Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

التفاصيل البيبلوغرافية
العنوان:	Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.
المؤلفون:	Nowakowski P; Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.; University of Technology, Katowice, Poland., Uchto W; Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland., Hrycek E; Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.; Andrzej Frycz-Modrzewski, Kraków University, Kraków, Poland., Kachel M; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Ludyga T; EuroMedic Cardiovascular Center, Katowice, Poland., Polczyk F; EuroMedic Cardiovascular Center, Katowice, Poland., Żurakowski A; Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.; Andrzej Frycz-Modrzewski, Kraków University, Kraków, Poland., Kaźmierczak P; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Granada JF; Skirbal Center for Innovation, Cardiovascular Research Foundation, Orangeburg, NY, USA., Nowakowska I; Department of Balneoclimatology and Biological Regeneration, Chair of Physiotherapy, School of Health Sciences, Medical University of Silesia, Katowice, Poland., Kiesz RS; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.; San Antonio Heart and Endovascular Institute, San Antonio, TX, USA., Milewski KP; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Buszman PE; Department of Epidemiology, Medical University of Silesia, Katowice, Poland., Buszman PP; Andrzej Frycz-Modrzewski, Kraków University, Kraków, Poland.; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland.
المصدر:	Vascular medicine (London, England) [Vasc Med] 2021 Aug; Vol. 26 (4), pp. 401-408. Date of Electronic Publication: 2021 Mar 09.
نوع المنشور:	Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: SAGE Publications Country of Publication: England NLM ID: 9610930 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0377 (Electronic) Linking ISSN: 1358863X NLM ISO Abbreviation: Vasc Med Subsets: MEDLINE
أسماء مطبوعة:	Publication: London : SAGE Publications Original Publication: London, UK : Letchworth, Hertfordshire, UK : Arnold ; Turpin Distribution Services, c1996-
مواضيع طبية MeSH:	Angioplasty, Balloon/adverse effects , Cardiovascular Agents/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/etiology , Peripheral Arterial Disease*/therapy, Coated Materials, Biocompatible ; Femoral Artery/diagnostic imaging ; Humans ; Paclitaxel/adverse effects ; Popliteal Artery/diagnostic imaging ; Prospective Studies ; Treatment Outcome ; Vascular Patency
مستخلص:	The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; p sup < 0.01). Binary restenosis occurred in 23% vs 52% of patients ( p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065 .
فهرسة مساهمة:	Keywords: drug-eluting balloon; femoropopliteal disease; innovation; paclitaxel
سلسلة جزيئية:	ClinicalTrials.gov NCT02145065
المشرفين على المادة:	0 (Cardiovascular Agents) 0 (Coated Materials, Biocompatible) P88XT4IS4D (Paclitaxel)
تواريخ الأحداث:	Date Created: 20210309 Date Completed: 20220309 Latest Revision: 20220309
رمز التحديث:	20221213
DOI:	10.1177/1358863X20988360
PMID:	33686879
قاعدة البيانات:	MEDLINE

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تدمد:	1477-0377
DOI:	10.1177/1358863X20988360