CREST finds carotid stenting broadly equivalent to endarterectomy Reply

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 asymptomatic patients with carotid stenosis at 117 centers in the US and Canada. The primary endpoint was the 30 day rate of stroke, death, and MI combined with the rate of ipsilateral stroke over the next 4 years. There was no significant difference between the two procedures (7.2% for stenting versus 6.8% for surgery) at a median followup of 2.5 years.
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Carotid endarterectomy beats stenting in first results from ICSS 1

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).
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Avandia: a plaque on both your houses! 5

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 Nobel Prize, issued a 30 page White Paper in response to the Senate report published on Saturday.
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Study finds increased rate of stent thrombosis in primary PCI patients who get distal protection Reply

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.
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Senate releases Avandia report, GSK responds to attacks 6

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 company rejects the conclusions reported in the story.

Here are links to the documents:
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NY Times: FDA and senate reports slam continued availability of Avandia (rosiglitazone) 4

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

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 interpreted cautiously.”
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ARTS II at 5 years: what have we learned? Reply

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:
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Lancet: large meta-analysis confirms small increase in diabetes with statins 1

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 diabetes with statins was highest in older patients, and was not found in patients 60 years old or younger.

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

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

(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 during the Boston Scientific quarterly earnings call on Thursday. (See our previous stories about the ICD problem here and here. Here are links to the Heart Rhythm article, a letter to the editor from Boston Scientific scientists, and a response to the letter from the article’s authors.)

In his remarks, a clearly agitated Elliott said the journal “was completely out of line to publish this article prematurely” and then remarked:
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Roche announces more positive results for taspoglutide, but… Reply

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.)
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Rosuvastatin (Crestor) gains expanded primary prevention indication 1

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.”

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Study finds significant lesions in one-fifth of patients with zero calcium scores 3

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 291 patients enrolled in the study, of whom 72 had a calcium score of zero. 14 of these patients (19%) had at least one lesion with > 50% stenosis. In the study as a whole there were 64 totally occluded vessels, of which 13 (20%) had no calcium. 9 patients with no calcium underwent revascularization.
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New concerns raised about Boston Scientific ICDs 2

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.
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The two sides of aspirin: too much and not enough 1

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.

Chris Cannon and fellow REACH registry investigators analyzed data from more than 25,000 US patients with vascular disease or multiple risk factors and found that only 70% were taking aspirin. Approximately half of these were taking other antithrombotic agents, but the other half– 15% of the study population– were not receiving any antithrombotic therapy.
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Live AF ablation broadcast on Today Show: what’s wrong with this picture? 17

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 making any effort to truly educate their viewers, the producers took the easy route. Arruda, staring at a bank of large display monitors, might as well have been playing a video game, for all anyone watching might have known. And the reporter, NBC Medical correspondent Dr Nancy Snyderman, substituted schmaltz for substance and presented the “heartwarming” story of the patient, a great-grandmother, accompanied by stirring music and sentimental images.
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Alderman in JAMA: universal sodium reductions are a “rash route” 2

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 heartwireAlderman says these measures have not been validated, and he calls for “large-scale, population-based randomized clinical trials.”
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