Abstract 3237: Safety and Long-Term Outcomes with the TAXUS Paclitaxel-Eluting Stent in Everyday Practice: The ARRIVE Program
Objective: Whether the long-term safety and effectiveness of drug-eluting stents observed in clinical trial populations translates to wide-spread use in the more complex populations treated in routine interventional cardiology practice is not known. The ARRIVE program registries were designed to compile data on real-world usage, safety, and clinical outcomes for the TAXUS® Express® Paclitaxel-Eluting Coronary Stent System (Boston Scientific, Natick, MA).
Methods: In two multicenter, consecutively enrolling registries, ARRIVE 1 and ARRIVE 2, investigators enrolled up to 75 or 100 consenting, consecutive patients receiving TAXUS stents at mainly community-based US sites. Anti-platelet therapy included long-term aspirin and 6 months clopidogrel. Clinical or telephone follow-up at 1, 6, 12, and 24 months collected data on TAXUS-related death, myocardial infarction (MI), stent thrombosis, re-intervention, and hypersensitivity events. Additional 1-year observation was conducted in patients requiring re-intervention. Event data were adjudicated by an independent Clinical Events Committee.
Findings: In the ARRIVE program 7592 patients with 10,782 lesions in 8893 vessels received 11,978 stents at 103 sites. As shown in the table⇓, TAXUS stent usage in complex patients, lesions, and procedures was commonplace. One-year clinical follow-up for 2458/2585 (95%) ARRIVE 1 patients and 6-month data for 3910/4057 (96%) ARRIVE 2 patients are presented in the table⇓. Cardiac event rates in the high-risk subgroups were typically comparable to rates in the overall study population.
Conclusions: In this “all-comers” registry program involving community-based physicians, the long-term durability and safety of the TAXUS stent observed in randomized, controlled trials is extended to the spectrum of disease routinely treated in interventional labs. Two-year follow-up for ARRIVE 1 and combined 6-month data for 7592 patients in both ARRIVE studies will be presented.