Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (S. Sorrentino, S. Sartori, U.B., B.E.C., G.G., J.C., J.C., P.G., G.D., B.V., A.S.K., R.M.).
Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy (S. Sorrentino).
Circ Cardiovasc Interv. 2020 Apr;13(4):e008226. doi: 10.1161/CIRCINTERVENTIONS.119.008226. Epub 2020 Mar 27.
Whether the underlying risk of bleeding influences the associations between patterns of dual antiplatelet therapy (DAPT) cessation and adverse events after percutaneous coronary intervention is unknown.
Patients enrolled in the prospective, international, multicenter PARIS registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients) were categorized according to their risk of bleeding using the PARIS bleeding risk score. We evaluated the incidence, patterns, and association between modes of DAPT cessation and outcomes across bleeding risk groups. Modes of DAPT cessations were defined as physician-guided DAPT discontinuation, brief interruption (<14 days) or disruption for bleeding, or noncompliance. The primary end point of interest was major adverse cardiac events, defined as the composite of cardiac death, myocardial infarction, or definite-probable stent thrombosis.
From a total of 5018 patients, 513 (10.2%) were classified as high, 2058 (41.0%) as intermediate, and 2447 (48.8%) as low risk for bleeding. High bleeding risk (HBR) patients were older and had greater prevalence of comorbidities. Compared with non-HBR, HBR patients had higher rates of both ischemic and bleeding events. The cumulative incidence of DAPT cessation was higher in HBR patients, mostly driven by physician-guided discontinuation and disruption. Of note, DAPT disruption occurred in 17.7%, 10.4%, and 7.8% at 1 year and 22.0%, 15.1%, and 12.0% at 2 years (<0.0001) in high, intermediate, and low bleeding risk groups, respectively. Physician-guided DAPT discontinuation was not associated with increased risk of major adverse cardiac events in both HBR and non-HBR patients, while DAPT disruption was associated with an increased risk of major adverse cardiac events across all bleeding risk groups. There was no interaction between bleeding risk status and clinical outcomes for any cessation mode.
Patients at HBR remain at higher risk of adverse events. Disruption of DAPT is associated with an increased risk of major adverse cardiac events irrespective of the underlying bleeding risk. Physician-guided discontinuation of DAPT appears to be safe, irrespective of HBR.
尚不清楚出血风险是否会影响经皮冠状动脉介入治疗（PCI）后双联抗血小板治疗（DAPT）停药模式与不良事件之间的关联。
根据 PARIS 出血风险评分，将前瞻性、国际性、多中心 PARIS 注册研究（支架置入患者抗血小板治疗方案不依从模式）中的患者分为出血风险分层。我们评估了不同出血风险分层患者中 DAPT 停药模式的发生率、模式及与结局之间的关联。DAPT 停药模式定义为医生指导的 DAPT 停药、短暂中断（<14 天）或因出血而中断、或不遵医嘱。主要终点是主要不良心脏事件，定义为心脏死亡、心肌梗死或明确/可能的支架血栓形成的复合终点。
在总共 5018 例患者中，513 例（10.2%）为高出血风险，2058 例（41.0%）为中出血风险，2447 例（48.8%）为低出血风险。高出血风险（HBR）患者年龄较大，且合并症发生率更高。与非 HBR 患者相比，HBR 患者的缺血和出血事件发生率均更高。HBR 患者的 DAPT 停药累积发生率更高，主要是由于医生指导的停药和中断。值得注意的是，1 年时高、中、低出血风险组的 DAPT 中断发生率分别为 17.7%、10.4%和 7.8%，2 年时分别为 22.0%、15.1%和 12.0%（<0.0001）。在 HBR 和非 HBR 患者中，医生指导的 DAPT 停药与主要不良心脏事件风险增加无关，而 DAPT 中断与所有出血风险分层患者的主要不良心脏事件风险增加有关。任何停药模式均不存在出血风险分层与临床结局之间的交互作用。
HBR 患者仍面临更高的不良事件风险。DAPT 的中断与主要不良心脏事件风险增加相关，而与基础出血风险无关。医生指导的 DAPT 停药似乎是安全的，与 HBR 无关。
