Usage patterns and 2-year outcomes with the TAXUS express stent: results of the US ARRIVE 1 registry.
Publication/Presentation Date
10-1-2008
Abstract
BACKGROUND: It is unclear how well the long-term safety and effectiveness of drug-eluting stents observed in tightly defined randomized controlled trials (RCT) translates to expanded use in routine practice.
METHODS: The FDA-mandated TAXUS Express(2) ARRIVE 1 postmarket registry was designed to consecutively enroll patients receiving > or = 1 TAXUS stent in low-, medium-, and high-volume US sites (n = 50). All cardiac events plus an additional 20% sample of records were monitored and all endpoints were independently adjudicated.
RESULTS: Detailed follow-up data through 2 years were compiled for 2,487 patients (95%). Simple-use (on-label) ARRIVE 1 patients (35%) had outcomes similar to 4 pooled TAXUS RCTs for death (3.5% vs. 3.4%, respectively, P = 0.78), Q-wave myocardial infarction (QWMI, 0.7% vs. 0.9%, P = 0.72), and stent thrombosis (ST, 2.2% vs. 1.2%, P = 0.12), but lower target vessel revascularization (7.8% vs. 13.4%, P < 0.0001). Compared with simple-use, cases representing expanded use to treat broader patient/lesion characteristics showed higher 2-year rates for death (7.4% vs. 3.5%, respectively, P = 0.0003), target lesion revascularization (9.4% vs. 5.8%, P = 0.0031), and ST (3.4% vs. 2.2%, P = 0.061, concentrated early in the first year).
CONCLUSIONS: By including methods usually found in RCT, ARRIVE 1 captured a broad spectrum of disease treated in standard practice with high levels of ascertainment of clinical outcomes. In the more complicated cases, expectedly higher adverse event rates were seen compared to that found in the simple-use cases or pivotal RCT. These results have now been included in the Directions for Use, to aid in physician and patient decision-making.
Volume
72
Issue
4
First Page
433
Last Page
445
ISSN
1522-726X
Published In/Presented At
Lasala, J. M., Cox, D. A., Dobies, D., Muhlestein, J. B., Katopodis, J. N., Revtyak, G., Baim, D. S., & ARRIVE 1 Participating Physicians (2008). Usage patterns and 2-year outcomes with the TAXUS express stent: results of the US ARRIVE 1 registry. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 72(4), 433–445. https://doi.org/10.1002/ccd.21618
Disciplines
Medicine and Health Sciences
PubMedID
18814217
Department(s)
Department of Medicine
Document Type
Article