Two-year follow-up data from the STEPP-AMI study: A prospective, observational, multicenter study comparing tenecteplase-facilitated PCI versus primary PCI in Indian patients with STEMI.

ABSTRACT

BACKGROUND: A pharmacoinvasive strategy may alleviate the logistical and geographical barriers in timely reperfusion of ST-segment elevation myocardial infarction (STEMI), especially in a developing country like India. AIM: To assess the safety and efficacy of pharmacoinvasive strategy versus primary PCI in STEMI patients at 2 years. METHODS: Patients enrolled in STEPP-AMI, an observational, multicenter, prospective study of 200 patients presenting with STEMI, were followed up for 2 years. Group 'A' comprised of patients with pharmacoinvasive strategy (n=45), and patients who underwent primary PCI (n=155) formed group 'B'. Primary endpoint was composite of death, cardiogenic shock, reinfarction, repeat revascularization of the culprit artery, or congestive heart failure at 30 days, with follow-up till 2 years. RESULTS: The primary endpoint occurred in 11.1% and 17.8% in group A and in 3.9% and 13.6% in group B, at 30 days and 2 years, respectively (p=0.07, RR=2.87; 95% CI 0.92-8.97 at 30 days and p=0.47, RR=1.31; 95% CI 0.62-2.76). There was no difference in bleeding risk between groups, 2.2% in group A and 0.6% in group B ('p'=0.4). The infarct-related artery patency varied at angiogram; it was 82.2% in arm A and 22.6% in arm B ('p'<0.001). In group A, failed fibrinolysis occurred in 12.1%. CONCLUSION: A pharmacoinvasive strategy resulted in outcomes that were comparable with primary PCI at 2 years, suggesting it might be a viable option in India. Larger studies are required to confirm these findings.