Subject: Assessment of Post Coronary Artery Disease/Myocardial Infarction (CAD/MI) Patients and Dual AntiPlatelet Therapy (DAPT) Usage: A Cross-sectional, Multicentric Real-World Evidence (RWE) Study (CADAPT study)
Coronary artery disease (CAD) and myocardial infarction (MI) are significant causes of morbidity and mortality worldwide. It is the leading cause of deaths and disease burden among adults in India. In 2019, IHD alone claimed approximately 1.5 million deaths in India with a mortality rate of 109.23 deaths per 100 000 populations.1 Between 2009 and 2019, deaths due to IHD increased significantly by 29.8% in India and in the year 2019 contributed to 7.79% of the total disability-adjusted life years (DALYs). IHD affected all age groups, including the country’s working population, leading to their premature deaths. Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a cornerstone treatment for patients with CAD and MI, as it reduces the risk of recurrent cardiovascular events. However, there is a lack of realworld evidence (RWE) on the assessment of CAD/MI patients and their usage of DAPT. Platelets initiate the formation of a thrombus at the site of an arterial injury, and the clotting cascade is activated as the thrombus matures. After coronary stent placement, dual antiplatelet therapy (DAPT) with aspirin and ticlopidine dramatically reduces the risk of stent thrombosis, compared with anticoagulation therapy, and has become the standard of care for prevention of stent thrombosis. Clopidogrel is a second-generation thienopyridine that eliminates the serious side effects of ticlopidine, and new P2Y12 receptor blockers have emerged to overcome the limitations of clopidogrel. Current guidelines recommend DAPT with aspirin and clopidogrel for 1 month after implantation of bare-metal stents, and for 6-12 months after implantation of drug-eluting stents (DES). In patients with acute coronary syndrome (ACS), DAPT administration for 12 months was shown to be superior to aspirin alone for the prevention of recurrent events. Treatment with aspirin and new P2Y12 receptor blockers has further reduced the rate of cardiovascular death, myocardial infarction or stroke after ACS compared with aspirin and clopidogrel. Nonetheless, long-term DAPT increases the risk of major bleeding, requiring a delicate balance between anti-ischemic benefit and bleeding risk. In summary, DAPT should be maintained for at least 6-12 months after implantation of DES, and for at least 12 months after ACS, unless contraindicated. The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains unsettled. In patients with chronic coronary syndrome, the 2016 American College of Cardiology/American Heart Association update recommended DAPT (aspirin and a P2Y12 inhibitor) for 6 months after PCI with drug-eluting stent (DES), with the potential to extend DAPT for a longer duration in those who remain free of a bleeding complication during this period and do not carry high bleeding risk. Conversely, patients at high bleeding risk may discontinue DAPT at 3 months. Similarly, the 2017 European Society of Cardiology update recommends 6-month DAPT in chronic coronary syndrome irrespective of stent type, with further prolongation of DAPT reserved for patients with low bleeding risk but high thrombotic risk, and 1 to 3 months of DAPT for patients with high bleeding risk. In patients with acute coronary syndromes (ACS), both the American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend at least 12 months of DAPT, with consideration that the duration could be extended beyond 12 months in patients with lower risk of bleeding, and 6 months of DAPT in patients with high risk of bleeding. Both guidelines recommend indefinite continuation of aspirin monotherapy after discontinuation of DAPT. These recommendations were based on the evidence derived from 15 randomized, controlled trials conducted in patients with predominantly chronic coronary syndrome. More recent clinical trials have been performed, including several conducted in ACS and those studying ≤3- month DAPT followed by discontinuation of aspirin rather than the P2Y12 inhibitor. Real-world evidence (RWE) studies aim to provide insights into the effectiveness, safety, and usage patterns of medical interventions in real-world clinical practice. Unlike randomized controlled trials (RCTs), which are conducted under controlled conditions, RWE studies analyze data from routine clinical practice, including electronic health records, claims databases, and registries. These studies help bridge the gap between controlled trials and real-world patient populations, providing valuable information for healthcare decisionmaking.
Thus, this retrospective, cross-sectional multicenter study is aimed to investigate the utilization of Dual Antiplatelet Therapy (DAPT) in patients who have experienced Coronary Artery Disease (CAD) or Myocardial Infarction (MI)
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