One-month dual antiplatelet therapy following stent implantation in patients with acute coronary syndromes and high bleeding risk

Abstract

Abstract Background/introduction There is a paucity of data regarding the safety of a one-month dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). Purpose We aimed to compare the clinical outcomes of patients at HBR with ACS or chronic coronary syndromes (CCS) treated with PCI using bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT. Methods This is a pre-specified sub-analysis of the POEM trial, an interventional, prospective, multicenter, single-arm trial, that evaluated the safety of PCI with bioresorbable-polymer everolimus-eluting stent followed by one-month DAPT in patients with HBR against an objective performance criterion (OPC). The OPC was derived from the reported 1-year primary endpoint rate of 9.4% observed in the LEADERS FREE trial. According to the POEM protocol, patients were treated with one-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for one month, followed by oral anticoagulation only after that. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Results 263 (59.4%) patients with CCS and 180 (40.6%) patients with ACS were included. Most of the HBR inclusion criteria were comparable between the two groups, Figure 1. At one year, the rates of the primary outcome were 4.3% (95% CI, 2.4-7.6%) and 5.7% (95% CI, 3.1-10.3%) among patients with CCS and ACS, respectively. Both 1-sided 97.5% upper confidence limits of the risk difference between the primary outcome and the prespecified OPC of 9.4% were below the non-inferiority margin of 3.85 % (CCS: -1.8 %; ACS: 0.9 %), Figure 2. No significant difference was evident between CCS and ACS patients for each isolated component of the primary endpoint (cardiac death: 1.7% vs. 2.0%, p= 0.857; myocardial infarction: 3.9% vs. 3.1%, p= 0.934; definite/probable stent thrombosis: 1.2% vs. 0.8%, p= 0.689). The risk for Bleeding Academic Research Consortium (BARC) type 1-5 or type 3-5 bleedings was also similar between CCS and ACS patients (4.3% vs. 5.2%, p=0.677, and 1.6% vs. 2.9%, p=0.351, respectively). Conclusions Among HBR patients with ACS who underwent PCI with BP-EES, a one-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared to those with CCS. These findings support the hypothesis that DAPT should be tailored to patients’ bleeding risk profiles and that a one-month strategy might be safely applied also in a particular setting of ACS.Figure 1.HBR inclusion criteria.Figure 2.Primary endpoint analysis.