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Paclitaxel-Eluting Stent Effective for High-Risk Patients: Presented at SCAI

By Crystal Phend

CHICAGO, I.L. -- May 15, 2006 -- Paclitaxel-eluting stents (Taxus) appear to have a good safety profile and satisfactory clinical outcomes in high-risk patients, according to a study presented here at the Society for Cardiovascular Angiography and Interventions annual meeting (SCAI).

"Taxus can be effectively employed in challenging lesions such as left main, true bifurcations and CTO [chronic total occlusions]," said presenting author Giuseppe Sangiorgi, MD, associate director, EMO Centro Cuore Columbus, San Raffaele Hospital, Milan, Italy.

The researchers looked at data from the Taxus in Real-Life Usage Evaluation (TRUE) study, which was a prospective, multicenter trial of 1,065 consecutive high-risk patients undergoing paclitaxel-eluting stent placement in 7 high-volume European centers.

Compared to other trials, patients in this study had more complex lesions, Dr. Sangiorgi said in his presentation on May 11^th. The target was an unprotected left main coronary artery in 113 patients, a bifurcation in 219, a chronic total occlusion in 183, a lesion longer than 28 mm in 283, and a small vessel of less than 2.75 mm in diameter in 417 patients.

All patients had a least 1 stent implanted and received aspirin and clopidogrel for 8 months after the procedure.

Within 1 month, 5.5% of patients experienced a major adverse cardiovascular event -- 1.2% had revascularization for the same blood vessel, 1.2% had a coronary artery bypass graft (CABG), myocardial infarction (MI) occurred in 3.5%, and 0.7% died.

Intermediate major cardiac adverse outcomes occurred in more than a quarter of those who received a paclitaxel-eluting stent.

The rate of major adverse cardiovascular events increased to 26.8% by month 7. Of these, death accounted for 2.5%, MI for 4.7%, CABG for 1.2%, target vessel revascularization for 18.4%, and target lesion revascularization for 12.8%.

Stent thrombosis was confirmed by angiography in 1.2% of patients overall within the first 7 months after placement. Thrombosis was most likely to occur early, with one-third each happening acutely, within the first 30 days and after the first 30 days.

"The performance of the Taxus stent was very satisfactory, especially given the overall profile of enrolled subjects and the limited number of stent thromboses," Dr. Sangiorgi said.

The study was supported by Boston Scientific, makers of the Taxus stent.


[Presentation title: Safety and Effectiveness of Paclitaxel-Eluting Stent Implantation in Over 1000 Very High-Risk Patients: Insights From the Prospective Multicenter Taxus in Real-Life Usage Evaluation (TRUE) Study. Abstract O-2]

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