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G. Michael Deeb, MD On Behalf of the US Pivotal Trial Investigators 3-Year Results From the US Pivotal High Risk Randomized Trial Comparing Self-Expanding.

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Presentation on theme: "G. Michael Deeb, MD On Behalf of the US Pivotal Trial Investigators 3-Year Results From the US Pivotal High Risk Randomized Trial Comparing Self-Expanding."— Presentation transcript:

1 G. Michael Deeb, MD On Behalf of the US Pivotal Trial Investigators 3-Year Results From the US Pivotal High Risk Randomized Trial Comparing Self-Expanding Transcatheter and Surgical Aortic Valves CoreValve US Pivotal Trial

2 Medtronic personnel performed all statistical analyses and verified the accuracy of the data, and assisted in the graphical display of the data presented. Dr. Deeb serves: On an Advisory Board, as a Proctor and Research Investigator for Medtronic As a Consultant and Research Investigator for Edwards Lifesciences As a Consultant and Proctor for Terumo As a Research Investigator for Gore He receives no personal remunerations Presenter Disclosure Information ACC2016 2

3 In years 1 and 2 of this randomized high-risk study, TAVR with self-expanding valve showed survival advantage (clinical benefit) over surgical AVR. 1,2 This analysis presented today was to determine: —If the clinical benefit is sustained for TAVR vs. SAVR through 3 years AND —If signals of hemodynamic deterioration exist 1 Adams DH, et al. New Engl J Med 2014; 370:1790-8. 2 Reardon MJ, et al. J Am Coll Cardiol 2015: 66:113-21. 3 Background ACC2016

4 US Pivotal Trial Extreme Risk High Risk TAVR Iliofemoral TAVR Iliofemoral Iliofemoral Access > 18 Fr Sheath Randomization* 1:1 TAVR Non-Iliofemoral TAVR Non-Iliofemoral TAVR (any route) TAVR (any route) SAVR (any type) * Randomization stratified by intended access site Pivotal Trial Design ACC2016 4

5 Transfemoral Subclavian Direct Aortic 18F Delivery System 4 Valve Sizes (23, 26, 29, 31 mm) (18–29 mm Annular Range) All Access Study Device and Access Routes ACC2016 5

6 Severe aortic stenosis: AVA ≤0.8 cm 2 OR AVAI ≤0.5 cm 2 /m 2 AND MVG >40 mm Hg OR peak velocity >4 m/sec at rest or with dobutamine stress echocardiogram if LVEF <50% NYHA functional class II or greater for heart failure 30-Day mortality risk of ≥15% AND combined mortality/morbidity <50% as assessed by 2 local CV surgeons and 1 cardiologist (STS PROM & Incrementals) Patient eligibility verified by a National Screening Committee Inclusion Criteria ACC2016 6

7 Recent active GI bleed <3 months Recent stroke <6 months Recent MI ≤30 days Any interventional procedure with BMS (<30 days) or DES (<6 months) Significant untreated CAD Creatinine clearance <20 mL/min LVEF <20% Life expectancy <1 year due to comorbidities Annulus 29 mm Exclusion Criteria ACC2016 7

8 3-Year follow-up analysis with a median of 35.8 months TAVR and 34.6 months SAVR Surgical valve selection based on the surgeons preference Site-reported echocardiographic results through 3 years Hemodynamic deterioration was defined as an increase in mean AVG of >50% from 1-month to 3-year follow-up Event rates are presented as Kaplan-Meier estimates and comparisons are based on two-tailed log-rank test Methodology ACC2016 8

9 US Pivotal Trial High Risk 3-Year Results

10 As-Treated Population N=750 N=750 Underwent attempted SAVR N=359 N=359 2-Year SAVR N=219/235 (93.2%) 2-Year TAVR N=280/297 (94.3%) 2-Year TAVR N=280/297 (94.3%) Underwent attempted TAVR N=391 N=391 1-Year TAVR N=324/329 (98.5%) 1-Year TAVR N=324/329 (98.5%) 1-Year SAVR N=265/282 (94.0%) 1-Year SAVR N=265/282 (94.0%) 3-Year SAVR N=179/194 (92.3%) 3-Year TAVR N=228/246 (92.7%) 3-Year TAVR N=228/246 (92.7%) Patient Flow ACC2016 10

