Subject: Evaluation of Drug utilization pattern of Ticagrelor in patients with Myocardial Infarction: A Retrospective, Cross sectional Study (AXCEMI Study)
Myocardial infarction (MI), colloquially known as “heart attack,” is caused by decreased or complete cessation of blood flow to a portion of the myocardium. Myocardial infarction may be “silent” and go undetected, or it could be a catastrophic event leading to hemodynamic deterioration and sudden death. Most myocardial infarctions are due to underlying coronary artery disease (CAD). With coronary artery occlusion, the myocardium is deprived of oxygen. Prolonged deprivation of oxygen supply to the myocardium can lead to myocardial cell death and necrosis. Patients can present with chest discomfort or pressure that can radiate to the neck, jaw, shoulder, or arm. In addition to the history and physical exam, myocardial ischemia may be associated with ECG changes and elevated biochemical markers such as cardiac troponins.
In India, cardiac diseases affect approximately 45 million patients, of whom more than 30 million have CAD. Acute coronary syndrome (ACS), a complication of coronary artery disease (CAD) comprises of ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), and unstable angina (UA). The prevalence of CAD and the incidence of ACS also are very high among Indians due to changes in the lifestyle, westernization of the food practices, increasing prevalence of diabetes mellitus and probably genetic factors. Indians present with CVD a decade earlier compared with people of European ancestry.5 Of note, nearly two-thirds (62%) of all cardiovascular deaths in Indian populations are premature. The INTERHEART study reported a lower mean (SD) age of first myocardial infarction among South Asians (53.0 [11.4] years) compared with other countries (58.8 [12.2] years; p < 0.001).
Dual antiplatelet therapy is the cornerstone therapeutic strategy in patients with acute myocardial infarction (AMI). Ticagrelor, an oral, direct and reversible, P2Y12 receptor antagonist significantly was found to reduce the composite primary end point of vascular death, myocardial infarction, and stroke, without a significant increase in the safety end point of major bleeding, when compared with clopidogrel in the PLATO (platelet inhibition and patient outcomes) trial.
The 2018 ESC guideline on myocardial revascularization in STEMI and Non-STEMI has given 1A level of recommendation for P2Y12 inhibitor in addition to Aspirin for at least 12 months unless there is contraindication such as bleeding. The guidelines have also preferred Ticagrelor over Clopidogrel, unless the former agents are not available.
In patients with bleeding risk the 2021 AHA/ACC/SCAI guideline for coronary revascularization has recommended a short duration therapy (1-3 months) of DAPT after percutaneous revascularization in case of stable ischemic heart disease to reduce the risk of bleeding events. This should be followed by stopping of Aspirin and continuation of P2Y12 inhibitor monotherapy.
Thus, it is evident that even in presence of guidelines directed therapy for MI, the mortality rate is higher in India. This warrants for real world study to understand drug utilization pattern and adherence to above recommendations.
In lieu of the same the current retrospective cross-sectional study is planned to evaluate the drug utilization pattern of Ticagrelor among treating physicians in cases of MI, duration of Ticagrelor, and factors for discontinuation. This study will also help understand MI disease profile, and associated comorbidities in India.
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