Author + information
- Received September 13, 2019
- Revision received September 26, 2019
- Accepted September 27, 2019
- Published online November 25, 2019.
- David A. Wood, MDa,∗ (, )@CHVI85209027,
- John A. Cairns, MDa,
- Jia Wang, MScb,
- Roxana Mehran, MDc,
- Robert F. Storey, MDd,
- Helen Nguyen, BScb,
- Brandi Meeks, MScb,
- Vijay Kunadian, MBBSe,
- Jean-Francois Tanguay, MDf,
- Hahn-Ho Kim, MDg,
- Asim Cheema, MDh,
- Payam Deghani, MDi,
- Madhu K. Natarajan, MDb,
- Sanjit S. Jolly, MDb,
- John Amerena, MDj,
- Matyas Keltai, MDk,
- Stefan James, MDl,
- Ota Hlinomaz, MDm,
- Kari Niemela, MDn,
- Khalid AlHabib, MDo,
- Basil S. Lewis, MDp,
- Michel Nguyen, MDq,
- Jaydeep Sarma, MDr,
- Vladimir Dzavik, MDs,
- Anthony Della Siega, MDt,
- Shamir R. Mehta, MDb,∗∗ (, )@PHRIresearch,
- on behalf of the COMPLETE Investigators
- aCentre for Cardiovascular Innovation, St. Paul’s and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada
- bPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
- cThe Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- dDepartment of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom
- eInstitute 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
- fMontreal Heart Institute and Universite de Montreal, Montreal, Quebec, Canada
- gSt Mary’s General Hospital, Kitchener, Ontario, Canada
- hSt. Michael's Hospital, Toronto, Ontario, Canada
- iPrairie Vascular Research Network, University of Saskatchewan, Regina, Saskatchewan, Canada
- jKardinia House, Geelong, Victoria, Australia
- kHungarian Institute of Cardiology, Budapest, Hungary
- lUppsala Clinical Research Centre and Department of Medical Sciences, Uppsala, Sweden
- mUniversity Hospital St Anne, Brno, Czech Republic
- nHeart Centre, Tampere University Hospital, Tampere, Finland
- oDepartment of Cardiac Services, King Fahad Cardiac Center, Saudi Arabia
- pCardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel
- qDivision of Cardiology, Centre Hospitalier, Universitaire de Sherbrooke, Quebec, Quebec, Canada
- rNorth West Heart Centre, Wythenshawe Hospital, Manchester, United Kingdom
- sPeter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
- tDepartment of Cardiac Services, Victoria Heart Institute Foundation, Victoria, British Columbia, Canada
- ↵∗Address for correspondence:
Dr. David A Wood, Centre for Cardiovascular Innovation, St. Paul’s and Vancouver General Hospitals, University of British Columbia, 2775 Laurel Street (9th Floor), Vancouver, British Columbia V5Z 1M9, Canada.
- ↵∗∗Dr. Shamir R. Mehta, Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.
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.
The COMPLETE trial was supported by the Canadian Institutes of Health Research (CIHR), Canadian Network and Center for Trials Internationally, Population Health Research Institute (PHRI), and unrestricted grants from AstraZeneca and Boston Scientific. Drs. Wood, Cairns, and Mehta have received unrestricted grant support from the Canadian Institutes of Health Research, AstraZeneca, and Boston Scientific to conduct the COMPLETE Study. Dr. Cairns has been a consultant for Abbott, Bayer, and Bristol-Myers Squibb/Pfizer. Dr. Mehran has served as a consultant, paid to the institution, for Abbott Laboratories and Spectranetics/Phillips/Volcano Corporation; has had speaking engagements (personal) with Abbott Laboratories; has received research funding (to the institution) from Abbott Laboratories, AstraZeneca, Bayer, and Beth Israel; has served as deaconess for Bristol-Myers Squibb, Chiesi USA, Inc., CSL Behring, Eli Lilly/DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and PLc/Renal Guard; her spouse has served as a consultant for Abiomed and The Medicines Company; has served as a consultant for Boston Scientific, Bracco group, Medscape/Web MD, Siemens Medical Solutions, Roivant Sciences, Inc., Sanofi, and Janssen Pharmaceuticals; has served on the Scientific Advisory Board of and received personal fees from PLx Opco, Inc. dba PLx Pharma Inc.; has served as a consultant (personal, no fee) for Pharmaceuticals Inc.; has served as an advisor/speaker for Medtelligence (Janssen); has received advisory board funding to the institution from Bristol-Myers Squibb; has received institutional research grant support from AstraZeneca, Boston Scientific, Abbott, Bristol-Myers Squibb, DSI, Sanofi, Bayer, Janssen, CSL and Behring; and has received consultancy fees from Abbott, Sanofi, Janssen, Web MD, and DSI; holds equity of <1% in Claret, Applied Therapeutics; and has received DSMB membership paid to the institution from Watermark Research Partners. Dr. Storey has served as a consultant to AstraZeneca, Amgen, Bayer, Bristol-Myers Squibb/Pfizer, GlyCardial Diagnostics, Haemonetics, Novartis, Medscape, and Thromboserin; has received honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, and Medscape; and has received research grants from AstraZeneca, GlyCardial Diagnostics, and Thromboserin. Dr. Tanguay has received research grants to his institution from Abbott Vascular, Biosensors, Idorsia, and Novartis; and has received scientific advisory board or speaker honorarium from Abbott Vascular, Bayer, Bristol-Myers Squibb-Pfizer Alliance, AstraZeneca, Servicer, Novartis, and Daiichi-Sankyo. Dr. Jolly has received grant support from Boston Scientific. Dr. James has received institutional research grants from Boston Scientific, Abbott, Biotronik, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Matthew J. Price, MD, served as Guest Associate Editor for this paper.
- Received September 13, 2019.
- Revision received September 26, 2019.
- Accepted September 27, 2019.
- 2019 American College of Cardiology Foundation
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