3) in the skin. Pharmacological inhibition of MMP-13, in contrast, largely rescued paclitaxel-induced epithelial damage and neurotoxicity, whereas MMP-13 overexpression in zebrafish embryos rendered the skin vulnerable to injury under mechanical stress conditions. Thus, our studies provide evidence that the epidermis plays a critical role in this condition, and we provide a previously unidentified candidate for therapeutic interventions.

Inhibition of the Receptor Tyrosine Kinase AXL Restores Paclitaxel Chemosensitivity in Uterine Serous Cancer.

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Palisoul, Marguerite L; Quinn, Jeanne M; Schepers, Emily; Hagemann, Ian S; Guo, Lei; Reger, Kelsey; Hagemann, Andrea R; McCourt, Carolyn K; Thaker, Premal H; Powell, Matthew A; Mutch, David G; Fuh, Katherine C

2017-12-01

Uterine serous cancer (USC) is aggressive, and the majority of recurrent cases are chemoresistant. Because the receptor tyrosine kinase AXL promotes invasion and metastasis of USC and is implicated in chemoresistance in other cancers, we assessed the role of AXL in paclitaxel resistance in USC, determined the mechanism of action, and sought to restore chemosensitivity by inhibiting AXL in vitro and in vivo We used short hairpin RNAs and BGB324 to knock down and inhibit AXL. We assessed sensitivity of USC cell lines to paclitaxel and measured paclitaxel intracellular accumulation in vitro in the presence or absence of AXL. We also examined the role of the epithelial-mesenchymal transition (EMT) in AXL-mediated paclitaxel resistance. Finally, we treated USC xenografts with paclitaxel, BGB324, or paclitaxel plus BGB324 and monitored tumor burden. AXL expression was higher in chemoresistant USC patient tumors and cell lines than in chemosensitive tumors and cell lines. Knockdown or inhibition of AXL increased sensitivity of USC cell lines to paclitaxel in vitro and increased cellular accumulation of paclitaxel. AXL promoted chemoresistance even in cells that underwent the EMT in vitro Finally, in vivo studies of combination treatment with BGB324 and paclitaxel showed a greater than 51% decrease in tumor volume after 2 weeks of treatment when compared with no treatment or single-agent treatments ( P USC. Mol Cancer Ther; 16(12); 2881-91. ©2017 AACR . ©2017 American Association for Cancer Research.

Advanced ovarian cancer: phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel vs carboplatin-paclitaxel.

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Hoskins, P; Vergote, I; Cervantes, A; Tu, D; Stuart, G; Zola, P; Poveda, A; Provencher, D; Katsaros, D; Ojeda, B; Ghatage, P; Grimshaw, R; Casado, A; Elit, L; Mendiola, C; Sugimoto, A; D'Hondt, V; Oza, A; Germa, J R; Roy, M; Brotto, L; Chen, D; Eisenhauer, E A

2010-10-20

Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy. Women aged 75 years or younger with newly diagnosed stage IIB or greater ovarian cancer, Eastern Cooperative Oncology Group Performance Status of 1 or less, were stratified by type of primary surgery and residual disease, treatment center, and age; then randomly assigned to one of the two 21-day intravenous regimens. Patients in arm 1 (n = 409) were administered four cycles of cisplatin 50 mg/m(2) on day 1 and topotecan 0.75 mg/m(2) on days 1-5, then four cycles of paclitaxel 175 mg/m(2) over 3 hours on day 1 followed by carboplatin (area under the curve = 5) on day 1. Patients in arm 2 (n = 410) were given paclitaxel plus carboplatin as in arm 1 for eight cycles. We compared progression-free survival (PFS), overall survival, and cancer antigen-125 normalization rates in the two treatment arms. A stratified log-rank test was used to assess the primary endpoint, PFS. All statistical tests were two-sided. A total of 819 patients were randomly assigned. At baseline, the median age of the patients was 57 years (range = 28-78); 81% had received debulking surgery, and of these, 55% had less than 1 cm residual disease; 66% of patients were stage III and 388 (47.4%) patients had measurable disease. After a median follow-up of 43 months, 650 patients had disease progression or died without documented progression and 406 had died. Patients in arm 1 had more hematological toxicity and hospitalizations than patients in arm 2; PFS was 14.6 months in arm 1 vs 16.2 months in arm 2 (hazard ratio = 1.10, 95% confidence interval = 0.94 to 1.28, P = .25). Among patients with elevated baseline cancer antigen-125, fewer in arm 1 than in arm 2 had levels return to normal by 3 months after random assignment (51.6% vs 63.3%, P = .007) Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and

Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial.

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Wilke, Hansjochen; Muro, Kei; Van Cutsem, Eric; Oh, Sang-Cheul; Bodoky, György; Shimada, Yasuhiro; Hironaka, Shuichi; Sugimoto, Naotoshi; Lipatov, Oleg; Kim, Tae-You; Cunningham, David; Rougier, Philippe; Komatsu, Yoshito; Ajani, Jaffer; Emig, Michael; Carlesi, Roberto; Ferry, David; Chandrawansa, Kumari; Schwartz, Jonathan D; Ohtsu, Atsushi

2014-10-01

VEGFR-2 has a role in gastric cancer pathogenesis and progression. We assessed whether ramucirumab, a monoclonal antibody VEGFR-2 antagonist, in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel. This randomised, placebo-controlled, double-blind, phase 3 trial was done at 170 centres in 27 countries in North and South America, Europe, Asia, and Australia. Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy (platinum plus fluoropyrimidine with or without an anthracycline) were randomly assigned with a centralised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15, plus paclitaxel 80 mg/m(2) intravenously on days 1, 8, and 15 of a 28-day cycle. A permuted block randomisation, stratified by geographic region, time to progression on first-line therapy, and disease measurability, was used. The primary endpoint was overall survival. Efficacy analysis was by intention to treat, and safety analysis included all patients who received at least one treatment with study drug. This trial is registered with ClinicalTrials.gov, number NCT01170663, and has been completed; patients who are still receiving treatment are in the extension phase. Between Dec 23, 2010, and Sept 23, 2012, 665 patients were randomly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel. Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group (median 9·6 months [95% CI 8·5-10·8] vs 7·4 months [95% CI 6·3-8·4], hazard ratio 0·807 [95% CI 0·678-0·962]; p=0·017). Grade 3 or higher adverse events that occurred in more than 5% of patients in the ramucirumab plus paclitaxel group versus placebo

Coronary artery bypass grafting versus percutaneous intervention in coronary revascularization: a historical perspective and review

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Burgess SN

2015-06-01

Full Text Available Sonya N Burgess,1 John J Edmond,2 Craig P Juergens,1 John K French11Department of Cardiology, Liverpool Hospital and South Western Sydney Clinical School, The University of New South Wales, Sydney, NSW, Australia; 2Department of Cardiology, Dunedin Public Hospital, Dunedin, New Zealand Background: Coronary artery bypass graft surgery is arguably the most intensively studied surgical procedure, and percutaneous coronary intervention (PCI has been subjected to more randomized clinical trials than any other interventional procedure. Changes seen in revascularization techniques have been numerous. The rapid evolution of evidence-based revascularization procedures has occurred as a result of many pivotal large randomized clinical trials. Objective: This review compares and contrasts outcomes from two coronary revascularization techniques, coronary artery bypass grafting (CABG and PCI, with particular reference to the landmark trials that inform practice guidelines. Methods: We undertook a comprehensive review of published literature addressing trials in this field performed to address current knowledge both in the predrug-eluting stent and postdrug-eluting stent era. Results and discussion: Surgical and percutaneous revascularization strategies have different strengths and weaknesses, and neither strategy is superior in all patients, clinical presentations, or anatomical subgroups. Current data support the use of percutaneous intervention in ST elevation myocardial infarction and in single-vessel disease. In noncomplex multivessel disease and isolated left main stem PCI, the data support non-inferiority of PCI compared to CABG as reflected in the 2014 European Society of Cardiology guidelines. Landmark revascularization trials of multivessel disease comparing CABG to PCI found no survival benefit to CABG over PCI, except in patients with complex disease. In these trials, revascularization drove differences in primary endpoints and in all but the

Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry.

Science.gov (United States)

Baber, Usman; Mehran, Roxana; Kirtane, Ajay J; Gurbel, Paul A; Christodoulidis, Georgios; Maehara, Akiko; Witzenbichler, Bernhard; Weisz, Giora; Rinaldi, Michael J; Metzger, D Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Xu, Ke; Parise, Helen; Brodie, Bruce R; Stuckey, Thomas D; Stone, Gregg W

2015-06-01

Chronic kidney disease (CKD) is associated with increased rates of adverse events after percutaneous coronary intervention. We sought to determine the impact of CKD on platelet reactivity in clopidogrel-treated patients and whether high platelet reactivity (HPR) confers a similar or differential risk for adverse events among patients with CKD and non-CKD. We performed a post hoc analysis of the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) registry, which included 8582 patients undergoing percutaneous coronary intervention with drug-eluting stents and platelet function testing using the VerifyNow assay. We compared HPR and its impact on ischemic and bleeding events >2 years among patients with CKD and non-CKD. Patients with CKD (n=1367) were older, more often female, diabetic, and had lower ejection fraction compared with their non-CKD counterparts (n=7043). Although HPR prevalence increased with worsening renal function in unadjusted analyses, these associations were no longer present after adjustment. Major adverse cardiac event rates at 2 years among those without CKD or HPR, HPR alone, CKD alone, and both CKD and HPR were 9.0%, 11.2%, 13.3%, and 17.5%, respectively (Pimpact of HPR on ischemic and bleeding events is similar irrespective of CKD status. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00638794. © 2015 American Heart Association, Inc.

Suberoylanilide hydroxamic acid sensitizes neuroblastoma to paclitaxel by inhibiting thioredoxin-related protein 14-mediated autophagy.

Science.gov (United States)

Zhen, Zijun; Yang, Kaibin; Ye, Litong; You, Zhiyao; Chen, Rirong; Liu, Ying; He, Youjian

2017-07-01

Paclitaxel is not as effective for neuroblastoma as most of the front-line chemotherapeutics due to drug resistance. This study explored the regulatory mechanism of paclitaxel-associated autophagy and potential solutions to paclitaxel resistance in neuroblastoma. The formation of autophagic vesicles was detected by scanning transmission electron microscopy and flow cytometry. The autophagy-associated proteins were assessed by western blot. Autophagy was induced and the autophagy-associated proteins LC3-I, LC3-II, Beclin 1, and thioredoxin-related protein 14 (TRP14), were found to be upregulated in neuroblastoma cells that were exposed to paclitaxel. The inhibition of Beclin 1 or TRP14 by siRNA increased the sensitivity of the tumor cells to paclitaxel. In addition, Beclin 1-mediated autophagy was regulated by TRP14. Furthermore, the TRP14 inhibitor suberoylanilide hydroxamic acid (SAHA) downregulated paclitaxel-induced autophagy and enhanced the anticancer effects of paclitaxel in normal control cancer cells but not in cells with upregulated Beclin 1 and TRP14 expression. Our findings showed that paclitaxel-induced autophagy in neuroblastoma cells was regulated by TRP14 and that SAHA could sensitize neuroblastoma cells to paclitaxel by specifically inhibiting TRP14. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

MENA Confers Resistance to Paclitaxel in Triple-Negative Breast Cancer.

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Oudin, Madeleine J; Barbier, Lucie; Schäfer, Claudia; Kosciuk, Tatsiana; Miller, Miles A; Han, Sangyoon; Jonas, Oliver; Lauffenburger, Douglas A; Gertler, Frank B

2017-01-01

Taxane therapy remains the standard of care for triple-negative breast cancer. However, high frequencies of recurrence and progression in treated patients indicate that metastatic breast cancer cells can acquire resistance to this drug. The actin regulatory protein MENA and particularly its invasive isoform, MENA INV , are established drivers of metastasis. MENA INV expression is significantly correlated with metastasis and poor outcome in human patients with breast cancer. We investigated whether MENA isoforms might play a role in driving resistance to chemotherapeutics. We find that both MENA and MENA INV confer resistance to the taxane paclitaxel, but not to the widely used DNA-damaging agents doxorubicin or cisplatin. Furthermore, paclitaxel treatment does not attenuate growth of MENA INV -driven metastatic lesions. Mechanistically, MENA isoform expression alters the ratio of dynamic and stable microtubule populations in paclitaxel-treated cells. MENA expression also increases MAPK signaling in response to paclitaxel treatment. Decreasing ERK phosphorylation by co-treatment with MEK inhibitor restored paclitaxel sensitivity by driving microtubule stabilization in MENA isoform-expressing cells. Our results reveal a novel mechanism of taxane resistance in highly metastatic breast cancer cells and identify a combination therapy to overcome such resistance. Mol Cancer Ther; 16(1); 143-55. ©2016 AACR. ©2016 American Association for Cancer Research.

Paclitaxel and doxorubicin in metastatic breast cancer

DEFF Research Database (Denmark)

Gehl, J; Boesgaard, M; Paaske, T

1996-01-01

For the past decades the anthracyclines have been regarded as among the most active drugs for the treatment of metastatic breast cancer. However, the 5-year survival rate in patients with stage IV breast cancer continues to be below 20%, and new active drugs and drug combinations clearly must...... be explored. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been demonstrated to be highly effective in treating patients with advanced breast cancer, including those with anthracycline-resistant breast cancer, a fact that has led to efforts to combine paclitaxel and anthracyclines...

Percutaneous common femoral artery interventions using angioplasty, atherectomy, and stenting.

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Mehta, Manish; Zhou, Yi; Paty, Philip S K; Teymouri, Medhi; Jafree, Kamran; Bakhtawar, Humayun; Hnath, Jeffrey; Feustel, Paul

2016-08-01

This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis. During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424). Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has

Effect of a thiolated polymer on oral paclitaxel absorption and tumor growth in rats.

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Föger, Florian; Malaivijitnond, Suchinda; Wannaprasert, Thanakul; Huck, Christian; Bernkop-Schnürch, Andreas; Werle, Martin

2008-02-01

The anticancer agent paclitaxel is currently commercially available only as an infusion due to its low oral bioavailability. An oral formulation would be highly beneficial for patients. Besides the low solubility, the main reason for the limited oral bioavailability of paclitaxel is that it is a substrate of the efflux pump P-glycoprotein (P-gp). Recently, it has been demonstrated that P-gp can be inhibited by thiolated polymers. In this study, an oral paclitaxel formulation based on thiolated polycarbophil was evaluated in vivo in wild-type rats and in mammary cancer-induced rats. The paclitaxel plasma level after a single administration of paclitaxel was observed for 12 h in healthy rats. Moreover, cancer-induced rats were treated weekly for 5 weeks with the novel formulation. It was demonstrated that (1) co-administration of thiolated polycarbophil significantly improved paclitaxel plasma levels, (2) a more constant pharmacokinetic profile could be achieved and (3) the tumor growth was reduced. These effects can most likely be attributed to P-gp inhibition. According to the achieved results, thiolated polymers are believed to be interesting tools for the delivery of P-gp substrates such as paclitaxel.

Paclitaxel Induced MDS and AML: A Case Report and Literature Review

Directory of Open Access Journals (Sweden)

Udit Bhaskar Bhatnagar

2016-01-01

Full Text Available Therapy related acute myelogenous leukemia (AML and myelodysplastic syndromes (MDS have been classically linked to alkylating agents and topoisomerase inhibitors. They constitute about 1% of all AMLs. There is less evidence on association of taxanes (paclitaxel and docetaxel with these myeloid neoplasms. We present a case of paclitaxel therapy related acute myelogenous leukemia after treatment of endometrial cancer with a regimen containing paclitaxel and carboplatin. A 63-year-old female underwent surgery followed by a total of 6 cycles of chemotherapy with carboplatin and paclitaxel. Six months after last cycle of chemotherapy, she was diagnosed with myelodysplastic syndrome with refractory anemia and excess blasts. Six weeks later, she had worsening anemia and thrombocytopenia which prompted a bone marrow biopsy which revealed acute myelomonocytic leukemia. A thorough literature review revealed 12 other case reports where taxanes have been implicated in the development of therapy related myeloid neoplasm. Based on the timeline of events in our patient, paclitaxel is the likely culprit in the pathogenesis of this myeloid neoplasm. This rare but significantly grave adverse effect should be kept in consideration when deciding on treatment options for gynecological malignancies.

Delivery of paclitaxel across cellular barriers using a dendrimer-based nanocarrier.

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Teow, Huey Minn; Zhou, Zhengyuan; Najlah, Mohammad; Yusof, Siti R; Abbott, N Joan; D'Emanuele, Antony

2013-01-30

The aim of this study was to investigate the ability of a third-generation (G3) polyamidoamine (PAMAM) dendrimer-based carrier to enhance the permeability of paclitaxel (pac) and to overcome cellular barriers. G3 dendrimers were surface modified with lauryl chains (L) and conjugated with paclitaxel (pac) via a glutaric anhydride (glu) linker, followed by labeling with FITC. Biological evaluation of the dendrimer and conjugates was conducted using the human colon adenocarcinoma cell line (Caco-2) and primary cultured porcine brain endothelial cells (PBECs). LDH assay was used to evaluate the cytotoxicity of the dendrimer and conjugates. Cytotoxicity studies showed that the conjugation of lauryl chains and paclitaxel on G3 dendrimer significantly (pdendrimer-drug conjugates demonstrated an increase in the apparent permeability coefficient (P(app)) in both apical to basolateral A→B and basolateral to apical B→A directions across both cell monolayers compared to unmodified G3 and free drug. The B→A P(app) of paclitaxel was significantly (ptransporter system in both cell models. L6-G3-glu-pac conjugate had approximately 12-fold greater permeability across both cell monolayers than that of paclitaxel alone. Copyright © 2012 Elsevier B.V. All rights reserved.

A new high-performance liquid chromatography-tandem mass spectrometry method for the determination of paclitaxel and 6α-hydroxy-paclitaxel in human plasma: Development, validation and application in a clinical pharmacokinetic study.

Directory of Open Access Journals (Sweden)

Bianca Posocco

Full Text Available Paclitaxel belongs to the taxanes family and it is used, alone or in multidrug regimens, for the therapy of several solid tumours, such as breast-, lung-, head and neck-, and ovarian cancer. Standard dosing of chemotherapy does not take into account the many inter-patient differences that make drug exposure highly variable, thus leading to the insurgence of severe toxicity. This is particularly true for paclitaxel considering that a relationship between haematological toxicity and plasma exposure was found. Therefore, in order to treat patients with the correct dose of paclitaxel, improving the overall benefit-risk ratio, Therapeutic Drug Monitoring is necessary. In order to quantify paclitaxel and its main metabolite, 6α-hydroxy-paclitaxel, in patients' plasma, we developed a new, sensitive and specific HPLC-MS/MS method applicable to all paclitaxel dosages used in clinical routine. The developed method used a small volume of plasma sample and is based on quick protein precipitation. The chromatographic separation of the analytes was achieved with a SunFire™ C18 column (3.5 μM, 92 Å, 2,1 x 150 mm; the mobile phases were 0.1% formic acid/bidistilled water and 0.1% formic acid/acetonitrile. The electrospray ionization source worked in positive ion mode and the mass spectrometer operated in selected reaction monitoring mode. Our bioanalytical method was successfully validated according to the FDA-EMA guidelines on bioanalytical method validation. The calibration curves resulted linear (R2 ≥0.9948 over the concentration ranges (1-10000 ng/mL for paclitaxel and 1-1000 ng/mL for 6α-hydroxy-paclitaxel and were characterized by a good accuracy and precision. The intra- and inter-day precision and accuracy were determined on three quality control concentrations for paclitaxel and 6α-hydroxy-paclitaxel and resulted respectively <9.9% and within 91.1-114.8%. In addition, to further verify the assay reproducibility, we tested this method by re

Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis.

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Poder, Thomas G; Erraji, Jihane; Coulibaly, Lucien P; Koffi, Kouamé

2017-01-01

Drug-eluting stents (DESs) were considered as ground-breaking technology promising to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention. Soon after DESs were released on the market, however, there were reports of a potential increase in mortality and of early or late thrombosis. In addition, DESs are far more expensive than bare-metal stents (BMSs), which has led to their limited use in many countries. The technology has improved over the last few years with the second generation of DESs (DES-2). Moreover, costs have come down and an improved safety profile with decreased thrombosis has been reported. Perform a cost-benefit analysis of DES-2s versus BMSs in the context of a publicly funded university hospital in Quebec, Canada. A systematic review of meta-analyses was conducted between 2012 and 2016 to extract data on clinical effectiveness. The clinical outcome of interest for the cost-benefit analysis was target-vessel revascularization (TVR). Cost units are those used in the Quebec health-care system. The cost-benefit analysis was based on a 2-year perspective. Deterministic and stochastic models (discrete-event simulation) were used, and various risk factors of reintervention were considered. DES-2s are much more effective than BMSs with respect to TVR rate ratio (i.e., 0.29 to 0.62 in more recent meta-analyses). DES-2s seem to cause fewer deaths and in-stent thrombosis than BMSs, but results are rarely significant, with the exception of the cobalt-chromium everolimus DES. The rate ratio of myocardial infraction is systematically in favor of DES-2s and very often significant. Despite the higher cost of DES-2s, fewer reinterventions can lead to huge savings (i.e., -$479 to -$769 per patient). Moreover, the higher a patient's risk of reintervention, the higher the savings associated with the use of DES-2s. Despite the higher purchase cost of DES-2s compared to BMSs

[Thomas' shunt for hemodialysis: dysfunction and its percutaneous treatment].

