Akihito Tanaka1, Gennaro Giustino2, Ieva Briede3, Fadi J Sawaya4, Joost Daemen5, Hiroyoshi Kawamoto6, Emanuele Meliga7, Fabrizio D'Ascenzo8, Enrico Cerrato9, Giulio G Stefanini10, Davide Capodanno11, Andrea Mangiameli12, Christian Templin13, Andrejs Erglis3, Marie Claude Morice4, Roxana Mehran2, Nicolas M Van Mieghem5, Sunao Nakamura6, Mauro De Benedictis7, Marco Pavani8, Ferdinando Varbella9, Marco Pisaniello10, Samin K Sharma2, Corrado Tamburino11, Didier Tchetche12, Antonio Colombo1, Alaide Chieffo14. 1. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America. 3. Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. 4. Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France. 5. Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands. 6. Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan. 7. Department of Cardiology, Mauriziano Hospital, Turin, Italy. 8. Department of Internal Medicine, Division of Cardiology, University of Turin, Città della Salute e della Scienza, Turin, Italy. 9. San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Italy. 10. Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. 11. C.A.S.T., P.O. Gaspare Rodolico, Azienda-Ospedaliero Universitaria "Policlinico-Vittorio Emanuele", Catania, Italy. 12. Clinique Pasteur, Toulouse, France. 13. University Hospital of Zurich, Zurich, Switzerland. 14. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.
Abstract
BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.
BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.