Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial

Gennaro Giustino; Patrick W Serruys; Joseph F Sabik 3rd; Roxana Mehran; Akiko Maehara; John D Puskas; Charles A Simonton; Nicholas J Lembo; David E Kandzari; Marie-Claude Morice; David P Taggart; Anthony H Gershlick; Michael Ragosta 3rd; Irving L Kron; Yangbo Liu; Zixuan Zhang; Thomas McAndrew; Ovidiu Dressler; Philippe Généreux; Ori Ben-Yehuda; Stuart J Pocock; Arie Pieter Kappetein; Gregg W Stone

doi:10.1016/j.jcin.2019.09.019

Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial

JACC Cardiovasc Interv. 2020 Feb 10;13(3):375-387. doi: 10.1016/j.jcin.2019.09.019. Epub 2020 Jan 15.

Authors

Gennaro Giustino¹, Patrick W Serruys², Joseph F Sabik 3rd³, Roxana Mehran⁴, Akiko Maehara⁵, John D Puskas⁶, Charles A Simonton⁷, Nicholas J Lembo⁵, David E Kandzari⁸, Marie-Claude Morice⁹, David P Taggart¹⁰, Anthony H Gershlick¹¹, Michael Ragosta 3rd¹², Irving L Kron¹², Yangbo Liu¹³, Zixuan Zhang¹³, Thomas McAndrew¹³, Ovidiu Dressler¹³, Philippe Généreux¹⁴, Ori Ben-Yehuda⁵, Stuart J Pocock¹⁵, Arie Pieter Kappetein¹⁶, Gregg W Stone¹⁷

Affiliations

¹ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
² Imperial College of Science, Technology and Medicine, London, United Kingdom.
³ Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.
⁴ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
⁵ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
⁶ Mount Sinai Heart at Mount Sinai St Luke's, New York, New York.
⁷ Abbott Vascular, Santa Clara, California.
⁸ Piedmont Heart Institute, Atlanta, Georgia.
⁹ Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France.
¹⁰ Department Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom.
¹¹ University Hospitals of Leicester, Leicester, United Kingdom.
¹² Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia.
¹³ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
¹⁴ Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
¹⁵ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹⁶ Erasmus University Medical Center, Rotterdam, the Netherlands.
¹⁷ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gregg.stone@mountsinai.org.

PMID: 31954680
DOI: 10.1016/j.jcin.2019.09.019

Abstract

Objectives: The aim of this study was to investigate the incidence and impact on mortality of repeat revascularization after index percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD).

Background: The impact on mortality of the need of repeat revascularization following PCI or CABG in patients with unprotected LMCAD is unknown.

Methods: All patients with LMCAD and site-assessed low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores randomized to PCI (n = 948) or CABG (n = 957) in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were included. Repeat revascularization events were adjudicated by an independent clinical events committee. The effect of repeat revascularization on mortality through 3-year follow-up was examined in time-varying Cox regression models.

Results: During 3-year follow-up, there were 346 repeat revascularization procedures among 185 patients. PCI was associated with higher rates of any repeat revascularization (12.9% vs. 7.6%; hazard ratio: 1.73; 95% confidence interval: 1.28 to 2.33; p = 0.0003). Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval: 1.13 to 3.70; p = 0.02) and cardiovascular mortality (adjusted hazard ratio: 4.22; 95% confidence interval: 2.10 to 8.48; p < 0.0001) consistently after both PCI and CABG (p_int = 0.85 for both endpoints). Although target vessel revascularization and target lesion revascularization were both associated with an increased risk for mortality, target vessel non-target lesion revascularization and non-target vessel revascularization were not.

Conclusions: In the EXCEL trial, repeat revascularization during follow-up was performed less frequently after CABG than PCI and was associated with increased mortality after both procedures. Reducing the need for repeat revascularization may further improve long-term survival after percutaneous or surgical treatment of LMCAD. (EXCEL Clinical Trial; NCT01205776).

Keywords: CABG; PCI; left main coronary artery; repeat revascularization.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Coronary Angiography
Coronary Artery Bypass / adverse effects
Coronary Artery Bypass / mortality*
Coronary Artery Disease / diagnostic imaging
Coronary Artery Disease / mortality
Coronary Artery Disease / therapy*
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention / adverse effects
Percutaneous Coronary Intervention / instrumentation
Percutaneous Coronary Intervention / mortality*
Reoperation / adverse effects
Reoperation / mortality*
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01205776