TY - JOUR
T1 - Association of Statin Use and Mortality After Transcatheter Aortic Valve Replacement
AU - Peri-Okonny, Poghni A.
AU - Liu, Yangbo
AU - Malaisrie, S. Chris
AU - Huded, Chetan P.
AU - Kapadia, Samir
AU - Thourani, Vinod H.
AU - Kodali, Susheel K.
AU - Webb, John
AU - McAndrew, Thomas C.
AU - Leon, Martin B.
AU - Cohen, David J.
AU - Arnold, Suzanne V.
N1 - Funding Information:
The PARTNER trial was sponsored by Edwards Lifesciences. This current study was self-funded, and the funding organization for the trial did not play a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. Dr Peri-Okonny is supported by a T32 training grant from the National Heart, Lung, and Blood Institute (T32 HL110837). Dr Arnold is supported by a Career Development Grant Award from the National Heart, Lung, and Blood Institute (K23 HL116799). The content of this study is solely the responsibility of the authors and does not necessarily the represent the official views of the Institutes of Health.
Funding Information:
Dr Thourani has received grant support from Edwards Lifesciences and is a consultant for Edwards Lifesciences and Medtronic. Dr Kodali has been a consultant for Edwards Lifesciences, Merrill Lifesciences, and Claret Medical; has served on the advisory boards of Abbott Vascular, Biotrace Medical, Dura Biotech, Thubrikar Aortic Valve, Duratech, and VS Medtech and has equity in Thubrikar Aortic Valve, Dura Biotech, and Biotrace Medical. Dr Webb has been a member of the PARTNER Trial Executive Committee, for which he received no direct compensation and has been a consultant for Edwards Lifesciences. Dr Leon has been a member of the PARTNER Trial Executive Committee, for which he received no direct compensation. Dr Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular and consulting income from Edwards Lifesciences and Medtronic. The remaining authors have no disclosures to report.
PY - 2019/4/16
Y1 - 2019/4/16
N2 - Background: Statins may reduce mortality after transcatheter aortic valve replacement (TAVR) through prevention of atherosclerotic events or pleiotropic effects. However, the competing mortality risks in TAVR patients may dilute any positive effect of statins. We sought to understand the association of statin use with post-TAVR mortality. Methods and Results: We included high– or intermediate–surgical risk patients who underwent TAVR as a part of the PARTNER (Placement of Aortic Transcatheter Valves) II and Sapien 3 trials and registries. Outcomes included 2-year all-cause, cardiovascular, and noncardiovascular mortality. We used propensity score matching to generate matched pairs between those discharged on a statin and those not on a statin after TAVR. Bias was explored with falsification end points (urinary infection, hip fracture). Among 3956 patients who underwent TAVR, we matched 626 patients on a statin with 626 patients not on a statin at discharge. Among matched patients, statin use was associated with lower risk of all-cause (hazard ratio [HR] 0.65, 95% CI 0.49-0.87, P=0.001), cardiovascular (HR 0.66, 95% CI 0.46-0.96, P=0.030), and noncardiovascular mortality (HR 0.64, 95% CI 0.44-0.99, P=0.045) compared with no statin use. The survival curves diverged within 3 months and continued to separate over a median follow-up of 2.1 years. The falsification end points were similar among groups (urinary infection, P=0.66; hip fracture, P=0.64). Conclusions: In an observational, propensity-matched analysis of TAVR patients, statin use was associated with lower rates of cardiovascular and noncardiovascular mortality compared with no statin use. Given the early emergence of the apparent protective effect of statins, this result may be driven either by pleiotropic effects or by residual confounding despite propensity-matching methodology.
AB - Background: Statins may reduce mortality after transcatheter aortic valve replacement (TAVR) through prevention of atherosclerotic events or pleiotropic effects. However, the competing mortality risks in TAVR patients may dilute any positive effect of statins. We sought to understand the association of statin use with post-TAVR mortality. Methods and Results: We included high– or intermediate–surgical risk patients who underwent TAVR as a part of the PARTNER (Placement of Aortic Transcatheter Valves) II and Sapien 3 trials and registries. Outcomes included 2-year all-cause, cardiovascular, and noncardiovascular mortality. We used propensity score matching to generate matched pairs between those discharged on a statin and those not on a statin after TAVR. Bias was explored with falsification end points (urinary infection, hip fracture). Among 3956 patients who underwent TAVR, we matched 626 patients on a statin with 626 patients not on a statin at discharge. Among matched patients, statin use was associated with lower risk of all-cause (hazard ratio [HR] 0.65, 95% CI 0.49-0.87, P=0.001), cardiovascular (HR 0.66, 95% CI 0.46-0.96, P=0.030), and noncardiovascular mortality (HR 0.64, 95% CI 0.44-0.99, P=0.045) compared with no statin use. The survival curves diverged within 3 months and continued to separate over a median follow-up of 2.1 years. The falsification end points were similar among groups (urinary infection, P=0.66; hip fracture, P=0.64). Conclusions: In an observational, propensity-matched analysis of TAVR patients, statin use was associated with lower rates of cardiovascular and noncardiovascular mortality compared with no statin use. Given the early emergence of the apparent protective effect of statins, this result may be driven either by pleiotropic effects or by residual confounding despite propensity-matching methodology.
KW - aortic stenosis
KW - outcome
KW - statin therapy
KW - transcutaneous aortic valve implantation
UR - http://www.scopus.com/inward/record.url?scp=85064320710&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064320710&partnerID=8YFLogxK
U2 - 10.1161/JAHA.118.011529
DO - 10.1161/JAHA.118.011529
M3 - Article
C2 - 30947591
AN - SCOPUS:85064320710
VL - 8
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
SN - 2047-9980
IS - 8
M1 - e011529
ER -