番茄社区

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SAN FRANCISCO -- The advantage of MitraClip in functional mitral regurgitation (MR) continues to grow over time and the procedure is cost-effective, with benefit nearly identical for those who crossover to clipping after 2 years, further analyses of the COAPT trial showed.

The survival without heart failure hospitalization curves continued to separate, with a highly significant 52% reduction in risk for MitraClip over guideline-directed medical therapy alone (88.1% vs 58.5%) at 3 years, up from the 47% reduction reported at 2 years, according to Michael Mack, MD, of Baylor Scott & White Health in Plano, Texas, a presentation at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting.

Notably, for those patients who survived to crossover to the procedure after it was allowed at 2 years, the all-cause mortality and heart failure hospitalization advantage was similar (HR 0.43 at 36 months, 95% CI 0.24-0.78) from that point to that seen in patients originally randomized to it in the trial.

"To me, the most significant finding from this study today is the fact that the patients who made it in the medical therapy when they crossed over to MitraClip benefited," said TCT press conference moderator Roxana Mehran, MD, of Mount Sinai Hospital in New York City.

COAPT primary investigator Gregg Stone, MD, of Icahn School of Medicine at Mount Sinai in New York City and director of TCT, said it might not be surprising that patients who survived to this point benefit, "because the patients who got in this trial had heart failure for many, many years. So it's never too late to try to improve their prognosis."

It served as a sort of internal validation of the results, albeit not randomized, he said.

COAPT included 614 patients randomized open-label to MitraClip or medical therapy alone who remained symptomatic despite optimization of guideline-directed medical therapy and who had heart failure and at least moderate secondary MR (classified as 3+ or 4+). Crossover for the medical therapy group was allowed at 2 years, and 38% of eligible patients did so. Death prior to 24 months was the most common reason for ineligibility for crossover (124 of 169).

The procedure was cost-effective, boosting life-expectancy by a projected 1.13 years at a cost of $45,648 for a lifetime incremental price of $55,600 per quality-adjusted life-year gained, reported David Cohen, MD, of the University of Missouri-Kansas City, reported at another TCT late-breaking clinical trial session, and online in Circulation.

During the trial, the procedure cost $35,755 and the index hospitalization $48,198, which remained higher than medical therapy cumulative to 2 years ($73,416 vs $38,345, P<0.001) despite somewhat cheaper follow-up care costs.

The "acceptable economic value" of the procedure adds to the main findings of clinical benefit, the researchers wrote, supporting transcatheter mitral valve repair as "a reasonable treatment strategy for this patient population."

Enthusiasm for transcatheter treatment of secondary mitral regurgitation has been somewhat "dampened by concerns regarding the economic impact of TMVr [transcatheter mitral valve replacement], considering the large numbers of heart failure patients who might be candidates for this expensive and invasive treatment," wrote Robert Bonow, MD, of Northwestern University in Chicago, and colleagues in an accompanying editorial.

The cost-effectiveness findings help allay those concerns, despite finding no hint of a reduction in healthcare expenses compared with medical therapy alone for heart failure -- even if the device cost nothing, they noted.

But the negative findings of MITRA-FR for the same procedure in the same indication make clear the importance of patient selection, instead of being "carte blanche for interventional cardiologists to dramatically escalate their use of MitraClip procedures in patients with moderate or severe functional MR," Bonow's group wrote.

"Rather, these data support the thoughtful and deliberate use" following all of the COAPT criteria for patients who aren't surgical candidates," they suggested.

If so, it offers "exciting potential for substantial improvements in longevity and quality of life, while also providing society good value for its health care dollars," the editorialists concluded. "In 21st century medicine, that win-win scenario is often as good as it gets."