Celecoxib cuts paclitaxel-eluting stent restenosis rate

Last Updated: 2007-08-17 17:01:15 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Celecoxib inhibits neointimal hyperplasia after implantation of a paclitaxel-eluting coronary stent, and thereby reduces restenosis and the need for target revascularization, physicians in South Korea report. The drug also appears to be safe for 6 months, with no increased risk of adverse cardiac events.

Even with the use of drug-eluting stents, restenosis is still a problem, Dr. Hyo-Soo Kim, at the National University Hospital in Seoul, and associates note in their paper in the August 18th issue of The Lancet. The researchers hypothesized that the COX-2 inhibitor celecoxib, which has anti-inflammatory, antiproliferative and pro-apoptotic effects, would decrease the rate of restenosis.

In their prospective trial, the investigators randomly assigned 267 patients to a control group (n = 123) or to celecoxib (n = 124), 400 mg before angioplasty and 200 g twice daily for the next 6 months. All the subjects were also prescribed aspirin 100 mg daily, and clopidogrel 75 mg daily during the 6-month trial.

At 6 months, the mean in-stent late luminal loss was significantly less in the celecoxib group than the control group (0.49 mm versus 0.75 mm, 35% relative reduction, p < 0.001).

Target lesion revascularization was performed for 7 patients treated with celecoxib and 21 in the control group (p < 0.008). One non-fatal MI occurred in the celecoxib group, and one cardiac death occurred in the control group.

Dr. Kim and associates note that the COX-2 inhibitor was not associated with any increased risk of adverse cardiac events during the 6-month study, but they acknowledge that they have no basis for predicting longer term safety.

Drs. Francesco Pelliccia and Vincenzo Pasceri, at Ospedale San Filippo Neri in Rome, Italy, writing in a related editorial, call the trial results "impressive," and say that the study "underscores that systemic therapy might still have a role in prevention of restenosis, even in the era of drug-eluting stents."

Nevertheless, they caution, large studies have demonstrated an increased risk of MI in patients using COX-2 inhibitors. Even though celecoxib is the least selective of the COX-2 antagonists, "clinical trials suggest that long-term use of celecoxib can expose patients to an additional risk of myocardial infarction."

They conclude that further studies are needed to clarify the optimal duration of therapy and risk-benefit ratios.

Lancet 2007;370:541-542,567-574.