Science.gov (United States)

Gallego, J J; Santos, E; Méndez, J V; Coronel, F; Torrente, J; Holguín, A; Moreno, R

2003-01-01

To assess the usefulness of percutaneous treatment of abnormalities of the venous tree in extending the survival of external Thomas shunts (TS). Twelve cases of TS were included in a hemodialysis access fistula dysfunction monitoring program and were followed for up to 48 months. The abnormalities found were treated by percutaneous transluminal angioplasty (PTA) or thrombolysis and PTA. Survival curves and the Kaplan-Meier method were used to calculate the likelihood of primary patency (P1), secondary patency (P2), and overall patency (OP). A total of 61 interventions were performed during the period of follow-up. On 12 occasions the fistula was thrombosed; in the rest, increased venous pressure to 150 mmHg or higher was detected during dialysis. Fistulography was performed after washing the thrombosed fistulas with urokinase, and revealed one or more of the following angiographic signs: 1) a short reduction of more than 50% in lumen caliber in the femoral vein adjacent to the anastomosis, present in 52% of the cases (fig. 1); 2) imaging a "jet" of contrast material at the site of entry of the shunt into the femoral vein (fig. 2), present in 22% of the cases; and 3) a filling defect or "flap" at the same site, owing to hyperplastic tissue or piece of thrombus adhering to the intima, present in 34% of the cases (figs. 3-5). This last-mentioned finding ordinarily gave rise to a "valve" effect, whereby injection into the venous branch was feasible but aspiration from the venous branch was difficult or impossible. PTA was carried out and attained anatomical and functional success in 100% of cases. PI was 58%, 33%, 8%, and 0% at 6, 12, 24, and 36 months, respectively; P2 was 100%, 75%, 58%, and 25%; respectively, at those same times. The comparison of the PI and P2 curves was statistically significant; p < 0.001 (table 1). OP was 83%, 66%, 50% and 41% at 12, 24, 36 and 48 months. The comparison of the PI surgical and OP curves was statistically significant; p < 0

Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

DEFF Research Database (Denmark)

Raungaard, Bent; Christiansen, Evald H; Bøtker, Hans Erik

2017-01-01

artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion......OBJECTIVES: The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BACKGROUND: Biodegradable-polymer biolimus-eluting stents are superior to first......-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. METHODS: The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary...

Endoscopic treatment of multilocular walled-off pancreatic necrosis with the multiple transluminal gateway technique.

Science.gov (United States)

Jagielski, Mateusz; Smoczyński, Marian; Adrych, Krystian

2017-06-01

The development of minimally invasive techniques allowed access to the necrotic cavity through transperitoneal, retroperitoneal, transmural and transpapillary routes. The choice of access to walled-off pancreatic necrosis (WOPN) should depend not only on the spread of necrosis, but also on the experience of the clinical center. Herein we describe treatment of a patient with multilocular symptomatic walled-off pancreatic necrosis using minimally invasive techniques. The single transmural access (single transluminal gateway technique - SGT) to the necrotic collection of the patient was ineffective. The second gastrocystostomy was performed using the same minimally invasive technique as an extra way of access to the necrosis (multiple transluminal gateway technique - MTGT). In the described case the performance of the new technique consisting in endoscopic multiplexing transmural access (MTGT) was effective enough and led to complete recovery of the patient.

Below knee angioplasty in elderly patients: Predictors of major adverse clinical outcomes.

LENUS (Irish Health Repository)

Keeling, Aoife N

2011-03-01

To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI).

Paclitaxel Induces Apoptosis in Breast Cancer Cells through Different Calcium—Regulating Mechanisms Depending on External Calcium Conditions

Science.gov (United States)

Pan, Zhi; Avila, Andrew; Gollahon, Lauren

2014-01-01

Previously, we reported that endoplasmic reticulum calcium stores were a direct target for paclitaxel initiation of apoptosis. Furthermore, the actions of paclitaxel attenuated Bcl-2 resistance to apoptosis through endoplasmic reticulum-mediated calcium release. To better understand the calcium-regulated mechanisms of paclitaxel-induced apoptosis in breast cancer cells, we investigated the role of extracellular calcium, specifically; whether influx of extracellular calcium contributed to and/or was necessary for paclitaxel-induced apoptosis. Our results demonstrated that paclitaxel induced extracellular calcium influx. This mobilization of extracellular calcium contributed to subsequent cytosolic calcium elevation differently, depending on dosage. Under normal extracellular calcium conditions, high dose paclitaxel induced apoptosis-promoting calcium influx, which did not occur in calcium-free conditions. In the absence of extracellular calcium an “Enhanced Calcium Efflux” mechanism in which high dose paclitaxel stimulated calcium efflux immediately, leading to dramatic cytosolic calcium decrease, was observed. In the absence of extracellular calcium, high dose paclitaxel’s stimulatory effects on capacitative calcium entry and apoptosis could not be completely restored. Thus, normal extracellular calcium concentrations are critical for high dose paclitaxel-induced apoptosis. In contrast, low dose paclitaxel mirrored controls, indicating that it occurs independent of extracellular calcium. Thus, extracellular calcium conditions only affect efficacy of high dose paclitaxel-induced apoptosis. PMID:24549172

Studies of peripheral sensory nerves in paclitaxel-induced painful peripheral neuropathy: Evidence for mitochondrial dysfunction

OpenAIRE

Flatters, Sarah J.L.; Bennett, Gary J.

2006-01-01

Paclitaxel chemotherapy frequently induces neuropathic pain during and often persisting after therapy. The mechanisms responsible for this pain are unknown. Using a rat model of paclitaxel-induced painful peripheral neuropathy, we have performed studies to search for peripheral nerve pathology. Paclitaxel-induced mechano-allodynia and mechano-hyperalgesia were evident after a short delay, peaked at day 27 and finally resolved on day 155. Paclitaxel- and vehicle-treated rats were perfused on d...

Innovative Elution Processes for Recovering Uranium from Seawater

International Nuclear Information System (INIS)

Wai, Chien; Tian, Guoxin; Janke, Christopher

2014-01-01

Utilizing amidoxime-based polymer sorbents for extraction of uranium from seawater has attracted considerable interest in recent years. Uranium collected in the sorbent is recovered typically by elution with an acid. One drawback of acid elution is deterioration of the sorbent which is a significant factor that limits the economic competitiveness of the amidoxime-based sorbent systems for sequestering uranium from seawater. Developing innovative elution processes to improve efficiency and to minimize loss of sorbent capacity become essential in order to make this technology economically feasible for large-scale industrial applications. This project has evaluated several elution processes including acid elution, carbonate elution, and supercritical fluid elution for recovering uranium from amidoxime-based polymer sorbents. The elution efficiency, durability and sorbent regeneration for repeated uranium adsorption- desorption cycles in simulated seawater have been studied. Spectroscopic techniques are used to evaluate chemical nature of the sorbent before and after elution. A sodium carbonate-hydrogen peroxide elution process for effective removal of uranium from amidoxime-based sorbent is developed. The cause of this sodium carbonate and hydrogen peroxide synergistic leaching of uranium from amidoxime-based sorbent is attributed to the formation of an extremely stable uranyl peroxo-carbonato complex. The efficiency of uranium elution by the carbonate-hydrogen peroxide method is comparable to that of the hydrochloric acid elution but damage to the sorbent material is much less for the former. The carbonate- hydrogen peroxide elution also does not need any elaborate step to regenerate the sorbent as those required for hydrochloric acid leaching. Several CO2-soluble ligands have been tested for extraction of uranium from the sorbent in supercritical fluid carbon dioxide. A mixture of hexafluoroacetylacetone and tri-n-butylphosphate shows the best result but uranium

Innovative Elution Processes for Recovering Uranium from Seawater

Energy Technology Data Exchange (ETDEWEB)

Wai, Chien [Univ. of Idaho, Moscow, ID (United States); Tian, Guoxin [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Janke, Christopher [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2014-05-29

Utilizing amidoxime-based polymer sorbents for extraction of uranium from seawater has attracted considerable interest in recent years. Uranium collected in the sorbent is recovered typically by elution with an acid. One drawback of acid elution is deterioration of the sorbent which is a significant factor that limits the economic competitiveness of the amidoxime-based sorbent systems for sequestering uranium from seawater. Developing innovative elution processes to improve efficiency and to minimize loss of sorbent capacity become essential in order to make this technology economically feasible for large-scale industrial applications. This project has evaluated several elution processes including acid elution, carbonate elution, and supercritical fluid elution for recovering uranium from amidoxime-based polymer sorbents. The elution efficiency, durability and sorbent regeneration for repeated uranium adsorption- desorption cycles in simulated seawater have been studied. Spectroscopic techniques are used to evaluate chemical nature of the sorbent before and after elution. A sodium carbonate-hydrogen peroxide elution process for effective removal of uranium from amidoxime-based sorbent is developed. The cause of this sodium carbonate and hydrogen peroxide synergistic leaching of uranium from amidoxime-based sorbent is attributed to the formation of an extremely stable uranyl peroxo-carbonato complex. The efficiency of uranium elution by the carbonate-hydrogen peroxide method is comparable to that of the hydrochloric acid elution but damage to the sorbent material is much less for the former. The carbonate- hydrogen peroxide elution also does not need any elaborate step to regenerate the sorbent as those required for hydrochloric acid leaching. Several CO2-soluble ligands have been tested for extraction of uranium from the sorbent in supercritical fluid carbon dioxide. A mixture of hexafluoroacetylacetone and tri-n-butylphosphate shows the best result but uranium

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

Science.gov (United States)

Suwannasom, Pannipa; Sotomi, Yohei; Ishibashi, Yuki; Cavalcante, Rafael; Albuquerque, Felipe N; Macaya, Carlos; Ormiston, John A; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Tijssen, Jan G; Wykrzykowska, Joanna J; de Winter, Robbert J; Chevalier, Bernard; Serruys, Patrick W; Onuma, Yoshinobu

2016-06-27

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p 0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American

Acute occlusion of the coronary artery after transluminal balloon coronary angioplasty

International Nuclear Information System (INIS)

Savchenko, A.P.; Matchin, Yu.G.; Lyakishev, A.A.

1995-01-01

The research was aimed at elucidation of the relationship of the clinical and angiographic factors, on the one hand, and development of acute occlusion following transluminal balloon coronary angioplasty TBCA, on the other. TBCA was carried out in 162 patients. Eight (4.9 %) patients developed acute occlusion of the coronary artery, which was complicated by acute myocardial infarction in 50 % cases. 35 refs.; 4 tabs

Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction: a retrospective study

Directory of Open Access Journals (Sweden)

Chih-Yuan Fang

2018-04-01

Full Text Available Background Good results of drug-eluting balloon (DEB use are achieved in in-stent restenosis (ISR lesions, small vessel disease, long lesions, and bifurcations. However, few reports exist about DEB use in acute myocardial infarction (AMI with ISR. This study’s aim was to evaluate the efficacy of DEB for AMI with ISR. Methods Between November 2011 and December 2015, 117 consecutive patients experienced AMI including ST-segment elevation MI, and non-ST-segment elevation MI due to ISR, and received percutaneous coronary intervention (PCI. We divided our patients into two groups: (1 PCI with further DEB, and (2 PCI with further drug-eluting stent (DES. Clinical outcomes such as target lesion revascularization, target vessel revascularization, recurrent MI, stroke, cardiovascular mortality, and all-cause mortality were analyzed. Results The patients’ average age was 68.37 ± 11.41 years; 69.2% were male. A total of 75 patients were enrolled in the DEB group, and 42 patients were enrolled in the DES group. The baseline characteristics between the two groups were the same without statistical differences except for gender. Peak levels of cardiac biomarker, pre- and post-PCI cardiac function were similar between two groups. The major adverse cardiac cerebral events rate (34.0% vs. 35.7%; p = 0.688 and cardiovascular mortality rate (11.7% vs. 12.8%; p = 1.000 were similar in both groups. Conclusions DEB is a reasonable strategy for AMI with ISR. Compared with DES, DEB is an alternative strategy which yielded acceptable short-term outcomes and similar 1-year clinical outcomes.

Clinical efficacy of paclitaxel in the treatment of mid-stage and ...

African Journals Online (AJOL)

Conclusion: Paclitaxel has a significant effect when used to treat mid-stage and advanced gastric cancer. Moreover, additional nursing not only enhances the therapeutic effect but also improves prognosis and quality-of-life. Keywords: Paclitaxel, Mid-stage/advanced cancer, Gastric cancer, Nursing efficacy, Karnofsky ...

How firms set prices for medical materials: a multi-country study.

Science.gov (United States)

Ide, Hiroo; Mollahaliloglu, Salih

2009-09-01

This study presents a comparison of medical material prices, discusses why differences exist, and examines methods for comparing prices. Market prices for drug-eluting stents (DES), non-drug-eluting stents (non-DES), and percutaneous transluminal coronary angioplasty (PTCA) catheters were collected from five countries: the United States, Japan, Korea, Turkey, and Thailand. To compare prices, three adjustment methods were used: currency exchange rates, purchasing power parity (PPP), and gross domestic product (GDP) per capita. The ratios of medical material prices compared with those in the United States were higher in Japan (from 1.4 for DES to 5.0 for PTCA catheters) and Korea (from 1.2 for DES to 4.0 for PTCA catheters), and lower in Turkey (from 0.8 for non-DES to 1.4 for DES) and Thailand (from 0.5 for non-DES to 1.3 for PTCA catheters). The PPP-adjusted ratios changed slightly for Japan, Korea, and Turkey. When the prices were adjusted by GDP per capita, the ratios were much higher. Comparing prices using currency exchange rates or PPP is applicable only between countries with stable economic relations; adjustment by GDP per capita reflects the actual burden. Further study is needed to fully elucidate the factors influencing the global medical material market.

Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series.

Science.gov (United States)

Cuadrado-Garcia, Angel; Noguera, Jose F; Olea-Martinez, Jose M; Morales, Rafael; Dolz, Carlos; Lozano, Luis; Vicens, Jose-Carlos; Pujol, Juan José

2011-01-01

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. Currently, it is not possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids fusing minilaparoscopy and transluminal endoscopic surgery. This report presents a prospective clinical series of 25 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. The study comprised a clinical series of 25 consecutive nonrandomized women who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two trocars for cholelithiasis: one 5-mm umbilical trocar and one 3-mm trocar in the upper left quadrant. The study had no control group. The scheduled surgical intervention was performed for all 25 women. No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, but no other complications occurred during an average follow-up period of 140 days. Of the 25 women, 20 were discharged in 24 h, and 5 were discharged less than 12 h after the procedure. Hybrid transvaginal cholecystectomy, combining NOTES and minilaparoscopy, is a good surgical model for minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.

A preliminary report on the effects of paclitaxel-impregnated stents on sheep nasal mucosa.

Science.gov (United States)

Herrmann, Brian W; Citardi, Martin J; Vogler, George; Gardner, Laura; Smith, Greg; Javer, Amin R; Burt, Helen M; Jackson, John; Kuhn, Frederick A

2004-01-01

Traditional frontal sinus stents serve only as mechanical devices. It has been proposed that stents also may serve as drug-delivery systems for the topical application of drugs that minimize postoperative scarring. Paclitaxel (Taxol), which has recognized antiscarring effects, may be incorporated via a polymeric formulation into standard rubber stents. The impact of topically applied paclitaxel on the morphology of the nasal mucosa is unknown. An adult sheep model was used for this study. A modified rubber T-tube stent (incorporating paclitaxel at varying dosages) was secured to each side of the septum in four animals (eight sides). An unmodified T-tube was placed on each side of one animal, a T-tube with the drug carrier (but no paclitaxel) was placed on each side of the second animal, and T-tubes with varying paclitaxel were placed on each side of the final two animals. After 4 weeks, animals were killed and the nasal mucosa was harvested. The nasal mucosa was sectioned and stained with hematoxylin and eosin. A pathologist then assessed the nasal mucosa for vascular congestion, glandular atrophy, chronic inflammation, mucosal metaplasia, and mucosal ulceration. No consistent histopathological differences were noted in the specimens. All specimens showed varying degrees of vascular congestion, glandular atrophy, chronic inflammation, and mucosal metaplasia; the paclitaxel-impregnated stents were not consistently associated with more severe mucosal injury. Finally, mucosal ulceration was noted to be very rare in all specimens. This preliminary report describes the impact of paclitaxel-impregnated stents on sheep nasal mucosa, which tolerated these stents very well. Because paclitaxel minimizes scarring reactions at very low concentrations, paclitaxel-impregnated stents may prove useful in clinical situations in which frontal sinus stenting is deemed necessary. Additional investigations with animal models, as well as clinical trials, may be warranted.

Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

DEFF Research Database (Denmark)

Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

2012-01-01

Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

A Liposomal Formulation Able to Incorporate a High Content of Paclitaxel and Exert Promising Anticancer Effect

Directory of Open Access Journals (Sweden)

Pei Kan

2011-01-01

Full Text Available A liposome formulation for paclitaxel was developed in this study. The liposomes, composed of naturally unsaturated and hydrogenated phosphatidylcholines, with significant phase transition temperature difference, were prepared and characterized. The liposomes exhibited a high content of paclitaxel, which was incorporated within the segregated microdomains coexisting on phospholipid bilayer of liposomes. As much as 15% paclitaxel to phospholipid molar ratio were attained without precipitates observed during preparation. In addition, the liposomes remained stable in liquid form at 4∘C for at least 6 months. The special composition of liposomal membrane which could reduce paclitaxel aggregation could account for such a capacity and stability. The cytotoxicity of prepared paclitaxel liposomes on the colon cancer C-26 cell culture was comparable to Taxol. Acute toxicity test revealed that LD50 for intravenous bolus injection in mice exceeded by 40 mg/kg. In antitumor efficacy study, the prepared liposomal paclitaxel demonstrated the increase in the efficacy against human cancer in animal model. Taken together, the novel formulated liposomes can incorporate high content of paclitaxel, remaining stable for long-term storage. These animal data also demonstrate that the liposomal paclitaxel is promising for further clinical use.

Nab-Paclitaxel plus gemcitabine in patients with metastatic pancreatic adenocarcinoma: experience of use

Directory of Open Access Journals (Sweden)

Elena Ferris Villanueva

2015-02-01

Full Text Available Objective: To evaluate the results obtained with the combined use of nab-paclitaxel and gemcitabine in the treatment of patients with metastatic pancreatic adenocarcinoma. Materials and methods: Retrospective observational study. Patients treated with nab-paclitaxel and gemcitabine between January of 2013 and January of 2014 were selected. Demographical and clinical data were gathered. Results: 15 patients (mean age 59,4 ± 10,3 years were included. All patients received the combination of nab-paclitaxel and gemcitabine in first-line metastatic disease. Nine received adjuvant treatment before the disease was metastatic. The median progression-free survival rate with combined nab-paclitaxel and gemcitabine was 5,6 months (95% CI: 4,44 - 8,03. In two patients the treatment was stopped due to toxicity. Conclusions: The treatment with nab-paclitaxel and gemcitabine in our patients resulted in progression-free survival rates similar to those published in clinical trials with good treatment tolerability

Nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy of breast cancer: a systematic review and meta-analysis.

Science.gov (United States)

Zong, Yu; Wu, Jiayi; Shen, Kunwei

2017-03-07

The value of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in neoadjuvant systemic therapy for breast cancer remains uncertain. Both electronic databases and proceedings of oncologic meetings were included in systematic literature search. Pooled rates of pathological complete response (pCR), odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using fixed-effect or random-effect model to determine the effect of neoadjuvant nab-paclitaxel. Twenty-one studies with 2357 patients were included, 3 of which were randomized clinical trials. The aggregate pCR(ypT0/is ypN0) rate was 32% (95% CI 25-38%) in unselected breast cancer patients and variated in different subtypes. Within randomized clinical trials, the probability of achieving pCR was significantly higher in the nab-paclitaxel group than in the conventional taxanes group (OR = 1.383, 95%CI 1.141-1.676, p = 0.001). For non-hematological toxic effect, any grade and grade 3-4 peripheral sensory neuropathy occurred more frequently with nab-paclitaxel compared to paclitaxel (any grade, OR = 2.090, 95%CI 1.016-4.302, p = 0.045; grade3-4, OR = 3.766, 95%CI 2.324-6.100, p < 0.001). Hypersensitivity was more common with paclitaxel than nab-paclitaxel at any grade and grade 3-4. nab-paclitaxel is an effective cytotoxic drug in neoadjuvant treatment of breast cancer, especially for aggressive tumors in terms of pCR. Exchange of nab-paclitaxel for conventional taxanes could significantly improve pCR rate with reasonable toxicities.

Design, Synthesis and Applications of Hyaluronic Acid-Paclitaxel Bioconjugatesâ€

Directory of Open Access Journals (Sweden)

Rinaldo Marini Bettolo

2008-02-01

Full Text Available Paclitaxel (1a, a well known antitumor agent adopted mainly for the treatmentof breast and ovarian cancer, suffers from significant disadvantages such as low solubility,certain toxicity and specific drug-resistance of some tumor cells. To overcome theseproblems extensive research has been carried out. Among the various proposed strategies,the conjugation of paclitaxel (1a to a biocompatible polymer, such as hyaluronic acid(HA, 2, has also been considered. Coupling a bioactive compound to a biocompatiblepolymer offers, in general, many advantages such as better drug solubilization, betterstabilization, specific localization and controlled release. Hereafter the design, synthesisand applications of hyaluronic acid-paclitaxel bioconjugates are reviewed. An overview ofHA-paclitaxel combinations is also given.

