Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

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• 作者：Koen Teeuwen ; MD^a ; ^{k.teeuwen@gmail.com} ; René ; J. van der Schaaf ; MD ; PhD^b ; Tom Adriaenssens ; MD ; PhD^c ; Jacques J. Koolen ; MD ; PhD^d ; Pieter C. Smits ; MD ; PhD^e ; José ; P.S. Henriques ; MD ; PhD^f ; Paul H.M.J. Vermeersch ; MD ; PhD^g ; R. Melvyn Tjon Joe Gin ; MD^h ; Bastiaan E. Schö ; lzel ; MD ; PhDⁱ ; Johannes C. Kelder ; MD ; PhD^j ; Jan G.P. Tijssen ; PhD^k ; Pierfrancesco Agostoni ; MD ; PhD^a ; Maarten J. Suttorp ; MD ; PhD^a
• 关键词：biodegradable polymer ; chronic total occlusion ; drug-eluting stent(s) ; percutaneous coronary intervention
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2017
• 出版时间：23 January 2017
• 年：2017
• 卷：10
• 期：2
• 页码：133-143
• 全文大小：892 K
• 卷排序：10

文摘

The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups.ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.