Showing posts with label PCI. Show all posts
Showing posts with label PCI. Show all posts

Monday, May 25, 2009

Statin ‘reloading’ improves PCI outcomes

Medical Tribune May 2009 P8
David Brill

Topping up a patient’s statin levels before percutaneous coronary intervention (PCI) could improve outcomes in long-term statin users, a new study suggests.

The ARMYDA*-RECAPTURE trial found that “reloading” with high-dose atorvastatin before PCI reduced the relative risk of major adverse cardiac events by 48 percent at 30-day follow-up.

Treating seventeen patients with this strategy would prevent one such adverse event, the investigators reported.

The study, which involved 352 chronic statin users, extends the findings of the earlier ARMYDA trial which demonstrated the benefits of a statin loading dose in statin-naïve patients undergoing PCI.

“These findings may support a strategy of routine reload with high-dose atorvastatin early before intervention, even in the background of chronic therapy,” said lead investigator Dr. Germanio Di Sciascio, of the University of Rome, Italy.

“If confirmed by future studies, the results of ARMYDA-RECAPTURE may influence practice patterns, particularly for the acute care of non-ST elevation acute coronary syndromes [ACS].”

The researchers randomized 175 patients to placebo and 177 to atorvastatin reloading, which comprised an 80mg dose 12 hours before angiography, followed by a further 40mg dose 2 hours before.

Just 3.4 percent of statin-treated patients reached the primary endpoint – a composite of cardiovascular death, myocardial infarction and target vessel revascularization – as compared to 9.1 percent of those in the placebo group (P=0.045).

This effect was driven largely by patients who presented with ACS, rather than those presenting with stable angina. In a separate analysis of ACS patients alone, the relative risk reduction with atorvastatin was 87 percent and the number needed to treat was 9.

Atorvastatin reloading also significantly reduced the proportion of patients with elevation of creatine kinase-MB and troponin-I following PCI, and non-significantly reduced the proportion with elevated C-reactive protein. These findings suggest that a rapid LDL-independent effect may underlie the cardioprotective phenomenon, said Di Sciascio.

Dr. Robert Harrington, director of the Duke Clinical Research Institute, US, said that ARMYDA-RECAPTURE adds to the literature supporting early, intensive statin therapy both before and after ACS.

“The trial was very carefully done and it adds to the totality of the data. It is, however, small, and it does have borderline P values with very broad confidence intervals, suggesting a high degree of uncertainty as to the true estimate of effect.

“The limitations of the trial, I believe, warrant replication or validation before recommending widespread adoption of statin reloading,” he said. “Efforts to reduce periprocedural MI should absolutely explore options other than anti-thrombotic therapy, and inflammation certainly is a reasonable target.”

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*Atorvastatin for Reduction of Myocardial Damage during Angioplasty

Thursday, March 5, 2009

Study stirs debate on PCI for stable coronary artery disease

Medical Tribune November 2008 SFXI
David Brill

A recent meta-analysis has reignited the debate over whether to employ an invasive strategy for patients with stable coronary artery disease (CAD).

The study by Professor Albert Schömig and colleagues concluded that percutaneous coronary intervention (PCI) reduced the risk of all-cause death by 20 percent compared with medical therapy alone.

The findings appear at odds with the pivotal COURAGE* trial which, to the consternation of interventional cardiologists the world over, found that PCI offered no benefits on a composite endpoint of death, myocardial infarction and stroke.

"The take-home message of this metaanalysis is that patients with stable CAD might benefit from PCI not only in terms of symptom alleviation but also of prognosis," said Schömig, who is based at the German Heart Centre Munich, Germany.

"PCI should not be seen as a substitute for effective pharmacological therapies that are available for patients with atherosclerotic CAD but as a treatment option on top of those therapies," he said.

The study comprised 7,513 patients with symptoms of myocardial ischemia but no acute coronary syndrome, drawn from 17 trials, including COURAGE. After an average of 51 months of follow up 335 patients died in the medical therapy group compared to 271 in the PCI group. [J Am Coll Cardiol 2008 Sep 9;52(11):894-904]

Schömig added that despite the apparently different conclusions, the results of the meta-analysis should not be seen as contradicting those of COURAGE since the trial alone was underpowered to assess mortality. He noted that COURAGE reported a 13 percent reduction in overall mortality with PCI but this did not reach significance.

Dr. Paul Chiam, a consultant cardiologist at the National Heart Centre, Singapore, said that the meta-analysis would be useful for informing treatment decisions in future.

"Cardiologists may be able to advise patients that PCI is more effective than medical therapy in relieving symptoms and may reduce events in those with moderate to severe ischemia on functional testing. In addition PCI may even reduce all cause mortality, or at the very least does not worsen mortality outcomes," he said.

Chiam noted, however, that the methodological limitations inherent to meta-analyses mean that the study does not carry the same weight as a large-scale trial.

COURAGE randomized 2,287 patients at 50 centers to PCI or optimal medical therapy. After a median of 4.6 years the rates of the composite end point were 20 percent and 19.5 percent, respectively, in the two groups (hazard ratio 1.05; P=0.62). [N Engl J Med 2007;356(15):1503-16]

One of the co-principal investigators for COURAGE, writing in a commentary accompanying the meta-analysis, said that the study had several limitations, such as the fact that some trials included patients with recent myocardial infarction whereas others did not.

"The difference between the findings of the meta-analysis and the COURAGE trial may be attributable to a difference in the accuracy of the data being analyzed, with pa-tient-level data from a large randomized controlled trial being superior," wrote Dr. Robert O’Rourke of the University of Texas Health Science Center at San Antonio, US. [J Am Coll Cardiol 2008 Sep 9;52(11):905-7] – DB