[Developments in percutaneous coronary intervention and coronary stents].

Science.gov (United States)

Simsek, C; Daemen, J; Zijlstra, F

2014-01-01

In The Netherlands, more than 30.000 patients undergo a percutaneous coronary intervention every year, during which a coronary stent implantation will be performed in 90% of the cases. It is estimated that more than 5 million coronary stent implantations will be performed worldwide this year. While these numbers are impressive, however, coronary stents still have as a limitation the possibility of stent thrombosis. This has been and is an important stimulus for the development of both coronary stents, from a bare metal stent via a drug eluting stent to the present-day development of bio-absorbable stents, and anti-platelet drugs,from acenocoumarol to thieropyridines. The possibility of shortening the period of use of this powerful medication by developing new kinds of non-thrombogenic stents would, for example, make it possible to achieve significant reductions in subsequent bleeding during (dental) procedures.

Cold therapy to prevent paclitaxel-induced peripheral neuropathy.

Science.gov (United States)

Griffiths, Claire; Kwon, Nancy; Beaumont, Jennifer L; Paice, Judith A

2018-04-21

This case-control study was designed to assess the efficacy of cryotherapy to prevent paclitaxel-induced painful peripheral neuropathy in women with breast cancer. Participants served as their own paired control, with randomization of the cooled glove/sock to either the dominant or the non-dominant hand/foot, worn for 15 min prior to, during, and 15 min after completion of the paclitaxel infusion. Outcome measures included the Neuropathic Pain Symptom Inventory, the Brief Pain Inventory, and quantitative sensory testing. Data were measured at each of six time points-baseline, post-treatment (approximately 2 weeks after the last paclitaxel infusion), and at the first, fifth, ninth, and final weekly paclitaxel treatments. Of 29 randomized participants, 20 (69%) received at least one cryotherapy treatment, and 11 (38%) received all four cryotherapy treatments. Ten (34%) participants could not tolerate the cryotherapy, and six (21%) declined further participation at some point during the trial. Only seven participants (24%) were available for the final post-chemotherapy QST and questionnaires. There were no significant differences in measures of neuropathy or pain between treated and untreated hands or feet. Strategies to prevent painful peripheral neuropathy are urgently needed. In this current trial, dropout due to discomfort precluded adequate power to fully understand the potential benefits of cryotherapy. Much more research is needed to discover safe and effective preventive strategies that can be easily implemented within busy infusion centers.

A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

Directory of Open Access Journals (Sweden)

Teeuwen Koen

2012-12-01

Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

Rationalization of paclitaxel insensitivity of yeast β-tubulin and human βIII-tubulin isotype using principal component analysis

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Das Lalita

2012-08-01

Full Text Available Abstract Background The chemotherapeutic agent paclitaxel arrests cell division by binding to the hetero-dimeric protein tubulin. Subtle differences in tubulin sequences, across eukaryotes and among β-tubulin isotypes, can have profound impact on paclitaxel-tubulin binding. To capture the experimentally observed paclitaxel-resistance of human βIII tubulin isotype and yeast β-tubulin, within a common theoretical framework, we have performed structural principal component analyses of β-tubulin sequences across eukaryotes. Results The paclitaxel-resistance of human βIII tubulin isotype and yeast β-tubulin uniquely mapped on to the lowest two principal components, defining the paclitaxel-binding site residues of β-tubulin. The molecular mechanisms behind paclitaxel-resistance, mediated through key residues, were identified from structural consequences of characteristic mutations that confer paclitaxel-resistance. Specifically, Ala277 in βIII isotype was shown to be crucial for paclitaxel-resistance. Conclusions The present analysis captures the origin of two apparently unrelated events, paclitaxel-insensitivity of yeast tubulin and human βIII tubulin isotype, through two common collective sequence vectors.

Bioadhesive drug delivery system using glyceryl monooleate for the intravesical administration of paclitaxel.

Science.gov (United States)

Lee, Seung-Ju; Kim, Sae Woong; Chung, Hesson; Park, Yeong Taek; Choi, Young Wook; Cho, Yong-Hyun; Yoon, Moon Soo

2005-10-01

Many reports have shown that the efficacy of intravesical therapy for bladder cancer is in part limited by the poor penetration of drugs into the urothelium. The present study evaluated the effect of glyceryl monooleate (GMO) on the absorption of intravesically administered paclitaxel in a rabbit model of bladder cancer. Urine, plasma, and tissue pharmacokinetics were determined in rabbits treated for 120 min with paclitaxel (500 microg/20 ml) by intravesical instillation. Two formulations of GMO/paclitaxel were evaluated using different proportions of water, 15 and 30%, and Taxol was used as a control. Animals were observed for clinical signs of toxicity and necropsy was performed. 120 min after instillation, the bladder was emptied and excised. In the urine, paclitaxel concentration was decreased by 39.6 and 41.2% in the two experimental groups and by 25.2% in the control group. The paclitaxel concentrations in the urothelium were 53 and 56% of the urine concentration in both experimental groups, but 11% in the control group. The concentration then declined exponentially in the underlying capillary-perfused tissues, reaching equilibrium at a depth of 1,400-1,700 microm. The plasma concentrations were extremely low compared with concentrations in urine and bladder tissues and were not associated with clinical toxicity. We conclude that GMO has a significantly increased bioadhesiveness to bladder mucosa. Therefore, intravesical administration of GMO/paclitaxel/water provides a significant advantage for drugs targeting the bladder tissue, and paclitaxel represents a viable option for intravesical bladder cancer therapy. Copyright 2005 S. Karger AG, Basel.

LBA50 - Influence of concomitant clopidogrel consumption on development of paclitaxel-associated toxicity: A pharmacoepidemiological study

DEFF Research Database (Denmark)

K, Agergaard; Mau-Sørensen, M; Stage, Tore Bjerregaard

clopidogrel to a metabolite, which is a strong inhibitor of CYP2C8. To determine if this interaction has clinical relevance, we investigated whether concomitant clopidogrel and paclitaxel was associated with severe paclitaxel toxicity, primarily peripheral sensory neuropathy. Methods Patients concomitantly...... from medical charts by reviewers partially blinded to clopidogrel exposure. The association of clopidogrel use and development of paclitaxel induced neuropathy was evaluated over accumulated paclitaxel dose with censoring after 1500 mg using Cox-regression analysis with adjustment for high intensity...... neuropathy or worse. Clopidogrel use was associated with increased risk of neuropathy with hazard ratios of 1.7 (95% CI 0.9-3.0), 2.0 (1.0-3.9) and 2.3 (1.1-4.5) in overall unadjusted, high intensity paclitaxel unadjusted and high intensity paclitaxel full adjusted analyses, respectively. Conclusions...

Nicotine Prevents and Reverses Paclitaxel-Induced Mechanical Allodynia in a Mouse Model of CIPN.

Science.gov (United States)

Kyte, S Lauren; Toma, Wisam; Bagdas, Deniz; Meade, Julie A; Schurman, Lesley D; Lichtman, Aron H; Chen, Zhi-Jian; Del Fabbro, Egidio; Fang, Xianjun; Bigbee, John W; Damaj, M Imad; Gewirtz, David A

2018-01-01

Chemotherapy-induced peripheral neuropathy (CIPN), a consequence of peripheral nerve fiber dysfunction or degeneration, continues to be a dose-limiting and debilitating side effect during and/or after cancer chemotherapy. Paclitaxel, a taxane commonly used to treat breast, lung, and ovarian cancers, causes CIPN in 59-78% of cancer patients. Novel interventions are needed due to the current lack of effective CIPN treatments. Our studies were designed to investigate whether nicotine can prevent and/or reverse paclitaxel-induced peripheral neuropathy in a mouse model of CIPN, while ensuring that nicotine will not stimulate lung tumor cell proliferation or interfere with the antitumor properties of paclitaxel. Male C57BL/6J mice received paclitaxel every other day for a total of four injections (8 mg/kg, i.p.). Acute (0.3-0.9 mg/kg, i.p.) and chronic (24 mg/kg per day, s.c.) administration of nicotine respectively reversed and prevented paclitaxel-induced mechanical allodynia. Blockade of the antinociceptive effect of nicotine with mecamylamine and methyllycaconitine suggests that the reversal of paclitaxel-induced mechanical allodynia is primarily mediated by the α 7 nicotinic acetylcholine receptor subtype. Chronic nicotine treatment also prevented paclitaxel-induced intraepidermal nerve fiber loss. Notably, nicotine neither promoted proliferation of A549 and H460 non-small cell lung cancer cells nor interfered with paclitaxel-induced antitumor effects, including apoptosis. Most importantly, chronic nicotine administration did not enhance Lewis lung carcinoma tumor growth in C57BL/6J mice. These data suggest that the nicotinic acetylcholine receptor-mediated pathways may be promising drug targets for the prevention and treatment of CIPN. Copyright © 2017 by The American Society for Pharmacology and Experimental Therapeutics.

Application of paclitaxel as adjuvant treatment for benign cicatricial airway stenosis.

Science.gov (United States)

Qiu, Xiao-Jian; Zhang, Jie; Wang, Juan; Wang, Yu-Ling; Xu, Min

2016-12-01

Benign cicatricial airway stenosis (BCAS) is a potentially life-threatening disease. Recurrence occurs frequently after endoscopic treatment. Paclitaxel is known to prevent restenosis, but its clinical efficacy and safety is undetermined. Therefore, in this study, we investigated the efficacy and associated complications of paclitaxel as adjuvant treatment for BCAS of different etiologies. The study cohort included 28 patients with BCAS resulting from tuberculosis, intubation, tracheotomy, and other etiologies. All patients were treated at the Department of Respiratory Diseases, Beijing Tian Tan Hospital, Capital Medical University, China, between January 2010 and August 2014. After primary treatment by balloon dilation, cryotherapy, and/or high-frequency needle-knife treatment, paclitaxel was applied to the airway mucosa at the site of stenosis using a newly developed local instillation catheter. The primary outcome measures were the therapeutic efficacy of paclitaxel as adjuvant treatment, and the incidence of complications was observed as well. According to our criteria for evaluating the clinical effects on BCAS, 24 of the 28 cases achieved durable remission, three cases had remission, and one case showed no remission. Thus, the durable remission rate was 85.7%, and the combined effective rate was 96.4%. No differences in outcomes were observed among the different BCAS etiologies (P=0.144), and few complications were observed. Our results indicated that paclitaxel as an adjuvant treatment has greater efficacy than previously reported BCAS treatment methods.

Vasodilatation in the rat dorsal hindpaw induced by activation of sensory neurons is reduced by Paclitaxel

OpenAIRE

Gracias, N.G.; Cummins, T.R.; Kelley, M.R.; Basile, D.P.; Iqbal, T.; Vasko, M.R.

2010-01-01

Peripheral neuropathy is a major side effect following treatment with the cancer chemotherapeutic drug paclitaxel. Whether paclitaxel-induced peripheral neuropathy is secondary to altered function of small diameter sensory neurons remains controversial. To ascertain whether the function of the small diameter sensory neurons was altered following systemic administration of paclitaxel, we injected male Sprague Dawley rats with 1 mg/kg paclitaxel every other day for a total of four doses and exa...

Effects of Goshajinkigan, Hachimijiogan, and Rokumigan on Mechanical Allodynia Induced by Paclitaxel in Mice

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Tsugunobu Andoh

2014-10-01

Full Text Available Peripheral neuropathy is a major dose-limiting side effect of the chemotherapeutic agent paclitaxel. This study examined whether the three related traditional herbal formulations, goshajinkigan (GJG; 牛車腎氣丸 Niú Chē Shèn Qì Wán, hachimijiogan (HJG; 八味地黃丸 Bā Wèi Dì Huáng Wán, and rokumigan (RMG; 六味丸 Liù Wèi Wán, would relieve paclitaxel-induced mechanical allodynia in mice. A single intraperitoneal injection of paclitaxel (5 mg/kg induced mechanical allodynia, which peaked on day 14 after injection. On day 14 after paclitaxel injection, oral administration of GJG (0.1-1.0 g/kg produced a significant inhibition of established allodynia, but HJG and RMG did not affect the allodynia. Repeated oral administration of GJG (0.1-1.0 g/kg starting from the day after paclitaxel injection did not affect allodynia development, but significantly inhibited allodynia exacerbation. Repeated oral administration of HJG produced a slight inhibition of allodynia exacerbation, but that of RMG did not. These results suggest that prophylactic administration of GJG is effective in preventing the exacerbation of paclitaxel-induced allodynia. The herbal medicines Plantaginis Semen (車前子 Chē Qián Zǐ and Achyranthis Radix (牛膝 Niú Xī, which are present in GJG but not in HJG, may contribute to the inhibitory action of GJG on the exacerbation of paclitaxel-induced allodynia.

The battle of "nano" paclitaxel

NARCIS (Netherlands)

Sofias, Alexandros Marios; Dunne, Michael; Storm, Gert; Allen, Christine

2017-01-01

Paclitaxel (PTX) is one of the three most widely used chemotherapeutic agents, together with doxorubicin and cisplatin, and is first or second line treatment for several types of cancers. In 2000, Taxol, the conventional formulation of PTX, became the best-selling cancer drug of all time with annual

Elution behaviors of elements from the hair

International Nuclear Information System (INIS)

Akashi, Junko; Fukushima, Ichiro; Imahori, Akira

1981-01-01

The elution of the neutron activated elements out of hair soaked in some organic solvents and EDTA solution was studied. Soakage of the hair sample, which was washed with water and acetone in advance as IAEA's proposal, in ether and acetone for 30 minutes each resulted in no elution of Hg, Zn, Co and Se. Elution of Zn and Co from the powdered hair sample soaked in 0.1 M EDTA solution was rapid, while Zn did not elute out from the cut hair (2 -- 3 mm length) on the same condition. Hg, Se and Au were not eluted out by 0.1 M EDTA solution in the both case of cut hair and of powdered hair. Br was removed by 0.1 M EDTA solution from the cut hair and from the powdered hair with equal ease. (author)

Paclitaxel Encapsulated in Halloysite Clay Nanotubes for Intestinal and Intracellular Delivery.

Science.gov (United States)

Yendluri, Raghuvara; Lvov, Yuri; de Villiers, Melgardt M; Vinokurov, Vladimir; Naumenko, Ekaterina; Tarasova, Evgenya; Fakhrullin, Rawil

2017-10-01

Naturally formed halloysite tubules have a length of 1 μm and lumens with a diameter of 12-15 nm which can be loaded with drugs. Halloysite's biocompatibility allows for its safe delivering to cells at a concentration of up to 0.5 mg/mL. We encapsulated the anticancer drug paclitaxel in halloysite and evaluated the drug release kinetics in simulated gastric and intestinal conditions. To facilitate maximum drug release in intestinal tract, halloysite tubes were coated with the pH-responsive polymer poly(methacrylic acid-co-methyl methacrylate). Release kinetics indicated a triggered drug release pattern at higher pH, corresponding to digestive tract environment. Tablets containing halloysite, loaded with paclitaxel, as a compression excipient were formulated with drug release occurring at a sustained rate. In vitro anticancer effects of paclitaxel-loaded halloysite nanotubes were evaluated on human cancer cells. In all the treated cell samples, polyploid nuclei of different sizes and fragmented chromatin were observed, indicating a high therapeutic effect of halloysite formulated paclitaxel. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Impact of CYP2C8*3 on paclitaxel clearance in ovarian cancer patients

DEFF Research Database (Denmark)

Bergmann, Troels Korshøj; Vach, Werner; Gréen, Henrik

be partly responsible for this variation. Paclitaxel is mainly metabolized by CYP2C8; SNPs have been investigated in this context before but conclusions are still lacking. We present a prospective study of paclitaxel clearance (CL) in 93 Caucasian females with epithelial ovarian cancer with regard...... to the CYP2C8 *1b, *1c, *3 and *4 genotypes. Material and methods All patients were diagnosed with primary ovarian/peritoneal cancer and received 175mg/m2 paclitaxel over 3 hrs plus carboplatin (AUC5-6) q3w. All patients gave written and verbal consent. The study was approved by ethics committees in Denmark...... and Sweden. Blood was sampled at 3hrs, 5-8 hrs and 18-24hrs after start of infusion. Total plasma paclitaxel was quantified using HPLC. CremophorEL® (CrEL) was determined as described by Sparreboom et al.1998. CL of unbound paclitaxel was estimated using total concentrations, CrEL and other parameters...

Induction of apoptosis and cell proliferation inhibition by paclitaxel in ...

African Journals Online (AJOL)

In this study, anti-proliferative and apoptotic effects of paclitaxel, which is itself an antichemotherapeutic agent, to FM3A cell line originated from Mouse mammary carcinoma at 7 different doses were examined. Seven different doses of paclitaxel (P1 = 3 nM, P2 = 7.5 nM, P3 = 15 nM, P4 = 30 nM, P5 = 60 nM, P6 = 120 nM, ...

CIRUGÍA ENDOSCÓPICA TRANSLUMINAL: ¡ES POSIBLE!

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Arecio Peñaloza-Ramírez

2015-03-01

Full Text Available Introducción: La cirugía endoscópica transluminal es una técnica de ingreso a través de orificios naturales a la cavidad peritoneal y a los órganos allí contenidos, que busca disminuir los efectos adversos y las complicaciones de los procedimientos abiertos, acorde con la tendencia mundial de obtener resultados iguales a través de abordajes menos invasivos. Objetivo: Determinar las complicaciones de la cirugía endoscópica transluminal para la revisión de la cavidad peritoneal y la toma de biopsia hepática en cerdos. Metodología: Estudio experimental en 12 cerdos. Se tomó biopsia hepática transgástrica y se hizo un seguimiento durante 30 días, evaluando complicaciones y mortalidad. Al final se realizó autopsia al animal. Resultados: No se encontró mortalidad intraoperatoria. La mediana de tiempo quirúrgico fue de 84,5 minutos (RIQ 76-99. Se utilizaron para el cierre de la gastrotomía en promedio 7,8 clips (DE 3.5. En la peritoneoscopia se observó el intestino delgado, bazo, hígado y colon en la mayoría de los casos. La calidad de la biopsia hepática fue buena en 10 especímenes. La cicatrización gástrica fue adecuada en el 81.8%. Se encontraron cultivos de líquido peritoneal positivos en 9 casos. Conclusiones: La técnica requiere destreza y la peritoneoscopia es difícil por la falta de apoyo del equipo al maniobrar en retroflexión. El potencial de la técnica y el enorme beneficio para los pacientes son razones suficientes para continuar avanzando en este tipo de abordajes

Evaluation of the cytotoxicity of the Bithionol-paclitaxel combination in a panel of human ovarian cancer cell lines.

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Vijayalakshmi N Ayyagari

Full Text Available Previously, Bithionol (BT was shown to enhance the chemosensitivity of ovarian cancer cell lines to cisplatin treatment. In the present study, we focused on the anti-tumor potential of the BT-paclitaxel combination when added to a panel of ovarian cancer cell lines. This in vitro study aimed to 1 determine the optimum schedule for combination of BT and paclitaxel and 2 assess the nature and mechanism(s underlying BT-paclitaxel interactions. The cytotoxic effects of both drugs either alone or in combination were assessed by presto-blue cell viability assay using six human ovarian cancer cell lines. Inhibitory concentrations to achieve 50% cell death (IC50 were determined for BT and paclitaxel in each cell line. Changes in levels of cleaved PARP, XIAP, bcl-2, bcl-xL, p21 and p27 were determined via immunoblot. Luminescent and colorimetric assays were used to determine caspases 3/7 and autotaxin (ATX activity. Cellular reactive oxygen species (ROS were measured by flow cytometry. Our results show that the efficacy of the BT-paclitaxel combination depends upon the concentrations and sequence of addition of paclitaxel and BT. Pretreatment with BT followed by paclitaxel resulted in antagonistic interactions whereas synergistic interactions were observed when both drugs were added simultaneously or when cells were pretreated with paclitaxel followed by BT. Synergistic interactions between BT and paclitaxel were attributed to increased ROS generation and enhanced apoptosis. Decreased expression of pro-survival factors (XIAP, bcl-2, bcl-xL and increased expression of pro-apoptotic factors (caspases 3/7, PARP cleavage was observed. Additionally, increased expression of key cell cycle regulators p21 and p27 was observed. These results show that BT and paclitaxel interacted synergistically at most drug ratios which, however, was highly dependent on the sequence of the addition of drugs. Our results suggest that BT-paclitaxel combination therapy may be

Paclitaxel Plasma Concentration after the First Infusion Predicts Treatment-Limiting Peripheral Neuropathy.

