Department of Clinical and Experimental Medicine, Policlinic "G. Martino," University of Messina, Messina, Italy; Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.
J Am Coll Cardiol. 2019 Feb 26;73(7):741-754. doi: 10.1016/j.jacc.2018.11.048.
Complex percutaneous coronary intervention (PCI) is associated with higher ischemic risk, which can be mitigated by long-term dual antiplatelet therapy (DAPT). However, concomitant high bleeding risk (HBR) may be present, making it unclear whether short- or long-term DAPT should be prioritized.
This study investigated the effects of ischemic (by PCI complexity) and bleeding (by PRECISE-DAPT [PREdicting bleeding Complications in patients undergoing stent Implantation and SubsequEnt Dual AntiPlatelet Therapy] score) risks on clinical outcomes and on the impact of DAPT duration after coronary stenting.
Complex PCI was defined as ≥3 stents implanted and/or ≥3 lesions treated, bifurcation stenting and/or stent length >60 mm, and/or chronic total occlusion revascularization. Ischemic and bleeding outcomes in high (≥25) or non-high (<25) PRECISE-DAPT strata were evaluated based on randomly allocated duration of DAPT.
Among 14,963 patients from 8 randomized trials, 3,118 underwent complex PCI and experienced a higher rate of ischemic, but not bleeding, events. Long-term DAPT in non-HBR patients reduced ischemic events in both complex (absolute risk difference: -3.86%; 95% confidence interval: -7.71 to +0.06) and noncomplex PCI strata (absolute risk difference: -1.14%; 95% confidence interval: -2.26 to -0.02), but not among HBR patients, regardless of complex PCI features. The bleeding risk according to the Thrombolysis In Myocardial Infarction scale was increased by long-term DAPT only in HBR patients, regardless of PCI complexity.
Patients who underwent complex PCI had a higher risk of ischemic events, but benefitted from long-term DAPT only if HBR features were not present. These data suggested that when concordant, bleeding, more than ischemic risk, should inform decision-making on the duration of DAPT.
复杂经皮冠状动脉介入治疗（PCI）与较高的缺血风险相关，可通过长期双联抗血小板治疗（DAPT）来减轻。然而，可能存在同时高出血风险（HBR），因此不清楚是应优先考虑短期还是长期 DAPT。
本研究探讨了缺血（由 PCI 复杂性决定）和出血（由 PRECISE-DAPT [预测支架植入和随后双联抗血小板治疗患者出血并发症]评分决定）风险对临床结果的影响，并探讨了冠状动脉支架置入后 DAPT 持续时间的影响。
复杂 PCI 定义为植入≥3 个支架和/或治疗≥3 个病变、分叉支架和/或支架长度>60mm 和/或慢性完全闭塞血运重建。根据随机分配的 DAPT 持续时间，评估高（≥25）或非高（<25）PRECISE-DAPT 分层中缺血和出血结局。
在来自 8 项随机试验的 14963 例患者中，3118 例患者接受了复杂 PCI，其缺血事件发生率较高，但出血事件发生率没有增加。在非 HBR 患者中，长期 DAPT 降低了复杂（绝对风险差异：-3.86%；95%置信区间：-7.71 至 0.06）和非复杂 PCI 分层（绝对风险差异：-1.14%；95%置信区间：-2.26 至 -0.02）中的缺血事件，但在 HBR 患者中则没有，无论其是否存在复杂 PCI 特征。根据心肌梗死溶栓治疗（Thrombolysis In Myocardial Infarction）量表，长期 DAPT 仅增加了 HBR 患者的出血风险，而与 PCI 复杂性无关。
接受复杂 PCI 的患者缺血事件风险较高，但如果不存在 HBR 特征，则仅从长期 DAPT 中获益。这些数据表明，在两者一致时，出血风险应比缺血风险更能影响 DAPT 持续时间的决策。
