• A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed High-Risk for Surgery

    On Behalf of the US CoreValve Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed High-Risk for Surgery CoreValve US Pivotal Trial I receive royalties through the Icahn School of Medicine at Mount Sinai related to intellectual property for mitral and tricuspid valve repair products now owned by Edwards Lifesciences and Medtronic Presenter Disclosure Information TAVR with a balloon expandable valve improved survival compared to medical therapy in inoperable patients TAVR with a balloon expandable valve had similar survival compared to surgery in patients at high risk for surgery Background Leon MB, Smith CR, Mack M, et al. N Engl J Med 2010;363-1597–1607.Smith CR, Leon MB, Mack M, et al. N Engl J Med 2011;364- 2187–2198. * Extreme Risk Trial Popma JJ, Adams DH, Reardon MJ, et al. J Am Coll Cardiol 2014; March 19 (Epub ahead of print). * Study Purpose * Adams DH, Popma JJ, Reardon MJ, et al. New Engl J Med 2014; in press. 4 valve sizes (18-29 mm annular range) Transfemoral Subclavian Direct Aortic Study Device and Access Routes * * * Non-inferiority Testing- TAVR with the CoreValve prosthesis was non-inferior to SAVR for 1 year all-cause mortality with a 7.5% non-inferiority margin Primary Endpoint * ? mean gradient baseline to 1 year (non-inferior) ? effective orifice area baseline to 1 year (non-inferior) ? NYHA class baseline to 1 year (non-inferior) ? KCCQ baseline to 1 year (non-inferior) Difference in MACCE* rate at hospital discharge or 30 days, whichever is later (superiority) ? SF-12 baseline to 30 days (inequality) * Major adverse cardiovascular and cerebrovascular events, defined as a composite of all-cause mortality, myocardial infarction, all stroke, or aortic-valve reintervention Secondary Endpoints * H0- pMCS TAVR = pSAVR + 7.5% HA- pMCS TAVR < pSAVR + 7.5% Study Size- 790 patients for a minimum of 355 patients in each arm Sample Size Determination * * * Severe aortic stenosis- AVA = 0.8 cm2 or AVAI = 0.5 cm2/m2 AND mean gradient > 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress echocardiogram Inclusion Criteria * Risk of death at 30 days after surgery was = 15% and the risk of death or irreversible complications within 30 days was < 50% Surgical risk assessment included consideration of STS Predicted Risk of Mortality estimate and other risk factors not captured in the STS risk model Inclusion Criteria * Clinical and Anatomic Exclusion Criteria Included- Recent active GI bleed (< 3 mos), stroke (< 6 mos), or MI (= 30 days) Any interventional procedure with bare metal stents (< 30 days) and drug eluting stents (< 6 months) Creatinine clearance < 20 mL/min Significant untreated coronary artery disease LVEF < 20% Life expectancy < 1 year due to co-morbidities Exclusion Criteria * Chairman- Michael J. Reardon, M.D. Two clinical site cardiac surgeons and one interventional cardiologist determined patient eligibility All patients were reviewed on web-based conference calls with site investigators to confirm eligibility and access route Detailed portfolio included- STS PROM and all other risk factors Independent review of transthoracic echocardiogram Independent review of chest/abdominal CTA findings Two senior surgeons and one cardiologist on the screening committee had to concur with the local heart team assessment to qualify the patient for trial enrollment National Screening Committee * All randomized patients with an attempted implant procedure, defined as when the patients is brought into the procedure room and any of the following have occurred- anesthesia administered, vascular line placed, TEE placed or any monitoring line placed Primary Analysis Cohort * * * * ACC 2014 * Non-inferiority and superiority thresholds were met in both AT and ITT cohorts * ACC 2014 * * * * Results with transcatheter CoreValve prosthesis were outstanding (O/E ratio 0.45 vs. STS PROM) Prior to the beginning of the CoreValve US Pivotal Trial, our Heart Teams had no TAVR experience Our findings were not influenced by poor outcomes in either arm of the trial Clinical Results * ? mean gradient baseline to 1 year (non-inferior; P<0.001) ? effective orifice area baseline to 1 year (non-inferior; P<0.001) ? NYHA class baseline to 1 year (non-inferior; P<0.001) ? KCCQ baseline to 1 year (non-inferior; P=0.006) Difference in MACCE rate at hospital discharge or 30 days, whichever is later (superiority; P=0.103) ? SF-12 baseline to 30 days (inequality; nominal P<0.001) Secondary Endpoints * * * * * * Subgroup Analysis for 1 Year Mortality Subgroup Analysis for 1 Year Mortality Patients had a lower 30-day mortality rate than was specified in our study inclusion criteria, and the trial population may have been at lower risk than was intended Limitations * We found that survival at 1 year was superior in patients that underwent transcatheter replacement with CoreValve Conclusion *

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