Science.gov (United States)

Hertz, Daniel L; Kidwell, Kelley M; Vangipuram, Kiran; Li, Feng; Pai, Manjunath P; Burness, Monika; Griggs, Jennifer J; Schott, Anne F; Van Poznak, Catherine; Hayes, Daniel F; Lavoie Smith, Ellen M; Henry, N Lynn

2018-04-27

Purpose: Paclitaxel exposure, specifically the maximum concentration ( C max ) and amount of time the concentration remains above 0.05 μmol/L ( T c >0.05 ), has been associated with the occurrence of paclitaxel-induced peripheral neuropathy. The objective of this study was to validate the relationship between paclitaxel exposure and peripheral neuropathy. Experimental Design: Patients with breast cancer receiving paclitaxel 80 mg/m 2 × 12 weekly doses were enrolled in an observational clinical study (NCT02338115). Paclitaxel plasma concentration was measured at the end of and 16-26 hours after the first infusion to estimate C max and T c >0.05 Patient-reported peripheral neuropathy was collected via CIPN20 at each dose, and an 8-item sensory subscale (CIPN8) was used in the primary analysis to test for an association with T c >0.05 Secondary analyses were conducted using C max as an alternative exposure parameter and testing each parameter with a secondary endpoint of the occurrence of peripheral neuropathy-induced treatment disruption. Results: In 60 subjects included in the analysis, the increase in CIPN8 during treatment was associated with baseline CIPN8, cumulative dose, and relative dose intensity ( P 0.05 ( P = 0.27) nor C max ( P = 0.99). In analyses of the secondary endpoint, cumulative dose (OR = 1.46; 95% confidence interval (CI), 1.18-1.80; P = 0.0008) and T c >0.05 (OR = 1.79; 95% CI, 1.06-3.01; P = 0.029) or C max (OR = 2.74; 95% CI, 1.45-5.20; P = 0.002) were associated with peripheral neuropathy-induced treatment disruption. Conclusions: Paclitaxel exposure is predictive of the occurrence of treatment-limiting peripheral neuropathy in patients receiving weekly paclitaxel for breast cancer. Studies are warranted to determine whether exposure-guided dosing enhances treatment effectiveness and/or prevents peripheral neuropathy in these patients. Clin Cancer Res; 1-9. ©2018 AACR. ©2018 American Association for Cancer Research.

CX3CL1-mediated macrophage activation contributed to paclitaxel-induced DRG neuronal apoptosis and painful peripheral neuropathy.

Science.gov (United States)

Huang, Zhen-Zhen; Li, Dai; Liu, Cui-Cui; Cui, Yu; Zhu, He-Quan; Zhang, Wen-Wen; Li, Yong-Yong; Xin, Wen-Jun

2014-08-01

Painful peripheral neuropathy is a dose-limiting side effect of paclitaxel therapy, which hampers the optimal clinical management of chemotherapy in cancer patients. Currently the underlying mechanisms remain largely unknown. Here we showed that the clinically relevant dose of paclitaxel (3×8mg/kg, cumulative dose 24mg/kg) induced significant upregulation of the chemokine CX3CL1 in the A-fiber primary sensory neurons in vivo and in vitro and infiltration of macrophages into the dorsal root ganglion (DRG) in rats. Paclitaxel treatment also increased cleaved caspase-3 expression, induced the loss of primary afferent terminal fibers and decreased sciatic-evoked A-fiber responses in the spinal dorsal horn, indicating DRG neuronal apoptosis induced by paclitaxel. In addition, the paclitaxel-induced DRG neuronal apoptosis occurred exclusively in the presence of macrophage in vitro study. Intrathecal or systemic injection of CX3CL1 neutralizing antibody blocked paclitaxel-induced macrophage recruitment and neuronal apoptosis in the DRG, and also attenuated paclitaxel-induced allodynia. Furthermore, depletion of macrophage by systemic administration of clodronate inhibited paclitaxel-induced allodynia. Blocking CX3CL1 decreased activation of p38 MAPK in the macrophage, and inhibition of p38 MAPK activity blocked the neuronal apoptosis and development of mechanical allodynia induced by paclitaxel. These findings provide novel evidence that CX3CL1-recruited macrophage contributed to paclitaxel-induced DRG neuronal apoptosis and painful peripheral neuropathy. Copyright © 2014 Elsevier Inc. All rights reserved.

Is a reduction in radiation lung volume and dose necessary with paclitaxel chemotherapy for node-positive breast cancer?

Science.gov (United States)

Taghian, Alphonse G; Assaad, Sherif I; Niemierko, Andrzej; Floyd, Scott R; Powell, Simon N

2005-06-01

To evaluate and quantify the effect of irradiated lung volume, radiation dose, and paclitaxel chemotherapy on the development of radiation pneumonitis (RP) in breast cancer patients with positive lymph nodes. We previously reported the incidence of RP among 41 patients with breast cancer treated with radiotherapy (RT) and adjuvant paclitaxel-containing chemotherapy. We recorded the central lung distance, a measure of the extent of lung included in the RT volume, in these patients. We used this measure and the historical and observed rates of RP in our series to model the lung tolerance to RT in patients receiving chemotherapy (CHT) both with and without paclitaxel. To evaluate the risk factors for the development of RP, we performed a case-control study comparing paclitaxel-treated patients who developed RP with those who did not, and a second case-control study comparing patients receiving paclitaxel in addition to standard CHT/RT (n = 41) and controls receiving standard CHT/RT alone (n = 192). The actuarial rate of RP in the paclitaxel-treated group was 15.4% compared with 0.9% among breast cancer patients treated with RT and non-paclitaxel-containing CHT. Our mathematical model found that the effective lung tolerance for patients treated with paclitaxel was reduced by approximately 24%. No statistically significant difference was found with regard to the dose delivered to specific radiation fields, dose per fraction, central lung distance, or percentage of lung irradiated in the case-control study of paclitaxel-treated patients who developed RP compared with those who did not. In the comparison of 41 patients receiving RT and CHT with paclitaxel and 192 matched controls receiving RT and CHT without paclitaxel, the only significant differences identified were the more frequent use of a supraclavicular radiation field and a decrease in the RT lung dose among the paclitaxel-treated patients. This finding indicates that the major factor associated with development

Percutaneous transluminal angioplasty of supraaortic vessel

International Nuclear Information System (INIS)

Belli, L.; Puricelli, G.; Cerasano, A.; Cornalba, P.; Rota, L.; Facchinetti, P.

1988-01-01

Sixteen cases are reported of dilatation of supra-aortic vessels; in 14/16 patients the vessel involved was either the subclavian artery or the brachio-cephalich trunk. Special attention is paid to the choice of patients - the ideal one presenting with a single uncalcified lesion, with stenosis more than 50% of diameter; the symptoms have recently appeared, with a significant difference (more than 20 mmHg) in the pressure of the two arms. The technical aspects of the angioplastic procedure are discussed, especially in order to preserve the intracriminal circulation and to limit possible complications. The presence of reversed blood flow in the vertebral artery is extremely important to preserve intracranial circulation from possible embolism; normal flow obtained at the end of the procedure is therefore an useful proof of successful dilatation. The advantages are stressed of dilatation over the surgical technique used in the past. Finally, the importance is emphasized of a correct follow-up and doppler control of supra-aortic circulation

Transluminal endovascular stent-graft for the treatment of aortic aneurysms

Energy Technology Data Exchange (ETDEWEB)

Lee, Do Yun; Chang, Byung Chul; Shim, Won Heum; Cho, Seung Yun; Chung, Nam Sik; Kwon, Hyuk Moon; Lee, Young Joon; Lee, Jong Tae [Yonsei University College of Medicine, Seoul (Korea, Republic of)

1995-09-15

The standard treatment for aortic aneurysms is surgical replacement with a prosthetic graft. Currently there is great interest in endoluminal intervention for treatment of aortic aneurysm. The purpose of this study was to evaluate the safety and effectiveness of endoluminally placed Stent-graft for the treatment of aortic aneurysms. Transluminal endovascular Stent-graft placements were attempted in 9 patients with infra-renal aortic aneurysms(n 6), thoracic aortic aneurysm(n = 1), and aortic dissection(n = 2). The endovascular Stent-grafts were custom-designed for each patient and were constructed of self-expandable modified Gianturco Stents covered with polytetrafluroethylene. The Stent-grafts were introduced through a 16-18 French sheath and expanded to 17-30 mm in diameter. The endovascular therapy was performed using a common femoral artery cutdown with local anesthesia. The endovascular Stent-graft deployment was achieved in 7 of 9 patients. Two cases failed deployment of the Stent-graft due to iliac artery stenosis and tortousity. There were complete thrombosis of the thoracic and infra-renal aortic aneurysm surround the Stent-graft in 3 patients, and persistent leak with partial thrombosis in 2. Two patients with aortic dissection were successfully treated by obliteration of entry tears. There were no major complication associated with Stent-graft placement. These preliminary results show that transluminal endovascular Stent-grafts offer great promise and good results. Further investigation is needed to establish its long-term safety and efficacy.

Transluminal endovascular stent-graft for the treatment of aortic aneurysms

International Nuclear Information System (INIS)

Lee, Do Yun; Chang, Byung Chul; Shim, Won Heum; Cho, Seung Yun; Chung, Nam Sik; Kwon, Hyuk Moon; Lee, Young Joon; Lee, Jong Tae

1995-01-01

The standard treatment for aortic aneurysms is surgical replacement with a prosthetic graft. Currently there is great interest in endoluminal intervention for treatment of aortic aneurysm. The purpose of this study was to evaluate the safety and effectiveness of endoluminally placed Stent-graft for the treatment of aortic aneurysms. Transluminal endovascular Stent-graft placements were attempted in 9 patients with infra-renal aortic aneurysms(n 6), thoracic aortic aneurysm(n = 1), and aortic dissection(n = 2). The endovascular Stent-grafts were custom-designed for each patient and were constructed of self-expandable modified Gianturco Stents covered with polytetrafluroethylene. The Stent-grafts were introduced through a 16-18 French sheath and expanded to 17-30 mm in diameter. The endovascular therapy was performed using a common femoral artery cutdown with local anesthesia. The endovascular Stent-graft deployment was achieved in 7 of 9 patients. Two cases failed deployment of the Stent-graft due to iliac artery stenosis and tortousity. There were complete thrombosis of the thoracic and infra-renal aortic aneurysm surround the Stent-graft in 3 patients, and persistent leak with partial thrombosis in 2. Two patients with aortic dissection were successfully treated by obliteration of entry tears. There were no major complication associated with Stent-graft placement. These preliminary results show that transluminal endovascular Stent-grafts offer great promise and good results. Further investigation is needed to establish its long-term safety and efficacy

Evaluation of the Distribution of Paclitaxel After Application of a Paclitaxel-Coated Balloon in the Rabbit Urethra.

Science.gov (United States)

Barbalias, Dimitrios; Lappas, Georgios; Ravazoula, Panagiotia; Liourdi, Despoina; Kyriazis, Iason; Liatsikos, Evangelos; Kallidonis, Panagiotis

2018-03-02

Urethral strictures are a common urologic problem that could require complex reconstructive procedures. Urethral dilatation represents a frequent practiced intervention associated with high recurrence rates. Drug-coated percutaneous angioplasty balloons (DCBs) with cytostatic drugs have been effectively used for the prevention of vascular restenosis after balloon dilatation. To reduce restenosis rates of urethral dilatation, these balloons could be used in the urethra. Nevertheless, the urothelium is different than the endothelium and these drugs may not be distributed to the outer layers of the urethra. Thus, an experiment was performed to evaluate the distribution of paclitaxel (PTX) in the rabbit urethra after the inflation of a PTX-coated balloon (PCB). Eleven rabbits underwent dilatation of the posterior urethra with common endoscopic balloons after urethrography. Nine of these rabbits were additionally treated with PCB. The urethras of the two control animals were removed along with three more dilated with PCB urethras immediately after the dilatation. The remaining of the urethras were removed after 24 (n = 3) and 48 hours (n = 3). The posterior segments of the urethras were evaluated with hematoxylin and eosin staining as well as with immunohistochemistry with polyclonal anti-PTX antibody. The two control specimens showed denudation of the urothelium after balloon dilatations and no PTX was observed. All specimens from dilated PCB urethras showed distribution of PTX to all layers of the urethra. The specimens that were immediately removed exhibited denudation of the urothelium without any inflammation. The specimens removed at 24 and 48 hours showed mild acute inflammation. PTX was distributed to the urothelial, submucosal, and smooth muscle layers of the normal rabbit urethra immediately after dilatation with a DCB. PTX and mild inflammation were present at the site 24 and 48 hours after the dilatation.

Impact of Hemoglobin A1c Levels on Residual Platelet Reactivity and Outcomes After Insertion of Coronary Drug-Eluting Stents (from the ADAPT-DES Study)

DEFF Research Database (Denmark)

Schoos, Mikkel M.; Dangas, George D.; Mehran, Roxana

2016-01-01

An increasing hemoglobin A1c (HbA1c) level portends an adverse cardiovascular prognosis; however, the association between glycemic control, platelet reactivity, and outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is unknown. We sought to investigate whether Hb...... With Drug Eluting Stents registry, HbA1c levels were measured as clinically indicated in 1,145 of 8,582 patients, stratified by HbA1c 8.5% (n = 171, 14.9%). HPR on clopidogrel and aspirin was defined after PCI as P2Y12 reaction units (PRU) >208...... >208 (42.5%, 50.2%, and 62.3%, p definite or probable stent thrombosis (ST; 0.9%, 2.7%, and 4.2%, p = 0.02) increased progressively with HbA1c groups. Clinically relevant bleeding was greatest in the intermediate HbA1c group (8.2% vs 13.1% vs 9.5%, p = 0.04). In adjusted models...

Percutaneous intervention in the menagement of insufficient native arteriovenous hemodialysis fistulae

International Nuclear Information System (INIS)

Kim, Hye Jung; Seong, Chang Kyu; Kwon, Jae Hyun; Kim, Young Hwan; Park, Noh Hyuck; Kim, Tae Hun; Kim, Yong Joo; Kang, Duck Sik; Shin, Tae Beom

2002-01-01

To determine the effectiveness and patency of percutaneous intervention in insufficient native arteriovenous hemodialysis fistulae (AVFs). Between March 1997 and September 2001, 67 cases of insufficient native AVFs resulted from central vein lesion, PTA was performed in 48 cases, and thrombolytic therapy with or without PTA in 11. In eight of the cases, in which central vein stenosis had led to the insufficency, percutaneous transluminal angioplasty (PTA) was performed, and in three of the eight, a stent was inserted. Angiography findings and complications, as well as success and patency rates in the non-thrombosis and thrombosis group, were evaluated; the central vein lesion group was analysed separately. Among 84 lesions observed at angiography, three were 54 cases of stenosis, 17 of occlusion, and 13 of combined thrombosis. The lesions were located in a proximal vein (n=51), distal vein (n=14), artery (n=6), and at the site of anastomosis (n=13). In the central vein lesion group (n=8), seven cases of stenosis and one of occlusion were noted. The overall procedural success rate was 79.1% (53/67). That is, in patients with no central vein lesion, the procedural success rate of PTA of native AVFs was 85.4% (41/48) and the patency rates of this were 83.1% at 6 months and 67.4% at 12 months. In cases of thrombolysis with/without PTA, the procedural success rate was 54.5% (6/11) and the patency rates were 83.3% at 6 months and 62.5% at 12 months. Finally, in patients with a central vein lesion, the procedural success rate was 75% (6/8) and the patency rates were 80% at 6 months and 30% at 12 months. There was one case of pseudoaneurysm formation at the puncture site of the brachial artery, which was used as the access route for intervention; one embolism in the brachial artery; and three cases of vascular spasm and two of hematoma which did not require active treatment. Percutaneous intervention offers effective and safe management of insufficient AVFs. The procedural

CYP3A4*22 genotype and systemic exposure affect paclitaxel-induced neurotoxicity

NARCIS (Netherlands)

A.J.M. de Graan (Anne-Joy); L. Elens (Laure); J.A. Sprowl (Jason); A. Sparreboom (Alex); L.E. Friberg (Lena); B. van der Holt (Bronno); P.J. de Raaf (Pleun); P. de Bruijn (Peter); F.K. Engels (Frederike); F.A.L.M. Eskens (Ferry); E.A.C. Wiemer (Erik); J. Verweij (Jaap); A.H.J. Mathijssen (Ron); R.H.N. van Schaik (Ron)

2013-01-01

textabstractPurpose: Paclitaxel is used for the treatment of several solid tumors and displays a high interindividual variation in exposure and toxicity. Neurotoxicity is one of the most prominent side effects of paclitaxel. This study explores potential predictive pharmacokinetic and

A Segmental Hypoplastic Anterior Tibial Artery Coexisting with a Hypertrophied Perforating Fibular Artery a Case Report and Clinical Implications

OpenAIRE

Ariyo, Olutayo

2015-01-01

Vascular injuries of the lower limb, especially from penetrating gunshot wounds, and peripheral arterial diseases are on the increase and management of these and many other lower limb injuries involve increasing usage of vascular interventions like by-pass surgery, per-cutaneous transluminal angioplasty, arterial cannulation, arterial bypass graft or minimally invasive measures like percutaneous trans-arterial catheterization, among others. A thorough knowledge of infrapopliteal branching mos...

Loss of FBXW7 and accumulation of MCL1 and PLK1 promote paclitaxel resistance in breast cancer.

Science.gov (United States)

Gasca, Jessica; Flores, Maria Luz; Giráldez, Servando; Ruiz-Borrego, Manuel; Tortolero, María; Romero, Francisco; Japón, Miguel A; Sáez, Carmen

2016-08-16

FBXW7 is a component of SCF (complex of SKP1, CUL1 and F-box-protein)-type ubiquitin ligases that targets several oncoproteins for ubiquitination and degradation by the proteasome. FBXW7 regulates cellular apoptosis by targeting MCL1 for ubiquitination. Recently, we identified PLK1 as a new substrate of FBXW7 modulating the intra-S-phase DNA-damage checkpoint. Taxanes are frequently used in breast cancer treatments, but the acquisition of resistance makes these treatments ineffective. We investigated the role of FBXW7 and their substrates MCL1 and PLK1 in regulating the apoptotic response to paclitaxel treatment in breast cancer cells and their expression in breast cancer tissues. Paclitaxel-sensitive MDA-MB-468 and a paclitaxel-resistant MDA-MB-468R subclone were used to study the role of FBXW7 and substrates in paclitaxel-induced apoptosis. Forced expression of FBXW7 or downregulation of MCL1 or PLK1 restored sensitivity to paclitaxel in MDA-MB-468R cells. By contrary, FBXW7-silenced MDA-MB-468 cells became resistant to paclitaxel. The expression of FBXW7 and substrates were studied in 296 invasive carcinomas by immunohistochemistry and disease-free survival was analyzed in a subset of patients treated with paclitaxel. In breast cancer tissues, loss of FBXW7 correlated with adverse prognosis markers and loss of FBXW7 and MCL1 or PLK1 accumulation were associated with diminished disease-free survival in paclitaxel-treated patients. We conclude that FBXW7 regulates the response to paclitaxel by targeting MCL1 and PLK1 in breast cancer cells and thus targeting these substrates may be a valuable adjunct for paclitaxel treatment. Also, FBXW7, MCL1 and PLK1 may be relevant predictive markers of tumor progression and response to paclitaxel treatment.

Drug-eluting stent implantation for the percutaneous treatment of vertebro-basilar arterial stenosis

International Nuclear Information System (INIS)

Ma Rujun; Liu Jianmin; Huang Haiqing; Hong Bo; Xu Yi; Zhao Wenyuan; Zhao Rui; Chen Jun

2006-01-01

Objective: To evaluate the early results and mid-term outcomes following angioplasty of vertebro-basilar arterial stenosis with drug-eluting stents. Methods: All of the patients presented with recurrent TIA or ceretral infarction with >50% stenoses in vertebro-basilar arteries, and having failure in maximal medical therapy. All of the lesions were treated with primary stenting under local or general anesthesia and followed by continual anticoagulant therapy of clopidogrel and aspirin together with clinical follow-up and vascular imagings. Results: Of 28 stenoses (27 patients), 27 lesions were successfully treated with implantation of 24 Cypher stents, 2 Taxus stents and one Firebird stent. The mean stenotic severity reduced from (74 ± 6.7)% to (8.7 ± 4.4)%. Two patients had inchemic events relating to penetration vascular obstruction. During 2-14 months follow-up, the patients were clinically asymptomatic with no recurrent TIA/stoke. Angiographic follow-up was obtained in 14 patients at a mean of 7.2 months. Proximal restenosis (<50%) occurred in one patient (3.3%), and corrected with restenting, while others were free of intra-stent restenoses. Conclusion: Using DES in cerebrovascular stenosis is safe and effective with lowing the risk of intra-stent restenosis in comparison with bare stent. Further study for long term efficiency is still in need. (authors)

The Urtica dioica extract enhances sensitivity of paclitaxel drug to MDA-MB-468 breast cancer cells.

