Author + information
- Received June 24, 2015
- Revision received September 2, 2015
- Accepted September 22, 2015
- Published online December 22, 2015.
- Gerry P. McCann, MD∗∗ (, )
- Jamal N. Khan, MBChB∗,
- John P. Greenwood, MBChB, PhD†,
- Sheraz Nazir, MBBChir∗,
- Miles Dalby, MD‡,
- Nick Curzen, BM, PhD§,
- Simon Hetherington, MD‖,
- Damian J. Kelly, MD¶,
- Daniel J. Blackman, MD†,
- Arne Ring, PhD#∗∗,
- Charles Peebles, MBChB§,
- Joyce Wong, MD‡,
- Thiagarajah Sasikaran, PhD††,
- Marcus Flather, MBBS, PhD‡‡,
- Howard Swanton, MD§§ and
- Anthony H. Gershlick, MBBS∗
- ∗Department of Cardiovascular Sciences, University of Leicester and the National Institute of Health Research (NIHR) Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester National Health Service (NHS) Trust, Glenfield Hospital, Leicester, United Kingdom
- †Multidisciplinary Cardiovascular Research Centre & Division of Cardiovascular and Diabetes Research, Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), University of Leeds, Leeds, United Kingdom
- ‡Department of Cardiology, Royal Brompton and Harefield Foundation Trust, Harefield Hospital, Middlesex, United Kingdom, and the Cardiovascular Biomedical Research Unit of Royal Brompton and Harefield NHS Foundation Trust and Imperial College London, London, United Kingdom
- §Department of Cardiology and Radiology, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom
- ‖Department of Cardiology, Kettering General Hospital, Kettering, United Kingdom
- ¶Department of Cardiology, Royal Derby Hospital, Derby, United Kingdom
- #Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom
- ∗∗Department of Mathematical Statistics and Actuarial Science, University of the Free State, Bloemfontein, South Africa
- ††Clinical Trials & Evaluation Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom
- ‡‡Clinical Trials Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School, University of East Anglia, Norwich, United Kingdom
- §§Department of Cardiology, Heart Hospital, University College London Hospitals, London, United Kingdom
- ↵∗Reprint requests and correspondence:
Dr. Gerry McCann, Department of Cardiovascular Sciences, University of Leicester, Glenfield Hospital, LE3 9QP Leicester, England, United Kingdom.
Background Complete revascularization may improve outcomes compared with an infarct-related artery (IRA)-only strategy in patients being treated with primary percutaneous coronary intervention (PPCI) who have multivessel disease presenting with ST-segment elevation myocardial infarction (STEMI). However, there is concern that non-IRA PCI may cause additional non-IRA myocardial infarction (MI).
Objectives This study sought to determine whether in-hospital complete revascularization was associated with increased total infarct size compared with an IRA-only strategy.
Methods This multicenter prospective, randomized, open-label, blinded endpoint clinical trial evaluated STEMI patients with multivessel disease having PPCI within 12 h of symptom onset. Patients were randomized to either IRA-only PCI or complete in-hospital revascularization. Contrast-enhanced cardiovascular magnetic resonance (CMR) was performed following PPCI (median day 3) and stress CMR at 9 months. The pre-specified primary endpoint was infarct size on pre-discharge CMR. The study had 80% power to detect a 4% difference in infarct size with 100 patients per group.
Results Of the 296 patients in the main trial, 205 participated in the CMR substudy, and 203 patients (98 complete revascularization and 105 IRA-only) completed the pre-discharge CMR. The groups were well-matched. Total infarct size (median, interquartile range) was similar to IRA-only revascularization: 13.5% (6.2% to 21.9%) versus complete revascularization, 12.6% (7.2% to 22.6%) of left ventricular mass, p = 0.57 (95% confidence interval for difference in geometric means 0.82 to 1.41). The complete revascularization group had an increase in non-IRA MI on the pre-discharge CMR (22 of 98 vs. 11 of 105, p = 0.02). There was no difference in total infarct size or ischemic burden between treatment groups at follow-up CMR.
Conclusions Multivessel PCI in the setting of STEMI leads to a small increase in CMR-detected non-IRA MI, but total infarct size was not significantly different from an IRA-only revascularization strategy. (Complete Versus Lesion-Only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605)
The CMR substudy was funded by the Medical Research Council and managed by the NIHR Efficacy and Mechanism Evaluation programme (10-27-01). The main CvLPRIT trial was funded by the British Heart Foundation (SP/10/001) with support from the NIHR Comprehensive Local Research Networks. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Dr. McCann is funded by an NIHR research fellowship. Dr. McCann has received research grants from Servier, Novartis, and Menarini International. Dr. Dalby has been a consultant for AstraZeneca, Medtronic, Boston Scientific, and Eli Lilly and Company; and has received research grants from Abbott Vascular, Daiichi Sankyo, Eli Lilly and Company, and Sanofi. Dr. Curzen has received research grants from Boston Scientific, St. Jude Medical, Haemonetics, and Medtronic; honoraria from St. Jude Medical, Haemonetics, and HeartFlow; travel sponsorship from Biosensors, Abbott Vascular, St. Jude Medical, and Haemonetics; and has also received nonfinancial support from Volcano. Dr. Ring is an employee of Medac; and has received research funding and travel grants from Boehringer Ingelheim, Novartis, and Roche. Dr. Flather has served on advisory and speakers boards for AstraZeneca and Menarini International; and has received research funding from Menarini International. Dr. Gershlick has served on advisory boards of Medtronic, Abbott Vascular, and AstraZeneca; and is on the speakers bureaus of Abbott Vascular and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. McCann and Khan contributed equally to this work.
- Received June 24, 2015.
- Revision received September 2, 2015.
- Accepted September 22, 2015.
- 2015 American College of Cardiology Foundation