New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry.

Autor: Tanaka A; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy., Giustino G; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America., Briede I; Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia., Sawaya FJ; Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France., Daemen J; Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands., Kawamoto H; Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan., Meliga E; Department of Cardiology, Mauriziano Hospital, Turin, Italy., D'Ascenzo F; Department of Internal Medicine, Division of Cardiology, University of Turin, Città della Salute e della Scienza, Turin, Italy., Cerrato E; San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Italy., Stefanini GG; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy., Capodanno D; C.A.S.T., P.O. Gaspare Rodolico, Azienda-Ospedaliero Universitaria 'Policlinico-Vittorio Emanuele', Catania, Italy., Mangiameli A; Clinique Pasteur, Toulouse, France., Templin C; University Hospital of Zurich, Zurich, Switzerland., Erglis A; Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia., Morice MC; Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France., Mehran R; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America., Van Mieghem NM; Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands., Nakamura S; Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan., De Benedictis M; Department of Cardiology, Mauriziano Hospital, Turin, Italy., Pavani M; Department of Internal Medicine, Division of Cardiology, University of Turin, Città della Salute e della Scienza, Turin, Italy., Varbella F; San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Italy., Pisaniello M; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy., Sharma SK; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America., Tamburino C; C.A.S.T., P.O. Gaspare Rodolico, Azienda-Ospedaliero Universitaria 'Policlinico-Vittorio Emanuele', Catania, Italy., Tchetche D; Clinique Pasteur, Toulouse, France., Colombo A; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy., Chieffo A; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.
Jazyk: angličtina
Zdroj: International journal of cardiology [Int J Cardiol] 2019 Apr 01; Vol. 280, pp. 30-37. Date of Electronic Publication: 2018 Dec 15.
DOI: 10.1016/j.ijcard.2018.12.003
Abstrakt: 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.
(Copyright © 2018 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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