Author + information
- Received March 17, 2018
- Accepted April 23, 2018
- Published online July 16, 2018.
- Stuart J. Head, MD, PhDa,∗ (, )@ErasmusMC,
- Milan Milojevic, MD, MSca,
- Joost Daemen, MD, PhDb,
- Jung-Min Ahn, MDc,
- Eric Boersma, PhDb,
- Evald H. Christiansen, MD, PhDd,
- Michael J. Domanski, MDe,f,
- Michael E. Farkouh, MD, MSce,f,
- Marcus Flather, MBBSg,
- Valentin Fuster, MD, PhDe,
- Mark A. Hlatky, MDh,
- Niels R. Holm, MDd,
- Whady A. Hueb, MD, PhDi,
- Masoor Kamalesh, MDj,
- Young-Hak Kim, MDc,
- Timo Mäkikallio, MDk,
- Friedrich W. Mohr, MD, PhDl,
- Grigorios Papageorgiou, MSca,m,
- Seung-Jung Park, MDc,
- Alfredo E. Rodriguez, MD, PhDn,
- Joseph F. Sabik III, MDo,
- Rodney H. Stables, MA, DMp,
- Gregg W. Stone, MDq,
- Patrick W. Serruys, MD, PhDr and
- A. Pieter Kappetein, MD, PhDa
- aDepartment of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands
- bDepartment of Cardiology, Erasmus Medical College, Rotterdam, the Netherlands
- cDepartment of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
- dDepartment of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
- eCardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- fDivision of Cardiology, Peter Munk Cardiac Centre and Department of Medicine, Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada
- gDepartment of Medicine and Health Sciences, Norwich Medical School University of East Anglia and Norfolk and Norwich University Hospital, Norwich, United Kingdom
- hDepartment of Health Research and Policy, and Department of Medicine (Cardiovascular Medicine), Stanford University School of Medicine, Stanford, California
- iHeart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
- jDepartment of Cardiology, Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana
- kDepartment of Cardiology, Oulu University Hospital, Oulu, Finland
- lDepartment of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany
- mDepartment of Biostatistics, Erasmus Medical Center, Rotterdam, the Netherlands
- nCardiac Unit, Otamendi Hospital, Buenos Aires, Argentina
- oDepartment of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio
- pInstitute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
- qDepartment of Cardiology, Columbia University Medical Center and Clinical Trials Center, the Cardiovascular Research Foundation, New York, New York
- rDepartment of Cardiology, Imperial College London, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Stuart J. Head, Department of Cardiothoracic Surgery, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.
Background Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are used for coronary revascularization in patients with multivessel and left main coronary artery disease. Stroke is among the most feared complications of revascularization. Due to its infrequency, studies with large numbers of patients are required to detect differences in stroke rates between CABG and PCI.
Objectives This study sought to compare rates of stroke after CABG and PCI and the impact of procedural stroke on long-term mortality.
Methods We performed a collaborative individual patient-data pooled analysis of 11 randomized clinical trials comparing CABG with PCI using stents; ERACI II (Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease) (n = 450), ARTS (Arterial Revascularization Therapy Study) (n = 1,205), MASS II (Medicine, Angioplasty, or Surgery Study) (n = 408), SoS (Stent or Surgery) trial (n = 988), SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial (n = 1,800), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial (n = 600), FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900), VA CARDS (Coronary Artery Revascularization in Diabetes) (n = 198), BEST (Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease) (n = 880), NOBLE (Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis) trial (n = 1,184), and EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial (n = 1,905). The 30-day and 5-year stroke rates were compared between CABG and PCI using a random effects Cox proportional hazards model, stratified by trial. The impact of stroke on 5-year mortality was explored.
Results The analysis included 11,518 patients randomly assigned to PCI (n = 5,753) or CABG (n = 5,765) with a mean follow-up of 3.8 ± 1.4 years during which a total of 293 strokes occurred. At 30 days, the rate of stroke was 0.4% after PCI and 1.1% after CABG (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.20 to 0.53; p < 0.001). At 5-year follow-up, stroke remained significantly lower after PCI than after CABG (2.6% vs. 3.2%; HR: 0.77; 95% CI: 0.61 to 0.97; p = 0.027). Rates of stroke between 31 days and 5 years were comparable: 2.2% after PCI versus 2.1% after CABG (HR: 1.05; 95% CI: 0.80 to 1.38; p = 0.72). No significant interactions between treatment and baseline clinical or angiographic variables for the 5-year rate of stroke were present, except for diabetic patients (PCI: 2.6% vs. CABG: 4.9%) and nondiabetic patients (PCI: 2.6% vs. CABG: 2.4%) (p for interaction = 0.004). Patients who experienced a stroke within 30 days of the procedure had significantly higher 5-year mortality versus those without a stroke, both after PCI (45.7% vs. 11.1%, p < 0.001) and CABG (41.5% vs. 8.9%, p < 0.001).
