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

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 primar...

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Main Authors: Suma M. Victor, S. Vijayakumar, Thomas Alexander, C.G. Bahuleyan, Arun Srinivas, S. Selvamani, S. Marutha Priya, K. Kamaleswari, Ajit S. Mullasari
Format: Article
Language:English
Published: Elsevier 2016-03-01
Series:Indian Heart Journal
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Online Access:http://www.sciencedirect.com/science/article/pii/S0019483215003715
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author Suma M. Victor
S. Vijayakumar
Thomas Alexander
C.G. Bahuleyan
Arun Srinivas
S. Selvamani
S. Marutha Priya
K. Kamaleswari
Ajit S. Mullasari
author_facet Suma M. Victor
S. Vijayakumar
Thomas Alexander
C.G. Bahuleyan
Arun Srinivas
S. Selvamani
S. Marutha Priya
K. Kamaleswari
Ajit S. Mullasari
author_sort Suma M. Victor
collection DOAJ
description 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.
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spelling doaj.art-cdeb4b4c4ee5442f9ee0ecd642089c7d2022-12-21T18:13:44ZengElsevierIndian Heart Journal0019-48322016-03-0168216917310.1016/j.ihj.2015.08.027Two-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 STEMISuma M. Victor0S. Vijayakumar1Thomas Alexander2C.G. Bahuleyan3Arun Srinivas4S. Selvamani5S. Marutha Priya6K. Kamaleswari7Ajit S. Mullasari8Consultant Cardiologist, Madras Medical Mission, Chennai, IndiaSenior Consultant Cardiologist, Madras Medical Mission, Chennai, IndiaConsultant Cardiologist, Kovai Medical Center and Hospital, Coimbatore, IndiaChairman, Cardiovascular Centre, Ananthapuri Hospitals and Research Institute, Trivandrum, Kerala, IndiaHead of the Department, Cardiology, Vikram Group of Hospitals, Mysore, IndiaSenior Consultant Cardiologist, Meenakshi Mission Hospital and Research Centre, Madurai, IndiaSenior CRA, Madras Medical Mission, Chennai, IndiaClinical Trial Manager, Madras Medical Mission, Chennai, IndiaSenior Consultant Cardiologist, Madras Medical Mission, Chennai, IndiaBackground: 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.http://www.sciencedirect.com/science/article/pii/S0019483215003715ST elevation myocardial infarctionTimely reperfusionPharmacoinvasive strategy
spellingShingle Suma M. Victor
S. Vijayakumar
Thomas Alexander
C.G. Bahuleyan
Arun Srinivas
S. Selvamani
S. Marutha Priya
K. Kamaleswari
Ajit S. Mullasari
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
Indian Heart Journal
ST elevation myocardial infarction
Timely reperfusion
Pharmacoinvasive strategy
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic ST elevation myocardial infarction
Timely reperfusion
Pharmacoinvasive strategy
url http://www.sciencedirect.com/science/article/pii/S0019483215003715
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