Comparative Evaluation of Efficacy and Safety of Aspirin + Clopidogrel With Aspirin+ticagrelor in Patients With Cardiovascular Diseases. An Observational Study.

Abstract

Background: Coronary artery disease (CAD) is one of the most common causes of mortality and morbidity in both developed and developing countries. It is a leading cause of death in India, and its contribution to mortality is rising. Platelets play an essential role in the pathogenesis of acute coronary syndromes (ACS). Therefore an important part of the treatment of ACS, and of primary and secondary preventive measures in coronary heart disease, consists of antiplatelet treatment. Dual antiplatelet therapy (DAPT) provides more intense platelet inhibition than single antiplatelet therapy resulting in incremental reductions in the risk of thrombotic events after percutaneous coronary intervention (PCI) or ACS, but it has been associated with an increased risk of major bleeding. It is interesting to consider that there is no Indian data on the efficacy of recently developed antiplatelet drugs other than in combination with aspirin, and that we remain unaware of the extent to which combinations with aspirin improve efficacy but increase risk.
 Methodology: Study was prospective, observational clinical study carried out in the Department of Medicine, of Index Medical College Hospital & Research Centre. A total of 80 patients with CAD were enrolled for the study and were equally divided in two groups each of 40 for evaluating efficacy and safety of dual antiplatelet therapy. Follow-up was done at 8 weeks, 16 weeks, and 24 weeks, patients were asked to provide information regarding their current medications, any morbidity and their complications [if any]. Demographic parameters were analyzed by descriptive statistics. Comparison between groups was done by Chi–square Test. Survival analysis was done by suitable statistical method.
 Result: The median age was 55 years in group 1 and 57 years in group 2. Hypertension was most common associated disorders in group 1 [25 (62.55%)] and group 2 [27 (67.5%)], which was followed by diabetes and dyslipidemia. index events for present study enrolment was unstable angina, non–ST-segment elevation MI, ST-segment elevation MI and others amongs the study groups. With 6 months of follow-up, the rate of the primary event like death from any cause was 7.5 percent in the clopidogrel plus aspirin group and 2.5 percent in the ticagrelor plus aspirin group. The primary safety end point (severe bleeding) was 2.5 % in the clopidogrel plus group 1 and none in group 2.
 Conclusion: the combination of clopidogrel plus aspirin was found to be non inferior to aspirin plus ticagrelor dual therapy in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes among patients with stable cardiovascular disease or multiple cardiovascular risk factors. The risk of moderate to severe bleeding was increased slightly in both the groups. Our findings do support the use of dual antiplatelet therapy across the broad population tested where single antiplatelet therapy are not giving maximum benefits
 Keywords: Acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), Coronary artery disease (CAD), Dual antiplatelet therapy (DAPT)