David A Wood1, John A Cairns2, Jia Wang3, Roxana Mehran4, Robert F Storey5, Helen Nguyen3, Brandi Meeks3, Vijay Kunadian6, Jean-Francois Tanguay7, Hahn-Ho Kim8, Asim Cheema9, Payam Dehghani10, Madhu K Natarajan3, Sanjit S Jolly3, John Amerena11, Matyas Keltai12, Stefan James13, Ota Hlinomaz14, Kari Niemela15, Khalid AlHabib16, Basil S Lewis17, Michel Nguyen18, Jaydeep Sarma19, Vladimir Dzavik20, Anthony Della Siega21, Shamir R Mehta22. 1. Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: david.wood@vch.ca. 2. Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada. 3. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. 4. The Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 5. Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom. 6. Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom. 7. Montreal Heart Institute and Universite de Montreal, Montreal, Quebec, Canada. 8. St Mary's General Hospital, Kitchener, Ontario, Canada. 9. St. Michael's Hospital, Toronto, Ontario, Canada. 10. Prairie Vascular Research Network, University of Saskatchewan, Regina, Saskatchewan, Canada. 11. Kardinia House, Geelong, Victoria, Australia. 12. Hungarian Institute of Cardiology, Budapest, Hungary. 13. Uppsala Clinical Research Centre and Department of Medical Sciences, Uppsala, Sweden. 14. University Hospital St Anne, Brno, Czech Republic. 15. Heart Centre, Tampere University Hospital, Tampere, Finland. 16. Department of Cardiac Services, King Fahad Cardiac Center, Saudi Arabia. 17. Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel. 18. Division of Cardiology, Centre Hospitalier, Universitaire de Sherbrooke, Quebec, Quebec, Canada. 19. North West Heart Centre, Wythenshawe Hospital, Manchester, United Kingdom. 20. Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada. 21. Department of Cardiac Services, Victoria Heart Institute Foundation, Victoria, British Columbia, Canada. 22. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: smehta@mcmaster.ca.
Abstract
BACKGROUND: The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). OBJECTIVES: The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization. METHODS: Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days. RESULTS: For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI. CONCLUSIONS: Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.
RCT Entities:
BACKGROUND: The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). OBJECTIVES: The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization. METHODS: Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days. RESULTS: For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI. CONCLUSIONS: Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.
Authors: Tatsuhiko Otsuka; Sarah Bär; Sylvain Losdat; Raminta Kavaliauskaite; Yasushi Ueki; Christian Zanchin; Jonas Lanz; Fabien Praz; Jonas Häner; George C M Siontis; Thomas Zanchin; Stefan Stortecky; Thomas Pilgrim; Stephan Windecker; Lorenz Räber Journal: J Am Heart Assoc Date: 2021-11-24 Impact factor: 6.106
Authors: Yousif Ahmad; James P Howard; Ahran Arnold; Megha Prasad; Henry Seligman; Christopher M Cook; Takayuki Warisawa; Matthew Shun-Shun; Ziad Ali; Manish A Parikh; Rasha Al-Lamee; Sayan Sen; Darrel Francis; Jeffrey W Moses; Martin B Leon; Gregg W Stone; Dimitri Karmpaliotis Journal: J Am Heart Assoc Date: 2020-06-01 Impact factor: 5.501
Authors: Simone Biscaglia; Vincenzo Guiducci; Andrea Santarelli; Ignacio Amat Santos; Francisco Fernandez-Aviles; Valerio Lanzilotti; Ferdinando Varbella; Luca Fileti; Raul Moreno; Francesco Giannini; Iginio Colaiori; Mila Menozzi; Alfredo Redondo; Marco Ruozzi; Enrique Gutiérrez Ibañes; José Luis Díez Gil; Elisa Maietti; Giuseppe Biondi Zoccai; Javier Escaned; Matteo Tebaldi; Emanuele Barbato; Dariusz Dudek; Antonio Colombo; Gianluca Campo Journal: Am Heart J Date: 2020-08-18 Impact factor: 4.749