An interim safety analysis of the ongoing International Carotid Stenting Study (ICSS) offers strong temporary evidence that carotid endarterectomy is preferable to carotid stenting. In a paper appearing in the Lancet, the ICSS investigators report on the incidence of stroke, death, or procedural MI in the 1,713 patients enrolled in the trial. In the carotid stenting group the rate was 8.5% (72 events) versus 5.2% (44 events) in the endarterectomy group (HR 1.69, 1.16-2.45, p=0.006).
Click to continue reading…

A Dutch study appearing in JAMA concludes that platelet function testing should not be used to influence clinical practice at this time. Breet and colleagues measured platelet function using 6 different tests in over 1,000 patients taking clopidogrel and undergoing elective PCI.
Click to continue reading, including a comment from David Kandzari…

Stent thrombosis occurred in 11 of 312 STEMI patients who received distal protection (DP) compared to 4 of 314 patients treated conventionally, according to the 15 month results of DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction Trial) published in JACC. The study also found more target lesion revascularizations (31 vs 18) and target vessel revascularizations (37 vs 22) in the group randomized to receive distal protection.
Click to continue reading, including a comment from Peter Berger…

A US Senate investigation concludes, along with some FDA officials, that Avandia (rosiglitazone) should no longer be on the market, according to a front page story in the New York Times by Gardiner Harris.

In reports obtained by Harris, FDA officials David Graham and Kate Gelperin conclude that “rosiglitazone should be removed from the market.”  Harris says the report, along with others, “are part of a fierce debate within the agency over what to do about Avandia.”  The Times also reports that Janet Woodcock, the director of FDA’s drug center, has “ordered officials to assemble another advisory committee… to reconsider whether the drug should be sold.”
Click to continue reading…

Five year results of the ARTS II trial suggest that SES is better than BMS but not as good as CABG, but conclusions are hard to reach given the limitations of the trial.

Recall that ARTS II (Arterial Revascularization Therapies Study II) enrolled 607 patients who received a sirolimus-eluting stent (SES). ARTS II patients were then compared with historical controls from the ARTS I trial who had been randomized to either a bare-metal stent (BMS) or CABG. Patrick Serruys and colleagues report in an expedited JACC paper the 5 year results from ARTS II, though they acknowledge the difficulty of reaching firm conclusions on the basis of a nonrandomized comparison to historical controls. Among their findings:
Click to continue reading, including a comment from Sanjay Kaul…

Two separate studies appearing in JAMA cast doubt on the practical value of genetic testing to improve cardiovascular risk assessment.

In the first study, Nina Paynter and colleagues, led by Paul Ridker, calculated genetic risk scores based on 101 SNPs (single nucleotide polymorphisms) from 19,313 women enrolled in the Women’s Genome Health Study. They found that after adjusting only for age, patients in the lowest tertile of genetic risk had a CV risk of 3% over 10 years, compared to a risk of 3.7% for those in the highest tertile. However, once the investigators adjusted for traditional risk factors, the genetic risk score no longer provided additional information of value. By contrast, “self-reported family history remained significantly associated with cardiovascular disease in multivariable models.”
Click to continue reading…

Roche announced more positive phase III results from its promising diabetes drug taspoglutide, but the announcement may not have amounted to the tsunami of new results that the press release seemed to promise.

Today’s press release (reprinted below) said that “results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose (blood sugar) in these studies.” However,  4 of the 5 studies were the subjects of similar announcements by Roche in December. (You can read the CardioBrief stories here and here.)
Click to continue reading…

The FDA today announced an expanded indication for rosuvastatin (Crestor) for the primary prevention of cardiovascular disease. The decision follows a positive vote last December by an FDA advisory panel.

Notably, the new label does not endorse the use of rosuvastatin for everyone with elevated CRP levels and does not contain an indication for the reduction of total mortality or cardiovascular death. Sanjay Kaul, who served on the FDA advisory panel and has been skeptical of a broad interpretation of JUPITER, provided the following comment: “The FDA recommendation for the use of Crestor is faithful to the evidence because in the JUPITER study individuals with less than two risk factors failed to derive significant treatment benefit. Furthermore, the label appropriately does not include a mortality indication.”

Click to continue reading…

Updated with remarks from William Maisel and a statement from Boston Scientific– A case of a weakened bond between the header and case of a subcutaneously implanted Cognis CRT-D is raising new concerns about the Boston Scientific Cognis and Teligen ICDs. Last December Boston Scientific issued a product advisory based on two cases of a weakened header bond in ICDs that had been implanted subpectorally. Subpectoral implants account for approximately 5% of procedures, according to the company. Now, with the report of a weakened header bond in a Cognis ICD that had been implanted subcutaneously, concerns are being raised about a much larger number of devices that have already been implanted.
Click to continue reading…

Following implantation of a drug-eluting stent (DES), patients who were taking a proton pump inhibitor (PPI) had more major adverse events (MACE) than patients not taking a PPI, according to a new report by Gaglia et al published online in the American Journal of Cardiology.
Click to continue reading…

In the absence of “definitive evidence,” universal dietary sodium reductions are a “rash route,”  writes Michael Alderman in a JAMA commentary. Although measures to cut salt have been gaining widespread support– see the recent study and editorial in the NEJM, as well as a detailed discussion of US efforts to cut salt in heartwire– Alderman says these measures have not been validated, and he calls for “large-scale, population-based randomized clinical trials.”
Click to continue reading…