Outcomes with Intermediate Left Main Disease on Coronary CT Angiography in the ISCHEMIA Trial (ISCHEMIA Intermediate LM Substudy)
Presenter
Sripal Bangalore, MD, MHA, FSCAI, NYU Grossman School of Medicine, New York, NY
Sripal Bangalore, MD, MHA, FSCAI1, John A. Spertus, M.D.2, Susanna R. Stevens, M.S.3, Philip G. Jones, M.S.4, G.B. John Mancini, M.D.5, Jonathon Leipsic, M.D.6, Harmony R. Reynolds, MD1, Matthew J. Budoff, M.D.7, Cameron J. Hague, M.D.8, JAMES K Min, MD9, William E. Boden, M.D.10, Sean M. O'Brien, PhD3, Robert A. Harrington, M.D., FSCAI11, Jeffrey S. Berger, M.D.1, Roxy Senior, MBBS, MD, DM12, Jesus Peteiro, MD, PhD13, Neeraj Pandit, M.D., FSCAI14, Leonid Bershtein, M.D.15, Mark A. de Belder, M.D.16, Hanna Szwed, MD, PhD17, Rolf Doerr, M.D.18, Lorenzo Monti, M.D.19, Khaled Alfakih, MBBS, MD20, Judith S. Hochman, M.D.1 and David J. Maron, M.D.21, (1)NYU Grossman School of Medicine, New York, NY, (2)Saint Luke's Mid America Heart Institute, Kansas City, MO, (3)Duke Clinical Research Institute, Durham, NC, (4)Saint Luke’s Mid America Heart Institute, Kansas City, MO, (5)University of British Columbia, Vancouver, BC, Canada, (6)Providence Health Care, Vancouver, BC, Canada, (7)Harbor–UCLA Medical Center, Torrance, CA, (8)University of British Columbia, St. Paul's Hospital Department of Radiology, Vancouver, BC, Canada, (9)Weill Cornell Medicine | NewYork-Presbyterian, NewYork, NY, (10)VA New England Healthcare System, Boston, MA, (11)Weill Cornell Medicine, New York, NY, (12)Northwick Park Hospital Harrow/ Royal Brompton Hospital London, London, United Kingdom, (13)Complejo Hospitalario Universitario de A Coruna, A Coruna, Spain, (14)PGIMER DR.RML HOSPITAL, New Dehli, Delhi, India, (15)North-Western State Medical University named after I.I Mechnikov, Saint Petersburg, Russian Federation, (16)Barts Health NHS Trust, London, United Kingdom, (17)National Institute of Cardiology, Warsaw, Poland, (18)Praxisklinik Herz und Gefaesse, Dresden, Germany, (19)Istituto Clinico Humanitas, Rozzano, Italy, (20)King's College Hospital, London, United Kingdom, (21)Department of Medicine, Stanford University, Stanford, CA
Keywords: Coronary and Drug-eluting Stent (DES)
Background:
Prior studies show that patients with significant (≥50%) left main disease (LMD) have a high risk of cardiovascular events and guidelines recommend revascularization to improve survival. However, the impact of intermediate LMD (stenosis: 25-49%) on outcomes is unclear.
Methods:
Randomized ISCHEMIA trial participants who underwent coronary computed tomography angiography (CCTA) at baseline were categorized into those with (25-49%) and without (<25%) intermediate LMD as determined by a core lab. Patients with LMD ≥50%, those with prior coronary artery bypass graft surgery (CABG), and those with non-evaluable or missing data on LM stenosis were excluded. Both clinical and quality of life (QoL) outcomes in those with and without intermediate LMD will be compared as will outcomes of participants randomized to an initial invasive versus conservative strategy. The primary outcome is a composite of cardiovascular mortality, myocardial infarction (MI), or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest. The primary QoL outcome is the Seattle Angina Questionnaire [SAQ] summary score.
Results:
ISCHEMIA randomized 5,179 participants to an initial invasive or conservative strategy; those who underwent coronary CCTA comprise the LMD Substudy cohort. Among the 3,913 participants who underwent CCTA, 3,699 satisfied the inclusion criteria. Of these participants, 962 (26%) had intermediate LMD and 2,737 (74%) did not. Among invasive strategy participants with intermediate LMD, 7.0% had significant LM stenosis on invasive angiography. The primary outcome event rate was significantly higher in those with intermediate LMD as compared to those without intermediate LMD (adjusted HR=1.31; 95% CI 1.06 to 1.61; P=0.0123). The clinical and QoL outcomes will be reported for the first time at SCAI 2020.
Conclusions:
The ISCHEMIA Intermediate LMD substudy will address whether an initial invasive strategy is associated with better clinical and QoL outcomes when compared with an initial conservative strategy.