2. EVEREST II (Endovascular Valve Edge-to-Edge Repair
Study)
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 surgeon's 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. 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 days
End point Clip (%) Surgery (%)
Safety, per protocol 9.6 57.0
Efficacy, per protocol 72.4 87.8
Safety, intention to treat 15 47.9
Efficacy, intention to treat 66.9 74.2
All between-group differences statistically significant
4. EVEREST II: Commentary*
"The most striking thing in our experience is the remarkable clinical response. I've had
patients who literally could not walk across the road without getting shortness of breath
and who go home after this procedure and, in less than a week, are doing water
aerobics."
- Dr Ted Feldman
"This is going to be considered banner news at a cardiology meeting, but it's not terribly
surprising 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+ mitral
regurgitation 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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