Rabin MC Tel-Aviv Israel.
Faculty of Medicine, Tel-Aviv University Tel Aviv Israel.
J Am Heart Assoc. 2024 Jan 16;13(2):e029051. doi: 10.1161/JAHA.122.029051. Epub 2024 Jan 12.
BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.
背景：接受经皮冠状动脉介入治疗的患者通常被认为存在高出血风险（HBR）。与裸金属支架相比，药物洗脱支架在 HBR 患者中的表现更为出色，即使患者接受了缩短的双联抗血小板治疗（DAPT）。尚未对 EluNIR 雷帕霉素洗脱支架进行短 DAPT 评估。本研究旨在评估在 HBR 患者中植入雷帕霉素洗脱支架后缩短 DAPT 时间的安全性和有效性。
方法和结果：这是一项前瞻性、多中心、双边、单臂、开放性试验。根据 LEADERS-FREE（前瞻性随机比较生物自由雷帕霉素 A9 药物涂层支架与 Gazelle 裸金属支架在高出血风险患者中的疗效）试验标准，患者被定义为 HBR。经皮冠状动脉介入治疗后，稳定型心绞痛患者接受 DAPT 治疗 1 个月。对于急性冠脉综合征患者，DAPT 治疗时间为 1 至 3 个月，由研究者决定。主要终点是 1 年内（学术研究联合会确定和可能）的心脏死亡、心肌梗死或支架血栓形成的复合终点。共纳入 315 例接受经皮冠状动脉介入治疗的患者，其中 56.4%为急性冠脉综合征患者；33.7%正在接受口服抗凝治疗。在 1 年时，15 例患者（4.9%）发生主要终点事件，达到了 14.1%（<0.0001）的预设性能目标。2 例患者（0.6%）发生支架血栓形成（学术研究联合会确定和可能）。6 例患者（1.9%）发生出血学术研究联合会 3 型和 5 型出血。
结论：我们观察到接受雷帕霉素洗脱支架经皮冠状动脉介入治疗且接受缩短 DAPT 的 HBR 患者有良好的结果，包括较低的缺血事件发生率和较低的支架血栓形成发生率。
J Am Heart Assoc. 2024-1-16
Circ Cardiovasc Interv. 2024-10
JACC Cardiovasc Interv. 2021-9-13
N Engl J Med. 2020-2-12
Zotero 插件