Science.gov (United States)

Mohammadi, Ali; Mansoori, Behzad; Aghapour, Mahyar; Shirjang, Solmaz; Nami, Sanam; Baradaran, Behzad

2016-10-01

Due to the chemo resistant nature of cancer cells and adverse effects of current therapies, researchers are looking for the most efficient therapeutic approach which has the lowest side effects and the highest toxicity on cancer cells. The aim of the present study was to investigate the synergic effect of Urtica dioica extract in combination with paclitaxel on cell death and invasion of human breast cancer MDA-MB-468 cell line. To determine the cytotoxic effects of Urtica dioica extract with paclitaxel, MTT assay was performed. The scratch test was exploited to assess the effects of Urtica dioica, Paclitaxel alone and combination on migration of cancer cells. The expression levels of snail-1, ZEB1, ZEB2, twist, Cdc2, cyclin B1 and Wee1 genes were quantified using qRT-PCR and western blot performed for snail-1expression. The effects of plant extract, Paclitaxel alone and combination on different phases of cell cycle was analyzed using flow cytometry. Results of MTT assay showed that Urtica dioica significantly destroyed cancer cells. Interestingly, Concurrent use of Urtica dioica extract with paclitaxel resulted in decreased IC50 dose of paclitaxel. Moreover, findings of scratch assay exhibited the inhibitory effects of Urtica dioica, Paclitaxel alone and combination on migration of MDA-MB-468 cell line. Our findings also demonstrated that the extract substantially decreased the Snail-1 and related gene expression. Ultimately, Cell cycle arrest occurred at G2/M phase post-treatment by deregulating Cdc2 and wee1. Our results demonstrated that the dichloromethane extract of Urtica dioica inhibit cell growth and migration. Also, Urtica dioica extract substantially increased sensitivity of breast cancer cells to paclitaxel. Therefore, it can be used as a potential candidate for treatment of breast cancer with paclitaxel. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Evaluation of Lercanidipine in Paclitaxel-Induced Neuropathic Pain Model in Rat: A Preliminary Study

Directory of Open Access Journals (Sweden)

Lekha Saha

2012-01-01

Full Text Available Objective. To demonstrate the antinociceptive effect of lercanidipine in paclitaxel-induced neuropathy model in rat. Materials and Methods. A total of 30 rats were divided into five groups of six rats in each group as follows: Gr I: 0.9% NaCl, Gr II: paclitaxel + 0.9% NaCl, Gr III: paclitaxel + lercanidipine 0.5 μg/kg, Gr IV: paclitaxel + lercanidipine 1 μg/kg, and Gr V: paclitaxel + lercanidipine 2.5 μg/kg. Paclitaxel-induced neuropathic pain in rat was produced by single intraperitoneal (i.p. injection of 1 mg/kg of paclitaxel on four alternate days (0, 2, 4, and 6. The tail flick and cold allodynia methods were used for assessing the pain threshold, and the assessments were done on days 0 (before first dose of paclitaxel and on days 7, 14, 21, and 28. Results. There was a significant decrease (P<0.001 in the tail flick and cold allodynia latency in the paclitaxel-alone group from day 14 onward when compared with day 0. In the lercanidipine groups, the decrease in the tail flick and cold allodynia latency was not observed in 1.0 and 2.5 μg/kg groups and it was statistically significant (P<0.01 when compared with paclitaxel-alone group.

Transluminal color-coded three-dimensional magnetic resonance angiography for visualization of signal Intensity distribution pattern within an unruptured cerebral aneurysm: preliminarily assessment with anterior communicating artery aneurysms

International Nuclear Information System (INIS)

Satoh, T.; Ekino, C.; Ohsako, C.

2004-01-01

The natural history of unruptured cerebral aneurysm is not known; also unknown is the potential growth and rupture in any individual aneurysm. The authors have developed transluminal color-coded three-dimensional magnetic resonance angiography (MRA) obtained by a time-of-flight sequence to investigate the interaction between the intra-aneurysmal signal intensity distribution patterns and configuration of unruptured cerebral aneurysms. Transluminal color-coded images were reconstructed from volume data of source magnetic resonance angiography by using a parallel volume-rendering algorithm with transluminal imaging technique. By selecting a numerical threshold range from a signal intensity opacity chart of the three-dimensional volume-rendering dataset several areas of signal intensity were depicted, assigned different colors, and visualized transparently through the walls of parent arteries and an aneurysm. Patterns of signal intensity distribution were analyzed with three operated cases of an unruptured anterior communicating artery aneurysm and compared with the actual configurations observed at microneurosurgery. A little difference in marginal features of an aneurysm was observed; however, transluminal color-coded images visualized the complex signal intensity distribution within an aneurysm in conjunction with aneurysmal geometry. Transluminal color-coded three-dimensional magnetic resonance angiography can thus provide numerical analysis of the interaction between spatial signal intensity distribution patterns and aneurysmal configurations and may offer an alternative and practical method to investigate the patient-specific natural history of individual unruptured cerebral aneurysms. (orig.)

The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

Science.gov (United States)

Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

2012-01-01

There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect

Genomic signatures for paclitaxel and gemcitabine resistance in breast cancer derived by machine learning.

Science.gov (United States)

Dorman, Stephanie N; Baranova, Katherina; Knoll, Joan H M; Urquhart, Brad L; Mariani, Gabriella; Carcangiu, Maria Luisa; Rogan, Peter K

2016-01-01

Increasingly, the effectiveness of adjuvant chemotherapy agents for breast cancer has been related to changes in the genomic profile of tumors. We investigated correspondence between growth inhibitory concentrations of paclitaxel and gemcitabine (GI50) and gene copy number, mutation, and expression first in breast cancer cell lines and then in patients. Genes encoding direct targets of these drugs, metabolizing enzymes, transporters, and those previously associated with chemoresistance to paclitaxel (n = 31 genes) or gemcitabine (n = 18) were analyzed. A multi-factorial, principal component analysis (MFA) indicated expression was the strongest indicator of sensitivity for paclitaxel, and copy number and expression were informative for gemcitabine. The factors were combined using support vector machines (SVM). Expression of 15 genes (ABCC10, BCL2, BCL2L1, BIRC5, BMF, FGF2, FN1, MAP4, MAPT, NFKB2, SLCO1B3, TLR6, TMEM243, TWIST1, and CSAG2) predicted cell line sensitivity to paclitaxel with 82% accuracy. Copy number profiles of 3 genes (ABCC10, NT5C, TYMS) together with expression of 7 genes (ABCB1, ABCC10, CMPK1, DCTD, NME1, RRM1, RRM2B), predicted gemcitabine response with 85% accuracy. Expression and copy number studies of two independent sets of patients with known responses were then analyzed with these models. These included tumor blocks from 21 patients that were treated with both paclitaxel and gemcitabine, and 319 patients on paclitaxel and anthracycline therapy. A new paclitaxel SVM was derived from an 11-gene subset since data for 4 of the original genes was unavailable. The accuracy of this SVM was similar in cell lines and tumor blocks (70-71%). The gemcitabine SVM exhibited 62% prediction accuracy for the tumor blocks due to the presence of samples with poor nucleic acid integrity. Nevertheless, the paclitaxel SVM predicted sensitivity in 84% of patients with no or minimal residual disease. Copyright © 2015 Federation of European Biochemical Societies

Application of solid-state tritium NMR in determining the bioactive conformation of paclitaxel

International Nuclear Information System (INIS)

Lin, T.

2012-01-01

The determination of the conformation of small molecule bound to its biological target would facilitate people to design improved drugs. This determination can be difficult due to technical limitations, as exemplified by the long standing debate on the microtubule-binding conformation of a natural anticancer drug - paclitaxel. Previous studies using X-ray crystallography and solution-state NMR failed to furnish direct information on the expected conformation. Solid-state NMR may help in this task by providing precise interatomic distances, and the selective labeling on different sites with tritium atoms enables accurate measurement of long-range distances (up to 14.4 Angstroms) owing to the high gyromagnetic ratio of this nucleus, without any structural modification of the molecule. So our project aiming at illustrating the bioactive conformation of paclitaxel consists the syntheses of 6 different paclitaxel isotopomers bearing a pair of tritium at specified positions, flowing by the preparations of corresponding microtubule-labeled paclitaxel complexes. The solid-state tritium NMR analyses of these complexes would provide key distances for determining the expected conformation. Up to now, 2 paclitaxel isotopomers have been prepared from labelling the di-brominated paclitaxel precursor and from coupling the tritiated taxane rings and the tritiated side chains, respectively. The synthetic strategy allowed us to realize the syntheses in generally high yield and good stereoselectivity. Different tritiation methods have been used, from which an isotopic enrichment of higher than 92% was obtained. The syntheses of other 4 isotopomers, together with the microtubule complexes are currently underway in our lab. (author) [fr

Nanoparticle albumin-bound (nab-paclitaxel for the treatment of pancreas ductal adenocarcinoma

Directory of Open Access Journals (Sweden)

Narayanan V

2015-01-01

Full Text Available Vignesh Narayanan,1 Colin D Weekes1,2 1Division of Medical Oncology, Department of Medicine, 2Developmental Therapeutics Program, University of Colorado Cancer Center, University of Colorado School of Medicine, Aurora, CO, USA Abstract: Pancreatic adenocarcinoma is a leading cause of cancer-related mortality worldwide, and surgical resection offers the only chance of cure. Since the majority of patients have unresectable disease at presentation, the emphasis has been on identifying effective chemotherapy regimens to prolong survival and control tumor burden. Gemcitabine has been the cornerstone of treatment ever since it was discovered to be an active agent in advanced pancreatic cancer nearly two decades ago, but the overall prognosis in patients with metastatic disease remains dismal. A dense fibrotic stroma around the tumor devoid of vasculature and the resultant hypoxic tumor microenvironment are implicated in the chemotherapy-resistant nature of this malignancy. In recent years, a growing body of literature has further elucidated several aspects of pancreatic tumor biology, such as its ability to utilize albumin from the peritumoral tissues to support its metabolic needs. High-pressure homogenization of paclitaxel with nanoparticle albumin results in the formation of soluble 130 nm complexes with albumin acting as the carrier for the otherwise hydrophobic paclitaxel. Once these complexes reach the tumor milieu, they act by depleting the tumor stroma. In addition, paclitaxel is also transported into the tumor cell along with albumin, where it then exerts its antineoplastic activity. Nanoparticle albumin-bound (nab-paclitaxel also increases gemcitabine levels inside the tumor cells by inhibiting cytidine deaminase, the enzyme that degrades gemcitabine. This review focuses on proposed mechanisms of efficacy of nab-paclitaxel in pancreatic cancer and discusses the preclinical and clinical studies of relevance. Keywords: pancreatic

Production of 99Tc generators with automatic elution

International Nuclear Information System (INIS)

Mengatti, J.; Yanagawa, S.T.I.; Mazzarro, E.; Gasiglia, H.T.; Rela, P.R.; Silva, C.P.G. da; Pereira, N.P.S. de.

1983-10-01

The improvements performed on the routine production of sup(99m) Tc-generators at the Instituto de Pesquisas Energeticas e Nucleares-CNEN/SP, are described. The old model generators (manual elution of sup(99m) Tc) were substituted by automatically eluted generators (Vacuum system). The alumina column, elution system and acessories were modified; the elution time was reduced from 60 to 20-30 seconds. The new generators give 80-90% elution yields using six mililiters of sodium chloride 0,9% as sup(99m) Tc eluant instead of the 10 mililiters necessary to eluate the old generators. So, the radioactive concentrations are now 70% higher. The radioactive, radiochemical, chemical and microbiological criteria were examinated for sup(99m) Tc solutions. Like old generators, automatic generators were considered safe for medical purpose. (Author) [pt

Preparation and evaluation of peptide-dendrimer-paclitaxel ...

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research April 2017; 16 (4): 737-742 ... conjugates for treatment of heterogeneous stage 1 non- small cell lung ... Keywords: Paclitaxel, Lung cancer, Non-small cell lung cancer, Dendrimer, Peptide, PAMAM.

Incidence and risk of peripheral neuropathy with nab-paclitaxel in patients with cancer: a meta-analysis.

Science.gov (United States)

Peng, L; Bu, Z; Ye, X; Zhou, Y; Zhao, Q

2017-09-01

Nab-paclitaxel, a Cremophor EL-free formulation of paclitaxel, is used to treat various malignancies. Peripheral neuropathy is one of its major toxicities, although the overall incidence remains unclear. We performed a meta-analysis to calculate the incidence of peripheral neuropathy in cancer patients treated with nab-paclitaxel and to compare the relative risk (RR) with conventional taxanes. The electronic databases were searched for relevant clinical trials. Eligible studies included phase II and III prospective clinical trials of cancer patients treated with nab-paclitaxel with toxicity profile on peripheral neuropathy. Statistical analyses were done to calculate summary incidences, RRs and 95% confidence intervals (CI), using fixed-effects or random-effects models based on the heterogeneity of the included studies. Nineteen trials were selected for the meta-analysis, yielding a total of 2878 cancer patients. The overall incidences of peripheral neuropathy (all-grade) was 51.0% (95% CI: 45.1-57.6%), and that of high-grade peripheral neuropathy was 12.4% (9.8-15.7%). The RRs of peripheral neuropathy of nab-paclitaxel compared to taxanes were not increased for all-grade and high-grade peripheral neuropathy. Nab-paclitaxel is associated with an increased risk of developing peripheral neuropathy. Future clinical studies are still needed to investigate the risk reduction and possible use of nab-paclitaxel. © 2015 John Wiley & Sons Ltd.

Delayed seizure associated with paclitaxel-Cremophor el in a patient with early-stage breast cancer.

Science.gov (United States)

O'Connor, Tracey L; Kossoff, Ellen

2009-08-01

Paclitaxel, a microtubule stabilizer, is an effective agent for treating cancer of the breast, ovary, head and neck, and lung. Because paclitaxel is insoluble in water, it is formulated with the micelle-forming Cremophor EL. Neurologic toxicity is well described with both the drug and this carrier, with most toxicities manifesting as peripheral neuropathy, motor neuropathy, autonomic neuropathy, and myopathy. Toxic effects on the central nervous system, such as seizures or encephalopathy, have been rarely reported; however, the seizures reported were closely related to the time of infusion. We describe a 41-year-old woman with no history of seizures who was treated with paclitaxel for breast cancer. Four days after the drug was infused, she developed a generalized tonic-clonic seizure that could not be attributed to other causes. The patient was treated with phenytoin and was able to complete her adjuvant chemotherapy with nab-paclitaxel without further events. Her condition was neurologically stable without phenytoin for the next 6 months. Use of the Naranjo adverse drug reaction probability scale indicated a possible association (score of 3) between the delayed seizure and paclitaxel or its solvent, Cremophor EL. Clinicians should be aware of the potential for seizure activity in patients who receive paclitaxel formulated with Cremophor EL.

Paclitaxel prodrugs, method for preparation as well as their use in selective chemotherapy

NARCIS (Netherlands)

de Bont, Hendricus BA; Leenders, Ruben GG; Scheeren, Johan W; Haisma, Hidde J; de Vos, Dick

1998-01-01

A paclitaxel prodrug has a paclitaxel portion coupled to a cleavable N-(aliphatic or aromatic)-O-glycosyl carbamate spacer group, and can be administered orally, topically or by injection to provide an anti-tumor effect, the prodrug being activated by a hydrolizing enzyme, an endogeneous enzyme or

The chemotherapeutic agent paclitaxel selectively impairs learning while sparing source memory and spatial memory.

Science.gov (United States)

Smith, Alexandra E; Slivicki, Richard A; Hohmann, Andrea G; Crystal, Jonathon D

2017-03-01

Chemotherapeutic agents are widely used to treat patients with systemic cancer. The efficacy of these therapies is undermined by their adverse side-effect profiles such as cognitive deficits that have a negative impact on the quality of life of cancer survivors. Cognitive side effects occur across a variety of domains, including memory, executive function, and processing speed. Such impairments are exacerbated under cognitive challenges and a subgroup of patients experience long-term impairments. Episodic memory in rats can be examined using a source memory task. In the current study, rats received paclitaxel, a taxane-derived chemotherapeutic agent, and learning and memory functioning was examined using the source memory task. Treatment with paclitaxel did not impair spatial and episodic memory, and paclitaxel treated rats were not more susceptible to cognitive challenges. Under conditions in which memory was not impaired, paclitaxel treatment impaired learning of new rules, documenting a decreased sensitivity to changes in experimental contingencies. These findings provide new information on the nature of cancer chemotherapy-induced cognitive impairments, particularly regarding the incongruent vulnerability of episodic memory and new learning following treatment with paclitaxel. Copyright © 2016 Elsevier B.V. All rights reserved.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

Science.gov (United States)

Meneguz-Moreno, Rafael Alexandre; Costa, José de Ribamar; Moscoso, Freddy Antônio Britto; Staico, Rodolfo; Tanajura, Luiz Fernando Leite; Centemero, Marinella Patrizia; Chaves, Auréa Jacob; Abizaid, Andrea Claudia Leão de Sousa; Sousa, Amanda Guerra de Moraes Rego E; Abizaid, Alexandre Antonio Cunha

2017-02-01

Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos

Minoxidil is a potential neuroprotective drug for paclitaxel-induced peripheral neuropathy

Science.gov (United States)

Chen, Yi-Fan; Chen, Li-Hsien; Yeh, Yu-Min; Wu, Pei-Ying; Chen, Yih-Fung; Chang, Lian-Yun; Chang, Jang-Yang; Shen, Meng-Ru

2017-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment. No medication has been shown to be effective in the treatment of CIPN. This study aims to integrate the image-based high-content screening, mouse behavior models and mechanistic cell-based assays to discover potential neuroprotective drugs. Among screened compounds, minoxidil showed the most potent neuroprotective effect against paclitaxel, with regard to neurite outgrowth of dorsal root ganglia (DRG). Minoxidil protected mice from thermal insensitivity and alleviated mechanical allodynia in paclitaxel-treated mice. The ultrastructure and quantified G-ratio of myelin integrity of sciatic nerve tissues supported the observations in mouse behavioral tests. The mechanistic study on DRG neurons suggested that minoxidil suppressed neuroinflammation and remodeled the dysregulation of intracellular calcium homeostasis provoked by paclitaxel. Importantly, minoxidil showed a synergistic anti-tumor effect with paclitaxel both in tumor xenograft models of cervical and breast cancer. Interestingly, the quantitative assays on hair length and hair growth both exhibited that minoxidil significantly improved the hair quality after chemotherapy. Since minoxidil is a drug approved by the Food and Drug Administration (FDA), the safety and biocompatibility are well documented. The immediate next step is to launch an early-stage clinical trial intending to prevent CIPN by minoxidil. PMID:28349969

Assessing transgastric Natural Orifice Transluminal Endoscopic Surgery prior to clinical implementation

DEFF Research Database (Denmark)

Donatsky, Anders Meller

2014-01-01

The objective was to investigate whether transgastric Natural Orifice Transluminal Endoscopic Surgery (NOTES) could be implemented safely in clinical practice. The experimental studies proved ultrasonography guided access through the stomach to be feasible and safe without iatrogenic complications......-abdominal abscess formation as a result of contamination from the access route was still present. To reduce this contamination, mouthwash with chlorhexidine was effective in a human randomised study. The same study also found significant higher bacterial load in the stomach of patients using proton pump inhibitor...

The battle of “nano” paclitaxel

NARCIS (Netherlands)

Sofias, Alexandros Marios; Dunne, Michael; Storm, Gert; Allen, Christine

2017-01-01

Paclitaxel (PTX) is one of the three most widely used chemotherapeutic agents, together with doxorubicin and cisplatin, and is first or second line treatment for several types of cancers. In 2000, Taxol, the conventional formulation of PTX, became the best-selling cancer drug of all time with annual

Impact of CYP2C8*3 on paclitaxel clearance

DEFF Research Database (Denmark)

Bergmann, T K; Brasch-Andersen, C; Gréen, H

2011-01-01

The primary purpose of this study was to evaluate the effect of CYP2C8*3 and three genetic ABCB1 variants on the elimination of paclitaxel. We studied 93 Caucasian women with ovarian cancer treated with paclitaxel and carboplatin. Using sparse sampling and nonlinear mixed effects modeling, the in...... associations found for CYP2C8*4 (P=0.04) and ABCC1 g.7356253C>G (P=0.04).The Pharmacogenomics Journal advance online publication, 6 April 2010; doi:10.1038/tpj.2010.19....

Enabling Anticancer Therapeutics by Nanoparticle Carriers: The Delivery of Paclitaxel

Directory of Open Access Journals (Sweden)

Bing Yan

2011-07-01

Full Text Available Anticancer drugs, such as paclitaxel (PTX, are indispensable for the treatment of a variety of malignancies. However, the application of most drugs is greatly limited by the low water solubility, poor permeability, or high efflux from cells. Nanoparticles have been widely investigated to enable drug delivery due to their low toxicity, sustained drug release, molecular targeting, and additional therapeutic and imaging functions. This review takes paclitaxel as an example and compares different nanoparticle-based delivery systems for their effectiveness in cancer chemotherapy.

Collagen turnover in arterial disease

NARCIS (Netherlands)

Sluijter, J.P.G.

2004-01-01

Increased atherosclerotic plaque formation can lead to lumen reduction and finally to lumen obstruction. Percutaneous transluminal angioplasty (PTA) or balloon angioplasty (dilation) are approaches generally used to treat coronary, but also peripheral atherosclerotic disease. Their goal is to

Oxygen-carbon nanotubes as a chemotherapy sensitizer for paclitaxel in breast cancer treatment.

Directory of Open Access Journals (Sweden)

Yongkun Wang

Full Text Available To study the in vivo and in vitro effects of adding oxygen carbon nanotubes (CNTs to chemotherapy for breast cancer.MCF-7 and SK-BR-3 breast cancer cells were co-cultured with paclitaxel and then exposed to oxygen-CNTs under hypoxic conditions. Cell proliferation, viability, and apoptosis rate were analyzed. Hypoxia-inducible factor-1 alpha (HIF-1α expression was measured using reverse transcription-polymerase chain reaction (RT-PCR and western blot. Nude mice were used as a human breast cancer model to explore the impact of oxygen-CNTs on the in vivo chemotherapeutic effect of paclitaxel.Oxygen-CNTs had no significant effects on the growth of breast cancer cells under normoxia and hypoxia. However, in the hypoxic environment, oxygen-CNTs significantly enhanced the inhibitory effect of paclitaxel on cell proliferation, as well as the apoptosis rate. Under hypoxia, downregulation of HIF-1α and upregulation of caspase-3, caspase-8, caspase-9, LC3 and Beclin-1 were observed when paclitaxel was combined with oxygen-CNT. Furthermore, addition of oxygen-CNTs to chemotherapy was found to significantly reduce tumor weight in the tumor-bearing mice model.Oxygen-CNTs can significantly increase the chemotherapeutic effect of paclitaxel on breast cancer cells. Oxygen-CNTs may be a potential chemosensitizer in breast cancer therapy.

