CREST finds carotid stenting broadly equivalent to endarterectomy

Carotid endarterectomy and carotid stenting produced broadly similar results in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), the largest comparison yet of the two procedures. The results were presented in San Antonio this morning at the American Stroke Association’s International Stroke Conference 2010. CREST, which was funded by NINDS and Abbott, randomized 2,502 symptomatic and…

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Carotid endarterectomy beats stenting in first results from ICSS

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…

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Avandia: a plaque on both your houses!

Comment on the News: Avandia continues to dominate cardiovascular-related news this week. Last night the AHA and the ACC issued a highly detailed, thoughtful, though perhaps slightly over-diplomatic science advisory on TZDs and CV risk. Taking a completely opposite tack, GSK, in no mood to take prisoners, and apparently about to nominate itself for a…

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JAMA study questions value of platelet function tests in PCI patients

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….

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More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review

In 2007 Steve Nissen secretly recorded a meeting with 4 GlaxoSmithKline executives, according to a story by Gardiner Harris in the New York Times. Harris reports that Nissen recently “shared the contents of the recording with The Times.”…

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Study finds increased rate of stent thrombosis in primary PCI patients who get distal protection

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)…

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Senate releases Avandia report, GSK responds to attacks

In the wake of Friday night’s New York Times story on the Avandia controversy (see our summary here), the Senate Finance Committee has posted its 334 page report, as well as a press release and the contents of its letter to FDA Commissioner Margaret Hamburg. GlaxoSmithKline has released its own press release in which the…

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NY Times: FDA and senate reports slam continued availability of Avandia (rosiglitazone)

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…

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ACCOMPLISH: amlodopine may (or may not) be better than hydrochlorothiazide in combo with benazepril to slow progression of kidney disease

Renal outcomes in the ACCOMPLISH trial appear to favor the combination of benazepril plus amlodipine over the combination of benazepril plus hydrochlorothiazide in helping to slow the progression of chronic kidney disease, according to a new report by Bakris and colleagues appearing online in the Lancet. But an accompanying comment says the result “should be…

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ARTS II at 5 years: what have we learned?

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…

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Lancet: large meta-analysis confirms small increase in diabetes with statins

People taking statins have a small but apparently real increased risk of developing diabetes, according to a large new meta-analysis appearing in the Lancet. Sattar and colleagues used data from 13 controlled statin trials with over 91,000 subjects and found a 9% increase in the risk of diabetes over 4 years. The risk of developing…

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JAMA: studies find little evidence to support genetic testing to improve CV risk assessment

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…

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Boston Scientific CEO: were the reports of ICD flaws tied to attempts to drive down the stock price?

(Updated with a statement from Douglas Zipes, the editor of Heart Rhythm)– The CEO of Boston Scientific, Ray Elliott, has implied that recent publicity about an article in Heart Rhythm involving a flawed Boston Scientific ICD somehow may be tied to attempts to drive down the stock price of the company. Elliott made his remarks…

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Roche announces more positive results for taspoglutide, but…

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…

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Boston Scientific and William Maisel clash over ICD flaws

In response to concerns raised about Boston Scientific Cognis and Teligen ICDs raised earlier this week in an article published online in Heart Rhythm, Boston Scientific has issued a rebuttal. Rebutting the rebuttal, William Maisel, the senior author of the paper, has sent a statement to CardioBrief….

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Rosuvastatin (Crestor) gains expanded primary prevention indication

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…

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Study finds significant lesions in one-fifth of patients with zero calcium scores

A calcium score of zero does not completely rule out significant coronary disease, according to the surprising results of a substudy of the CORE64 multicenter trial, in which patients referred for angiography were also asked to undergo a calcium scan. Ilan Gottlieb and colleagues report in the Journal of the American College of Cardiology on…

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New concerns raised about Boston Scientific ICDs

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…

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The two sides of aspirin: too much and not enough

On the one hand, a lot of people who should be taking aspirin aren’t doing so. On the other hand, a lot of people who are taking aspirin shouldn’t be doing so. Those are the dual conclusions of a new report and accompanying editorial from the REACH Registry appearing in the American Journal of Cardiology….

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More adverse events seen in patients on PPIs after DES

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….

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Live AF ablation broadcast on Today Show: what’s wrong with this picture?

Mauricio Arruda performed a live AF ablation at University Hospitals in Cleveland on the Today Show yesterday morning. The 6-minute segment was relentlessly upbeat. The TV producers pulled every trick in the book to overcome the inherent difficulty of portraying a hard-to-explain disease like AF and an even harder-to-explain procedure like catheter ablation. Instead of…

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Alderman in JAMA: universal sodium reductions are a “rash route”

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…

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Boston Scientific pays $1.725 to J&J to settle three patent disputes over stents

Boston Scientific said today that it had paid Johnson & Johnson $1.725 billion to settle 3 longstanding patent disputes. The Wall Street Journal Health Blog observed that J&J’s total sales of drug-eluting stents last year were only $919 million….

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