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Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: A pooled analysis of the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 trials Outcomes with drug-coated balloons in small-vessel coronary artery disease Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial Clinical and angiographic outcomes of coronary dissection after paclitaxel-coated balloon angioplasty for small vessel coronary artery disease Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial Treatment of Very Small De Novo Coronary Artery Disease With 2.0 mm Drug-Coated Balloons Showed 1-Year Clinical Outcome Comparable With 2.0 mm Drug-Eluting Stents Therapeutic efficacy of paclitaxel-coated balloon for de novo coronary lesions with diameters larger than 2.8 mm A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial
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Original Research2018 Nov 15;92(6):E416-E424.

JOURNAL：Catheter Cardiovasc Interv. Article Link

Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study

Pleva L, Kukla P, Zapletalova J et al. Keywords: everolimus-eluting stent; in-stent restenosis; paclitaxel-eluting balloon

ABSTRACT



BACKGROUND - The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined.


OBJECTIVES - We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR.


METHODS - We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group).


RESULTS - The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270).


CONCLUSIONS - At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

© 2018 Wiley Periodicals, Inc.


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