Usage patterns and 2-year outcomes with the TAXUS express stent: results of the US ARRIVE 1 registry.
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.
Lasala
John M
JM
Washington University School of Medicine, Cardiology, St. Louis, Missouri 63110, USA.
Cox
David A
DA
Dobies
David
D
Muhlestein
Joseph B
JB
Katopodis
John N
JN
Revtyak
George
G
Baim
Donald S
DS
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D016016:Proportional Hazards Models; D012042:Registries / Q000706:statistics & numerical data; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel