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Ed Federico, (215) 349-5659, ed.federico@uphs.upenn.edu

June 23, 2004

Expert Advisory
Contrasting Findings on the Use of Folic Acid Supplementation to Prevent Restenosis after Percutaneous Coronary Intervention

(Philadelphia, PA) – In an editorial in the April 24th issue of the New England Journal of Medicine, Howard C. Herrmann, MD, Director of Interventional Cardiology & the Cardiac Catheterization Laboratory at the Hospital of the University of Pennsylvania, compares the findings of two studies reporting on the use of folic acid supplementation to prevent restenosis – the re-clogging of arteries – after percutaneous coronary intervention (the opening up of clogged arteries with a balloon or stent.) Dr. Herrmann finds that the markedly different results in each study may warrant a change in how cardiologists treat patients after such procedures.

Dr. Herrmann compares the 2004 study “Folate therapy after coronary stenting” with one published 3 years earlier in 2001, “Decreased rate of coronary restenosis after lowering of plasma homocysteine levels.” Both studies targeted homocysteine, a moderate risk factor contributing to restenosis. For years, cardiologists have been targeting this potentially harmful amino acid by using dietary supplementation with folic acid. Dr. Hermann finds now that the 2004 study, “raises the disturbing possibility that a therapy that has previously been considered safe may actually be harmful.”

The most recent study reports oral supplementation with a combination of folic acid and vitamins B6 and B12 may increase the risk of restenosis among more than 600 patients who had received bare-metal stents. This finding directly contrasts the results of the 2001 Swiss Heart Study, in which folic acid supplementation was associated with a marked reduction in restenosis.

Although both trials were well-designed, Dr. Herrmann, concludes, “On the basis of these differences and the potential harm demonstrated in the current study, folic acid, vitamin B6, and vitamin B12, should not be routinely administered to patients receiving coronary stents in an effort to reduce the risks of restenosis.” More importantly, he points out that drug-eluting stents have made the problem of restenosis almost moot. After intracoronary stent placement, data now exists to recommend the use of aspirin, clopidogrel, statins, ACE inhibitors, diabetes and hypertension control, nutrition counseling, smoking cessation, and exercise in all patients. Pending the completion of clinical trials, folate (and vitamins B6 and B12) may be added by some physicians in patients with hyperhomocysteinemia (a high blood level of homocysteine, which may cause increased atherosclerosis) for secondary prevention of atherosclerosis (not restenosis).

“Interventional cardiologists, in particular, should be at the forefront of cardiovascular prevention refocusing our efforts to intervene on the disease process itself after the culprit lesion is successfully stented,” says Herrmann. “As restenosis becomes less of a problem post-PCI, we need to refocus on the underlying disease process to treat vulnerable plaques and atherosclerosis in an effort to prevent subsequent cardiac events and new and progressive atherosclerotic lesions,” adds Dr. Herrmann.

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Dr. Herrmann is available for interviews on this position. Please contact Ed Federico at (215)349-5659 to arrange an interview.

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Release available online at http://www.uphs.upenn.edu/news/News_Releases/june04/ExpertRestenosis.html