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74th Scientific Sessions of the American Heart Association (AHA), November 2001, Anaheim, California

TAXUS I: Prospective, randomized, double-blind comparison of NIRx stents coated with paclitaxel in a polymer carrier in de-novo coronary lesions compared with uncoated controls   Eberhard Grube, Heart Center Sieburg, Sieburg Germany; Sigmund M Silber, Kardiologische Praxis, Munchen Germany; Karl Eugen Hauptmann, Krankenhaus d. Barmh. Brüder, Trier Germany Circulation, 104, II-463 (2001)

Drug coated stents provide an opportunity for local delivery of pharmacologic agents to the target lesion at the precise site and time of stent implantion. Paclitaxel, a microtubular inhibitor, offers promise in preventing restenosis due to its known ability to interrupt cell migration and proliferation. The purpose of the TAXUS I Study is to evaluate the safety and performance of the NIRx, a NIR-Conformer Coronary stent coated with paclitaxel incorporated in a polymer carrier matrix. Enrollment into TAXUS I is now complete. Sixty-one patients with de novo coronary lesion (<= 12mm length, 3.0mm and <= 3.5mm reference diameter, 50 and <= 99% diameter stenosis) were randomized to recieve either the NIRx (paclitaxel coated) or uncoated control NIR-Conformer Coronary stent. Anti-platelet therapy included 300 mg clopidogrel pre stenting followed by 75 mg daily for 6 months post intervention and 80 mg acetylsalicylic acid pre stenting and continued daily up to 12 months post intervention. Planned follow-up included 30-day Major Adverse Cardiac Event (MACE) rates and angiographic and intravascular ultrasound evaluations pre, post and at 6 months. Data for 30-day MACE is summarized below. Collection of long-term results is ongoing and 6-month data will begin to be available by the end of September 2001. Early safety data continues to show promise for this pioneering technology however ongoing long term angiographic findings will yield insight on the efficacy of this NIRxä paclitaxel coated stent. Summary of 30-Day MACE Rates Event  Combined Total (%) Active and Control Arms  Death  0  Q-Wave Myocardial Infarction  0  Target Vessel Revascularization  0  Angiographic Stent Thrombosis  0  Total  0

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