• Cerebrovascular Disease
• Interventional Techniques & Devices
• Valvular Disease
• Cardiology Clinical Trials

• Cerebrovascular Disease
• Interventional Techniques & Devices
• Valvular Disease
• Cardiology
• Cardiology Clinical Trials

The Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High-Risk and Very High-Risk Subjects Who Need Aortic Valve Replacement [CoreValve; NCT01240902] evaluated transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. Extreme-risk patients were randomized to CoreValve implantation by iliofemoral (n = 489) or noniliofemoral (n = 150) access [Popma JJ et al. J Am Coll Cardiol. 2014]. At 1 year, the primary end point of all-cause mortality or major stroke rate was 26.0% (95% CI, 22.1% to 29.9%) compared with the objective performance goal (OPG) of 43.0% (P < .0001).

Steven J. Yakubov, MD, Riverside Methodist Hospital Columbus, Ohio, USA, presented the 2-year results of the CoreValve trial. At 2 years, 305 patients who received an implant by iliofemoral access remained in the study. The primary analysis cohort consisted of the “attempted implant” by iliofemoral access population (n = 489). The attempted implant population was defined as patients brought into the procedure room with anesthesia administration, transesophageal echocardiography, vascular line placement, or any other monitoring line placement. The OPG comparator for all-cause mortality was the calculated rate for 117 events in 179 patients (65.4%, lower confidence bound of 57.9% by Exact method).

The rate of all-cause mortality or major stroke (at risk n = 489) at 2 years was 38.0% (95% CI, 33.6% to 42.3%) vs the OPG of 57.9%.

All-cause mortality and cardiovascular mortality at 1 year were 24.3% and 18.3%, respectively, and at 2 years were 36.5% and 26.5%, respectively. All-cause mortality and cardiovascular mortality from 1 to 2 years were 16.1% and 10.0%. The 1-year, 2-year, and 1- to 2-year major stroke rates were 4.3%, 5.1%, and 0.9%, respectively.

The secondary end point rates are shown in Table 1. At 2 years, 92% of patients improved at least 1 NYHA class and 58% improved at least 2 NYHA classes. The effective orifice area increased from 0.73 cm² at baseline to 1.85 cm² at 2 years. The mean gradient decreased from 47.31 mm Hg at baseline to 8.66 mm Hg at 2 years. At 2 years, paravalvular regurgitation was absent or trivial in 64.8%, mild in 30.8%, moderate in 4.4%, and severe in 0.0% of patients.

Among patients with all-cause mortality, paravalvular leak (PVL) was absent or trivial in 30.3%, mild in 38.2%, moderate in 35.9%, and severe in 85.7%. Only severe PVL affected mortality (P < .001). Among patients with all-cause mortality, 38.7% had received a new pacemaker and 35% had not received a new pacemaker. Pacemaker implantation did not affect mortality (P = .534). A subgroup analysis showed that a Society of Thoracic Surgeons (STS) risk score > 15% (P = .0120), coronary artery disease (CAD; P = .0019), and assisted living (P < .0001) were associated with 2-year all-cause mortality or major stroke.

The CoreValve 2-year results demonstrated low rates of all-cause mortality, major stroke, and moderate or severe aortic insufficiency. Patients experienced improvement in NYHA classification and durable improvement in hemodynamic valve performance. There was no association between mild or moderate paravalvular regurgitation and mortality. The 2-year results confirm the improved survival benefit in patients with severe aortic stenosis at extreme risk for surgery.

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