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Published on: May 21, 2017
Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve
Andres M Pineda1, J Kevin Harrison2, Neal S Kleiman3
1Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida.
Insights
Transcatheter aortic valve replacement (TAVR) shows better outcomes than surgical aortic valve replacement (SAVR) for high-risk patients with moderate/severe chronic kidney disease (CKD). Worsening CKD increases mortality and adverse events in TAVR patients.
Area of Science:
- Cardiology
- Nephrology
- Interventional Cardiology
Background:
- The impact of chronic kidney disease (CKD) on mid-term outcomes for patients undergoing transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) remains unclear.
- CKD affects a significant proportion of patients undergoing aortic valve replacement procedures.
Purpose of the Study:
- To assess the 3-year clinical outcomes of TAVR compared to SAVR in patients stratified by CKD status.
- To evaluate the impact of baseline CKD severity on outcomes in patients undergoing TAVR.
Main Methods:
- Retrospective analysis of patients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial.
- Patients were stratified by estimated glomerular filtration rate (eGFR) into none/mild and moderate/severe CKD groups.
- Primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of mortality, myocardial infarction, stroke/TIA, and new dialysis requirement.
Main Results:
- Moderate/severe CKD was present in over 60% of high-risk patients in both TAVR and SAVR groups.
- Among high-risk patients with moderate/severe CKD, TAVR showed a significantly lower 3-year MACRE rate (42.1%) compared to SAVR (51.0%, P=.04).
- Worsening baseline CKD severity was associated with increased 3-year MACRE rates in TAVR patients (none/mild: 51.5%, moderate: 54.5%, severe: 63.1%, P=.001).
Conclusions:
- TAVR demonstrates superior 3-year clinical outcomes compared to SAVR in high-risk patients with moderate/severe CKD.
- Progressive CKD is linked to increased mid-term mortality and MACRE in patients treated with TAVR.
- Further randomized trials are warranted to confirm optimal treatment strategies for complex patients with moderate-to-severe CKD.
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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