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PARTNER A: Difference between revisions
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The 2011 Placement of Aortic Transcatheter Valves, cohort A (PARTNER A) trial randomized 699 patients with symptomatic severe AS at high perioperative risk (estimated perioperative mortality ~ 15%) to TAVR or surgical AVR. At 1 year, the primary endpoint of all-cause mortality was 2% lower in the TAVR group, meeting prespecified criteria for noninferiority (superiority not established). However, TAVR was associated with a borderline statistically significant (p=0.07) 3% absolute increase in major stroke at 1 year as well as a 15% increase in vascular complications. A composite outcome of all-cause mortality or major stroke showed very similar outcomes with TAVR and surgical AVR. In addition, patients in both groups had similar improvements in 6-minute walk distance and NYHA class at 1 year. Importantly, comparative outcomes with TAVR vs. surgical AVR stratified by access approach (transfemoral vs. transapical) were similar, although the transapical subgroup was underpowered. Complications more prevalent with open AVR included a 10% higher rate of major bleeding and a borderline statistically significant (p=0.07) 5% higher rate of new atrial fibrillation. Patients who received TAVR had an ICU length of stay that was 2 days shorter and an overall hospitalization that was 4 days shorter. | The 2011 Placement of Aortic Transcatheter Valves, cohort A (PARTNER A) trial randomized 699 patients with symptomatic severe AS at high perioperative risk (estimated perioperative mortality ~ 15%) to TAVR or surgical AVR. At 1 year, the primary endpoint of all-cause mortality was 2% lower in the TAVR group, meeting prespecified criteria for noninferiority (superiority not established). However, TAVR was associated with a borderline statistically significant (p=0.07) 3% absolute increase in major stroke at 1 year as well as a 15% increase in vascular complications. A composite outcome of all-cause mortality or major stroke showed very similar outcomes with TAVR and surgical AVR. In addition, patients in both groups had similar improvements in 6-minute walk distance and NYHA class at 1 year. Importantly, comparative outcomes with TAVR vs. surgical AVR stratified by access approach (transfemoral vs. transapical) were similar, although the transapical subgroup was underpowered. Complications more prevalent with open AVR included a 10% higher rate of major bleeding and a borderline statistically significant (p=0.07) 5% higher rate of new atrial fibrillation. Patients who received TAVR had an ICU length of stay that was 2 days shorter and an overall hospitalization that was 4 days shorter. | ||
Based largely on the results of PARTNER A, TAVR is now generally accepted as an appropriate alternative to surgical AVR in patients at high risk for operative complications. Notably, the 5 year results of PARTNER A were published in 2015 and continue to show no difference in mortality with TAVR versus open AVR, although there was a 10% increase in prevalence of severe aortic regurgitation, a complication for which careful monitoring is required in all TAVR patients.<ref name="partner fu">{{#pmid:25788234}}</ref> | Based largely on the results of PARTNER A, TAVR is now generally accepted as an appropriate alternative to surgical AVR in patients at high risk for operative complications. Notably, the 5 year results of PARTNER A were published in 2015 and continue to show no difference in mortality with TAVR versus open AVR, although there was a 10% increase in prevalence of severe aortic regurgitation, a complication for which careful monitoring is required in all TAVR patients and reintervention may be required.<ref name="partner fu">{{#pmid:25788234}}</ref> | ||
==Guidelines== | ==Guidelines== | ||