March 17, 2015 — The American College of Cardiology (ACC) hosted its 64th Annual Scientific Session & Expo over the weekend in San Diego, California. Key data from multiple transcatheter aortic valve replacement (TAVR) clinical trials were presented and we believe there was truly no loser between Edwards and Medtronic based on the positive data presented. In addition, St. Jude Medical announced retrospective analysis on CHAMPION data showing significant reduction in mortality rates and heart failure (HF) hospitalizations for heart failure patients with reduced ejection fraction.
Partner I Trial: Five-year data from Cohort A (candidates for surgery but considered high risk) of Edwards' Sapien transcatheter heart valve trial demonstrated equivalent outcomes to traditional open-heart surgery and no structural valve deterioration requiring intervention. The PARTNER series demonstrated TAVR as equivalent to surgery. The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization. Results reinforce TAVR as an effective treatment for high-risk patients.
Sapien 3 Trial: Edwards announced positive 30-day outcomes for high- and intermediate-risk patients treated with the Sapien 3 transcatheter aortic valve which demonstrated the lowest all-cause mortality rates of any of the PARTNER studies (2.2 percent and 1.1 percent, respectively). In addition, the rates of significant paravalvular leaks were low in each cohort at 3.0 for high-risk and 4.2 for intermediate. Sapien 3 data is the first report on intermediate risk TAVR patients, with more than 1,000 intermediate-risk patients treated with a Sapien 3 valve.
CoreValve U.S. High-Risk Two-Year Data: The CoreValve U.S. High-Risk study is the first and only head-to-head study to show statistically significant survival differences favoring TAVR in aortic stenosis patients who are considered high-risk for surgery. Two-year outcome data found the rate of all-cause mortality significantly lower in TAVR patients than in SAVR patients (22.2 percent vs. 28.6 percent, p=0.04). The rate of stroke was significantly lower in TAVR as compared to surgical aortic valve replacement (SAVR) at two years (10.9 percent vs. 16.6 percent, p=0.05).
CoreValve Evolut-R 30-Day Data: The Evolut R system showed remarkable results at 30-days with no incidents of all-cause mortality or stroke in a high and extreme risk patient population. However, we note that the Evolut R study was a very small study, with 60 patients enrolled. In addition, the pacemaker rate was 11.7 percent.
CHAMPION Trial: St. Jude Medical announced retrospective data analysis from the CHAMPION trial showing that heart failure patients with reduced ejection fraction on optimal doses of guideline directed medical therapy (GDMT) managed by pulmonary artery (PA) pressure monitoring with the CardioMEMS HF System had a 57 percent reduction in mortality and a 43 percent reduction in HF hospitalizations compared with patients on GDMT and managed by the standard of care. This analysis demonstrated that PA pressure monitoring, coupled with GDMT, significantly reduced HF hospitalizations and mortality in patients with reduced ejection fraction.
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