Conclusions This individual patient-data pooled analysis demonstrates that 5-year stroke rates are significantly lower after PCI compared with CABG, driven by a reduced risk of stroke in the 30-day post-procedural period but a similar risk of stroke between 31 days and 5 years. The greater risk of stroke after CABG compared with PCI was confined to patients with multivessel disease and diabetes. Five-year mortality was markedly higher for patients experiencing a stroke within 30 days after revascularization.
- coronary artery bypass graft
- left main
- percutaneous coronary intervention
This current study was performed without funding.
Individual trials did receive funding: SoS (Stent or Surgery) trial received funding from Boston Scientific Corp., Guidant ACS, and Medtronic. MASS II received funding from Zerbini Foundation. ERACI II received funding from Cook Inc. ARTS received funding from Cordis. SYNTAX trial received funding from Boston Scientific Corp. PRECOMBAT trial received funding from the Cardiovascular Research Foundation (Seoul, Korea), Cordis, Johnson and Johnson, and grant 0412-CR02-0704-0001 from Health 21 R&D Project, Ministry of Health and Welfare, South Korea. VA CARDS received funding from the VA Cooperative Studies Program. FREEDOM trial was supported by grants U01 01HL071988 and 01HL092989 from the National Heart, Lung, and Blood Institute, Cordis, Johnson and Johnson, Boston Scientific Corp., Eli Lilly, Sanofi, and Bristol-Myers Squibb. BEST received funding from CardioVascular Research Foundation, Abbott Vascular, and grant HI10C2020 from the Korea Healthcare Technology Research and Development Project, Ministry for Health and Welfare Affairs, South Korea. EXCEL trial received funding from Abbott Vascular. NOBLE trial received funding from Biosensors, Aarhus University Hospital, and participating sites. Dr. Daemen has received institutional research grants from Abbott, Acist Medical, Boston Scientific, Pie Medical, St. Jude Medical, ReCor Medical, and Medtronic; and has received consulting fees from Acist, AstraZeneca, Pythagoras Medical, and ReCor. Dr. Farkouh has received research support from Amgen and Novo Nordisk. Dr. Holm has received institutional research grants from Abbott, Biosensors, Biotronik, and Boston Scientific; and has received speaking honoraria from Abbott, Biotronik, and Terumo. Dr. Sabik has served on the Cardiac Surgery Advisory Board of Medtronic; and is the North American surgical principal investigator for the EXCEL trial, sponsored by Abbott. Dr. Stone has received grant support from the Cardiovascular Research Foundation during the conduct of the study; has received personal fees from Velomedix, Toray, Matrizyme, Miracor, TherOx, Reva, V-wave, Vascular Dynamics, Ablative Solutions, Neovasc, and Medical Development Technologies; has received other support from the MedFocus family of funds, Guided Delivery Systems, Micardia, Vascular Nonotransfer Technologies, Cagent, Qool Therapeutics, Caliber, Aria, and the Biostar family of funds outside the submitted work; has served as a consultant on prasugrel patent litigation paid for by Lupin Pharmaceuticals; and his institution, Columbia University, receives royalties from Abbott Vascular for sale of the MitraClip. Dr. Serruys has served as a consultant for Abbott Laboratories, AstraZeneca Pharmaceuticals, Biotronik, Cardialysis B.V., GLG Research, Medtronic, Sino Medical Sciences Technology Inc. Tianjin China, Stentys France, Svelte Medical Systems Inc., Volcano/Philips Europe, Q3Medical Devices Limited, and St. Jude Medical; and has served as a member of the corporate advisory board for Xeltis. Dr. Kappetein is an employee of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Amar Krishnaswarmy, MD, served as Guest Editor for this paper.
- Received March 17, 2018.
- Accepted April 23, 2018.
- 2018 American College of Cardiology Foundation
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