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Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.

Abstract：

BACKGROUND:There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. METHODS:A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients. RESULTS:The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P(non-inf) < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38). CONCLUSIONS:Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.

journal_name

J Interv Cardiol

journal_title

Journal of interventional cardiology

authors

Żurakowski A,Buszman PP,Milewski KP,Janas A,Gorycki B,Kondys M,Gąsior P,Michalak M,Boxberger M,Peppas A,Granada JF,Buszman PE

doi

10.1111/joic.12210

subject

Has Abstract

pub_date

2015-08-01 00:00:00

pages

348-57

issue

eissn

0896-4327

issn

1540-8183

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.