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FDA Approves CoreValve for Patients with Severe Aortic Stenosis
Medtronic announced that the FDA has approved its self-expanding transcatheter CoreValve System for patients with severe aortic stenosis who are too frail or too ill to have their aortic valves replaced through traditional surgery.
The device was approved without a review by an FDA advisory panel because of strong clinical outcomes from the Extreme Risk study of the CoreValve US pivotal trial, Medtronic stated in a press release.
The primary endpoint of Extreme Risk was all-cause mortality or major stroke at 12 months. Investigators used a meta-analysis of five contemporary balloon valvuloplasty trials and data from the 12-month PARTNER B trial to estimate the risk for all-cause mortality or major stroke in patients treated with standard therapy. This rate — 43% — served as the objective performance goal (OPG) for the trial.
All-cause mortality or major stroke occurred in 25.5% of the cohort after 1 year, which was significantly lower than the OPG (P<.0001). The all-cause mortality rate was 7.9% at 30 days and 24% at 1 year, with most deaths occurring due to CV issues. Major stroke occurred in 2.4% of patients at 30 days and 4.1% at 1 year.
Jeffrey J. Popma
The CoreValve system also achieved exceptional hemodynamics after implantation in patients in the US pivotal trial, according to the press release, with results similar to those of surgical valves. Valve leakage rates were low and decreased over time, according to the release.
“The low rates of stroke and valve leakage with the CoreValve System — two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life — set a new standard for transcatheter valves,” Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the US pivotal trial, said in the press release.
The entire CoreValve platform received approval, including valves of 23 mm (called the CoreValve Evolut), 26 mm, 29 mm and 31 mm, Medtronic stated in the press release.
The High Risk study of the US pivotal trial, which compares CoreValve with traditional open-heart surgery, is being reviewed separately by the FDA, according to the press release.
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It’s always good to have a second entry into clinical use because it provides more options for patients. The CoreValve in particular can accommodate a smaller sheath size, so it may allow patients that wouldn’t be eligible for the commercialized Edwards device to have access to this procedure via the femoral delivery. However, we do anticipate that the newer iteration of the Edwards valve (Sapien XT) will be approved very soon as well, which has a similar sheath size. Also, the CoreValve has a wider range of annulus sizes, so there are patients who cannot be treated with the commercially available Sapien valve that will now have that option.
In terms of the CoreValve Extreme Risk data presented TCT 2013, these data appear to be strong, but head-to-head comparisons with the Edwards device across studies are very difficult. Even though the patient population is arguably similar to that in the PARTNER trial, there can be differences between the sites and patients that were enrolled. Specifically, when one looks at echo parameters, even though both groups of studies had a core lab, different core labs will read different things in different ways. So I would just give pause before trying to over interpret head-to-head comparisons because there are not really any head-to-head comparisons that are direct.
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First, the FDA approval of the CoreValve for inoperable patients was faster than anticipated. In fact, many predicted a late 2014 date, so this is way ahead of schedule. Could this be the new dawn of fast track FDA approvals for future valves/devices?
The results of the pivotal US trial were presented late October 2013 at TCT and met expectations regarding efficacy and safety. Seventy-five percent of patients were alive and free of stroke at 1 year and this is significantly better than what medical management would have achieved in this cohort. Some CoreValve enthusiasts have already underscored the favorable rates of stroke, major vascular complications and paravalvular leak complications compared with rival valves. Others have cautioned about head-to-head comparisons and we agree with them. Incidentally, a propensity matched analysis comparing Medtronic CoreValve and Edwards Sapien did not reveal any significant difference in patient outcomes except for a higher requirement for permanent pacemakers in the former.
Moving beyond the aforementioned nuances, the big picture here is that aortic stenosis patients will have more options available to them. The smaller profile of the sheath and the wider array of valve sizes are definite advantages. The Edwards Sapien XT valve is not far behind and 2014 will see more patients in the US benefiting from TAVR than previous years. Obviously, the transcatheter valve technology is a moving target and newer lower-profile, retrievable and conformable valves are on the horizon. The FDA will be monitoring this revolution and will determine the pace of entry into the market and the appropriate label designation.
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Having another valve, particularly a valve that is self-expanding, enriches the armamentarium of the practitioners who treat patients with inoperable severe aortic stenosis. I am also looking forward to seeing the results of trials with the new-generation valves.
The currently available FDA-approved Edwards valve still requires larger sheaths, whereas the CoreValve requires smaller sheaths, which are advantageous in patients who can only be treated by a smaller delivery system.
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This is a major development in the treatment of aortic valvular disease and very exciting, but expected based on the excellent results of the CoreValve Extreme Risk study. We are now one step closer to getting this important therapy to many patients who need it, as the lower profile technology allows for transfemoral treatment of many more of our very high-risk patients.