Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation: Cardiovascular Interventions Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI:10.1161/CIRCINTERVENTIONS.123.013735

Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati

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引用次数: 0

Abstract

Background: Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.

Methods: Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.

Results: A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; P=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; P_{noninferiority}=0.07).

Conclusions: In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.

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COBRA PzF 支架植入术缩短三联疗法时间的随机试验：COBRA-REDUCE试验。

背景：有口服抗凝适应症并接受经皮冠状动脉介入治疗的患者需要同时接受口服抗凝和抗血小板治疗。使用具有抗血栓和促进愈合涂层的冠状动脉支架可以缩短双重抗血小板疗法（DAPT）的持续时间，同时不会增加血栓栓塞事件的风险：接受经皮冠状动脉介入治疗的有口服抗凝适应症的患者被随机分配到使用COBRA polyzene F (PzF)支架，然后进行14天的DAPT治疗，或使用食品药品管理局批准的新一代药物洗脱支架，然后进行3个月或6个月的DAPT治疗。出血的主要终点是 14 天后（或出院后）至 6 个月的出血学术研究联合会类型≥2。血栓栓塞共同主要终点为 6 个月时全因死亡、心肌梗死、明确或可能的支架血栓或缺血性卒中的复合终点。试验假设是，COBRA PzF 支架策略在出血事件方面更具优势，在血栓栓塞事件方面不具劣势：共有996名患者接受了随机分组。COBRA PzF 组 475 例患者中有 37 例（7.8%）出现出血终点，对照组 482 例患者中有 47 例（9.8%）出现出血终点（差异为-2.0 [95% CI，-5.6 至 1.6]；P=0.14）。COBRA PzF治疗组492例患者中有37例（7.5%）出现血栓栓塞终点，对照组490例患者中有24例（4.9%）出现血栓栓塞终点（差异为2.6%；预设非劣效边际为5%，差异的单侧95% CI上限为5.2%；P=0.07）：结论：对于有口服抗凝适应症的经皮冠状动脉介入治疗患者，使用COBRA PzF支架加14天DAPT治疗与使用美国食品药品管理局批准的标准药物洗脱支架加3至6个月DAPT治疗相比，在出血事件方面没有优越性，在6个月血栓栓塞事件方面也没有非劣效性：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02594501。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.