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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

Original Research2018 Sep 28.[Epub ahead of print]

JOURNAL:Coron Artery Dis. Article Link

Long-term clinical outcomes after treatment of stent restenosis with two drug-coated balloons

Schröder J, Vogt F, Burgmaier M et al. Keywords: two drug-coated balloons; Long-term clinical outcomes; major adverse cardiac event; in-stent restenosis; Paclitaxel-coated balloon;

ABSTRACT


BACKGROUND - Treatment of in-stent restenosis (ISR) is still a clinical challenge in interventional cardiology. Paclitaxel-coated balloons (PCBs) are an attractive therapeutic option for ISR. There are several different types of PCBs available for percutaneous coronary intervention, but to date, comparative data between different types of PCBs for the treatment of ISR are scarce.


PATIENTS AND METHODS - This single centre, nonrandomized, retrospective study under real-world condition included 194 patients with 194 ISR treated by repeat percutaneous coronary intervention with PCBs. The primary end point was major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and need for target lesion revascularization (TLR) at 1 year. Secondary end points were MACE and TLR at long-term follow-up.


RESULTS - Baseline clinical and angiographic parameters were comparable between the two groups. Patients in the iopromide-based PCB and butyryl-tri-hexyl citrate (BTHC)-PCB groups were followed up for 32.2±20.5 and 24.2±13.3 months, respectively (P=0.001). MACEs at 1-year follow-up were 15.0 and 15.8% (P=0.879) for the BTHC-PCB and iopromide-based PCB groups, respectively. TLR, myocardial infarction and cardiac death for BTHC-PCB versus iopromide-based PCB at 1-year follow-up were 9.6 versus 11.8%, P=0.622; 5.3 versus 3.9%, P=0.640; and 5.3 versus 3.9%, P=0.640, respectively. If complete follow-up periods were included in the analysis, BTHC-PCB and iopromide-based PCB had comparable rates of MACE (P=0.835) and TLR (P=0.792).


CONCLUSION - BTHC-PCB and iopromide-based PCB had comparable rates of MACE and TLR for the treatment of ISR at 1-year and long-term follow-up.