Anthony H Gershlick1, Amerjeet S Banning2, Emma Parker2, Duolao Wang3, Charley A Budgeon2, Damian J Kelly4, Peter O Kane5, Miles Dalby6, Simon L Hetherington7, Gerry P McCann2, John P Greenwood8, Nick Curzen9. 1. Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom. Electronic address: agershlick@aol.com. 2. Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom. 3. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom. 4. Department of Cardiology, Royal Derby Hospital, Derby, United Kingdom. 5. Department of Cardiology, Royal Bournemouth and Christchurch Hospitals, Bournemouth, United Kingdom. 6. Department of Cardiology, Royal Brompton & Harefield NHS Foundation Trust, Harefield Hospital, Middlesex, London, United Kingdom. 7. Department of Cardiology, Kettering General Hospital, Rothwell Road, Kettering, United Kingdom. 8. Multidisciplinary Cardiovascular Research Centre & The Division of Biomedical Imaging, Leeds Institute of Cardiovascular & Metabolic Medicine, Leeds University, Leeds, United Kingdom. 9. Department of Cardiology, University Hospital Southampton, and University of Southampton, Southampton, United Kingdom.
Abstract
BACKGROUND: Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure). OBJECTIVES: The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints. METHODS:CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions. RESULTS: The median follow-up (achieved in >90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint. CONCLUSIONS: Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605).
RCT Entities:
BACKGROUND: Randomized trials have shown that complete revascularization in patients with ST-segment elevation myocardial infarction (MI) with multivessel disease results in lower major adverse cardiovascular events (MACE) (all-cause death, MI, ischemia-driven revascularization, heart failure). OBJECTIVES: The goal of this study was to determine whether the benefits of complete revascularization are sustained long-term and their impact on hard endpoints. METHODS:CvLPRIT (Complete versus Lesion-only Primary PCI Trial) was a randomized trial of complete inpatient revascularization versus infarct-related artery revascularization only at the index admission. Randomized patients have been followed longer-term. The components of the original primary endpoint were collected from physical and electronic patient records, and from local databases for all readmissions. RESULTS: The median follow-up (achieved in >90% patients) from randomization to first event or last follow-up was 5.6 years (0.0 to 7.3 years). The primary MACE endpoint rate at this time point was 24.0% in the complete revascularization group but 37.7% of the infarct-related artery-only group (hazard ratio: 0.57; 95% confidence interval: 0.37 to 0.87; p = 0.0079). The composite endpoint of all-cause death/MI was 10.0% in the complete revascularization group versus 18.5% in the infarct-related artery-only group (hazard ratio: 0.47; 95% confidence interval: 0.25 to 0.89; p = 0.0175). In a landmark analysis (from 12 months to final follow-up), there was no significant difference between MACE, death/MI, and individual components of the primary endpoint. CONCLUSIONS: Long-term follow-up of the CvLPRIT trial shows that the significantly lower rate of MACE in the complete revascularization group, previously seen at 12 months, is sustained to a median of 5.6 years. A significant difference in composite all-cause death/MI favoring the complete revascularization was also observed. (Complete versus Lesion-only Primary PCI Trial; ISRCTN70913605).
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