1. Updates From SURTAVI in Intermediate Risk Patients
Jeffrey J. Popma, MD
Professor of Medicine
Harvard Medical School
Director, Interventional Cardiology
Beth Israel Deaconess Medical Center
Boston, MA

2. Conflict of Interest Statement
Over the past year, I have received the following:
Institutional Grants: Medtronic, Boston Scientific, Abbott Vascular, Direct Flow, Cook
Medical Advisory Board: Boston Scientific, Abbott Vascular, GE Healthcare, Covidien
Non Vested Equity: Intelemage, Healthworks, Direct Flow Medical

3. It has been a long road . . .

4. The SURTAVI Braintrust
Serruys 2012

5. The SURTAVI Initial Selection Criteria
Serruys 2012

6. Serruys 2012

7. Serruys 2012

8. Revision of Protocol and the
Expansion to US

9. Current SURTAVI Trial Design
Primary Objective
Evaluate in a prospective randomized fashion whether TAVI is non-inferior to SAVR with respect to composite endpoint of all-cause mortality and disabling stroke at 24 months in patients with symptomatic severe aortic stenosis and at intermediate surgical risk
Primary Endpoint
All-cause mortality or disabling stroke at 24-months

10. CoreValve SURTAVI Trial Clinical Sites
Up to 115 worldwide centers in Europe, Canada, and United States

11. Patient Selection Frailty assessments identifies:
Severe, symptomatic AS
Intermediate surgical risk: Heart Team predicted risk of 30- day operative mortality is ≥3% to <15% at 30 days)
Subjects with CAD and a Syntax score ≤22 will be eligible
Concomitant PCI and TAVI can be performed; staging is left at discretion of operator
CABG should be conducted during the index SAVR procedure
Frailty assessments identifies:
Subject is < 80 years of age and three or more
Subject is ≥ 80 years of age and two or more
Wheelchair bound, resides in an institutional care facility, BMI < 20 kg/m2, Grip strength < 16kg, Katz Index Score ≤ 4, Albumin < 3.5 g/dl

12. SURTAVI Trial Timeline
2012
2013
2014
2015
2016
Entry STS 4-10%
Risk Based Entry Heart Team >3% to < 15%
June 2012
First EU Pt
Evolut R
Nov 2012
First US Pt
Randomized Enrollment Concluded May 2016
Activation of 40 Sites from US High and Extreme Risk Trials
Activation of ~30 Additional Sites

13. CoreValve SURTAVI Trial Update
Randomization concluded on 19-May-2016 with ~1600 subjects enrolled into primary analysis cohort
Study is designed with an interim analysis which permits analysis of the primary endpoint prior to complete 24 month follow-up
Data release is anticipated at ACC 2017