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Clinical outcomes in real‐world patients with bifurcation lesions receiving Xience V everolimus‐eluting stents: Four‐year results from the Xience V USA study
Author(s) -
Hermiller James B.,
Applegate Robert J.,
Baird Colleen,
Butler Michael M.,
Rutledge David,
Wang Jin,
Kakarala Kalyan,
Krucoff Mitchell W.,
Sudhir Krishnankutty
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26217
Subject(s) - medicine , stent , myocardial infarction , population , surgery , clinical endpoint , cardiology , clinical trial , environmental health
Background The Xience V USA Study demonstrated safety and efficacy of the XIENCE V ® everolimus‐eluting stent (EES) in a large, prospective study of a real‐world, unselected patient population. There is limited long‐term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long‐term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study. Methods The Xience V USA Study was a single arm, prospective, multicenter, real‐world study ( n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co‐primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC‐defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC. Results Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow‐up data was available in 4,459 patients (466 BIF, 3,993 non‐BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non‐BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2‐4 years. The 4‐year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non‐BIF ( P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven‐target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups. Conclusions This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4 years with no incremental stent thrombosis increase in BIF patients from 2 to 4 years. © 2015 Wiley Periodicals, Inc.