The medical news of the year comes at the hands of Abott

While preparing The Week in Review issue from Prohost, our attention  shifted towards historical news about a procedure that improved the heart function in severe heart failure patients. For cardiologists and their patients, the positive results were surprising, stunning and beyond anticipation. Current treatments of severe heart failure are only symptomatic and do not stop the heart muscle deterioration that results in imminent death. Data from a trial, which are published in The New England Journal of Medicine (NEJM) demonstrated that the tiny MitraClip inserted into the heart has sharply reduced the progression of heart failure and the percentage of deaths in patients with severe heart failure. The MitraClip device belongs to Abott Laboratories (ABT), which paid for the clinical study known as COAPT.

The Trial

The COAPT clinical trial is a randomized controlled trial that recruited 614 patients with severe heart failure who received the MitraClip + the standard care treatment or the standard of care alone. The results, which were announced yesterday by Abott demonstrate that MitraClip plus standard of care therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years. They met both the primary safety and efficacy endpoints and all the secondary endpoints of the trials. The data was presented yesterday during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Diego.

Here are some results:

• MitraClip plus medical therapy resulted in a statistically significant reduction in heart failure hospitalization through two years compared to medical therapy alone (annualized rate of 67.9 percent per year vs. 35.8 percent per year).

• MitraClip treatment reduced all-cause mortality through two years, from 46.1 percent of patients in the control group to 29.1 percent in the device group at two years of follow-up. And more…

• The results were consistent across numerous subgroups, including patients with ischemic and non-ischemic cardiomyopathy – a disease of the heart muscle that weakens the ability of the heart to pump blood to the rest of the body – and those at high and low surgical risk.

Commenting on the study results, Gregg W. Stone, M.D., co-principal investigator of the COAPT study, director of cardiovascular research and education at the New York Presbyterian/Columbia University Irving Medical Center and professor of medicine at Columbia University Vagelos College of Physicians and Surgeons said,  “These highly anticipated results from the COAPT trial are quite remarkable, and conclusively demonstrate that heart failure patients with clinically significant secondary mitral regurgitation who remain symptomatic despite best medical practices benefit from treatment with MitraClip. These results have the potential to transform clinical practice and help patients who otherwise have an extremely poor prognosis – patients who, to date, have had to rely only on medications to manage their symptoms without treating the underlying cause.” It is important to note that MitraClip repairs the mitral valve with no need for an invasive surgical procedure and is delivered to the heart through the femoral vein, a blood vessel in the leg.      Neil Moat, M.D., chief medical officer of Abbott's structural heart business said, " While MitraClip is already the gold standard for repairing leaky heart valves in patients with primary mitral valve disease who are not surgical candidates, we now have very robust clinical evidence that MitraClip is a life-changing technology for people whose heart failure has resulted in a leaky mitral valve, providing hope to these very sick heart failure patients and their caregivers."

Prohost Observations

For more than a century the dream of cardiologists and cardiac surgeons was treating severe heart failure. They used everything, including therapeutic molecules, surgical interventional procedures, other invasive procedures and devices in hundreds of clinical trials with no successful outcome. Yesterday’s news is the first ever to announce the successful outcome of the MitraClip, with statistically significant reduction in heart failure hospitalization and death. This is a great news for severe heart failure patients and cardiologists. It is one of the most important and impressive medical news of the year.