scholarly journals Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome or Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Author(s):  
Yuttana Wonngsalap ◽  
Supakorn Ungsriwong ◽  
Wanalee Kumtepm ◽  
Surasak Saokaew ◽  
Vichai Senthong ◽  
...  

Abstract Purpose To assess the efficacy and safety of prasugrel at low doses compared to clopidogrel by looking at the occurrence of major adverse cardiac events (MACE) and major bleeding in patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). Methods We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for eligible randomized controlled trials (RCTs) and observational studies assessing efficacy and safety of low-dose prasugrel versus clopidogrel in patients with ACS or undergoing PCI up to May 22, 2020. We did a meta-analysis using a random-effects model to estimate relative risks (RRs). The primary efficacy and safety endpoints were MACE and major bleeding, respectively. Results Six RCTs (n = 6,131) and six observational studies (n = 31,426) were included. There was no MACE reduction in patients receiving low-dose prasugrel compared with those receiving clopidogrel (RR 1.02, 95%CI 0.91 to 1.14), but there was an increased risk of major bleeding (RR 1.35, 95%CI 1.10 to 1.67). Conclusions Low-dose prasugrel yields no increase in efficacy when compared with clopidogrel, but it does expose patients to an increased risk of bleeding. Most studies considered here were conducted in Japan. Studies conducted with non-Asian patients may find that low-dose prasugrel offers a more favorable efficacy and risk profile. Considering the results of this analysis we believe low-dose prasugrel should be prescribed with extreme caution as it may result in bleeding events without any additional benefit over clopidogrel.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Guedeney ◽  
J Mesnier ◽  
S Sorrentino ◽  
F Abcha ◽  
M Zeitouni ◽  
...  

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


2020 ◽  
Author(s):  
Yi Xu ◽  
Yimin Shen ◽  
Pengfei Zhao ◽  
Yuanyuan Han ◽  
Jun Jiang

Abstract Background: This network meta-analysis was committed to evaluating the efficacy and safety of different dual antiplatelet therapies (DAPTs) after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs).Methods: Randomized controlled trials (RCTs) comparing two of the following DAPT strategies: long-term (>12 months) DAPT (L-DAPT), 12-months DAPT (DAPT 12Mo), short-term (≤6 months) DAPT followed by aspirin monotherapy (S-DAPT+ASA), short-term DAPT followed by a P2Y12 receptor inhibitor monotherapy (S-DAPT+P2Y12) were searched. Primary outcomes were all-cause mortality, cardiac death, myocardial infarction (MI), stroke, major bleeding, any bleeding, definite or probable stent thrombosis (ST). This Bayesian network meta-analysis was performed with the random-effects model.Results: Twenty-four RCTs (n=81,376) were included. L-DAPT increased the risk of major bleeding (OR 2.37, 95%CI 1.32-5.03 compared with S-DAPT+P2Y12) and any bleeding (OR 2.95, 95%CI 1.91-4.34 compared with S-DAPT+P2Y12). When compared with L-DAPT, DAPT 12Mo (OR 1.54, 95%CI 1.13-2.02) and DAPT+ASA (OR 1.67, 95%CI 1.22-2.19) were associated with higher rates of MI, but S-DAPT+P2Y12 obtained no statistical difference. The sensitivity analysis revealed that the risks of major bleeding and any bleeding further increased for ≥18 months of DAPT. In the subgroup analysis, short-term DAPT (S-DAPT) presented similar efficacy and safety to DAPT 12Mo for patients with the acute coronary syndrome (ACS), and lower risks of major bleeding and all-cause mortality were observed in S-DAPT+P2Y12 among patients with newer-generation DES.Conclusions: S-DAPT+P2Y12 presented superiority in patients with all clinical presentations, for a lower risk of bleeding and not associated with increased ischemic harm. Besides, prospective research between aspirin monotherapy and P2Y12 monotherapy was required.


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