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PARTNER A: Difference between revisions
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==Major Points== | ==Major Points== | ||
It is well-accepted that aortic valve replacement prolongs survival in patients with severe aortic stenosis (AS).<ref>[http://www.ncbi.nlm.nih.gov/pubmed/7127696 Schwarz F, et al. "The effect of aortic valve replacement on survival." ''Circulation.'' 1982;66(5):1105-1110.]</ref> However, the condition often presents at an advanced age when patients are poor surgical candidates due to multiple comorbidities. Transcatheter aortic valve replacement (TAVR) is an emerging technology whereby a self-expanding aortic valve prosthesis is inserted using a transcatheter approach. The [[PARTNER B]] trial established the role of TAVR in patients with severe AS who are not surgical candidates due to cormorbidity, as TAVR led to an absolute 20% reduction in all-cause mortality at 1 year with TAVR versus | It is well-accepted that aortic valve replacement prolongs survival in patients with severe aortic stenosis (AS).<ref>[http://www.ncbi.nlm.nih.gov/pubmed/7127696 Schwarz F, et al. "The effect of aortic valve replacement on survival." ''Circulation.'' 1982;66(5):1105-1110.]</ref> However, the condition often presents at an advanced age when patients are poor surgical candidates due to multiple comorbidities. Transcatheter aortic valve replacement (TAVR) is an emerging technology whereby a self-expanding aortic valve prosthesis is inserted using a transcatheter approach. The [[PARTNER B]] trial established the role of TAVR in patients with severe AS who are not surgical candidates due to cormorbidity, as TAVR led to an absolute 20% reduction in all-cause mortality at 1 year with TAVR versus medical therapy. Given its inherently less invasive design, the benefit of TAVR may extend to patients who remain surgical candidates but are nevertheless high-risk. | ||
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 open AVR. At 1 year, the primary endpoint of all-cause mortality was 2% lower in the TAVR group, meeting prespecified criteria for noninferiority. 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 open 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 open AVR. At 1 year, the primary endpoint of all-cause mortality was 2% lower in the TAVR group, meeting prespecified criteria for noninferiority. 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 open 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. | ||