TY - JOUR
T1 - Expanded use of the TAXUS express stent
T2 - Two-year safety insights from the 7,500 patient ARRIVE registry programme
AU - Lasala, John M.
AU - Cox, David A.
AU - Lewis, Stephen J.
AU - Tadros, Peter N.
AU - Haas, Robert C.
AU - Schweiger, Marc J.
AU - Chhabra, Anil
AU - Untereker, William J.
AU - Starzyk, Ruth M.
AU - Mascioli, Stephen R.
AU - Dawkins, Keith D.
AU - Baim, Donald S.
PY - 2009
Y1 - 2009
N2 - Aims: 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). Methods and 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.
AB - Aims: 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). Methods and 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.
KW - Coronary disease
KW - Expanded use of drug-eluting stents
KW - Registries
KW - Restenosis
KW - Stents
UR - https://www.scopus.com/pages/publications/72149131152
U2 - 10.4244/EIJV5I1A11
DO - 10.4244/EIJV5I1A11
M3 - Article
C2 - 19577985
AN - SCOPUS:72149131152
SN - 1774-024X
VL - 5
SP - 67
EP - 77
JO - EuroIntervention
JF - EuroIntervention
IS - 1
ER -