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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Should older patients who undergo elective coronary artery stenting be sent home the same day? Using data from the CathPCI Registry, Rao and colleagues examined outcomes in Medicare-eligible patients who underwent elective, first-time PCI. The investigators identified 107,018 patients (<11% of the million-plus older patients undergoing PCI during 2005–2008 after exclusion of those with ACS or shock and those transferred from another hospital or…

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Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the…

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Intra-aortic balloon counterpulsation (IABP) is a bust in AMI patients without cardiogenic shock, according to the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP AMI) trial. This open-label, 30-center, randomized, controlled trial was performed to determine if a routine strategy of IABP before primary PCI (and continued for at least 12 hours afterward)…

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