COBRA PzF 支架置入减少三联疗法持续时间的随机试验：COBRA-REDUCE 试验。
Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.
机构信息
Cardiovascular Research Institute, Mater Private Network, Dublin, Ireland (R.A.B., R.C., J.J.C.).
School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin (R.A.B., R.C., J.J.C.).
出版信息
Circ Cardiovasc Interv. 2024 Oct;17(10):e013735. doi: 10.1161/CIRCINTERVENTIONS.123.013735. Epub 2024 Oct 15.
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]; =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%; =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.
背景
需要口服抗凝治疗的经皮冠状动脉介入治疗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联抗血小板治疗（DAPT）的时间，而不会增加血栓栓塞事件的风险。
方法
经皮冠状动脉介入治疗适应证为口服抗凝的患者随机分为 COBRA 聚醚砜 F（PzF）支架治疗组，随后接受 14 天 DAPT 治疗，或接受食品和药物管理局批准的新一代药物洗脱支架治疗组，随后接受 3 或 6 个月 DAPT 治疗。主要出血复合终点是 14 天后（或出院后）至 6 个月时 Bleeding Academic Research Consortium 类型≥2 的出血。主要血栓栓塞复合终点是 6 个月时全因死亡、心肌梗死、明确或可能的支架血栓形成或缺血性卒中的复合终点。试验假设 COBRA PzF 支架策略在出血事件方面更优，在血栓栓塞事件方面非劣效。
结果
共 996 例患者接受随机分组。COBRA PzF 组 475 例患者中有 37 例（7.8%）发生出血终点事件，对照组 482 例患者中有 47 例（9.8%）（差值-2.0[95%CI，-5.6 至 1.6]；=0.14）。COBRA PzF 组 492 例患者中有 37 例（7.5%）发生血栓栓塞终点事件，对照组 490 例患者中有 24 例（4.9%）（差值 2.6%；预先设定的非劣效性边界为 5%，差异单侧 95%CI 上限为 5.2%；=0.07）。
结论
在需要口服抗凝治疗的经皮冠状动脉介入治疗患者中，与标准食品和药物管理局批准的药物洗脱支架加 3 至 6 个月 DAPT 相比，COBRA PzF 支架加 14 天 DAPT 治疗在出血事件方面并不更优，在 6 个月时血栓栓塞事件方面也不非劣效。
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