11 Characteristic, mean ± SD or % TAVR N=391 SAVR N=359 Age (years) 83.2 ± 7.183.3 ± 6.4 Men52.952.4 Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (%) 7.3 ± 3.07.5 ± 3.3 New York Heart Association (NYHA) class III/IV85.486.9 Prior coronary artery bypass surgery29.431.5 Diabetes mellitus34.8*45.1* Insulin requiring11.013.1 Prior stroke 12.514.0 Modified Rankin 0 or 1 74.587.2 Modified Rankin >1 25.512.8 STS severe chronic lung disease13.68.9 Baseline Demographics *P <0.01 11 ACC2016

12 Assessment, % TAVR N=391 SAVR N=359 Home oxygen12.811.4 Liver cirrhosis2.61.9 Anemia with prior transfusion18.215.9 Severe (>5) Charlson comorbidity*54.057.8 Falls in past 6 months18.518.1 5-Meter gait speed >6 seconds79.380.2 Assisted living9.710.9 Katz ≥1 activities of daily living deficits10.712.3 *Charlson Score: = 1 MI, CHF, PVD, CVD, dementia, chronic lung disease, connective tissue disease, ulcer, mild liver disease, DM; = 2 hemiplegia, mod-severe kidney disease, diabetes with end organ damage, leukemia, lymphoma; = 3 moderate or severe liver disease; = 6 metastatic solid tumor, AIDS. Incremental Risk Factors 12 ACC2016

13 13 All-Cause Mortality or Stroke ACC2016

14 14 All-Cause Mortality or Major Stroke ACC2016

15 15 All Stroke ACC2016

16 16 All-Cause Mortality ACC2016

17 17 Sub-Group Analysis for 3-Year Mortality ACC2016

18 18 Sub-Group Analysis for 3-Year Mortality ACC2016

19 19 ACC2016 All-Cause Mortality – STS ≤ 7%

20 20 ACC2016 MACCE

21 EventsTAVRSAVR Log-Rank P Value Life threatening or disabling bleeding19.141.3<0.001 Atrial fibrillation19.836.3<0.001 Reintervention2.50.40.020 Pacemaker implant28.014.5<0.001 Aortic valve hospitalization27.621.90.087 Endocarditis0.91.70.346 21 Other Endpoints at 3 Years ACC2016

22 Percentage of Patients 22 NYHA Class ACC2016

23 TAVR had significantly better valve performance vs SAVR at all follow-ups (P<0.001) 23 ACC2016 Valve Hemodynamics* *Site-reported

24 Mean AV Gradients for Patients With >50% Increase From 1 Month to 3 Years 24 ACC2016 *Site-reported Hemodynamic Signals*

25 25 Significantly less AR with SAVR vs. TAVR at Each Time Point (P<0.001) Total Aortic Regurgitation* ACC2016

26 At 3 years in this randomized, prospective, multicenter trial: Incidence of all-cause mortality or stroke significantly favors TAVR Incidence of all-cause mortality or major stroke significantly favors TAVR Incidence of any stroke significantly favors TAVR The difference in all-cause mortality between groups maintains separation favoring TAVR Incidence of MACCE significantly favors TAVR 26 Conclusions I ACC2016

27 At 3 years in this randomized, prospective, multicenter trial: TAVR showed significantly lower, single-digit mean gradients, and larger effective orifice areas than SAVR at all time points. Incidence of moderate or greater AR significantly favored SAVR Signals of hemodynamic deterioration defined as an increase in mean gradient of >50% was low and similar between groups. 27 Conclusions II ACC2016

28 At 3 years in this randomized, prospective, multicenter trial: TAVR showed significantly lower, single-digit mean gradients, and larger effective orifice areas than SAVR at all time points. Incidence of moderate or greater AR significantly favored SAVR Signals of hemodynamic deterioration defined as an increase in mean gradient of >50% was low and similar between groups. Through 3 years TAVR with a self expanding device maintains clinical benefit over SAVR 28 Conclusions II ACC2016

29 Click to edit Master title style

30 On Behalf of the US Pivotal Clinical Trial Investigators, I Would like to Thank the ACC for the Opportunity and Privilege of Presenting the Data from this Trial

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