Protocol for systematic review and meta-analysis on randomized clinical trials for direct oral anticoagulant in subjects with acute coronary syndrome

Background: Recently, direct oral anticoagulant (DOAC) has been projected for secondary prevention of recurrent ischemic events post-acute coronary syndrome (ACS). The addition of a DOAC to the antiplatelet regimen of subjects with the ACS is clinically practiced in candidates where compelling anticoagulation is indicated by high thromboembolic risk. The current evidence provides approved compelling indication for the DOAC, particularly for rivaroxaban which bears the strongest existing evidence. Objective: We intend to assess the role of DOAC in addition to single or dual antiplatelet therapy in subjects with ACS. We will compare the clinical characteristics and explore the efficacy and safety of the DOAC class members (apixaban, betrixaban, dabigatran, edoxaban and rivaroxaban) in terms of reduction in ischemic events in subjects with ACS (ST-segment elevation myocardial infarction [STEMI] or non–ST-segment elevation [NSTEMI]) or subjects who underwent percutaneous coronary intervention (PCI) and or ACS and coexisting atrial fibrillation (AF). Methods: Relevant data will be searched on known data-bases such as Embase, Google Scholar, the Cochrane Central, and PubMed. The trials included will be randomized controlled trials from 2009 to 2022. Subjects will be receiving DOAC for ACS were evaluated for inclusion. The extraction, synthesis, quality, and validity of data will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The risk of bias tool, version 2.0 (Cochrane) will be used for risk of bias assessment. Data will be pooled using random-effects models. The primary outcome measure will be efficacy end point (composite of cardiovascular death, myocardial infarction, and stroke), while the safety outcome will be minor/major bleeding. (AU)

The Role of Direct Oral Anticoagulant in Patients with Acute Coronary Syndrome on Single or Dual Antiplatelet Regime: Review of Opportunities and Challenges.

BACKGROUND: Despite the developments of single or dual antiplatelet therapy consisting of aspirin and/or clopidogrel, prasugrel or ticagrelor, post-acute coronary syndrome a room for potential improvement towards optimal prevention persist. The addition of a direct oral anticoagulant to the antiplatelet treatment of patients with the acute coronary syndrome is clinically practiced in cases where anticoagulation is indicated by high thromboembolic risk. OBJECTIVE: The main objective of this review was to explore the role of supplementation with a direct oral anticoagulant to antiplatelet (aspirin or P2Y12 inhibitor) in patients with the acute coronary syndrome. METHODS: We have searched the Medline for studies involving direct oral anticoagulant use in acute coronary syndrome. We have reviewed specific relevant 9 meta-analyses between the years 2012 to 2019. RESULTS: Our review of nine meta-analyses has revealed that the addition of direct oral anticoagulant to antiplatelet therapy compared with antiplatelet alone was beneficial about the composite endpoints of major ischemic events in patients with the acute coronary syndrome. Furthermore, the combined regimen of single antiplatelet plus direct oral anticoagulant is as effective as the triple regimen of dual antiplatelet plus direct oral anticoagulant and results in less bleeding. CONCLUSION: Cardiologists should balance the efficacy with a higher risk of bleeding with more intensified DOAC therapy. Better risk characterization and timely adaptation of the regime to the patient's need should be tested. Recurrent ischemic events and bleeding event risk scoring should guide individualized treatment.