Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E213-E221. doi: 10.1002/ccd.29650. Epub 2021 Mar 22.
We aimed to assess the ischemic and bleeding risks of single antiplatelet therapy (SAPT) with prasugrel compared with standard dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel for 1 year) in patients with chronic coronary syndrome (CCS) treated with new generation drug-eluting stents (DES).
To date, data on SAPT with potent P2Y12 inhibitors in the absence of aspirin immediately after PCI are limited.
Between January 2009 and November 2019, all CCS patients undergoing percutaneous coronary intervention (PCI) enrolled to the Bern PCI registry were considered for analysis. We performed propensity score matching in a 1:4 fashion to compare patients who received SAPT with prasugrel versus standard DAPT. The primary ischemic endpoint was a composite of cardiovascular death, myocardial infarction, and stroke and the primary bleeding endpoint was BARC 3 or 5 bleeding, both assessed at 1 year.
After propensity score matching, the final study population consisted of 225 patients with SAPT and 889 with DAPT. There was no significant difference in rates of the primary ischemic (5.2% vs. 4.2%, p = .50) or the primary bleeding (1.5% vs. 2.0%, p = .60) endpoints between groups. SAPT was not associated with an increased risk of definite stent thrombosis (0.9% vs. 0.8%, p = .83).
Among selected CCS patients undergoing PCI with DES, SAPT with prasugrel was not associated with an excess of ischemic events compared with standard DAPT. No difference in bleeding was observed either. The results may serve as the basis for larger trials assessing the potential benefits and risks of SAPT.
我们旨在评估新型药物洗脱支架（DES）置入后，与标准双联抗血小板治疗（DAPT，阿司匹林联合氯吡格雷治疗 1 年）相比，使用普拉格雷进行单药抗血小板治疗（SAPT）的缺血和出血风险，治疗慢性冠脉综合征（CCS）患者。
迄今为止，关于 PCI 术后即刻停用阿司匹林的强效 P2Y12 抑制剂进行 SAPT 的数据有限。
2009 年 1 月至 2019 年 11 月，我们对参与 Bern PCI 注册登记研究的所有 CCS 经皮冠状动脉介入治疗（PCI）患者进行了分析。我们采用 1:4 的倾向评分匹配法比较了接受 SAPT 与普拉格雷与标准 DAPT 的患者。主要缺血终点为心血管死亡、心肌梗死和卒中和主要出血终点（BARC 3 或 5 级出血）的复合终点，均在 1 年时评估。
经倾向评分匹配后，最终研究人群包括 225 例 SAPT 患者和 889 例 DAPT 患者。两组间主要缺血（5.2% vs. 4.2%，p=0.50）或主要出血（1.5% vs. 2.0%，p=0.60）终点发生率无显著差异。SAPT 与明确的支架血栓形成（0.9% vs. 0.8%，p=0.83）风险增加无关。
在接受 DES 置入的 CCS 患者中，与标准 DAPT 相比，SAPT 应用普拉格雷不会导致缺血事件增加。也没有观察到出血方面的差异。这些结果可以为评估 SAPT 的潜在获益和风险的更大规模试验提供依据。
