Stuart J Head1, Milan Milojevic2, Joost Daemen3, Jung-Min Ahn4, Eric Boersma3, Evald H Christiansen5, Michael J Domanski6, Michael E Farkouh6, Marcus Flather7, Valentin Fuster8, Mark A Hlatky9, Niels R Holm5, Whady A Hueb10, Masoor Kamalesh11, Young-Hak Kim4, Timo Mäkikallio12, Friedrich W Mohr13, Grigorios Papageorgiou14, Seung-Jung Park4, Alfredo E Rodriguez15, Joseph F Sabik16, Rodney H Stables17, Gregg W Stone18, Patrick W Serruys19, A Pieter Kappetein2. 1. Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: s.head@erasmusmc.nl. 2. Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. 3. Department of Cardiology, Erasmus Medical College, Rotterdam, the Netherlands. 4. Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 5. Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. 6. Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Cardiology, Peter Munk Cardiac Centre and Department of Medicine, Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada. 7. Department of Medicine and Health Sciences, Norwich Medical School University of East Anglia and Norfolk and Norwich University Hospital, Norwich, United Kingdom. 8. Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 9. Department of Health Research and Policy, and Department of Medicine (Cardiovascular Medicine), Stanford University School of Medicine, Stanford, California. 10. Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. 11. Department of Cardiology, Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana. 12. Department of Cardiology, Oulu University Hospital, Oulu, Finland. 13. Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. 14. Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Biostatistics, Erasmus Medical Center, Rotterdam, the Netherlands. 15. Cardiac Unit, Otamendi Hospital, Buenos Aires, Argentina. 16. Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio. 17. Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. 18. Department of Cardiology, Columbia University Medical Center and Clinical Trials Center, the Cardiovascular Research Foundation, New York, New York. 19. Department of Cardiology, Imperial College London, London, United Kingdom.
Abstract
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.
RCT Entities:
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 diabeticpatients (PCI: 2.6% vs. CABG: 4.9%) and nondiabeticpatients (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.
Authors: Mario Gaudino; Dominick J Angiolillo; Antonino Di Franco; Davide Capodanno; Faisal Bakaeen; Michael E Farkouh; Stephen E Fremes; David Holmes; Leonard N Girardi; Sunao Nakamura; Stuart J Head; Seung-Jung Park; Michael Mack; Patrick W Serruys; Marc Ruel; Gregg W Stone; Derrick Y Tam; Michael Vallely; David P Taggart Journal: J Am Heart Assoc Date: 2019-06-27 Impact factor: 5.501
Authors: Mario Gaudino; Mohammed Rahouma; Michele Di Mauro; Bobby Yanagawa; Ahmed Abouarab; Michelle Demetres; Antonino Di Franco; Mohammed J Arisha; Dina A Ibrahim; Massimo Baudo; Leonard N Girardi; Stephen Fremes Journal: J Am Heart Assoc Date: 2019-06-19 Impact factor: 5.501
Authors: Karel M Van Praet; Markus Kofler; Timo Z Nazari Shafti; Alaa Abd El Al; Antonia van Kampen; Andrea Amabile; Gianluca Torregrossa; Jörg Kempfert; Volkmar Falk; Husam H Balkhy; Stephan Jacobs Journal: Interv Cardiol Date: 2021-05-19