January 9th, 2012
Do Drug-Eluting Stents Reduce Death? The Devil, the Details, and the Missing Swedes
Richard A. Lange, MD, MBA and L. David Hillis, MD
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 […]
December 30th, 2011
CYP2C19 Genotyping: Down For The Count?
Richard A. Lange, MD, MBA and L. David Hillis, MD
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 […]
December 15th, 2011
PCI and On-Site CABG: Out of Site, Out of Mind?
L. David Hillis, MD and Richard A. Lange, MD, MBA
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 patients undergoing […]
November 30th, 2011
Should FedEx Be in Charge of Primary PCI?
Richard A. Lange, MD, MBA and L. David Hillis, MD
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 called, […]
November 13th, 2011
ISAR-REACT 4: Bivalirudin Works Great, Less Bleeding
Richard A. Lange, MD, MBA
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 […]
November 11th, 2011
Transapical TAVR on the Ropes: Is It Down for the Count?
Richard A. Lange, MD, MBA and L. David Hillis, MD
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) in quality […]
November 11th, 2011
Shaky Start Ends STACCATO
L. David Hillis, MD and Richard A. Lange, MD, MBA
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 […]
November 3rd, 2011
FDA Approves TAVR But Remains in the Crosshairs
Richard A. Lange, MD, MBA
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 and […]
October 4th, 2011
Is “Stent and Send” Safe for Older Patients?
Richard A. Lange, MD, MBA and L. David Hillis, MD
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 […]
September 1st, 2011
How Is TAVI Like a European Toaster?
Richard A. Lange, MD, MBA and L. David Hillis, MD
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 FDA […]