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August 4, 2013

Study Compares Approaches to Managing Coexisting Severe Carotid and Coronary Disease

July 31, 2013—Mehdi H. Shishehbor, DO, et al published findings from a direct comparison of early and late risk-adjusted outcomes with three approaches to carotid revascularization and open heart surgery (OHS). The study is available online ahead of print in the Journal of the American College of Cardiology.

In the background to the study, the investigators noted that without randomized clinical trials, the best approach to managing coexisting severe carotid and coronary disease remains uncertain. Currently, staged carotid endarterectomy (CEA) followed by OHS or combined CEA and OHS are commonly used; carotid artery stenting (CAS) is a recent alternative.

As summarized in the Journal of the American College of Cardiology, in 1997–2009, 350 patients underwent carotid revascularization within 90 days before OHS at a tertiary center. There were 45 staged CEA-OHS, 195 combined CEA-OHS, and 110 staged CAS-OHS. The primary composite endpoint was all-cause death, stroke, and myocardial infarction (MI). Staged CAS-OHS patients had higher prevalence of prior stroke (P = .03) and underwent more complex OHS. Therefore, propensity score adjusted multiphase hazard function models with modulated renewal were used to account for staging, and competing risks were used.

Using propensity analysis, the investigators found that staged CAS-OHS and combined CEA-OHS had similar early hazard phase composite outcomes, while staged CEA-OHS incurred the highest risk driven by interstage MI. Subsequently, staged CAS-OHS experienced significantly fewer late hazard phase events in comparison to both staged CEA-OHS (adjusted hazard ratio [HR]: 0.33; 95% confidence interval [CI], 0.15 to 0.77; P = .01) and combined CEA-OHS (adjusted HR: 0.35; 95% CI, 0.18 to 0.7; P = .003).

Staged CAS-OHS and combined CEA-OHS are associated with similar risk of death, stroke, or MI in the short term, with both being better than staged CEA-OHS; however, the outcomes are significantly in favor of staged CAS-OHS after the first year, concluded the investigators.

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August 5, 2013

FDA Grants IDE for Trial of Edwards' Sapien 3 Transcatheter Valve

August 5, 2013

FDA Grants IDE for Trial of Edwards' Sapien 3 Transcatheter Valve