ACCESS-EUROPE, EVEREST II Data Support MitraClip in MR

San Francisco, CA—A percutaneous clip device has demonstrated encouraging survival rates in patients with mitral regurgitation (MR) in several ongoing and completed studies, according to presenters speaking at TCT 2013.

EVEREST II

Samir Kapadia, MD, of the Cleveland Clinic, presented 4-year outcomes of the EVEREST II trial, which compared percutaneous repair with the MitraClip (n=161; Abbott Vascular) vs. surgery (n=73) for grade 3+ or 4+ MR. 

The composite endpoint of freedom from mortality, mitral valve surgery or reoperation, and 3+ or 4+ MR occurred in 39.8% of patients in the percutaneous repair arm and 53.4% of those in the surgical arm (P=.070). Mortality was similar at 17.4% and 17.8%, respectively (P=.914). Additionally, the proportion of 3+ or 4+ MR was 21.7% in the percutaneous group and 24.7% for surgery (P=.745).

Three-year results indicated a change in LV end systolic volume (LVESV) of
–6 mL and change in LV end diastolic volume (LVEDV) of –30 mL among 178 patients in the device group. For surgery (n=80), those outcomes were change in LVESV of –11 mL and change in LVEDV of –44 mL. “We observed similar decreases in volume over time in both groups,” Kapadia said.

“The clinical benefits provided by MitraClip and mitral valve surgery are durable,” he said, adding that they were associated with a reduction in MR severity, improvement in LV dimensions and improvements in NYHA functional class.

Kapadia also highlighted low rates of adverse events between years 1 and 4 in both arms. “Beyond 6 months, the rate of surgery is low in the MitraClip group,” he concluded. 

ACCESS-EUROPE

Ralph Stephan von Bardeleben, MD, of the University Medical Center Mainz in Germany, highlighted encouraging safety results at 30 days with the device (see Figure).

“The death rate, interestingly, in functional MR is about half of what we saw in degenerative MR patients,” von Bardeleben said. “We were encouraged by the extremely low rates of stroke and MI.”

Twelve-month Kaplan-Meier curves showed a freedom from mortality of 81.8% in the functional MR group and 82.5% in the degenerative MR group. Among survivors freedom from surgery at this time point was 96% for functional MR and 94.5% for degenerative MR. 

“Freedom from surgery was much higher than the EVEREST trial,” von Bardeleben observed.

However, he noted that long-term results are still controversial. “There is yet no proven survival advantage,” he said. “Both surgical and percutaneous mitral valve repair is feasible in patients with functional and ischemic MR.”

The analysis included 393 patients in the functional MR group, 117 in the degenerative group and 57 with unknown etiology.

Disclosures:

Kapadia reports being a member of the COAPT steering committee.

Von Bardeleben reports receiving consulting fees or honoraria from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, the German Society of Cardiology, Philips Healthcare and Siemens.