Optimization of elution salt concentration in stepwise elution of protein chromatography using linear gradient elution data. Reducing residual protein A by cation-exchange chromatography in monoclonal antibody purification.

Science.gov (United States)

Ishihara, Takashi; Kadoya, Toshihiko; Endo, Naomi; Yamamoto, Shuichi

2006-05-05

Our simple method for optimization of the elution salt concentration in stepwise elution was applied to the actual protein separation system, which involves several difficulties such as detection of the target. As a model separation system, reducing residual protein A by cation-exchange chromatography in human monoclonal antibody (hMab) purification was chosen. We carried out linear gradient elution experiments and obtained the data for the peak salt concentration of hMab and residual protein A, respectively. An enzyme-linked immunosorbent assay was applied to the measurement of the residual protein A. From these data, we calculated the distribution coefficient of the hMab and the residual protein A as a function of salt concentration. The optimal salt concentration of stepwise elution to reduce the residual protein A from the hMab was determined based on the relationship between the distribution coefficient and the salt concentration. Using the optimized condition, we successfully performed the separation, resulting in high recovery of hMab and the elimination of residual protein A.

Case report: renovascular hypertension following radiotherapy and chemotherapy treated by transluminal angioplasty

International Nuclear Information System (INIS)

Minton, M.J.; McIvor, J.; Cappuccio, F.P.; MacGregor, G.A.; Newlands, E.S.

1986-01-01

A man aged 33 with poorly controlled hypertension who had been treated with radiotherapy and combination chemotherapy for testicular teratoma 8 years earlier was found on arteriography to have 75% stenosis of the left renal artery and occlusion of the right renal artery. The stenosis was dilated by transluminal angioplasty and the hypertension adequately controlled. Patients who develop high blood pressure after abdominal radiotherapy with or without chemotherapy should be investigated for renal artery stenosis. (author)

Intraarterial 192Ir high-dose-rate brachytherapy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty: the prospective randomized Vienna-2-trial radiotherapy parameters and risk factors analysis

International Nuclear Information System (INIS)

Pokrajac, Boris; Poetter, Richard; Maca, Thomas; Fellner, Claudia; Mittlboeck, Martina; Ahmadi, Ramazanali; Seitz, Wolfgang; Minar, Erich

2000-01-01

Purpose: The aim of the Vienna-2-trial was to compare the restenosis rate of femoropopliteal arteries after percutaneous transluminal angioplasty (PTA) with or without intraarterial high-dose-rate (HDR) brachytherapy (BT) using an 192 Ir source. Materials and Methods: A prospective, randomized trial was conducted from 11/96 to 8/98. A total of 113 patients (63 men, 50 women), with a mean age of 71 years (range, 43-89 years) were included. Inclusion criteria were (1) claudication or critical limb ischemia, (2) de-novo stenosis of 5 cm or more, (3) restenosis after former PTA of any length, and (4) no stent implantation. Patients were randomized after successful PTA for BT vs. no further treatment. A well-balanced patient distribution was achieved for the criteria used for stratification, as there were 'de-novo stenosis vs. restenosis after former PTA', 'stenosis vs. occlusion', 'claudication vs. critical limb ischemia' and above these for 'diabetes vs. nondiabetes'. PTA length was not well balanced between the treatment arms: a PTA length of 4-10 cm was seen in 19 patients in the PTA alone group and in 11 patients in the PTA+BT group, whereas a PTA length of greater than10 cm was seen in 35 patients and 42 patients, respectively. A dose of 12 Gy was prescribed in 3-mm distance from the source axis. According to AAPM recommendations, the dose was 6.8 Gy in 5-mm distance (vessel radius + 2 mm). Primary endpoint of the study was femoropopliteal patency after 6 months. Results: PTA and additional BT were feasible and well tolerated by all 57 pts in this treatment arm. No acute, subacute, and late adverse side effects related to BT were seen after a mean follow up of 12 months (6-24 months) in 107 patients (PTA n = 54; PTA+ BT n = 53). Crude restenosis rate at 6 months was in the PTA arm 54% vs. 28% in the PTA + BT arm (χ 2 test; p 10 cm) showed significant decrease of the restenosis rate, if BT was added. Significant reduction was not achieved in diabetes patients

The battle of "nano" paclitaxel.

Science.gov (United States)

Sofias, Alexandros Marios; Dunne, Michael; Storm, Gert; Allen, Christine

2017-12-01

Paclitaxel (PTX) is one of the three most widely used chemotherapeutic agents, together with doxorubicin and cisplatin, and is first or second line treatment for several types of cancers. In 2000, Taxol, the conventional formulation of PTX, became the best-selling cancer drug of all time with annual sales of 1.6 billion. In 2005, the introduction of the albumin-based formulation of PTX, known as Abraxane, ended Taxol's monopoly of the PTX market. Abraxane's ability to push the Taxol innovator and generic formulations aside attracted fierce competition amongst competitors worldwide to develop their own unique, new and improved formulation of PTX. At this time there are at least 18 companies focused on pre-clinical and/or clinical development of nano-formulations of PTX. These pharmaceutical companies are investing substantial capital to capture a share of the lucrative global PTX market. It is hoped that any formulation that dominates the market will result in tangible benefits to patients in terms of both survival and quality of life. Given all of this activity, here we address the question: Who is going to win the battle of "nano" paclitaxel? Copyright © 2017 Elsevier B.V. All rights reserved.

Optical coherence tomography findings after chronic total occlusion interventions: Insights from the “AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions” (ACE-CTO) study (NCT01012869)

Energy Technology Data Exchange (ETDEWEB)

Sherbet, Daniel P.; Christopoulos, Georgios; Karatasakis, Aris; Danek, Barbara Anna; Kotsia, Anna; Navara, Rachita; Michael, Tesfaldet T.; Roesle, Michele; Rangan, Bavana V.; Haagen, Donald [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Garcia, Santiago [Minneapolis VA Healthcare System and University of Minnesota, Minneapolis, MN (United States); Maniu, Calin [Bon Secours Health System, Suffolk, VA (United States); Pershad, Ashish [Banner Good Samaritan Medical Center, Phoenix, AZ (United States); Abdullah, Shuaib M.; Hastings, Jeffrey L.; Kumbhani, Dharam J.; Luna, Michael; Addo, Tayo; Banerjee, Subhash [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Brilakis, Emmanouil S., E-mail: esbrilakis@gmail.com [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States)

2016-10-15

Background: There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. Methods: The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108 mm. Results: A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126 ± 0.140 mm and − 0.491 ± 0.440 mm, respectively. Conclusion: High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs. - Highlights: • Percutaneous coronary intervention with drug-eluting stents for chronic total occlusion is associated with a 40% rate of binary in-stent restenosis at 8 months • Of patients who receive a drug eluting stent for a chronic total occlusion 88.7% will have stent strut malapposition and 80.7% will

Targeted sequencing reveals low-frequency variants in EPHA genes as markers of paclitaxel-induced peripheral neuropathy.

OpenAIRE

Apellániz-Ruiz, Maria; Tejero, Héctor; Inglada-Pérez, Lucía; Sánchez-Barroso, Lara; Gutiérrez-Gutiérrez, Gerardo; Calvo, Isabel; Castelo, Beatriz; Redondo, Andrés; García-Donás, Jesus; Romero-Laorden, Nuria; Sereno, Maria; Merino, María; Currás-Freixes, Maria; Montero-Conde, Cristina; Mancikova, Veronika

2017-01-01

PURPOSE: Neuropathy is the dose limiting toxicity of paclitaxel and a major cause for decreased quality of life. Genetic factors have been shown to contribute to paclitaxel neuropathy susceptibility; however, the major causes for inter-individual differences remain unexplained. In this study we identified genetic markers associated with paclitaxel-induced neuropathy through massive sequencing of candidate genes. EXPERIMENTAL DESIGN: We sequenced the coding region of 4 EPHA genes, 5 genes invo...

Weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma

International Nuclear Information System (INIS)

Hu Wei; Ding Weijun; Yang Haihua; Shao Minghai; Wang Biyun; Wang Jianhua; Wu Sufang; Wu Shixiu; Jin Lihui; Ma, Charlie C.-M.

2009-01-01

Purpose: To evaluate the efficacy and toxicity of weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy (AC) in patients with locally advanced nasopharyngeal carcinoma (NPC). Methods and materials: Between 2004 and 2007, 54 patients with locally advanced NPC were included in this protocol. Patient characteristics: median age 48; 69% male; 52% World Health Organization (WHO) III; 50% stage III, 50% stage IV. The patients underwent a course of definitive conventional radiotherapy (70 Gy in 7 weeks with 2 Gy/fraction), with concurrent weekly paclitaxel 35 mg/m 2 from the first to the sixth week of radiation. AC was started 4 weeks after the end of the radiotherapy (RT), paclitaxel 135 mg/m 2 on day 1 and cisplatin 30 mg/m 2 on days 1-3 were administered every 4 weeks for two cycles. Results: Median follow-up was 32 months. Eighty-five percentage of complete response and 15% partial response were achieved at the time of one month after AC. The 3-year actuarial rate of local regional control was 86%; distant metastases-free survival, progression-free survival and overall survival at 3 years were 81%, 69% and 76%, respectively. Forty-nine (91%) patients completed six courses of concurrent chemotherapy with weekly paclitaxel, and 4 (7%) patients delayed at the second cycle of AC. No patient developed severe acute toxicities. Conclusions: Weekly paclitaxel with concurrent RT followed by AC is a potentially effective and toxicity tolerable method for locally advanced NPC. Further studies are needed to identify the optimal dose of weekly paclitaxel in this strategy.

Effect of kamikihito (TJ-137) on paclitaxel-induced olfactory neuropathy in vivo

International Nuclear Information System (INIS)

Yamamoto, Junpei

2012-01-01

A Kampo product, kamikihito (product name code: TJ-137), has ingredients that promote nerve growth. Paclitaxel, a cancer chemotherapeutic agent, is toxic to olfactory nerve cells in vivo. We found that TJ-137 is effective in reducing paclitaxel induced olfactory neuropathy in vivo. Female 7-week-old Bulb/c mice were fed food containing TJ-137, or control food, for 14 days before and after intravenous paclitaxel administration. 201 Tl uptake in nasal turbinates of TJ-137 treated mice (n=8) and control mice (n=9) was assessed by gamma spectrometry 6 hrs after nasal administration of 201 Tl. The epithelial changes in the nasal turbinates of mice were assessed by H and E and immunohistochemical staining for the olfactory marker protein (OMP). The accumulation of the neuronal tracer (Dextran tetramethylrhodamine) in the olfactory bulb was assessed in frozen sections of mice 48 hrs after nasal administration of the tracer. The epithelium of nasal turbinates of TJ-137 treated mice was less injured than that of the control mice after paclitaxel administration. The nasal epithelium was significantly thicker in TJ-137 treated mice compared to control mice (P=0.019). The accumulation of the neuronal tracer in the olfactory bulb was higher in the TJ-137 treated mice compared to controls. 201 Tl uptake per weight in nasal turbinate of TJ-137 treated mice was significantly higher than that of control mice (P=0.008). Pre-medication with TJ-137 (kamikihito) was effective in increasing olfactory nerve viability after paclitaxel administration in vivo. (author)

Determinants of protein elution rates from preparative ion-exchange adsorbents.

Science.gov (United States)

Angelo, James M; Lenhoff, Abraham M

2016-04-01

The rate processes involved in elution in preparative chromatography can affect both peak resolution and hence selectivity as well as practical factors such as facility fit. These processes depend on the physical structure of the adsorbent particles, the amount of bound solute, the solution conditions for operation or some combination of these factors. Ion-exchange adsorbents modified with covalently attached or grafted polymer layers have become widely used in preparative chromatography. Their often easily accessible microstructures offer substantial binding capacities for biomolecules, but elution has sometimes been observed to be undesirably slow. In order to determine which physicochemical phenomena control elution behavior, commercially available cellulosic, dextran-grafted and unmodified agarose materials were characterized here by their elution profiles at various conditions, including different degrees of loading. Elution data were analyzed under the assumption of purely diffusion-limited control, including the role of pore structure properties such as porosity and tortuosity. In general, effective elution rates decreased with the reduction of accessible pore volume, but differences among different proteins indicated the roles of additional factors. Additional measurements and analysis, including the use of confocal laser scanning microscopy to observe elution within single chromatographic particles, indicated the importance of protein association within the particle during elution. The use of protein stabilizing agents was explored in systems presenting atypical elution behavior, and l-arginine and disaccharide excipients were shown to alleviate the effects for one protein, lysozyme, in the presence of sodium chloride. Incorporation of these excipients into eluent buffer gave rise to faster elution and significantly lower pool volumes in elution from polymer-modified adsorbents. Copyright © 2016 Elsevier B.V. All rights reserved.

Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

DEFF Research Database (Denmark)

Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

2010-01-01

In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who we...

Rikkunshito prevents paclitaxel-induced peripheral neuropathy through the suppression of the nuclear factor kappa B (NFκB phosphorylation in spinal cord of mice.

Directory of Open Access Journals (Sweden)

Junzo Kamei

Full Text Available Peripheral neuropathy is the major side effect caused by paclitaxel, a microtubule-binding antineoplastic drug. Paclitaxel-induced peripheral neuropathy causes a long-term negative impact on the patient's quality of life. However, the mechanism underlying paclitaxel-induced peripheral neuropathy is still unknown, and there is no established treatment. Ghrelin is known to attenuate thermal hyperalgesia and mechanical allodynia in chronic constriction injury of the sciatic nerve, and inhibit the activation of nuclear factor kappa B (NFκB in the spinal dorsal horn. Rikkunshito (RKT, a kampo medicine, increases the secretion of ghrelin in rodents and humans. Thus, RKT may attenuate paclitaxel-induced peripheral neuropathy by inhibiting phosphorylated NFκB (pNFκB in the spinal cord. We found that paclitaxel dose-dependently induced mechanical hyperalgesia in mice. Paclitaxel increased the protein levels of spinal pNFκB, but not those of spinal NFκB. NFκB inhibitor attenuated paclitaxel-induced mechanical hyperalgesia suggesting that the activation of NFκB mediates paclitaxel-induced hyperalgesia. RKT dose-dependently attenuated paclitaxel-induced mechanical hyperalgesia. Ghrelin receptor antagonist reversed the RKT-induced attenuation of paclitaxel-induced mechanical hyperalgesia. RKT inhibited the paclitaxel-induced increase in the protein levels of spinal pNFκB. Taken together, the present study indicates that RKT exerts an antihyperalgesic effect in paclitaxel-induced neuropathic pain by suppressing the activation of spinal NFκB.

Safety and efficacy of recombinant hirudin (CGP 39 393) versus heparin in patients with stable angina undergoing coronary angioplasty

NARCIS (Netherlands)

van den Bos, A. A.; Deckers, J. W.; Heyndrickx, G. R.; Laarman, G. J.; Suryapranata, H.; Zijlstra, F.; Close, P.; Rijnierse, J. J.; Buller, H. R.; Serruys, P. W.

1993-01-01

Enhanced thrombin activity has been associated with acute and long-term complications following balloon angioplasty (percutaneous transluminal coronary angioplasty (PTCA). We evaluated, in a 2-to-1 randomized, double-blind trial, the effects of recombinant hirudin, CGP 39 393, relative to

Safety and efficacy of recombinant Hirudin (CGP 39 393) versus Heparin in patients with stable angina undergoing coronary angioplasty

NARCIS (Netherlands)

A.A. van den Bos (Arjan); G.R. Heyndrickx (Guy); G-J. Laarman (GertJan); H. Suryapranata (Harry); F. Zijlstra (Felix); P. Close (Philip); J.J.M.M. Rijnierse (Joep); H.R. Büller (Harry); P.W.J.C. Serruys (Patrick); J.W. Deckers (Jaap)

1993-01-01

textabstractBACKGROUND. Enhanced thrombin activity has been associated with acute and long-term complications following balloon angioplasty (percutaneous transluminal coronary angioplasty (PTCA). We evaluated, in a 2-to-1 randomized, double-blind trial, the effects of recombinant hirudin, CGP 39

Hemodynamic Measurements for the Selection of Patients With Renal Artery Stenosis: A Systematic Review

NARCIS (Netherlands)

van Brussel, Peter M.; van de Hoef, Tim P.; de Winter, Robbert J.; Vogt, Liffert; van den Born, Bert-Jan

2017-01-01

Interventions targeting renal artery stenoses have been shown to lower blood pressure and preserve renal function. In recent studies, the efficacy of catheter-based percutaneous transluminal renal angioplasty with stent placement has been called into question. In the identification of functional

Autophagy promotes paclitaxel resistance of cervical cancer cells: involvement of Warburg effect activated hypoxia-induced factor 1-?-mediated signaling

OpenAIRE

Peng, X; Gong, F; Chen, Y; Jiang, Y; Liu, J; Yu, M; Zhang, S; Wang, M; Xiao, G; Liao, H

2014-01-01

Paclitaxel is one of the most effective chemotherapy drugs for advanced cervical cancer. However, acquired resistance of paclitaxel represents a major barrier to successful anticancer treatment. In this study, paclitaxel-resistant HeLa sublines (HeLa-R cell lines) were established by continuous exposure and increased autophagy level was observed in HeLa-R cells. 3-Methyladenine or ATG7 siRNA, autophagy inhibitors, could restore sensitivity of HeLa-R cells to paclitaxel compared with parental ...

Revascularização miocárdica de urgência após complicação de angioplastia transluminal coronária: abordagem cirúrgica atual Emergency myocardial revascularization after complicated percutaneous transluminal coronary angioplasty: actual surgical approach

Directory of Open Access Journals (Sweden)

Luís Alberto Dallan

1990-04-01

Full Text Available Entre julho de 1981 e fevereiro de 1990, foram realizados no INCOR 3016 angioplastias transluminais coronárias (ATC, em 2431 pacientes portadores de insuficiência coronária em suas diferentes manifestações. A cirurgia de revascularizaçâo do miocárdio de urgência foi necessária em 79 (3,2% desses pacientes, dos quais 32 (40,5% infartaram e 12 (15,2% faleceram. Dos 1530 pacientes submetidos estivamente a ATC por angina estável, 11,9% (7/59 faleceram no intra ou no pós-operatório. Dentre os 112 pacientes em que a ATC foi realizada de urgência devido a angina instável, 18,2% (2/11 evoluíram para óbito operatório. Nos 789 já infartados previamente à ATC, a mortalidade cirúrgica foi de 33,3% (3/9. A análise estatística demonstrou mortalidade mais elevada em pacientes idosos, em pacientes com dissecção do tronco da artéria coronária esquerda ou trombose coronária tardia e, especialmente, naqueles com instabilidade hemodinâmica após a ATC. O tempo decorrido entre a complicação da ATC e a revascularizaçâo do miocárdio também constitui fator agravante no prognóstico. O número de cirurgias de urgência após ATC diminuiu significativamente nos últimos dois anos (10/1351, a despeito do grau progressivo de complexidade das lesões dilatadas. O emprego de balões com extremidade atraumática e, especialmente, de cateter de reperíusão (Stack, que mantém o fluxo coronário mesmo diante do desprendimento da placa ateromatosa, contribuiu, decisivamente, para esses resultados. As modificações introduzidas na sistematização operatória, principalmente o uso de cardioplegia sangüínea com indução normotérmica e administrada por vias anterógrada e retrógrada, também propiciaram melhores resultados cirúrgicos. A associação desses procedimentos vem se mostrando benéfica, não tendo sido observados óbitos nos últimos 14 meses.Between July 1981 and February 1990, 2431 patients underwent attempted percutaneous

Weekly nanoparticle albumin bound-paclitaxel in combination with cisplatin versus weekly solvent-based paclitaxel plus cisplatin as first-line therapy in Chinese patients with advanced esophageal squamous cell carcinoma

Directory of Open Access Journals (Sweden)

Wang HY

2016-09-01

Full Text Available Hai-ying Wang, Zhi-hua Yao, Hong Tang, Yan Zhao, Xiao-san Zhang, Shu-na Yao, Shu-jun Yang, Yan-yan Liu Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, People’s Republic of China Objective: More effective regimens for advanced esophageal squamous cell carcinoma (ESCC are urgently needed. Therefore, a retrospective study concerning the efficacy and safety of nanoparticle albumin-bound paclitaxel plus cisplatin (nab-TP versus solvent-based paclitaxel plus cisplatin (sb-TP as a first-line therapy was conducted in Chinese patients with advanced ESCC.Methods: From June 2009 to June 2015, 32 patients were treated with nab-paclitaxel (125 mg/m2 on the first and eighth days (30 minutes infusion and cisplatin (75 mg/m2 on the second day every 21 days (nab-TP arm. Also, 43 patients were treated with solvent-based paclitaxel (80 mg/m2 intravenously on the first and eighth days and the same dose of cisplatin (sb-TP arm. The two groups were compared in terms of objective response rate (ORR, disease control rate, progression-free survival (PFS, overall survival (OS, and safety profile. OS and PFS were estimated using Kaplan–Meier methods to determine associations between chemotherapy regimens and survival outcomes.Results: Nab-TP demonstrated a higher ORR (50% vs 30%; P=0.082 and disease control rate (81% vs 65%; P=0.124 than sb-TP. Median OS was similar for nab-TP and sb-TP (12.5 vs 10.7 months; P=0.269. However, nab-TP resulted in a longer median PFS (6.1 months [95% confidence interval: 5.3–6.9] than sb-TP (5.0 months [95% confidence interval: 4.4–5.6] (P=0.029. The most common adverse events included anemia, leukopenia, neutropenia, febrile neutropenia, and thrombocytopenia in both the groups and no statistically significant differences were observed between the groups. With statistically significant differences, significantly less grade ≥3 peripheral neuropathy

Polymeric nanoparticles for the intracellular delivery of paclitaxel in lung and breast cancer

Science.gov (United States)

Zubris, Kimberly Ann Veronica

Nanoparticles are useful for addressing many of the difficulties encountered when administering therapeutic compounds. Nanoparticles are able to increase the solubility of hydrophobic drugs, improve pharmacokinetics through sustained release, alter biodistribution, protect sensitive drugs from low pH environments or enzymatic alteration, and, in some cases, provide targeting of the drug to the desired tissues. The use of functional nanocarriers can also provide controlled intracellular delivery of a drug. To this end, we have developed functional pH-responsive expansile nanoparticles for the intracellular delivery of paclitaxel. The pH-responsiveness of these nanoparticles occurs due to a hydrophobic to hydrophilic transition of the polymer occurring under mildly acidic conditions. These polymeric nanoparticles were systematically evaluated for the delivery of paclitaxel in vitro and in vivo to improve local therapy for lung and breast cancers. Nanoparticles were synthesized using a miniemulsion polymerization process and were subsequently characterized and found to swell when exposed to acidic environments. Paclitaxel was successfully encapsulated within the nanoparticles, and the particles exhibited drug release at pH 5 but not at pH 7.4. In addition, the uptake of nanoparticles was observed using flow cytometry, and the anticancer efficacy of the paclitaxel-loaded nanoparticles was measured using cancer cell lines in vitro. The potency of the paclitaxel-loaded nanoparticles was close to that of free drug, demonstrating that the drug was effectively delivered by the particles and that the particles could act as an intracellular drug depot. Following in vitro characterization, murine in vivo studies demonstrated the ability of the paclitaxel-loaded responsive nanoparticles to delay recurrence of lung cancer and to prevent establishment of breast cancer in the mammary fat pads with higher efficacy than paclitaxel alone. In addition, the ability of nanoparticles to

Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer.

