The current standard of care for individuals undergoing carotid arterial stenting (CAS) entails the use of an embolic protection device (EPD) to minimize the risk for embolic stroke. At present, the only FDA-approved EPD is a filter that is placed distal to the stenosis (i.e., it is advanced across the lesion) before stenting. In a recently completed randomized trial, a proximal balloon occlusion device…

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The Gravina Island Bridge (also known as The Bridge to Nowhere) was a proposed bridge to replace the ferry that currently connects Ketchikan, Alaska (population, 14,000) to the Ketchikan International Airport on Gravina Island (population, 50) at a projected cost of $398 million. The bridge was to have been nearly as long as the Golden Gate…

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In a 2009 NEJM article, the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) study group published 1 to 5 (mean, 2.7) year follow-up data for almost 48,000 registry patients who received a bare metal (BMS) or drug-eluting coronary stent (DES) between 2003 and 2006, concluding that the two are associated with a similar long-term incidence…

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The controversy over the use of genetic testing to guide antiplatelet therapy reminds us of a WWF (Worldwide Wrestling Federation) tag team match.  What we agree upon (the match rules): Clopidogrel is a prodrug activated by several enzymes, including CYP2C19, and common genetic variations alter CYP2C19 activity. Here’s where the wrestling match begins: Are the CYP2C19 genetic…

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According to a recent meta-analysis of studies in patients undergoing PCI, rates of in-hospital mortality and emergency CABG for primary and non-primary PCI were similar at centers with and without on-site surgery.  At least, that’s the story the press is spreading around. However, several caveats should be noted . . . 1. The study included…

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Federal Express built its business on being a leader in transportation and delivering on time.  Perhaps the results of primary PCI in the U.S. would be better if FedEx ran the program. In patients with acute MI who must be transferred to another hospital for primary PCI, experts agree that the door-in to door-out (so…

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In the previously published REPLACE-2 and ACUITY trials, a trend was noted towards an increased incidence of ischemic complications with bivalirudin compared with glycoprotein IIb/IIIa treatment in high-risk patients undergoing PCI. The Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4 (ISAR-REACT 4) trial was designed to show whether abciximab plus unfractionated…

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STACCATO showed more adverse events with transapical transcatheter aortic valve replacement (TAVR) than with aortic valve replacement (AVR) in low risk, elderly patients. In patients with severe, symptomatic aortic stenosis who are believed to have high surgical risk, PARTNER substudy results presented at the AHA show Transapical TAVR provided no increase (and even a possible decrease)…

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The STACCATO trial planned to randomize 200 low-risk patients to transcatheter aortic heart valve implantation (TAVI) via the transapical approach (with the Sapien valve from Edwards Lifesciences) or surgical aortic valve replacement (AVR).  The primary endpoint was a composite of death, stroke, and renal failure at one month.  After enrolling only 70 patients (34 TAVI…

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I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons…

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