EVEREST II trial - Summary & Results

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The first randomized trial to compare outcomes with MitraClip vs surgery

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EVEREST II trial - Summary & Results

  1. 1. EVEREST II (Endovascular Valve Edge-to-Edge Repair Study)
  2. 2. EVEREST II (Endovascular Valve Edge-to-Edge RepairStudy)T Feldman (Evanston Hospital, Evanston, IL)American College of Cardiology 2010 Scientific Sessions/i2 Summit• The first randomized trial to compare outcomes with MitraClip vs surgery• Population and treatment: 279 patients with significant mitral regurgitation (3+ to 4+); patients had to be symptomatic or have documented LV dysfunction Randomized 2:1 to the MitraClip procedure or to surgical repair or replacement at the surgeons discretion• Outcomes: Primary efficacy end point: major adverse events at 30 days (to show superiority) and clinical success ratea Primary safety end point: wide-ranging combination of adverse events including death, major stroke, reoperation, urgent/emergent surgery, MI, renal failure, and blood transfusions, among others a. Freedom from a combination of death, mitral-valve surgery or reoperation for mitral-valve dysfunction, and an improvement of at least two grades of mitral regurgitation at 12 months (designed to demonstrate noninferiority of the clip device)
  3. 3. EVEREST II: Results• The primary safety end point (per-protocol analysis) significantly favored the percutaneous procedure at 30 days—need for blood transfusions was the main driver (8.8% vs 53.2%)• The overall clinical success rate was numerically higher in the surgery group for the primary efficacy end point (per-protocol analysis)—87.8% vs 72.4%—but this difference met the prespecified noninferiority hypothesis of 31%Safety and efficacy end points at 30 daysEnd point Clip (%) Surgery (%)Safety, per protocol 9.6 57.0Efficacy, per protocol 72.4 87.8Safety, intention to treat 15 47.9Efficacy, intention to treat 66.9 74.2All between-group differences statistically significant
  4. 4. EVEREST II: Commentary*"The most striking thing in our experience is the remarkable clinical response. Ive hadpatients who literally could not walk across the road without getting shortness of breathand who go home after this procedure and, in less than a week, are doing wateraerobics." - Dr Ted Feldman"This is going to be considered banner news at a cardiology meeting, but its not terriblysurprising for sites that have been involved in the trials." - Dr Craig Smith"There are very few surgeons who would leave an operating room with a 2+ mitralregurgitation after an attempted valve repair and feel good about it." - Dr Scott Millikan*All comments from EVEREST II: Mitral-clip device noninferior to surgical repair or replacement(http://www.theheart.org/article/1054941.do)
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