Science.gov (United States)

Muro, Kei; Oh, Sang Cheul; Shimada, Yasuhiro; Lee, Keun-Wook; Yen, Chia-Jui; Chao, Yee; Cho, Jae Yong; Cheng, Rebecca; Carlesi, Roberto; Chandrawansa, Kumari; Orlando, Mauro; Ohtsu, Atsushi

2016-03-01

East Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8 mg/kg or placebo on days 1 and 15 plus paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1 months for ramucirumab plus paclitaxel and 10.5 months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P = 0.929). Median progression-free survival was 5.5 months for ramucirumab plus paclitaxel and 2.8 months for placebo plus paclitaxel (hazard ratio: 0.628, 95% confidence interval: 0.473-0.834, P = 0.001). Objective response rates were 34% for ramucirumab plus paclitaxel and 20% for placebo plus paclitaxel. Grade ≥ 3 neutropenia (60% vs 28%) and leukopenia (34% vs 13%) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4% vs 4%). Special interest adverse events included any grade bleeding/hemorrhage (55% vs 25%), proteinuria (27% vs 7%), and hypertension (22% vs 2%). Ramucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer. © 2015 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

In vitro study of tumor seeking radiopharmaceutical uptake by human breast cancer cell line MCF-7 after paclitaxel treatment

International Nuclear Information System (INIS)

Choi, Joon Young; Choi, Yong; Choe, Yearn Seong; Lee, Kyung Han; Kim, Byung Tae

2007-01-01

This study was designed to investigate the cellular uptake of various tumor imaging radiopharmaceuticals in human breast cancer cells before and after paclitaxel exposure considering viable cell number. F-18-fluorodeoxyglucose, C-11-methionine. TI-201, Tc-99m-MIBI, and Tc-99m-tetrofosmin were used to evaluate the cellular uptake in MCF-7 cells. MCF-7 cells were cultured in multi-well plates. Wells were divided into DMSO exposure control group, and paclitaxel exposure group. The exposure durations of paclitaxel with 10 nM or 100 nM were 2 h, 6 h, 12 h, 24 h, and 48 h. Viable cell fraction was reduced as the concentration and exposure time of paclitaxel increased. After 10 nM paclitaxel exposure, the cellular uptake of all 5 radiopharmaceuticals was not reduced significantly, irrespective of exposure time and viable cell fraction. After 100 nM paclitaxel exposure, the cellular uptake of all 5 radiopharmaceuticals was enhanced significantly irrespective of viable cell fraction. The peak uptake was observed in experimental groups with paclitaxel exposure for 6 to 48 h according the type of radiopharmaceutical. When the cellular uptake was adjusted for the viable cell fraction and cell count, the peak cellular uptake was observed in experimental groups with paclitaxel exposure for 48 h, irrespective of the type of radiopharmaceutical. The cellular uptake of F-18-fluorodeoxyglucose, C-11-methionine, TI-201, Tc-99m-MIBI, and Tc-99m-tetrofosmin did not reflect viable cell number in MCF-7 cells after paclitaxel exposure for up to 48 h

Low Levels of NDRG1 in Nerve Tissue Are Predictive of Severe Paclitaxel-Induced Neuropathy.

Directory of Open Access Journals (Sweden)

Raghav Sundar

Full Text Available Sensory peripheral neuropathy caused by paclitaxel is a common and dose limiting toxicity, for which there are currently no validated predictive biomarkers. We investigated the relationship between the Charcot-Marie-Tooth protein NDRG1 and paclitaxel-induced neuropathy.Archived mammary tissue specimen blocks of breast cancer patients who received weekly paclitaxel in a single centre were retrieved and NDRG1 immunohistochemistry was performed on normal nerve tissue found within the sample. The mean nerve NDRG1 score was defined by an algorithm based on intensity of staining and percentage of stained nerve bundles. NDRG1 scores were correlated with paclitaxel induced neuropathy.111 patients were studied. 17 of 111 (15% developed severe paclitaxel-induced neuropathy. The mean nerve NDRG1 expression score was 5.4 in patients with severe neuropathy versus 7.7 in those without severe neuropathy (p = 0.0019. A Receiver operating characteristic (ROC curve analysis of the mean nerve NDRG1 score revealed an area under the curve of 0.74 (p = 0.0013 for the identification of severe neuropathy, with a score of 7 being most discriminative. 13/54 (24% subjects with an NDRG1 score 7 (p = 0.017.Low NDRG1 expression in nerve tissue present within samples of surgical resection may identify subjects at risk for severe paclitaxel-induced neuropathy. Since nerve biopsies are not routinely feasible for patients undergoing chemotherapy for early breast cancer, this promising biomarker strategy is compatible with current clinical workflow.

First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis.

Science.gov (United States)

Grube, Eberhard; Laborde, Jean C; Zickmann, Bernfried; Gerckens, Ulrich; Felderhoff, Thomas; Sauren, Barthel; Bootsveld, Andreas; Buellesfeld, Lutz; Iversen, Stein

2005-12-01

Percutaneous aortic valve replacement is a new technology for the treatment of patients with significant aortic valve stenosis. We present the first report on a human implantation of a self-expanding aortic valve prosthesis, which is composed of three bovine pericardial leaflets inserted within a self-expanding nitinol stent. The 73-year-old woman presented with severe symptomatic aortic valve stenosis (mean transvalvular gradient of 45 mmHg; valve area of 0.7 cm2). Surgical valve replacement had been declined for the patient because of comorbidities, including previous bypass surgery. A retrograde approach via the common iliac artery was used for valve deployment. The contralateral femoral vessels were used for a temporary extracorporal circulation, unloading the left ventricle during the actual stent expansion. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially during the procedure. Clinical and echocardiographic follow-up at day 1, 2, and 14 post procedure was performed to evaluate the short-term outcome. The prosthesis was successfully deployed within the native aortic valve, with accurate and stable positioning and with no impairment of the coronary artery or vein graft blood flow. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient (from 45 to 8 mmHg) without evidence of aortic or mitral valve insufficiency. The clinical status has then significantly improved. These results remained unchanged up to the day 14 follow-up. This case report demonstrates a successful percutaneous implantation of a self-expanding aortic valve prosthesis with remarkable functional and clinical improvements in the acute and short-term outcome. Copyright (c) 2005 Wiley-Liss, Inc.

Cryoplasty for the Prevention of Arterial Restenosis

International Nuclear Information System (INIS)

Wildgruber, Moritz G.; Berger, Hermann J.

2008-01-01

Restenosis after percutaneous transluminal angioplasty remains the limiting factor for the long-term benefit of endovascular therapies of peripheral arterial occlusive disease. Despite a variety of modifications and adjuncts to angioplasty such as bare metal stents, covered stents, and drug-eluting stents as well as a number of new technologies like laser angioplasty and cutting balloon angioplasty, restenosis rates have not been significantly affected and remain inferior to those for surgery for long lesions in the femoropopliteal segment. Cryoplasty, which combines balloon angioplasty with the application of cryothermal energy to the vessel wall, was suggested as a promising approach to prevent the formation of neointimal hyperplasia after angioplasty procedures. This review discusses the basic principles of cryoplasty, summarizes the current data on restenosis rates after cryoplasty treatment, and evaluates cryoplasty as a new treatment method to solve the problems associated with restenosis development. The results of the clinical studies suggest that cryoplasty is a feasible and safe technique in the treatment of femoropopliteal disease, however, they have failed to prove any superiority of cryoplasty over conventional angioplasty.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

Science.gov (United States)

Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

2018-05-28

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.

Science.gov (United States)

Jang, Jae-Sik; Han, Kyoo-Rok; Moon, Keon-Woong; Jeon, Dong Woon; Shin, Dong-Ho; Kim, Jung-Sun; Park, Duk-Woo; Kang, Hyun-Jae; Kim, Juhan; Bae, Jang-Whan; Hur, Seung-Ho; Kim, Byung Ok; Choi, Donghoon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo

2017-05-01

Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research.

DSC and EPR investigations on effects of cholesterol component on molecular interactions between paclitaxel and phospholipid within lipid bilayer membrane.

Science.gov (United States)

Zhao, Lingyun; Feng, Si-Shen; Kocherginsky, Nikolai; Kostetski, Iouri

2007-06-29

Differential scanning calorimetry (DSC) and electron paramagnetic resonance spectroscopy (EPR) were applied to investigate effects of cholesterol component on molecular interactions between paclitaxel, which is one of the best antineoplastic agents found from nature, and dipalmitoylphosphatidylcholine (DPPC) within lipid bilayer vesicles (liposomes), which could also be used as a model cell membrane. DSC analysis showed that incorporation of paclitaxel into the DPPC bilayer causes a reduction in the cooperativity of bilayer phase transition, leading to a looser and more flexible bilayer structure. Including cholesterol component in the DPPC/paclitaxel mixed bilayer can facilitate the molecular interaction between paclitaxel and lipid and make the tertiary system more stable. EPR analysis demonstrated that both of paclitaxel and cholesterol have fluidization effect on the DPPC bilayer membranes although cholesterol has more significant effect than paclitaxel does. The reduction kinetics of nitroxides by ascorbic acid showed that paclitaxel can inhibit the reaction by blocking the diffusion of either the ascorbic acid or nitroxide molecules since the reaction is tested to be a first order one. Cholesterol can remarkably increase the reduction reaction speed. This research may provide useful information for optimizing liposomal formulation of the drug as well as for understanding the pharmacology of paclitaxel.

Neurotoxicity and low paclitaxel clearance associated with concomitant clopidogrel therapy in a 60 year old Caucasian woman with ovarian carcinoma

DEFF Research Database (Denmark)

Bergmann, Troels K; Filppula, Anne M; Launiainen, Terhi

2015-01-01

% of the cohort geometric mean (385 L/h; range 176-726). She was hospitalised thrice, developed severe neuropathy and paclitaxel treatment was subsequently discontinued. In vitro, 30 min preincubation with 100 μM clopidogrel acyl-β-D-glucuronide inhibited the depletion rate of 0.5 μM paclitaxel by 51......AIM: The aim of this case report is to describe a novel pharmacokinetic drug-drug interaction between the antiplatelet agent clopidogrel and the antineoplastic agent paclitaxel. METHODS: The patient was identified in a previously described cohort of 93 patients with ovarian carcinoma treated...... with paclitaxel. The effect of clopidogrel acyl-β-D-glucuronide on the metabolism of paclitaxel was assessed in human liver microsomes. The analysis of clopidogrel in plasma and the quantification of paclitaxel and 6α-hydroxypaclitaxel in in vitro samples were performed by liquid chromatography tandem mass...

Retrospective study of the impact of pharmacogenetic variants on paclitaxel toxicity and survival in patients with ovarian cancer

DEFF Research Database (Denmark)

Bergmann, Troels K; Gréen, Henrik; Andersen, Charlotte Brasch

2011-01-01

Paclitaxel has a broad spectrum of anti-tumor activity and is useful in the treatment of ovarian, breast, and lung cancer. Paclitaxel is metabolized in the liver by CYP2C8 and CYP3A4 and transported by P-glycoprotein. The dose-limiting toxicities are neuropathy and neutropenia, but the interindiv......Paclitaxel has a broad spectrum of anti-tumor activity and is useful in the treatment of ovarian, breast, and lung cancer. Paclitaxel is metabolized in the liver by CYP2C8 and CYP3A4 and transported by P-glycoprotein. The dose-limiting toxicities are neuropathy and neutropenia...

Enhancing cognate target elution efficiency in gel-free chemical proteomics

Directory of Open Access Journals (Sweden)

Branka Radic-Sarikas

2015-12-01

Full Text Available Gel-free liquid chromatography mass spectrometry coupled to chemical proteomics is a powerful approach for characterizing cellular target profiles of small molecules. We have previously described a fast and efficient elution protocol; however, altered target profiles were observed. We hypothesised that elution conditions critically impact the effectiveness of disrupting drug-protein interactions. Thus, a number of elution conditions were systematically assessed with the aim of improving the recovery of all classes of proteins whilst maintaining compatibility with immunoblotting procedures. A double elution with formic acid combined with urea emerged as the most efficient and generically applicable elution method for chemical proteomics

Size distribution of DNA molecules recovered from non-denaturing filter elution

International Nuclear Information System (INIS)

Bloecher, D.; Iliakis, G.

1991-01-01

DNA fragments removed from the filter during non-denaturing filter elution were collected and loaded on top of neutral sucrose gradients. Their size distribution was determined by low-speed centrifugation in neutral sucrose gradients. The average size of eluted DNA was found to be approximately 110 S; the average size of DNA collected after short elution times was found to be slightly larger than after long elution times. It is concluded that the size of eluted DNA fragments is not correlated with elution rate, and it is proposed that shear forces generated at the filter pores cause degradation of the DNA. Comparison of sedimentation profiles of carefully prepared cellular DNA before and after elution revealed that generated shear forces during elution break down DNA to an extent equivalent to around 20 000 DNA double-strand breaks (dsb) per G 1 cell. The size of DNA fragments decreased with increasing radiation dose; five times more dsb were found than expected after exposure to radiation alone. It is proposed that excess of dsb may derive from the transformation of other radiation-induced lesions to dsb under the action of shear forces generated during elution. (author)

Transluminal coronary angioplasty (TCA) techniques, indications and results

International Nuclear Information System (INIS)

Kober, G.; Lang, H.; Vallbracht, C.; Bussmann, W.D.; Hopf, R.; Kunkel, B.; Kaltenbach, M.

1985-01-01

Transluminal coronary angioplasty (TCA) was introduced in 1977 for dilatation of coronary stenoses. From October 1977 to December 1984 1087 procedures have been performed in Frankfurt. The mean success rate was 77% with an increase from 58% to 84% since 1977. Recurrences were seen within the first year in 15% of the patients, which could be treated successfully in a high percentage with a second TCA. Emergency bypass operations were necessary in 5.2%. Four patients (fatality rate 0.37%) died as the consequence of the intervention. Within few years TCA has become an established procedure for myocardial revascularisation, with a high success rate. Major progress has been possible in the last few years due to technical developments, which are still going on. They may lead to further improvement of the results and enlargement of the indication for TCA. (orig.) [de

Renal sympathetic denervation: MDCT evaluation of the renal arteries.

LENUS (Irish Health Repository)

Hutchinson, Barry D

2013-08-01

Percutaneous transluminal renal sympathetic denervation is a new treatment of refractory systemic hypertension. The purpose of this study was to assess the clinical utility of MDCT to evaluate the anatomic configuration of the renal arteries in the context of renal sympathetic denervation.

Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)

DEFF Research Database (Denmark)

Okkels Jensen, Lisette; Thayssen, Per; Hansen, Henrik Steen

2012-01-01

was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were.......71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0...

Brief depression screening with the PHQ-2 associated with prognosis following percutaneous coronary intervention with paclitaxel-eluting stenting

DEFF Research Database (Denmark)

Pedersen, Susanne S.; Denollet, Johan; de Jonge, Peter

2009-01-01

Depression is associated with adverse prognosis in cardiac patients, warranting the availability of brief and valid instruments to identify depressed patients in clinical practice.......Depression is associated with adverse prognosis in cardiac patients, warranting the availability of brief and valid instruments to identify depressed patients in clinical practice....

The Indicating FTA Elute Cartridge

Science.gov (United States)

de Bie, Roosmarie P.; Schmeink, Channa E.; Bakkers, Judith M.J.E.; Snijders, Peter J.F.; Quint, Wim G.V.; Massuger, Leon F.A.G.; Bekkers, Ruud L.M.; Melchers, Willem J.G.

2011-01-01

The clinically validated high-risk human papillomavirus (hrHPV) Hybrid Capture 2 (HC2) and GP5+/6+-PCR assays were analyzed on an Indicating FTA Elute cartridge (FTA cartridge). The FTA cartridge is a solid dry carrier that allows safe transport of cervical samples. FTA cartridge samples were compared with liquid-based samples for hrHPV and high-grade cervical intraepithelial neoplasia (CIN) detection. One cervical sample was collected in a liquid-based medium, and one was applied to the FTA cartridge. DNA was eluted directly from the FTA cartridge by a simple elution step. HC2 and GP5+/6+-PCR assays were performed on both the liquid-based and the FTA-eluted DNA of 88 women. Overall agreement between FTA and liquid-based samples for the presence of hrHPV was 90.9% with GP5+/6+-PCR and 77.3% with HC2. The sensitivity for high-grade CIN of hrHPV testing on the FTA cartridges was 84.6% with GP5+/6+-PCR and only 53.8% with HC2. By comparison, these sensitivities on liquid-based samples were 92.3% and 100% for GP5+/6+-PCR and HC2, respectively. Therefore, the FTA cartridge shows reasonably good overall agreement for hrHPV detection with liquid-based media when using GP5+/6+-PCR but not HC2 testing. Even with GP5+/6+-PCR, the FTA cartridge is not yet capable of detecting all high-grade CIN lesions. PMID:21704269

Cytotoxicity and cell-cycle effects of paclitaxel when used as a single agent and in combination with ionizing radiation

International Nuclear Information System (INIS)

Gupta, Nalin; Hu, Lily J.; Deen, Dennis F.

1997-01-01

Purpose: This study aimed to determine the extent of paclitaxel-induced cytotoxicity and cell-cycle perturbations when used alone and in combination with radiation in human glioma cells. Methods and Materials: The effect of paclitaxel alone on three human glioma cells lines--SF-126, U-87 MG, and U-251 MG--was assessed after 24, 48, 72, or 96 h treatment. For experiments in combination with radiation, cells were exposed to either a long (48-h) or short (8-h) duration of paclitaxel treatment prior to irradiation. Cell survival was determined by clonogenic assay. Cell cycle perturbations were assessed by using flow cytometry to measure the proportion of cells in G 1 , S, and G 2 /M phases. Results: When cells were treated with paclitaxel alone for ≥24 h, cytotoxicity increased up to a threshold dose, after which it plateaued. When treatment duration was ≤24 h, cytotoxicity was appreciably greater in U-251 MG cells than in SF-126 and U-87 MG cells. After 24 h of paclitaxel treatment, cells in plateau phase growth had increased survival compared to cells in log phase growth. In contrast, after 8 h paclitaxel treatment, mitotic cells had reduced survival compared to cells from an asynchronous population. Cell-cycle perturbations were consistent with the presence of a mitotic block after paclitaxel treatment, although changes in other cell-cycle phase fractions varied among cell lines. For experiments in combination with radiation, cytotoxicity was increased when cells were irradiated after 48 h of paclitaxel treatment but not after 8 h of treatment. Conclusion: The duration of paclitaxel treatment and the location of cells in the cell cycle modify the degree of radiation cytotoxicity. The mechanisms of paclitaxel cytotoxicity are likely to be multifactorial because varying effects are seen in different cell lines. Furthermore, it is clear that simply increasing the number of cells in G 2 /M is insufficient in itself to increase the response of cells to radiation

Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer.

