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ACCESS-EUROPE: Percutaneous treatment of MR validated in real-world setting
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MUNICH — One-year results from the ACCESS-EUROPE study demonstrate that a percutaneous strategy provides significant clinical benefits for patients with mitral regurgitation, consistent with observations from controlled clinical trials.
The phase 1 study was conducted by Wolfgang Schillinger, MD, professor at the University Medical Center Göttingen-Heart Center, Göttingen, Germany, and colleagues. Researchers enrolled 567 patients at 14 European sites. Patients treated with the percutaneous approach (MitraClip, Abbott Vascular) had a mean age of 74 ± 10 years and significant baseline comorbidities, including CAD (63%), moderate-to-severe renal disease (42%) and functional mitral regurgitation (MR; 77%); many patients were also considered high-risk for surgery.
One year following treatment, 82% of patients were free from death, 79% were free from MR grade >2+, and 94% were free from mitral valve surgery. Seventy-two percent of patients were classified as NYHA Class I/II, while researchers reported a median improvement of 59.5 meters in 6-minute walking distance. Data also indicated an improvement in quality of life of 13.5 points on the Minnesota Living with Heart Failure Questionnaire.
Although P values for 30-day safety events, including death, MI, renal failure, bleeding complications and stroke, did not reach statistical significance in the study, Schillinger said at a press conference that the overall low number of events reported can cause statistics to be negative.
Overall, he said, “the MitraClip procedure provides significant clinical benefits to patients with severe MR in a real-world setting consistent with results in controlled clinical trials. The MitraClip therapy therefore provides a treatment option for a patient population with an unmet clinical need.” – by Brian Ellis
For more information:
Schillinger W. Hot line II: Late breaking trials on interventions. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.
Disclosure: Dr. Schillinger reports receiving lecture fees and honoraria from Abbott Vascular. The trial was sponsored by Abbott Vascular.