TY - JOUR
T1 - 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm
AU - Diletti, Roberto
AU - Onuma, Yoshinobu
AU - Farooq, Vasim
AU - Gomez-Lara, Josep
AU - Brugaletta, Salvatore
AU - Van Geuns, Robert Jan
AU - Regar, Evelyn
AU - De Bruyne, Bernard
AU - Dudek, Dariusz
AU - Thuesen, Leif
AU - Chevalier, Bernard
AU - McClean, Dougal
AU - Windecker, Stephan
AU - Whitbourn, Robert
AU - Smits, Pieter
AU - Koolen, Jacques
AU - Meredith, Ian
AU - Li, Dong
AU - Veldhof, Susan
AU - Rapoza, Richard
AU - Garcia-Garcia, Hector M.
AU - Ormiston, John A.
AU - Serruys, Patrick W.
PY - 2011/7/12
Y1 - 2011/7/12
N2 - Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background: BVS are a novel approach to treating coronary lesions and are untested in small vessels. Methods: The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Results: At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643). Conclusions: The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels.
AB - Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background: BVS are a novel approach to treating coronary lesions and are untested in small vessels. Methods: The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Results: At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643). Conclusions: The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels.
KW - bioresorbable everolimus-eluting vascular scaffold
KW - outcome
KW - small vessels
UR - https://www.scopus.com/pages/publications/79960038825
U2 - 10.1016/j.jacc.2011.02.052
DO - 10.1016/j.jacc.2011.02.052
M3 - Article
C2 - 21737016
AN - SCOPUS:79960038825
SN - 0735-1097
VL - 58
SP - 258
EP - 264
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 3
ER -
