Key data from many transcatheter aortic valve replacement (TAVR) clinical trials will be presented as late-breakers at the American College of Cardiology (ACC) Scientific Session this weekend, March 14-16, 2015, in San Diego, Calif. While the three-day conference will be packed with lectures, poster presentations, case studies, etc., most investors will be waiting for TAVR-related clinical data from Edwards and Medtronic. We expect these data to be positive for both vendors, which will only help to solidify their hold on the global TAVR market.
Below are four clinical trials financial mark analysis firm Sterne Agee believes investors should pay attention to.
The Placement of AoRtic TraNscathetER (PARTNER) Valve Trial for the Edwards' Sapien was the first randomized, controlled study, which tested safety and efficacy of transcatheter aortic heart valves. The PARTNER 1 trial was segmented into two separate groups, those patients with severe aortic stenosis who were not candidates for surgical replacement of an aortic valve (Cohort B) and those who are candidates for surgery but are considered high risk (Cohort A). On Sept. 22, 2010, Edwards announced The New England Journal of Medicine (NEJM) published results from Cohort B of the PARTNER 1 Trial, which successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization. On April 3, 2011, Edwards presented the data from Cohort A of the PARTNER 1 Trial, which demonstrated that the study achieved its primary endpoint at one year, and survival of patients treated with the Edwards Sapien transcatheter aortic valve was equivalent to those treated with surgical aortic valve replacement.
The PARTNER 1 Trial contains numerous secondary outcome measures, including improved quality of life (QOL) from baseline to 30 days, six months, and annually through year five.
Five-year data from Cohort A are scheduled to be presented as a "Late-Breaking Clinical Trial" Sunday, March 15, at 10:45 a.m. Pacific Time. Based on our research and the five-year data from Cohort B presented at last year's Transcatheter Cardiovascular Therapeutics (TCT) conference, the data from Cohort A is expected to demonstrate TAVR was associated with a continued significant mortality benefit, persistent symptom benefit, and a statistically significant reduction in re-hospitalizations.
CoreValve U.S. High-Risk Two-Year Data
Michael Reardon, M.D., is scheduled to present two-year data from Medtronic's CoreValve U.S. Pivotal Trial High Risk Study. As a reminder, this clinical trial compared CoreValve's self-expanding, transcatheter aortic valve replacement with traditional, surgical aortic valve replacement (SAVR). The one-year, all-cause mortality data (primary outcome) demonstrated the CoreValve prosthesis was non-inferior to SAVR with a 7.5% non-inferiority margin. Based on the positive data demonstrated from Medtronic's Italian Registry, three years of outcomes data of the self-expanding CoreValve prosthesis, we expect the two-year data from the U.S. trial will continue to demonstrate CoreValve is non-inferior to SAVR. The two-year CoreValve data from its U.S. trial will also be presented as a "Late-Breaking Clinical Trial" on Sunday, March 15.
Early clinical and echocardiographic outcomes in the PARTNER II trial with the SAPIEN 3 TAVR system in inoperable, high-risk, and intermediate-risk aortic stenosis patients will be presented on Sunday, March 15. We expect these data will show equivalent safety and efficacy as the 30-day data from the SAPIEN 3 Trial (Europe). In June 2014, Edwards released data from its SAPIEN 3 Trial, which demonstrated the Sapien 3 System was associated with a very low mortality of 2.1%, a stroke rate of 1%, and very few access-site complications. All-cause mortality in all access approaches was reported as 5.3% in the as-treated population.
Data from the Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation will be revealed Sunday, March 15, at 12:30 p.m. Pacific Time. The NOTION trial is the first randomized trial comparing TAVR (CoreValve) to SAVR in terms of safety and effectiveness in a population including low-risk patients. The study was designed with a randomization ratio of 1:1, enrolled a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. The trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention. While we do not expect the trial will show statistical superiority due to the lack of power, 280 patients, and multiple risk groupings in the TAVR group, we believe positive safety and efficacy in the low-risk group will push the industry towards expanding the use of TAVR for patients with lower risk profiles, pending FDA (United States Food and Drug Administration) approval and CE mark.
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