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EVEREST II (Endovascular Valve Edge-to-
Edge Repair Study)
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)
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
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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EVEREST II trial - Summary & Results

  • 1. EVEREST II (Endovascular Valve Edge-to- Edge Repair Study)
  • 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)
  • 5. Become a member of http://www.theheart.org Become a fan on Facebook: http://www.facebook.com/theheartorg Follow us on Twitter: http://www.twitter.com/theheartorg theheart.org is the leading online source of independent cardiology news. We are the top provider of news and opinions for over 100 000 physicians.