TAVR benefits may persist in lower-risk patients
medwireNews: Patients with relatively low surgical risk still benefit from transcatheter aortic valve replacement (TAVR), shows an analysis of patients from the CoreValve US Pivotal High Risk Trial.
The researchers looked at study participants with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) of 7% or less, chosen because it is the median score of patients entered into the STS/American College of Cardiology Transcatheter Valve Therapy Registry.
TAVR was originally trialled in patients with an STS PROM of 11.6%, leading to concerns of “risk creep” that could reduce the benefits of TAVR over surgery, say Michael Reardon (Houston Methodist DeBakey Heart and Vascular Center, Texas, USA) and study co-authors.
A total of 383 study participants had an STS PROM of 7% or less, with a median of 5.3%, although the team says “it is important to note that the patients in this analysis were deemed to be at high surgical risk based on screening committee assessment despite their STS scores.”
Two-year mortality rates were significantly lower for the 202 patients randomly assigned to undergo TAVR than the 181 who underwent surgical aortic valve replacement (SAVR), at 15.0% versus 26.3%, while rates of stroke and cardiovascular mortality were nonsignificantly lower.
Severe patient–prosthesis mismatch was significantly less common with TAVR than SAVR, at 8.1% versus 25.6%, as were life-threatening/disabling bleeding (20.2 vs 34.9%), acute kidney injury (5.0 vs 15.6%) and new atrial fibrillation/flutter (23.3 vs 34.8%). Conversely, more patients in the TAVR than SAVR groups had major vascular complications (8.2 vs 2.2%) and needed a new permanent pacemaker (27.7 vs 10.5%).
“Survival is influenced by the balance of these effects, which appear to favor TAVR in this analysis”, the researchers write in JAMA Cardiology.
Effective orifice areas and aortic valve gradients were significantly better in the TAVR than SAVR groups at all follow-up points, but both groups had similar improvements in quality of life on the Kansas City Cardiomyopathy Questionnaire between baseline and 2 years, with similar proportions of patients classed as gaining good medical benefit from their procedures.
“The results show that as the risk profile defined by STS score is lowered, the benefit seen with TAVR persists”, the team concludes.
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