"Transcatheter versus Surgical Aortic-Valve Replacement in Intermediate-Risk Patients". The New England Journal of Medicine. 2016.
Links to original sources: Wiki Journal Post Full Journal Article
In intermediate-risk patients with severe aortic stenosis, is transcatheter aortic-valve replacement (TAVR) comparable to surgical aortic-valve replacement with regard to survival and stroke risk?
In intermediate-risk patients with severe symptomatic aortic stenosis, TAVR was found to be noninferior to surgical aortic-valve replacement regarding the primary endpoint of death or disabling stroke for up to 2 years.
The Placement of Aortic Transcatheter Valves (PARTNER) 2 trial evaluated TAVR as compared with surgical aortic-valve replacement in patients at intermediate risk of complications from surgery. TAVR demonstrated noninferiority in terms of mortality or disabling strokes at 2 years follow-up. The TAVR group experienced less acute kidney injury, severe bleeding, and new-onset atrial fibrillation, but higher rates of major vascular complications and paravalvular leakage compared to the surgical group.
Current guidelines on the management of valvular heart disease have yet to be updated to reflect the findings of this trial.
- Multicenter, randomized, controlled trial - N=2,032 intermediate-risk patients with severe aortic stenosis - TAVR (n=1,011) vs. surgical replacement (n=1,021) - Setting: 57 centers in the United States and Canada - Enrollment: December 2011 to November 2013 - Mean follow-up: 2 years - Primary outcome: Death from any cause or disabling stroke at 2 years - Funding: Edwards Lifesciences
- Inclusion Criteria: Severe aortic stenosis with cardiac symptoms, STS risk score of ≥4.0%, or other factors leading to intermediate surgical risk. - Exclusion Criteria: Risk of death within 30 days after surgery less than 4%, severe comorbidities, or concomitant conditions not encompassed in the STS risk model. - Baseline Characteristics: Mean STS score of 5.8% in both groups, similar in demographic and clinical characteristics.
- TAVR with the balloon-expandable SAPIEN XT heart-valve system. - Surgical aortic-valve replacement.
- Primary Outcome: No significant difference in the primary endpoint of death or disabling stroke at 2 years. - Secondary Outcomes (at 2 years): TAVR resulted in larger aortic-valve areas, lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation. Surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.
- Withdrawal rate after randomization was high, notably in the surgery group. - The SAPIEN XT valve used is already succeeded by the next-generation SAPIEN 3 valve system. - Long-term durability of bioprosthetic transcatheter valves remains undetermined beyond the timeframe of the study. - Subclinical valve-leaflet thrombosis was not systematically evaluated.
The trial was funded by Edwards Lifesciences.
Details of the PARTNER 2 trial can be found in the New England Journal of Medicine, published on April 2, 2016, with supplemental content available online.