TY - JOUR
T1 - Five-Year Health Status after Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients with Severe Aortic Stenosis
AU - Arnold, Suzanne V.
AU - Chinnakondepalli, Khaja M.
AU - Magnuson, Elizabeth A.
AU - Reardon, Michael J.
AU - Deeb, G. Michael
AU - Gleason, Thomas
AU - Yakubov, Steven J.
AU - Cohen, David J.
N1 - Funding Information:
Accepted for Publication: July 13, 2020. Published Online: September 30, 2020. doi:10.1001/jamacardio.2020.4397 Author Contributions: Drs Arnold and Chinnakondepalli had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Arnold, Reardon, Deeb, Gleason, Cohen. Acquisition,analysis,orinterpretationofdata:Allauthors. Drafting of the manuscript: Arnold, Chinnakondepalli. Critical revision of the manuscript for important intellectual content: Arnold, Magnuson, Reardon, Deeb, Gleason, Yakubov, Cohen. Statistical analysis: Chinnakondepalli, Magnuson. Obtained funding: Cohen. Administrative, technical, or material support: Magnuson, Gleason. Supervision: Magnuson, Reardon, Cohen. ConflictofInterestDisclosures:DrMagnusonreports grantsfromMedtronicduringtheconductofthestudy and grants from Abbott Vascular, Cardiovascular Systems, Corvia Medical, Daiichi Sankyo, Edwards Lifesciences, and Svelte Medical Systems outside the submitted work. Dr Reardon reports honoraria from Medtronicforparticipationonadvisoryboardduringthe conduct of the study. Dr Deeb reports grants from Medtronic during the conduct of the study. Dr Gleason reportsinstitutionalgrantsfromMedtronicandBoston Scientific during the conduct of the study and serves onanadvisoryboardforAbbottoutsidethesubmitted work.DrYakubovreportspersonalfeesfromMedtronic outside the submitted work. Dr Cohen reports grants from Medtronic during the conduct of the study; and grants and personal fees from Medtronic, Edwards Lifesciences,BostonScientific,andAbbottoutsidethe submitted work. No other disclosures were reported. Funding/Support: The CoreValve US Pivotal trial was sponsored by Medtronic. Role of the Funder/Sponsor: All analyses, the preparation of the manuscript, and the decision to submit the manuscript for publication were done independently of the study sponsor. The CoreValve US Pivotal Trial Investigators: Timothy Byrne, MD; Michael Caskey, MD (Banner Good Samaritan, Phoenix, Arizona); Robert Stoler, MD; Robert Hebeler, MD (Baylor Heart and Vascular Hospital, Dallas, Texas); Jeffrey J. Popma, MD; Kamal Khabbaz, MD (Beth Israel Deaconess Medical Center, Boston, Massachusetts); Peter Fail, MD; Donald Netherland, MD (Cardiovascular Institute of the South/Terrebone General, Houma, Louisiana); Theodore Schreiber, MD (Detroit Medical Center Cardiovascular Institute, Detroit, Michigan); J. Kevin Harrison, MD; G. Chad Hughes, MD (Duke University Medical Center, Durham, North Carolina); James Joye, MD (El Camino Hospital, Mountain View, California); Shikhar Agarwal, MD (Geisinger Medical Center, Danville, Pennsylvania);
Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Importance: In the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups. Objective: To describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR. Design, Setting, and Participants: This randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020. Main Outcomes and Measures: Change in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral). Results: Of 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P =.61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey. Conclusions and Relevance: In high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status. Trial Registration: ClinicalTrials.gov Identifier: NCT01240902.
AB - Importance: In the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups. Objective: To describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR. Design, Setting, and Participants: This randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020. Main Outcomes and Measures: Change in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral). Results: Of 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P =.61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey. Conclusions and Relevance: In high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status. Trial Registration: ClinicalTrials.gov Identifier: NCT01240902.
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U2 - 10.1001/jamacardio.2020.4397
DO - 10.1001/jamacardio.2020.4397
M3 - Article
C2 - 32997095
VL - 6
SP - 97
EP - 101
JO - JAMA Cardiology
JF - JAMA Cardiology
SN - 2380-6583
IS - 1
ER -