Science.gov (United States)

Bishop, J F; Dewar, J; Toner, G C; Smith, J; Tattersall, M H; Olver, I N; Ackland, S; Kennedy, I; Goldstein, D; Gurney, H; Walpole, E; Levi, J; Stephenson, J; Canetta, R

1999-08-01

To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer. Patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m(2)/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy. A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P =.025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P = .07). Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

Science.gov (United States)

Janas, Adam; Buszman, Piotr P; Milewski, Krzysztof P; Wiernek, Szymon; Janas, Ksenia; Pruski, Maciej; Wojakowski, Wojciech; Błachut, Aleksandra; Picheta, Wojciech; Buszman, Pawel; Kiesz, Stefan

2017-02-24

The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

Science.gov (United States)

Giustino, Gennaro; Baber, Usman; Stefanini, Giulio Giuseppe; Aquino, Melissa; Stone, Gregg W; Sartori, Samantha; Steg, Philippe Gabriel; Wijns, William; Smits, Pieter C; Jeger, Raban V; Leon, Martin B; Windecker, Stephan; Serruys, Patrick W; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Kandzari, David; Dangas, George D; Mastoris, Ioannis; Von Birgelen, Clemens; Galatius, Soren; Kimura, Takeshi; Mikhail, Ghada; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Valgimigli, Marco; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

2015-09-15

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women. Published by Elsevier Inc.

Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure

DEFF Research Database (Denmark)

Donatsky, Anders Meller; Andersen, Luise; Nielsen, Ole Lerberg

2012-01-01

Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefi...

Biodistribution imaging of a paclitaxel-hyaluronan bioconjugate

Energy Technology Data Exchange (ETDEWEB)

Banzato, Alessandra; Rondina, Maria [Department of Oncology and Surgical Sciences, University of Padua, I-35128 Padova (Italy); Melendez-Alafort, Laura; Zangoni, Elena; Nadali, Anna [Department of Pharmaceutical Sciences, University of Padua, Padova (Italy); Renier, Davide [Fidia Farmaceutici, Abano Terme (Italy); Moschini, Giuliano [Department of Physics, University of Padua, Padova (Italy); Mazzi, Ulderico [Department of Pharmaceutical Sciences, University of Padua, Padova (Italy); Zanovello, Paola [Department of Oncology and Surgical Sciences, University of Padua, I-35128 Padova (Italy); Istituto Oncologico Veneto, IOV-IRCCS, Padova (Italy); Rosato, Antonio [Department of Oncology and Surgical Sciences, University of Padua, I-35128 Padova (Italy); Istituto Oncologico Veneto, IOV-IRCCS, Padova (Italy)], E-mail: antonio.rosato@unipd.it

2009-07-15

Introduction: Gamma-ray detectors represent sensitive and noninvasive instruments to evaluate in vivo the metabolic trapping of radiopharmaceuticals. This study aimed to assess the imaging biodistribution of a [{sup 99m}Tc]-radiolabelled new prototype bioconjugate composed of paclitaxel linked to hyaluronan (ONCOFID-P). Methods: A small gamma camera providing high-resolution images was employed. Imaging of biodistribution following intravenous, intraperitoneal, intravesical and oral administration was carried out for a 2-h period in anesthetized mice receiving [{sup 99m}Tc]ONCOFID-P. At the end of the observation time, radioactivity in organs was directly measured. As a control, groups of mice were treated with free [{sup 3}H]paclitaxel given according to the same administration routes, and organ biodistribution of the drug was assessed after 2 h. Results: Intravenous inoculation of [{sup 99m}Tc]ONCOFID-P was followed by a rapid and strong liver uptake. In fact, almost 80% of the imaging signal was detected in this organ 10 min after injection and such value remained constant thereafter, thus indicating that the bioconjugate given through the intravenous route could be well suited to targeting primary or metastatic liver neoplasias. Imaging of the bladder, abdomen and gastrointestinal tract after local administration disclosed that the radiolabelled compound remained confined to the cavities, suggesting a potential regional application for transitional bladder cell carcinomas, ovarian cancers and gastric tumors, respectively. Free [{sup 3}H]paclitaxel biodistribution profoundly differed from that of [{sup 99m}Tc]ONCOFID-P. Conclusions: Conjugation of drugs with polymers results in new chemical entities characterized by a modified biodistribution pattern. Therefore, preclinical studies based on imaging analysis of such new compounds can suggest novel therapeutic applications.

Cytotoxicity of Paclitaxel in biodegradable self-assembled core-shell poly(lactide-co-glycolide ethylene oxide fumarate) nanoparticles.

Science.gov (United States)

He, Xuezhong; Ma, Junyu; Mercado, Angel E; Xu, Weijie; Jabbari, Esmaiel

2008-07-01

Biodegradable core-shell polymeric nanoparticles (NPs), with a hydrophobic core and hydrophilic shell, are developed for surfactant-free encapsulation and delivery of Paclitaxel to tumor cells. Poly (lactide-co-glycolide fumarate) (PLGF) and Poly (lactide-fumarate) (PLAF) were synthesized by condensation polymerization of ultra-low molecular weight poly(L: -lactide-co-glycolide) (ULMW PLGA) with fumaryl chloride (FuCl). Similarly, poly(lactide-co-ethylene oxide fumarate) (PLEOF) macromer was synthesized by reacting ultra-low molecular weight poly(L: -lactide) (ULMW PLA) and PEG with FuCl. The blend PLGF/PLEOF and PLAF/PLEOF macromers were self-assembled into NPs by dialysis. The NPs were characterized with respect to particle size distribution, morphology, and loading efficiency. The physical state and miscibility of Paclitaxel in NPs were characterized by differential scanning calorimetry. Tumor cell uptake and cytotoxicity of Paclitaxel loaded NPs were measured by incubation with HCT116 human colon carcinoma cells. The distribution of NPs in vivo was assessed with Apc(Min/+)mouse using infrared imaging. PLEOF macromer, due to its amphiphilic nature, acted as a surface active agent in the process of self-assembly which produced core-shell NPs with PLGF/PLAF and PLEOF macromers as the core and shell, respectively. The encapsulation efficiency ranged from 70 to 56% and it was independent of the macromer but decreased with increasing concentration of Paclitaxel. Most of the PLGF and PLAF NPs degraded in 15 and 28 days, respectively, which demonstrated that the release was dominated by hydrolytic degradation and erosion of the matrix. As the concentration of Paclitaxel was increased from 0 to 10, and 40 mug/ml, the viability of HCT116 cells incubated with free Paclitaxel decreased from 100 to 65 and 40%, respectively, while those encapsulated in PLGF/PLEOF NPs decreased from 93 to 54 and 28%. Groups with Paclitaxel loaded NPs had higher cytotoxicity compared to

Drug therapy or coronary angioplasty for the treatment of coronary artery disease : New insights

NARCIS (Netherlands)

Amoroso, G; Van Boven, AJ; Crijns, HJGM

Background In the last decade percutaneous transluminal coronary angioplasty has become a very popular strategy For the treatment of coronary artery disease, although its efficacy in reducing ischemic events and the subsequent need for revascularization has yet to be proved. Methods We reviewed the

Quantitative angiographic follow-up of the coronary wallstent in native vessels and bypass grafts (European experience - March 1986 to March 1990)

NARCIS (Netherlands)

B.H. Strauss (Bradley); P.W.J.C. Serruys (Patrick); M.E. Bertrand (Michel); J. Puel (Jacques); B. Meier (Bernard); J-J. Goy (Jean-Jacques); L. Kappenberger (Lukas); A.F. Rickards (Anthony); U. Sigwart (Ulrich); M-A.M. Morel (Marie-Angèle); E.W.J. Montauban van Swijndregt (Eline)

1992-01-01

textabstractThe coronary stent has been investigated as an adjunct to percutaneous transluminal coronary angioplasty to obviate the problems of early occlusion and late restenosis. From March 1986 to March 1990, 265 patients (308 lesions) were implanted with the coronary Wallstent in 6 European

Coronary stenting as an adjunct to balloon angioplasty

NARCIS (Netherlands)

B.H. Strauss (Bradley)

1991-01-01

textabstractAndreas Gruentzig initiated the era of interventional cardiology in 19n with the introduction of percutaneous transluminal coronary angioplasty (PTCA) (1). The acceptance of coronary angioplasty is obvious by the widespread use of the procedure (>300,000 cases in the United States in

Laserassisteret ballonangioplastik af okklusioner i det femoropopliteale segment

DEFF Research Database (Denmark)

Eiberg, J P; Rasmussen, John Bøje Grønvall; Schroeder, T V

1995-01-01

of collateral vessels. In this series, laser angioplasty carried a high risk of perforation. The initial and long-term results were no better than could be expected of percutaneous transluminal angioplasty, suggesting that laser-assisted balloon angioplasty has no place in the vascular surgical armamentarium....

Percutaneous Management of Occlusive Arterial Disease Associated with Vasculitis: A Single Center Experience

International Nuclear Information System (INIS)

Both, M.; Jahnke, T.; Reinhold-Keller, E.; Reuter, M.; Grimm, J.; Biederer, J.; Brossmann, J.; Gross, W.L.; Heller, M.; Mueller-Huelsbeck, S.

2003-01-01

The purpose of this study was to evaluate the safety and effectiveness of percutaneous transluminal angioplasty for occlusive arterial disease associated with vasculitis. Eleven patients(10 women, 1 man; ages 35-82 years) with the diagnosis of vasculitis of the large vessels underwent interventional treatment during intraarterial angiography. The causes included giant cell arteritis(n = 8) and Takayasu arteritis (n = 3).Thirty-three occlusive lesions (including brachiocephalic and renalarteries, and arteries of upper and lower extremities) were treated with balloon angioplasty and/or stent placement. Follow-up included clinical examination, angiography, and color duplex ultrasound.Technical success was 100% (25/25) for stenoses and 50% (4/8) for occlusive lesions, representing all lesions combined from different anatomic locations. Dissection (n = 3) and arterial rupture with retroperitoneal hematoma (n = 1) was found in three patients. During follow-up (mean 12 months), restenoses(n = 8) and re-restenoses (n = 1)occurred in 8 vascular areas. Three of these lesions were treated with repeated PTA (n = 4). The cumulative primary clinical success rate was 67.6%, cumulative secondary success rate 74.4%, and cumulative tertiary success rate 75.9%. Interventional therapy in systemic vasculitis provides promising results in technical success rates and followup. Angioplasty may result in arterial injury, but the rate of complications is low

Alkaline elution of DNA from mammalian cells on cellulose triacetate filters

International Nuclear Information System (INIS)

Moss, A.J. Jr.; Nagle, W.A.; Henle, K.J.; Prior, R.M.

1984-01-01

The alkaline elution technique is widely used for the estimation of cellular DNA damage because of its sensitivity in the biologically relevant dose range. The authors have extended the original studies and provide additional characterization of the cellulose triacetate alkaline elution method. This filter material permits the elution of approximately 80 percent of cellular DNA from untreated V79 cells. the total radioactivity in the system was compartmentalized with respect to 1) lysing solution, 2) washing solution, 3) elution fractions, and 4) membrane retained activity. In these studies [/sup 3/H]-thymidine labeled untreated internal control cells were co-eluted with X-irradiated [/sup 14/C]-thymidine labeled cells. For the estimation of DNA damage, elution profiles for treated cells were directly compared with untreated internal control cells. The quantity of DNA eluting in excess of the labeled internal control per fraction is directly proportional to the extent of DNA damage in the treated sample. Using the technique the necessity of an irradiated internal control is eliminated

Peripheral neuropathy due to therapy with paclitaxel, gemcitabine, and cisplatin in patients with advanced ovarian cancer.

NARCIS (Netherlands)

Verstappen, C.C.P.; Postma, T.J.; Hoekman, K.; Heimans, J.J.

2003-01-01

BACKGROUND: To evaluate the peripheral neuropathic changes induced by combination chemotherapy including paclitaxel (taxol), gemcitabine and cisplatin (TGC regimen). PATIENTS AND METHODS: Eighteen patients with primary or recurrent ovarian cancer were treated with paclitaxel 150 or 110 mg/m2,

Global Inhibition of Reactive Oxygen Species (ROS) Inhibits Paclitaxel-Induced Painful Peripheral Neuropathy

OpenAIRE

Fidanboylu, Mehmet; Griffiths, Lisa A.; Flatters, Sarah J. L.

2011-01-01

Paclitaxel (Taxol (R)) is a widely used chemotherapeutic agent that has a major dose limiting side-effect of painful peripheral neuropathy. Currently there is no effective therapy for the prevention or treatment of chemotherapy-induced painful peripheral neuropathies. Evidence for mitochondrial dysfunction during paclitaxel-induced pain was previously indicated with the presence of swollen and vacuolated neuronal mitochondria. As mitochondria are a major source of reactive oxygen species (ROS...

Cannabidiol Prevents the Development of Cold and Mechanical Allodynia in Paclitaxel-Treated Female C57Bl6 Mice

OpenAIRE

Ward, Sara Jane; Ramirez, Michael David; Neelakantan, Harshini; Walker, Ellen Ann

2011-01-01

The taxane chemotherapeutic paclitaxel frequently produces peripheral neuropathy in humans. Rodent models to investigate mechanisms and treatments are largely restricted to male rats, whereas female mouse studies are lacking. We characterized a range of paclitaxel doses on cold and mechanical allodynia in male and female C57Bl/6 mice. Because the nonpsycho-active phytocannabinoid cannabidiol attenuates other forms of neuropathic pain, we assessed its effect on paclitaxel-induced allodynia. Pa...

Evaluation on elution feature of bentonite buffer materials

Energy Technology Data Exchange (ETDEWEB)

Ishikawa, Hirohisa; Kanno, Takeshi; Matsumoto, Kazuhiro

1997-09-01

In order to evaluate long term physical stability of artificial barrier in land disposal of high level radioactive wastes, it is necessary to know quantitatively elution behavior of buffering materials from disposal road (or cavity) to circumferential rock crack. When elution of the buffer material occurs on large scale, amount of bentonite in the disposal road (or cavity) reduces and reduction of various functions expected to the buffer materials is presumed. According to specification examples of road transverse arrangement and disposal vertical arrangement systems, evaluation on elution amount of the buffer materials at disposal environment was conducted. Opening width of rock crack in the disposal environment was supposed to be 0.5 mm. As a result, obtained mass elution ratios of the buffer materials due to extrusion phenomenon were 0.04 to 0.2% after 10,000 year and 2 to 12% after 1,000,000 years. (G.K.)

Phase I trial of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with thoracic malignancies.

Science.gov (United States)

Stinchcombe, Thomas E; Socinski, Mark A; Lee, Carrie B; Hayes, D Neil; Moore, Dominic T; Goldberg, Richard M; Dees, E Claire

2008-05-01

Nab-paclitaxel has a different toxicity profile than solvent-based paclitaxel including a lower rate of severe neutropenia. This trial was designed to determine the maximum tolerated dose and dose limiting toxicities (DLT) of nab-paclitaxel in combination with gemcitabine. Patients were required to have a performance status of 0 to 1, < or = three prior cytotoxic chemotherapy regimens, and preserved renal, hepatic, and bone marrow function. Patients received gemcitabine 1000 mg/m on days 1, 8 in all cohorts, and nab-paclitaxel at doses of 260, 300, 340 mg/m every 21 days depending on the treatment cohort (1 cycle = 21 days). DLT were assessed after the first cycle, and doses were escalated in cohorts of 3 to 6 patients. Eighteen patients were consented and 15 patients are evaluable [median age 62 years (range, 35-75); median number of prior treatments 3 (range, 1-4); tumor types: non-small cell lung cancer (NSCLC) (n = 8), small cell lung cancer (SCLC) (n = 6), and esophageal cancer (n = 1)]. At a nab-paclitaxel dose of 300 mg/m, 1 of 6 pts experienced a DLT (omission of day 8 gemcitabine due to absolute neutrophil count < 500), and at an nab-paclitaxel dose of 340 mg/m 2 of 3 patients experienced a DLT (1 pt grade 3 rash and pruritus; 1 pt grade 3 fatigue and anorexia). Responses were observed in NSCLC and SCLC. The maximum tolerated dose of nab-paclitaxel is 300 mg/m in combination with gemcitabine 1000 mg/m on days 1, 8 every 21 days. This combination demonstrated activity in previously treated NSCLC and SCLC patients.

A phase I study of paclitaxel as a radiation sensitizer for the treatment of non-small cell lung cancer and mesothelioma

International Nuclear Information System (INIS)

Herscher, L.; Hahn, S.; Pass, H.; Temeck, B.; Goldspiel, B.; Cook, J.; Mitchell, J.B.; Liebmann, J.

1995-01-01

Purpose/Objective Paclitaxel exposure of cancer cells in vitro results in a G 2 /M block in the cell cycle. Paclitaxel also has independent activity against a wide variety of tumors. We report here a phase I study of patients with non-small cell lung cancer and malignant pleural mesothelioma treated with radiation therapy and concurrent paclitaxel. Objectives were to determine the maximum tolerated dose (MTD) of paclitaxel when delivered as a 5-day continuous infusion with concurrent radiotherapy, to assess tumor response and toxicity, and to evaluate the biological effects of paclitaxel in tumor biopsy specimens. Materials and Methods 19 patients (pts.) were enrolled on study. 17 pts. were male and 2 were female. 18 pts. had mesothelioma and 1 had non-small cell lung cancer. Mean age was 59 yrs with a range of 47 to 72 years. One patient did not complete treatment due to progressive disease. Patients who completed treatment received from 5760 to 6300 cGy. Dose volume histography and multiple non-coplanar and non-coaxial fields were used. Patients received a continuous infusion of paclitaxel for 120 hours every three weeks during radiation therapy. The Results MTD of paclitaxel was determined to be 105 mg/m 2 delivered as a 120-hour continuous infusion. The dose-limiting toxicity of paclitaxel was neutropenia at 120 mg/m 2 given over 120 hrs. 13 patients were assessable for local control; 4 pts. are too early to evaluate and 2 pts. did not return for follow-up. (11(13)) pts. achieved local control. 3 of 13 patients are free of disease. 10 tumor biopsies were taken from 4 mesothelioma pts. Biopsies were taken prior to the paclitaxel infusion and then during the infusion. A modest G 2 /M block was observed in only 1 of the 5 specimens taken during the paclitaxel infusion. Conclusions This study demonstrates that paclitaxel can be safely delivered as a 120-hour continuous infusion at 105 mg/m 2 with concurrent thoracic radiotherapy. However, the biologic effect of

Technical skill set training in natural orifice transluminal endoscopic surgery: how should we approach it?

LENUS (Irish Health Repository)

Nugent, Emmeline

2011-03-01

The boundaries in minimally invasive techniques are continually being pushed further. Recent years have brought new and exciting changes with the advent of natural orifice transluminal endoscopic surgery. With the evolution of this field of surgery come challenges in the development of new instruments and the actual steps of the procedure. Included in these challenges is the idea of developing a proficiency-based curriculum for training.

New stent design for use in small coronary arteries during percutaneous coronary intervention

Directory of Open Access Journals (Sweden)

Juan F Granada

2010-10-01

Full Text Available Juan F Granada1, Barbara A Huibregtse2, Keith D Dawkins21The Jack H Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY, USA; 2Boston Scientific Corporation, Natick, MA, USAAbstract: Patients with diabetes mellitus, of female gender, increased age, and/or with peripheral vascular disease often develop coronary stenoses in small caliber vessels. This review describes treatment of these lesions with the paclitaxel-eluting 2.25 mm TAXUS® Liberté® Atom™ stent. Given the same stent composition, polymer, antirestenotic drug (paclitaxel, and release kinetics as the first-generation 2.25 mm TAXUS® Express® Atom™ stent, the second-generation TAXUS Liberté Atom stent incorporates improved stent design characteristics, including thinner struts (0.0038 versus 0.0052 inches, intended to increase conformability and deliverability. In a porcine noninjured coronary artery model, TAXUS Liberté Atom stent implantation in small vessels demonstrated complete strut tissue coverage compared with the bare metal stent control, suggesting a similar degree of tissue healing between the groups at 30, 90, and 180 days. The prospective, single-armed TAXUS ATLAS Small Vessel trial demonstrated improved instent late loss (0.28 ± 0.45 versus 0.84 ± 0.57 mm, P < 0.001, instent binary restenosis (13.0% versus 38.1%, P < 0.001, and target lesion revascularization (5.8% versus 17.6%, P < 0.001 at nine months with the TAXUS Liberté Atom stent as compared with the bare metal Express stent control, with similar safety measures between the two groups. The TAXUS Liberté Atom also significantly reduced nine-month angiographic rates of both instent late loss (0.28 ± 0.45 versus 0.44 ± 0.61 mm, P = 0.03 and instent binary restenosis (13.0% versus 25.9%, P = 0.02 when compared with the 2.25 mm TAXUS Express Atom control. The observed reduction in target lesion revascularization with the TAXUS

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.

Science.gov (United States)

Beschorner, Ulrich; Krankenberg, Hans; Scheinert, Dierk; Sievert, Horst; Tübler, Thilo; Sixt, Sebastian; Noory, Elias; Rastan, Aljoscha; Macharzina, Roland; Zeller, Thomas

2013-03-01

To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex. Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.