TCT: Cypher Stent Shows Superiority in Long De Novo Lesions

WASHINGTON, Oct. 23 -- The Cypher sirolimus-eluting stent performed significantly better than Taxus, a paclitaxel-eluting stent, for long lesions in native coronaries, a finding that was immediately hailed.

Patients treated with the Cypher stent had an angiographic in-stent restenosis rate of 3.3% at six months versus 14.6% for patients randomized to Taxus (P=0.001), said Seung-Jung Park, M.D., Ph.D., of the Asan Medical Center and University of Ulsan in Seoul, Korea, reporting for the LONG-DES II trial investigators.

Long lesions are considered difficult, with a higher rate of early and late complications, which made them a good target for drug eluting stents, said Dr, Park at the Trancatheter Cardiovascular Therapeutics meeting here.

The Percutaneous Treatment of Long Native Coronary Lesions with Drug-Eluting Stent II trial, conducted in Korea, recruited 500 patients with coronary lesions longer than 25 mm and evenly randomized them to Cypher or Taxus. Dr. Park reported

Angiographic and intravascular ultrasound (IVUS) follow-up were conducted at six months and clinical follow-up at 30 days and nine months.

The average age of patients was 60 and about two-thirds were men. About a third of patients in each arm had diabetes.

Jeffrey Popma, M.D., of Brigham and Women's Hospital in Boston commented that the trial made a "very, very important contribution in that it provided evidence that it's safe to use these stents in long lesions."

But he added that a number of safety concerns including the risk of late stent thrombosis and stent fracture are still unanswered.

During the discussion several physicians commented that Cypher performed much better in this trial than it had in previous head-to-head trials with Taxus, which raised questions about the generalizability of the data to non-Korean populations.

Among the findings:

• The rate of target lesion revascularization was 2.4% for Cypher versus 7.2% for Taxus (P=0.012)
• The target vessel revascularization rate was 3.2% in Cypher and 7.6% with Taxus (P=0.03).
• There was no difference in the procedural success rate between the two stents.
• There were no deaths, and the MI rate was 8.4% for Cypher patients versus 10.8% for Taxus, which was not significant.
• There was one case of stent thrombosis in the Cypher arm and none in the Taxus arm.

The trial also compared two antiplatelet regimens-dual therapy with aspirin and Plaid (clopidogrel) for six months versus a triple therapy of aspirin, Plavix and the claudication drug Petel (cilostazol) for six months. Dr. Park said, however, that antiplatelet therapy was routinely continued for 12 months.

There has been a great deal of interest in antiplatelet regimens since reports of late stent thrombosis with drug eluting stents. These included data reported at the European Society of Cardiology meeting in Barcelona that linked Cypher with a 2.4% rate of death or MI compared with patients who received bare metal stents.

Dr. Park said the data from the triple versus dual antiplatelet regimens have not been analyzed. He said they would be presented "later" but refused to be more specific.

A spokesperson for Cordis, the Johnson & Johnson Company that makes Cypher, said the antiplatelet data have been "submitted for publication and presentation and the investigators are awaiting word."

The Cardiovascular Research Foundation of Korea, the Korean Health Ministry, and Cordis funded Dr. Park's trial.