1. Cardiovacular Research Technologies
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients COAPT Trial
Ted Feldman, M.D., FSCAI FACC FESC
Evanston Hospital
CRT
Cardiovacular Research Technologies
Washington, D.C.
February 23rd– 26th 2013

2. Ted E. Feldman, MD Consulting: Abbott Laboratories
Boston Scientific Corporation
Edwards Lifesciences, LLC

3. CONCLUSIONS
Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes.

4. Endovascular Valve Edge-to-Edge REpair STudy
Subgroup Analyses for the Primary End Point at 12 Months
Feldman T et al. N Engl J Med 2011;364:

6. Guidelines on the management of valvular heart disease 2012
With CABG
European Heart Journal (2012) 33, 2474

7. Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk
The COAPT Trial

8. Purpose
evaluate the safety and effectivenessthe MitraClip device in an FMR patient population that is too high risk to undergo mitral valve surgery
study will generate clinical and economic data to support reimbursement and evidence to support the development of treatment guidelines
first RCT to compare non-surgical standard of care treatment to an intervention for MR
Take out the “surgical” in high risk 8

9. Clinical and TTE follow-up:
Trial design
~420 patients enrolled at up to 75 US sites
Significant FMR (≥3+ by core lab)
High risk for mitral valve surgery
Specific valve anatomic criteria
Randomize 1:1
Control group
Standard of care
MitraClip
N=210
N=210
Clinical and TTE follow-up:
1, 6, 12, 18, 24, 36, 48, 60 months
Protocol conditionally approved by FDA July 26, 2012

10. Key Inclusion Criteria
Functional MR ≥3+
ischemic or non-ischemic cardiomyopathy
Symptomatic
NYHA class II, III or ambulatory IV
STS mortality risk is ≥ 8% or Local Site Heart Team concludes that co-morbidities result in a prohibitive predicted operative risk of stroke or death
≥1 HF hospitalization during prior year
and/or BNP ≥400 pg/ml
or nT-proBNP ≥1600 pg/ml ≤90 days
treated per standards for CAD, LV dysfunction, MR or HF including CRT, revascularization, OMT
primary MR jet originates from malcoaptation of A2-P2 scallops
Remove lvef 10

11. Key Exclusion Criteria
severe LV dysfunction is defined as LVESD >55mm or LVEF<20%
MV area <4 cm2
MI ≤90 days
Untreated clinically significant CAD requiring revascularization
CVA or TIA within 6 months or severe carotid stenosis
Any percutaneous coronary, carotid or endovascular intervention or carotid surgery within 30 days, or any coronary or endovascular surgery within 6 months
CRT and/or ICD implant or revision within 90 days
Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR
Severe right ventricular failure or severe tricuspid regurgitation

12. Primary Endpoints Primary Effectiveness (min 1-year FU all pts)
Recurrent heart failure hospitalizations
Superiority hypothesis (Andersen-Gill)
Primary Safety (1 year)
Composite of all-cause death, stroke, worsening kidney function, or LVAD or cardiac transplant
Non-inferiority hypothesis 12

13. Hospitalizations for CHF EVEREST II High Surgical Risk Cohort
55% Reduction in Rate of CHF Hospitalizations
Matched data, patients still alive at 1 year
Rate of CHF Hospitalizations =
# CHF hospitalizations / # Patients
Annual Rate of CHF Hospitalizations =
# CHF Hospitalizations / PatientYr