CardioExchange Archive

Carotid Stenting vs. Endarterectomy: The International Carotid Stenting Study (ICSS) is an ongoing randomized trial comparing carotid stenting to carotid endarterectomy in 1,713 patients. The primary endpoint is the 3-year rate of fatal or disabling stroke. The ICSS investigators report in the Lancet the results of an interim safety analysis. The rate of stroke, death, or procedural MI at 120 days was 8.5% in the stenting group versus 5.2% in the endarterectomy group. Until completion of the trial, the investigators conclude that “carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.”

A related article in Lancet Neurology contains the results of a blinded analysis of 231 ICSS patients who received MRI scans before and after treatment. New ischemic lesions were found three times more often in the stenting group than in the endarterectomy group. Neuroprotective devices offered no benefit.

Remote Ischemic Preconditioning in MI: Bøtker et al. randomized 333 patients with a first acute MI to receive remote ischemic preconditioning, consisting of 4 cycles of intermittent arm ischemia, or to not receive remote preconditioning. The median salvage index of the patients who completed the trial was 0.75 in the remote conditioning group versus 0.55 in the control group, for a median difference of 0.10, p=0.0333. The investigators, writing in the Lancet, conclude that “the intervention’s simplicity, low cost, and effectiveness make it attractive for testing in large-scale clinical trials.” An accompanying comment by Michel Ovize and Eric Bonnefoy cautions that “any enthusiasm arising from this encouraging study must, however, be tempered by the need to show actual clinical benefit in larger-scale clinical studies.”

Krumholz on Avandia: CardioExchange editor-in-chief Harlan Krumholz wrote an editorial in Circulation: Cardiovascular Quality and Outcomes (where he is also the editor-in-chief) about the AHA/ACC science advisory statement, and said that “it is hard to make a case for rosiglitazone.” He concludes that the “simplest message” might be “the avoidance of rosiglitazone until more reassuring evidence for the drug becomes available.”

Separately, Krumholz wrote a commentary for Forbes in which he criticizes GlaxoSmithKline, the manufacturer of Avandia, for behavior that “is eroding the public trust in the pharmaceutical industry.” Krumholz proposes that after a drug is approved, “all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it.”