Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme.
OBJECTIVE
We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites).


RESULTS
No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two.


CONCLUSIONS
Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.
Lasala
John M
JM
Washington University School of Medicine, St. Louis, MO 63110, USA. jlasala@im.wustl.edu
Cox
David A
DA
Lewis
Stephen J
SJ
Tadros
Peter N
PN
Haas
Robert C
RC
Schweiger
Marc J
MJ
Chhabra
Anil
A
Untereker
William J
WJ
Starzyk
Ruth M
RM
Mascioli
Stephen R
SR
Dawkins
Keith D
KD
Baim
Donald S
DS
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005260:Female; D006331:Heart Diseases / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage*; D011358:Product Surveillance, Postmarketing; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D002317:Cardiovascular Agents; D017239:Paclitaxel