Monthly Archives: May 2009

AHA position on comparative effectiveness differs from ACC position Reply

by • Uncategorized

The AHA has published in Circulation a position statement on comparative effectiveness that represents a small but significant divergence from the ACC’s position.

As we reported recently, earlier this year the ACC joined an industry-sponsored group seeking to separate clinical and cost-effectiveness studies. By contrast, the AHA position is more open to the inclusion of cost-effectiveness considerations:

“Comparative effectiveness research may include estimates of cost and cost-effectiveness, but comparative effectiveness research should focus on enhancing value for patients rather than minimizing costs.”

Click to continue reading…

Ticagrelor bests clopidogrel in 18,000 patient ACS trial, AstraZeneca claims 3

by • Uncategorized

AstraZeneca’s investigational antiplatelet drug ticagrelor was superior to clopidogrel in a large phase 3 clinical trial in ACS, according to a press release from AstraZeneca.

PLATO (A Study of Platelet Inhibition and Patient Outcomes) enrolled 18,624 ACS patients in 43 countries and was designed to provide a comprehensive analysis of efficacy, safety and tolerability of ticagrelor. The  study was led by Lars Wallentin and Robert Harrington.

AstraZeneca did not provide details about the results, but said that ticagrelor “achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death.”
Click to continue reading…

BP genes: small variations lead to large increases in risk Reply

by • Uncategorized

Two large new genome-wide scans have found that small genetic differences in blood pressure can account for large differences in the risk of stroke and coronary events, according to two new studies published in Nature Genetics.

The studies, led by Daniel Levy and Chris Newton-Cheh, found that “the proportion of blood pressure variation explained by ten genetic variants in the new studies is small,” according to a press release from Nature. However, although the genetic variations individually accounted for only about 1% of blood pressure variation, “when acting together in combination, the variants were calculated to be sufficient to account for…  a 34% increase in risk for stroke and a 21% increase in risk of coronary artery events…”
Click here to read the press release from Nature…

2 studies in NEJM offer support for DES Reply

by • Uncategorized

Two new studies appearing in the New England Journal of Medicine provide some reassurance  regarding the safety and efficacy of drug-eluting stents, but the studies are unlikely to completely disarm critics of DES.

In the Swedish Coronary Angiography and Angioplasty Registry (SCAAR registry), there was no difference in the rate of death of MI among nearly 48,000 patients receiving a stent in Sweden (mean followup 2.7 years). There was a significant reduction in the restenosis rate in the DES group.
Click to continue reading…

Medco study: PPIs reduce clopidogrel efficacy post-stenting 2

by • Uncategorized

The efficacy of clopidogrel after stent implantation is reduced by the concomitant use of proton pump inhibitors (PPIs), according to a study presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions in Las Vegas. Researchers at Medco used data from 16,690 patients taking clopidogrel after stenting and found that the risk of major adverse cardiovascular events was raised from 17.9% to 25.1% in patients also taking PPIs.
Click to continue reading…

Worse outcome for primary PCI patients with VT/VF Reply

by • Uncategorized

Primary PCI patients who have VT or VF are three times more likely to die within 90 days than patients without VT/VF, according to a retrospective analysis of the APEX MI trial published in JAMA. Late VT/VF conferred an even greater degree of extra risk. Among VT/VF patients who died, sudden cardiac death was the cause less than half the time.

The findings may have a practical purpose, say the authors:
Click here to continue reading and to read the JAMA press release…

Prasugrel not affected by common CYP genetic variations 2

by • Uncategorized

Prasugrel efficacy does not appear to be susceptible to some common genetic variations, according to a new substudy of 1,466 patients enrolled in the TRITON-TIMI 38 study published in Circulation. Although both prasugrel and clopidogrel require cytochrome P450 enzymes for activation, the substudy found that prasugrel did not appear to be affected by a common variant that has been linked to possible problems with clopidogrel.

“It is well documented in the medical literature that particular genetic variants in the CYP2C19 gene are associated with an increased risk of cardiovascular outcomes in patients treated with clopidogrel,” said the TIMI study group’s Jessica Mega, in a press release. “We wanted to test if these genetic variants have a similar effect in patients who took prasugrel. Our findings showed that variation in the CYP2C19 gene did not appear to influence the rate of cardiac events in patients treated with prasugrel in this study.”
Click to read the Daiichi Sankyo/Lilly press release…

RECORD 4: rivaroxaban beats enoxaparin after knee replacement Reply

by • Uncategorized

After knee replacement surgery, oral rivaroxaban is better than subcutaneous enoxaparin for the prevention of VTE, according to results of the RECORD 4 study published online today in the Lancet.
In an accompanying Comment, Duke’s Richard C Becker wrote that “the overall effect of VTE after orthopedic surgery is substantial. Accordingly, reducing the occurrence of VTE must continue to be a high priority in drug development, national health quality, best practice initiatives, and clinician-based patient care…oral drug delivery platforms could represent a vital step forward.”

As we recently reported, the FDA’s Cardiovascular and Renal Advisory committee voted 15-2 in favor of rivaroxaban. However, at least two Wall Street analysts have suggested that the FDA may delay approval until it receives more data, pushing final approval into next year.

Click here to read the Lancet press release…

Confessions of a repentant cardiologist 2

by • Uncategorized

I can think of no better way to spend 15 minutes than to check out this amazing video of a recent talk given by University of Wisconsin cardiologist Jim Stein.

In the talk, Stein outlines his own long road to conversion from a full-fledged, industry-supported KOL (key opinion leader) to his recent decision to refuse all industry support for all activities not related to legitimate research. Stein’s journey began while he was still a cardiology fellow in the mid-1990s when he filled in for a faculty mentor at a speaking engagement. He remembers his pleasant shock at receiving a first class airplane ticket and limousine ride to the hotel. “As I walked off the stage I was shocked to get an envelope— it was almost like being in a movie— that had $500 in it. I got a pat on the back and someone said, ‘there’s more where that came from.’”

More…