Suzanne J Baron1, Elizabeth A Magnuson2, Michael Lu3, Kaijun Wang2, Khaja Chinnakondepalli2, Michael Mack4, Vinod H Thourani5, Susheel Kodali6, Raj Makkar7, Howard C Herrmann8, Samir Kapadia9, Vasilis Babaliaros10, Mathew R Williams11, Dean Kereiakes12, Alan Zajarias13, Maria C Alu6, John G Webb14, Craig R Smith6, Martin B Leon6, David J Cohen15. 1. Lahey Hospital and Medical Center, Burlington, Massachusetts; Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: suzanne.j.baron@lahey.org. 2. Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. 3. Edwards LifeSciences, Irvine, California. 4. Baylor Scott and White Healthcare, Plano, Texas. 5. Marcus Heart and Vascular Center, Piedmont Heart Institute, Atlanta, Georgia. 6. Columbia University Medical Center, New York, New York. 7. Cedars-Sinai Medical Center, Los Angeles, California. 8. Hospital of University of Pennsylvania, Philadelphia, Pennsylvania. 9. Cleveland Clinic, Cleveland, Ohio. 10. Emory University School of Medicine, Atlanta, Georgia. 11. New York University Langone Medical Center, New York, New York. 12. Christ Hospital Heart and Vascular Center, Cincinnati, Ohio. 13. Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, Missouri. 14. St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 15. University of Missouri-Kansas City, Kansas City, Missouri.
Abstract
BACKGROUND: In patients with severe aortic stenosis (AS) at low surgical risk, treatment withtranscatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES: This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS. METHODS:Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.
RCT Entities:
BACKGROUND: In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES: This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS. METHODS: Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.
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