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

• Israa Y El- Khidir ^[3] ; Asim Ahmed Elnour ^[4] ; Abdulla Al Amoodi ^[5] ; Abrar Ayad Alrashdi ^[1] ; Haifa Hamoud Almansour ^[1] ; Teif Abdulkarim Almarwani ^[1] ; Shahad Fayad Alrwili ^[1] ; Shahad Fayad Alrowaili ^[1] ; Shouq Lutfi Al Khudhairy ^[6] ; Asma Faisal Alshammari ^[1] ; Adel Sadeq ^[7] ; Nadia Al Mazrouei ^[2] ; Khalid Awad Al-Kubaisi ^[8] ; Hala Yousif EL Khidir ^[9] ; Maisoun Alkaabi ^[10] ; Afaf Ashoor ^[11]
  1. [1] University of Hail

     University of Hail

     Arabia Saudí

     
  2. [2] University of Sharjah

     University of Sharjah

     Emiratos Árabes Unidos

     
  3. [3] Assistant Professor, Department of Clinical Pharmacy & Pharmacy Practice, (PhD, MSc, B Pharm), College of Pharmacy, Najran University, Kingdom Saudi Arabia
  4. [4] PhD, MSc. Program of Clinical Pharmacy, College of Pharmacy, Al Ain University, Abu Dhabi campus, Abu Dhabi-United Arab Emirates. AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi, United Arab Emirates.
  5. [5] Ambulatory Healthcare Services, Academic Affairs, Abu Dhabi Health Services (SEHA), UAE.
  6. [6] Pharmacist (Pharm D), Umm Al Quraa University (UQU), Makkah- Saudi Arabia
  7. [7] PhD, MSc. Associate Professor, Program of Clinical Pharmacy, College of Pharmacy, Al Ain University, Al Ain-UAE.
  8. [8] Department of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy-University of Sharjah, United Arab Emirates.
  9. [9] Medical Doctor, King Abdul-Aziz Hospital, Makkah- Kingdom Saudi Arabia
  10. [10] General Manager, New Medical Center (NMC) Royal Women’s Hospital, Abu Dhabi, UAE.
  11. [11] Cardiologist, Alkuwaiti hospital-Dubai, UAE.

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• Localización: Pharmacy Practice (Granada), ISSN-e 1886-3655, Vol. 21, Nº. 2, 2023
• Idioma: inglés
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• Resumen

  • 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. Results: We will report the primary efficacy end point risk in the various regimens (DOAC plus SAPT or DAPT) with odds ratio (confidence interval) and both statistical and clinical significance. Further results of risk of bleeding will be compared between the regimens in the subsets of subjects with ACS (e.g. STEMI or NSTEMI) or with comorbid AF or heart failure (HF). Conclusion: We will critically appraise the evidence to support the effects of DOAC plus SAPT or DAPT based on the clinical presentation of subjects. The risk-benefit profile of DOAC will be presented in the two regimens of dual antithrombotic or triple antithrombotic therapy.