Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.
Centre for Outcomes Research, McGill University Health Centre-Research Institute, Montreal, Quebec, Canada.
Can J Cardiol. 2020 Nov;36(11):1805-1814. doi: 10.1016/j.cjca.2020.01.019. Epub 2020 Jan 25.
Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.
The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy.
A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials.
We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.
经皮冠状动脉介入治疗用于恢复梗死相关冠状动脉的血流，随后立即进行支架置入以防止再闭塞。置入富含血栓的动脉中的支架会导致远端栓塞，这反而会损害心肌再灌注和心室功能。在急性 ST 段抬高型心肌梗死（STEMI）患者中，延迟支架置入的策略是否能改善结局尚不确定。
原发性再灌注后支架置入（PRIMACY）是一项贝叶斯前瞻性、随机、开放标签、盲终点试验，比较了 STEMI 患者即刻与延迟支架置入在 9 个月时预防心血管死亡、非致死性心肌梗死、心力衰竭或计划外靶血管血运重建的效果。所有患者均立即再灌注，但随机分配至延迟支架置入组的患者在 24 至 48 小时后进行支架置入。在此期间，使用抗凝血酶治疗来减轻血栓负荷。在主要的贝叶斯分层随机效应分析中，来自可交换试验的数据将被合并到一个预先研究中，并根据 PRIMACY 更新后进行后验概率分析。
2014 年 4 月至 2017 年 9 月，在法国和加拿大的 15 个中心共随机分配了 305 名患者。基线时，患者的中位年龄为 59 岁，81%为男性，3%有经皮冠状动脉介入治疗史。PRIMACY 的结果将来自于在英国的延迟支架置入治疗急性心肌梗死 3 期（DEFER）、法国的最小化即刻机械干预（MIMI）、丹麦急性心肌梗死 3 期（DANAMI-3）和韩国的即刻支架置入与延迟支架置入对 ST 段抬高型心肌梗死患者梗死面积和微血管灌注影响（INNOVATION）试验中纳入的 1568 名患者的个体水平数据进行更新。
我们预计能够明确在 STEMI 患者中，与即刻支架置入相比，延迟支架置入是否能更安全地减少不良心血管终点事件的发生。
