03.16.15
During the American College of Cardiology's (ACC) 64th Annual Scientific Session in San Diego, Calif., and simultaneously published in The Lancet, Edwards Lifesciences Corp. reported final five-year clinical data for high-risk patients treated with the first-generation Sapietranscatheter aortic valve replacement .
The PARTNER trial—which the company says is the first prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients at high risk for surgery—demonstrated equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention.
"It's remarkable that this five-year data report continues to show equivalency between what was then a brand new procedure with a first-generation TAVR device and the gold standard of surgery, which has been honed over 50 years of experience," said Michael J. Mack, M.D., chair, cardiovascular service line, Baylor Scott & White Health. "Just as we observed in the five-year report from The PARTNER Trial on outcomes in inoperable patients treated with Sapien, the high-risk patients also had durable valve performance.
These data show that TAVR is an effective treatment for these patients."
The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization.
The high-risk surgery cohort (Cohort A) of the PARTNER trial enrolled between May 2007 and Sept. 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multi-disciplinary Heart Team and randomized to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery. This trial represented the initial TAVR experience for most trial sites in the United States.
The U.S. Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. In June 2014, the FDA approved the next-generation SAPIEN XT valve for the treatment of inoperable and high-risk patients.
A second data presentation during the ACC late-breaking clinical trials detailed outcomes with the investigational Sapien 3 valve.
According to the company, 30-day outcomes for high- and intermediate-risk patients treated with the Sapien 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation. This is the first report of Sapien 3 data in the United States, and first report on intermediate risk TAVR patients.
"These results of more than 1,600 patients treated with the Sapien 3 valve demonstrate the most significant progress in the development of TAVR and the Sapien family of valves since the first PARTNER study was initiated in 2007," said Susheel Kodali, M.D., director, Heart Valve Program, at NewYork-Presbyterian/Columbia University Medical Center and assistant professor of medicine at the Columbia University College of Physicians and Surgeons. Kodali is the co-principal investigator for the SAPIEN 3 studies. "With average ages in the 80s, the high-risk and intermediate-risk patients in the study had strikingly low mortality rates of 2.2 and 1.1, respectively, despite predicted 30-day mortality that was much higher. Additionally, the rates of significant paravalvular leaks were low in both cohorts—3.0 for high-risk and 4.2 for intermediate—which represented meaningful improvements over prior studies with earlier generation devices."
The Sapien 3 high-risk cohort enrolled 583 patients at 29 U.S. sites; the intermediate risk cohort enrolled 1,076 patients at 51 U.S. sites. Both studies were single-arm, nonrandomized cohorts of the PARTNER II Trial. Important clinical measures from the studies are presented in the table below.
The Sapien 3 valve is Edwards' most advanced transcatheter aortic valve, and can be delivered through a low-profile 14 French expandable sheath. It also has an outer skirt—a cuff of fabric surrounding the bottom of the frame—to provide a seal to minimize paravalvular leak. The Sapient 3 valve can be implanted via the transfemoral approach through an incision in the leg, as well as alternative access approaches.
The Sapien 3 valve was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. The valve is an investigational device not yet available commercially in the United States.
Edwards continues to plan for U.S. regulatory approval and launch of Sapien 3 early in 2016. The company is not updating its sales and earnings per share guidance for 2015. Edwards' projected 2015 diluted earnings per share of $4.00-4.30, excluding special items, reflects the expected reduction in reported sales due to changes in currency exchange rates, mitigated by currency hedge contracts and the benefit of the company's natural hedges.
Irvine, Calif.-based Edwards makes heart valves and technology for hemodynamic monitoring.
The PARTNER trial—which the company says is the first prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients at high risk for surgery—demonstrated equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention.
"It's remarkable that this five-year data report continues to show equivalency between what was then a brand new procedure with a first-generation TAVR device and the gold standard of surgery, which has been honed over 50 years of experience," said Michael J. Mack, M.D., chair, cardiovascular service line, Baylor Scott & White Health. "Just as we observed in the five-year report from The PARTNER Trial on outcomes in inoperable patients treated with Sapien, the high-risk patients also had durable valve performance.
These data show that TAVR is an effective treatment for these patients."
The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization.
The high-risk surgery cohort (Cohort A) of the PARTNER trial enrolled between May 2007 and Sept. 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multi-disciplinary Heart Team and randomized to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery. This trial represented the initial TAVR experience for most trial sites in the United States.
The U.S. Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. In June 2014, the FDA approved the next-generation SAPIEN XT valve for the treatment of inoperable and high-risk patients.
A second data presentation during the ACC late-breaking clinical trials detailed outcomes with the investigational Sapien 3 valve.
According to the company, 30-day outcomes for high- and intermediate-risk patients treated with the Sapien 3 transcatheter aortic valve demonstrated the lowest all-cause mortality rates of any of the PARTNER studies, as well as excellent clinical outcomes on the other components of the primary endpoint measures of stroke and paravalvular regurgitation. This is the first report of Sapien 3 data in the United States, and first report on intermediate risk TAVR patients.
"These results of more than 1,600 patients treated with the Sapien 3 valve demonstrate the most significant progress in the development of TAVR and the Sapien family of valves since the first PARTNER study was initiated in 2007," said Susheel Kodali, M.D., director, Heart Valve Program, at NewYork-Presbyterian/Columbia University Medical Center and assistant professor of medicine at the Columbia University College of Physicians and Surgeons. Kodali is the co-principal investigator for the SAPIEN 3 studies. "With average ages in the 80s, the high-risk and intermediate-risk patients in the study had strikingly low mortality rates of 2.2 and 1.1, respectively, despite predicted 30-day mortality that was much higher. Additionally, the rates of significant paravalvular leaks were low in both cohorts—3.0 for high-risk and 4.2 for intermediate—which represented meaningful improvements over prior studies with earlier generation devices."
The Sapien 3 high-risk cohort enrolled 583 patients at 29 U.S. sites; the intermediate risk cohort enrolled 1,076 patients at 51 U.S. sites. Both studies were single-arm, nonrandomized cohorts of the PARTNER II Trial. Important clinical measures from the studies are presented in the table below.
The Sapien 3 valve is Edwards' most advanced transcatheter aortic valve, and can be delivered through a low-profile 14 French expandable sheath. It also has an outer skirt—a cuff of fabric surrounding the bottom of the frame—to provide a seal to minimize paravalvular leak. The Sapient 3 valve can be implanted via the transfemoral approach through an incision in the leg, as well as alternative access approaches.
The Sapien 3 valve was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. The valve is an investigational device not yet available commercially in the United States.
Edwards continues to plan for U.S. regulatory approval and launch of Sapien 3 early in 2016. The company is not updating its sales and earnings per share guidance for 2015. Edwards' projected 2015 diluted earnings per share of $4.00-4.30, excluding special items, reflects the expected reduction in reported sales due to changes in currency exchange rates, mitigated by currency hedge contracts and the benefit of the company's natural hedges.
Irvine, Calif.-based Edwards makes heart valves and technology for hemodynamic monitoring.
