Transcatheter Aortic-Valve Replacement Reduces Death and Hospitalization
- Mon, 7/23/12 - 12:14pm
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Transcatheter aortic-valve replacement (TAVR) was found to reduce rates of death and hospitalization in patients with severe aortic stenosis who were not suitable candidates for surgery after 2 years of follow-up when compared with patients who received standard therapy. The updated results of the PARTNER (Placement of Aortic Transcatheter Valves) trial, including analysis from 2 years of follow-up, were recently published online in the New England Journal of Medicine [10.1056/NEJMoa1202277].
Previous findings from the PARTNER trial found that at 1-year, TAVR had decreased the rate of death, reduced cardiac symptoms, and improved the hemodynamic performance of the valve; however, the outcomes beyond 1-year of follow-up were unknown. According to the study's authors, additional long-term data about the TAVR procedure are essential to help clinicians make informed practice decisions.
In this latest report, researchers assessed 2-year outcomes data to determine the differences in terms of mortality, stroke, hospitalization, and echocardiographic assessments for patients who had been determined not suitable for surgery and randomized to either receive TAVR or standard therapy. Standard therapy included balloon aortic valvuloplasty for 82.3% of the standard group patients. Researchers also hoped the additional follow-up data would provide them with more information about the effect of coexisting conditions on survival.
The PARTNER trial was conducted in 21 centers with 358 severe aortic stenosis patients who had an aortic-valve area of <0.8cm2 and were determined to be unsuitable for surgery due to either clinical or anatomical factors.
The primary end point of the PARTNER trial was all-cause mortality, but researchers also identified key end points for this analysis that included the 2-year rates of death from any cause, death from cardiac causes, stroke, and repeat hospitalizations. Other key end points were the New York Heart Association functional class, the number of days alive and out of the hospital, and echocardiographic assessments of aortic-valve gradient, aortic-valve area, and paravalvular regurgitation at 2 years.
Researchers found that at the 2-year mark the rates of death were significantly lower for the TAVR group compared with the group receiving standard-therapy determined by their physician (43.3% vs 68.0%, respectively; P<.001). There was also a significant reduction in the rates of cardiac death at 2 years for those in the TAVR group (31.0%) compared with those in the standard-therapy group (62.4%, P<.001). Researchers noted that the survival advantage of TAVR evident at 1-year of follow-up continued to be significant after additional follow-up (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=.02 with the use of the log-rank test).
Whereas the rate of death decreased for the TAVR group, researchers found that the rate of stroke increased with TAVR when compared with standard therapy (13.8% vs 5.5%, respectively; P=.01), a trend that continued from the year 1 findings.
However, repeat hospitalization for cardiac reasons was significantly less for the TAVR group (35%) compared with the standard therapy group (72.5%, P<.001). In addition, the median number of days alive and out of the hospital was nearly double (699 days [interquartile range, 201 to 720]) for those patients in the TAVR group compared with those who received standard therapy (355 days [interquartile range, 116 to 712], P<.001). In another quality of life measure, more TAVR patients were either asymptomatic or having mild symptoms (83.1%) at 2-years compared with only 42.5% in the standard therapy group.
Researchers also found that at the 2-year follow-up there was a sustained increase in aortic valve area, a decrease in aortic-valve gradient for patients who had been treated with TAVR, and no worsening of the paravalvular aortic regurgitation.
They noted, however, that based on the study findings, the mortality benefits associated with TAVR could be limited to those patients without extensive coexisting conditions.