John D Puskas1, Michael E Halkos2, Joseph J DeRose3, Emilia Bagiella4, Marissa A Miller5, Jessica Overbey4, Johannes Bonatti6, V S Srinivas3, Mark Vesely7, Francis Sutter8, Janine Lynch9, Katherine Kirkwood4, Timothy A Shapiro8, Konstantinos D Boudoulas9, Juan Crestanello9, Thomas Gehrig10, Peter Smith10, Michael Ragosta11, Steven J Hoff12, David Zhao13, Annetine C Gelijns4, Wilson Y Szeto14, Giora Weisz15, Michael Argenziano15, Thomas Vassiliades16, Henry Liberman2, William Matthai14, Deborah D Ascheim17. 1. Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai Cardiovascular Institute, New York, New York; Mount Sinai Heart at Mount Sinai Beth Israel, New York, New York. Electronic address: john.puskas@mountsinai.org. 2. Emory University, Atlanta, Georgia. 3. Division of Cardiothoracic Surgery, Department of Surgery, Montefiore-Einstein Heart Center, Bronx, New York. 4. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. 5. National Heart, Lung, and Blood Institute, Bethesda, Maryland. 6. Department of Cardiothoracic Surgery, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates. 7. Division of Cardiothoracic Surgery, Department of Surgery, University of Maryland, Baltimore, Maryland. 8. Lankenau Hospital, Philadelphia, Pennsylvania. 9. Ohio State University, Columbus, Ohio. 10. Duke University, Durham, North Carolina. 11. University of Virginia, Charlottesville, Virginia. 12. Vanderbilt Heart Institute, Nashville, Tennessee. 13. Wake Forest University, Winston-Salem, North Carolina. 14. University of Pennsylvania, Philadelphia, Pennsylvania. 15. Columbia University, New York, New York. 16. Emory University, Atlanta, Georgia; Medtronic, Inc., Fridley, Minnesota. 17. Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai Cardiovascular Institute, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Abstract
BACKGROUND: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated. OBJECTIVES: This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial. METHODS: Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups. RESULTS: Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53). CONCLUSIONS: These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263).
BACKGROUND: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated. OBJECTIVES: This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial. METHODS: Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups. RESULTS: Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53). CONCLUSIONS: These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263).
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