Abstract
Abstract Background The respective ischemic and bleeding risks of early aspirin discontinuation following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) remains uncertain. Objectives To evaluate the safety and efficacy of early aspirin discontinuation in ACS or PCI patients treated with P2Y12 inhibitors with or without anticoagulants. Methods We performed a review of randomized controlled trials (RCTs) comparing a P2Y12 inhibitor-based single antiplatelet strategy following early aspirin discontinuation to a strategy of sustained dual antiplatelet therapy (DAPT) in ACS or PCI patients requiring or not anticoagulation for another indication. The primary safety endpoint was major bleeding while non-major bleeding and all bleeding were secondary safety endpoints. The primary efficacy endpoint was all-cause mortality while secondary efficacy endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarction (MI), definite stent thrombosis (ST) or any stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. The study is registered in PROSPERO (CRD42019139576). Results We included 9 RCTs comprising 40,621 patients.Compared to prolonged DAPT, major bleeding (2.2% vs. 2.8%; RR 0.68; 95% CI: 0.54 to 0.87; p=0.002; I2: 63%), non-major bleeding (5.0% vs. 6.1%; RR: 0.66; 95% CI: 0.47 to 0.94; p=0.02; I2:87%) and all bleeding (7.4% vs. 9.9%; RR: 0.65; 95% CI: 0.53 to 0.79; p<0.0001; I2: 88%) were significantly reduced with early aspirin discontinuation (Figure 1), without significant difference for all-cause death (p=0.60), MACCE (p=0.60), MI (p=0.77), definite ST (p=0.63), and any stroke (p=0.59). Results were consistent in patients with or without anticoagulation, without significant interaction for any outcomes but MI (p=0.04). Conclusions In patients on DAPT after an ACS or a PCI, early aspirin discontinuation prevents bleeding events with no effect on the ischemic risk or mortality. Figure 1. Central illustration Funding Acknowledgement Type of funding source: None
Highlights
The optimal antithrombotic regimen following acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) has known considerable evolutions over the last thirty years
A total of nine randomized controlled trials (RCTs) were included in the present meta-analysis (Supplementary Figure S1), comprising 40,621 patients of whom 20,320 (50%) were treated with a strategy of early aspirin discontinuation
Characteristics are detailed in Table 2, and procedural characteristics are detailed in Supplementary
Summary
The optimal antithrombotic regimen following ACS or PCI has known considerable evolutions over the last thirty years. Implementation of newer generation drug-eluting stents (DES), the widespread use of lipid lowering therapy, and a new generation of P2Y12 inhibitors have led to a reduction of ST or non-stent related MI following PCI or ACS [4,5] In these circumstances, the benefit of sustained DAPT may translate into a smaller absolute ischemic event risk reduction, which might be potentially outweighed by the associated higher risk of bleeding [6]. Since aspirin yields limited additional platelet inhibition when associated with P2Y12 inhibitors, aspirin-free strategies have been evaluated in several recent randomized controlled trials enrolling ACS or PCI patients; in some of these studies patients had an indication for chronic oral anticoagulation (OAC) [7,8,9,10,11,12,13,14,15,16,17,18,19]. This systematic review and meta-analysis aims to evaluate the safety and efficacy of early aspirin discontinuation with P2Y12 inhibitors single antiplatelet therapy continuation, as compared with a strategy of sustained DAPT following an ACS or PCI, in patients with or without concomitant OAC treatment
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