TY - JOUR
T1 - Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement
AU - Pineda, Andres M.
AU - Kevin Harrison, J.
AU - Kleiman, Neal S.
AU - Reardon, Michael J.
AU - Conte, John V.
AU - O'Hair, Daniel P.
AU - Chetcuti, Stanley J.
AU - Huang, Jian
AU - Yakubov, Steven J.
AU - Popma, Jeffrey J.
AU - Beohar, Nirat
N1 - Funding Information:
Dr. Conte serves on a surgical advisory board for Medtronic and Sorin. Dr. O'Hair reports receiving grant support from Medtronic and Edwards Lifesciences. Dr. Chetcuti has received grant support from Edwards Lifesciences, Boston Scientific, and Medtronic, and has received proctoring fees from Medtronic. Dr. Huang is an employee and shareholder of Medtronic. Dr. Yakubov has received grant support and served on advisory boards for Medtronic and Boston Scientific. Dr. Popma has received grants from Medtronic, Boston Scientific, and Direct Flow Medical.
Funding Information:
Jessica Dries-Devlin, PhD, CMPP, an employee of Medtronic, created all tables and figures, and ensured technical accuracy of the manuscript. The study was designed and funded by Medtronic (Minneapolis, MN).
Publisher Copyright:
© 2018 Wiley Periodicals, Inc.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - Objectives: To assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR. Background: The impact of CKD on mid-term outcomes of patients undergoing TAVR versus SAVR is unclear. Methods: Patients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all-cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis. Results: Moderate/severe CKD was present in 62.7% and 60.7% of high-risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high-risk patients with moderate/severe CKD, TAVR provided a lower 3-year MACRE rate compared with SAVR: 42.1% vs. 51.0, P =.04. Of 3,733 extreme- and high-risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3-year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P =.001]. Conclusions: TAVR results in lower 3-year MACRE versus SAVR in high-risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid-term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate-severe CKD would help elucidate the best treatment for these complex patients. Trial Registration: CoreValve US Pivotal Trial: NCT01240902. CoreValve Continued Access Study: NCT01531374.
AB - Objectives: To assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR. Background: The impact of CKD on mid-term outcomes of patients undergoing TAVR versus SAVR is unclear. Methods: Patients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all-cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis. Results: Moderate/severe CKD was present in 62.7% and 60.7% of high-risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high-risk patients with moderate/severe CKD, TAVR provided a lower 3-year MACRE rate compared with SAVR: 42.1% vs. 51.0, P =.04. Of 3,733 extreme- and high-risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3-year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P =.001]. Conclusions: TAVR results in lower 3-year MACRE versus SAVR in high-risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid-term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate-severe CKD would help elucidate the best treatment for these complex patients. Trial Registration: CoreValve US Pivotal Trial: NCT01240902. CoreValve Continued Access Study: NCT01531374.
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U2 - 10.1002/ccd.27928
DO - 10.1002/ccd.27928
M3 - Article
C2 - 30341970
AN - SCOPUS:85055248294
VL - 93
SP - 740
EP - 748
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 4
ER -
