Long-Term Outcomes of Inoperable Patients with Aortic Stenosis Randomized to Transcatheter Aortic Valve Replacement or Standard Therapy
Background—Long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis (AS) remain unknown.
Methods and Results—In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, as well as pooled outcomes for all randomized inoperable patients (n=449) in PARTNER, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9% respectively (p<0.001) [Hazard ratio (95% confidence interval) HR(95% CI): 0.53 (0.41 - 0.68), p<0.001)]. In survivors, there was significant improvement in NYHA functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients vs. 5.5% in standard therapy patients [HR (95% CI): 2.81 (1.26 - 6.26), p=0.012)]; however, the composite of death or strokes was significantly lower after TAVR vs. standard therapy (57.4% versus 80.9%, p<0.001) [HR (95% CI): 0.60 (0.46-0.77), p<0.001]. Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomized patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial.
Conclusions—TAVR resulted in better survival and functional status in inoperable patients with severe AS with durable hemodynamic benefit on long-term follow-up. However, high residual mortality even in successfully treated TAVR patients highlights the need for more strategic patient selection.
Clinical Trial Registration Information—clinicaltrials.gov. Identifier: NCT00530894.
- Received March 3, 2014.
- Revision received July 6, 2014.
- Accepted August 11, 2014.