| PLEVA, Leos, Pavel KUKLA, Pavlina KUSNIEROVA, Jana ZAPLETALOVA and Ota HLINOMAZ. Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis The Treatment of In-Stent Restenosis Study. Circulation: Cardiovascular Interventions. Philadelphia: Lippincott Williams & Wilkins, 2016, vol. 9, No 4, p. 1-8. ISSN 1941-7640. Available from: https://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316. |
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@article{1350834,
author = {Pleva, Leos and Kukla, Pavel and Kusnierova, Pavlina and Zapletalova, Jana and Hlinomaz, Ota},
article_location = {Philadelphia},
article_number = {4},
doi = {http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316},
keywords = {coronary restenosis; diabetes mellitus; drug-eluting stents; paclitaxel; stents},
language = {eng},
issn = {1941-7640},
journal = {Circulation: Cardiovascular Interventions},
title = {Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis The Treatment of In-Stent Restenosis Study},
volume = {9},
year = {2016}
}
TY - JOUR
ID - 1350834
AU - Pleva, Leos - Kukla, Pavel - Kusnierova, Pavlina - Zapletalova, Jana - Hlinomaz, Ota
PY - 2016
TI - Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis The Treatment of In-Stent Restenosis Study
JF - Circulation: Cardiovascular Interventions
VL - 9
IS - 4
SP - 1-8
EP - 1-8
PB - Lippincott Williams & Wilkins
SN - 19417640
KW - coronary restenosis
KW - diabetes mellitus
KW - drug-eluting stents
KW - paclitaxel
KW - stents
N2 - Background The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxel-eluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis. Methods and Results A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004). The difference in the incidence of repeated binary restenosis (8.7% versus 19.12%; P=0.078) and 12-month major adverse cardiac events (10.29% versus 19.12%; P=0.213) was not significant. The 12-month LLL was significantly less in the PEB group and also in subgroups with in-stent restenosis >10 mm (0.05 versus 0.26 mm; P=0.0002) and artery diameter <3 mm (0.05 versus 0.16 mm; P=0.003) compared with the EES groups, but not in the subgroup of patients with diabetes mellitus (P=0.254). In the EES group, repetitive binary restenosis had a significantly greater chance of occurring (odds ratio=3.132; 95% confidence interval, 1.058-9.269; P=0.039), even when adjusting for other risk factors. Conclusions Treatment of bare metal stent restenosis using PEB led to significantly less 12-month LLL than the implantation of second-generation EES.
ER -
PLEVA, Leos, Pavel KUKLA, Pavlina KUSNIEROVA, Jana ZAPLETALOVA and Ota HLINOMAZ. Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis The Treatment of In-Stent Restenosis Study. \textit{Circulation: Cardiovascular Interventions}. Philadelphia: Lippincott Williams \&{} Wilkins, 2016, vol.~9, No~4, p.~1-8. ISSN~1941-7640. Available from: https://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316.
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