Boston Scientific: Results of two studies favor Taxus stent over Cypher in some patients

By E. Janene Geiss

Philadelphia, March 13 - Angiotech Pharmaceuticals, Inc. announced Sunday that corporate partner Boston Scientific Corp. said results from the Stent registry - the largest prospective, comparative drug-eluting stent study ever reported - showed that insulin-treated diabetics who received a Taxus stent had improved survival and lower overall adverse cardiac events than those who received a Cypher stent.

The study included follow-up on 5,566 patients at eight coronary centers in the United States who received either a Taxus Express2 paclitaxel-eluting coronary stent system or a Cypher stent system, including 1,182 diabetic patients, nearly 500 of whom were insulin-treated diabetics, according to a company news release.

Among insulin-treated diabetics, the results demonstrated a numerical trend toward improved survival and a lower overall major adverse cardiac events rate for patients who received a Taxus stent system versus those who received a Cypher stent system. The results were presented at the American College of Cardiology's inaugural "Innovation in Intervention: the i2 Summit" in Atlanta, officials said.

Among the study's diabetic patients, the Taxus stent system was used in more complex lesions. Despite the higher complexity of the Taxus patients, the results favored the Taxus stent system over the Cypher stent system in each of the study's major adverse cardiac events categories for insulin-treated diabetics.

"In insulin-treated diabetics there is a slight separation in outcomes favoring the Taxus stent system, although this did not reach statistical significance," Charles Simonton, chairman of the executive steering committee for the Stent registry, said in the release.

"We plan continued enrollment to further investigate this apparent difference in outcomes," Simonton added.

Strategic Transcatheter Evaluation of New Therapies (Stent) is the first U.S. multi-center prospective registry initiated to evaluate the long-term efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among real-world patients and clinical situations.

In another study announced Sunday by Boston Scientific, nine-month data from a clinical trial demonstrated that patients treated for in-stent restenosis with the Taxus Express2 paclitaxel-eluting stent system achieved superior outcomes compared to those patients treated with radiation-based brachytherapy.

Boston Scientific also presented the results at the conference in Atlanta, officials said.

"The results of the drug-eluting stent arm are very impressive given the difficult challenges that restenotic lesions present," Gregg W. Stone, professor of medicine at Columbia University Medical Center in New York and the trial's principal investigator, said in the release.

"The Taxus V ISR trial clearly demonstrated that patients with bare-metal stent restenosis had better outcomes when treated with Taxus stents as compared to coronary radiation," Stone added.

The study met its primary endpoint of improved nine-month target vessel revascularization, which was significantly lower in the Taxus stent group as compared to the control group. The study demonstrated a nine-month target lesion revascularization rate of 6.3% in the Taxus stent group, as compared to 13.9% for the control group, officials said.

The study demonstrated an 11.5% rate of major adverse cardiac events for the Taxus stent group as compared to 20.1% rate for the control group, officials said.

Boston Scientific acquired worldwide exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and has co-exclusive rights to other vascular and non-vascular products.

Vancouver, B.C.-based Angiotech is a specialty pharmaceutical company pioneering the combination of pharmaceutical compounds with medical devices and biomaterials to both create novel solutions for poorly addressed disease states and improve surgical outcomes.

Boston Scientific is a Natick, Mass., maker of medical devices, including heart devices.

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