• CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results

    Jeffrey J. Popma, MD On Behalf of the CoreValve US Clinical Investigators Physician NameCompany/Relationship Jeffrey J. Popma, MD Research Grants- Cordis, Boston Scientific, Medtronic, Abbott, Abiomed,Covidien, eV3, Medical Advisory Board- Cordis, Boston Scientific, Covidien Conflict of Interest N=147 Pivotal Trial Design * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Risk Determined by- Two Clinical Site Cardiac Surgeons and One Interventional Cardiologist Risk Confirmed by- Two Screening Committee Cardiac Surgeons and One Interventional Cardiologist Study Purpose Primary Endpoint- All Cause Mortality or Major Stroke at 12 Months * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal An objective performance goal (OPG) was used to estimate the risk of all-cause mortality or major stroke in patients treated with standard therapy OPG constructed from- Meta-analysis of 5 contemporary balloon valvuloplasty series ? random effects meta-analytic all-cause mortality or major stroke rate at 12 months = 42.7% (95% CI 34.0%-51.4%) 12-Month PARTNER B all-cause mortality or major stroke rate of 50.3% with a corresponding 95% lower confidence bound of 43.0% Objective Performance Goal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 25.5% [21.6,29.4] All Cause Mortality or Major Stroke Months Post-Procedure All Cause Mortality or Major Stroke Primary Endpoint * Performance Goal = 43% TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Major Stroke Months Post-Procedure 2.4% 4.1% * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Paravalvular Regurgitation * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Paravalvular Regurgitation 80% of patients with moderate PVL at one month who survived to one year experienced a reduction in PVL over time * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Detailed analysis of co-morbidity, frailty, and disability confirmed unsuitability for surgical AVR The CoreValve Extreme Risk Study achieved its primary endpoint of a reduction in all cause mortality or major stroke at one year compared to a rigorously defined OPG Low rates of major stroke at 1 month and one year Low rate of moderate/severe aortic regurgitation that improved over time No association of mild/moderate PVL on late mortality Improved outcomes in Continued Access Study Conclusions * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal

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