[Paclitaxel-coated balloons for in-stent restenosis treatment: long-term clinical results and predictors of recurrent target lesion revascularization].

BACKGROUND

The aim of this study was to report clinical outcomes in patients treated with paclitaxel-coated balloons (PCB) for in-stent restenosis (ISR) in both bare metal (BMS) and drug-eluting stent (DES).

METHODS

Between May 2009 and December 2015, we treated 155 ISR in 140 patients. At recruitment, 35% of patients had diabetes. Among the lesions, 125 were first occurrence (55 within BMS and 70 within DES) and 30 recurrent; 24 ISR were multi-metal layered. Mean reference diameter was 2.79 ± 0.52 mm and mean lesion length 13.2 ± 7.1 mm. PCB use included 32 Dior I, 97 InPact Falcon, 18 Panthera Lux, and 8 Restore DEB.

RESULTS

At a median follow-up of 442 days, we observed 18 target lesion revascularizations (TLR), one myocardial infarction, 3 cardiac deaths, and 5 non-cardiac deaths. TLR occurrence differed according to type of ISR (4% within BMS, 14% within DES, 28% within recurrent ISR; p<0.05). TLR was associated with PCB type (35% Dior I, 9% InPact Falcon, 0% