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

• Published in: Indian heart journal Vol. 68; no. 2; pp. 169 - 173
• Main Authors: Victor, Suma M, Vijayakumar, S, Alexander, Thomas, Bahuleyan, C.G, Srinivas, Arun, Selvamani, S, Priya, S. Marutha, Kamaleswari, K, Mullasari, Ajit S
• Format: Journal Article
• Language: English
• Published: India Elsevier B.V 01.03.2016; Elsevier
• Subjects: Cardiovascular; Electrocardiography; Feasibility Studies; Fibrinolytic Agents - administration & dosage; Follow-Up Studies; Humans; India - epidemiology; Original; Percutaneous Coronary Intervention - methods; Pharmacoinvasive strategy; Pilot Projects; Prospective Studies; Recurrence; ST elevation myocardial infarction; ST Elevation Myocardial Infarction - diagnosis; ST Elevation Myocardial Infarction - mortality; ST Elevation Myocardial Infarction - therapy; Survival Rate - trends; Tenecteplase; Thrombolytic Therapy - methods; Time Factors; Timely reperfusion; Tissue Plasminogen Activator - administration & dosage; Treatment Outcome; Pharmacoinvasive strategy; ST elevation myocardial infarction; Timely reperfusion
• ISSN: 0019-4832; 2213-3763
• DOI: 10.1016/j.ihj.2015.08.027

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.