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

J 2016

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

PLEVA, Leos, Pavel KUKLA, Pavlina KUSNIEROVA, Jana ZAPLETALOVA, Ota HLINOMAZ et. al.

Základní údaje

Originální název

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

Autoři

PLEVA, Leos (203 Česká republika), Pavel KUKLA (203 Česká republika), Pavlina KUSNIEROVA (203 Česká republika), Jana ZAPLETALOVA (203 Česká republika) a Ota HLINOMAZ (203 Česká republika, garant, domácí)

Vydání

Circulation: Cardiovascular Interventions, Philadelphia, Lippincott Williams & Wilkins, 2016, 1941-7640

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 6.598

Kód RIV

RIV/00216224:14110/16:00090491

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316

UT WoS

000374886200009

Klíčová slova anglicky

coronary restenosis; diabetes mellitus; drug-eluting stents; paclitaxel; stents

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 3. 8. 2016 11:53, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

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.

Citovat

PLEVA, Leos, Pavel KUKLA, Pavlina KUSNIEROVA, Jana ZAPLETALOVA a 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, roč. 9, č. 4, s. 1-8. ISSN 1941-7640. Dostupné z: https://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316.

@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 a 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, roč.~9, č.~4, s.~1-8. ISSN~1941-7640. Dostupné z: https://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003316.

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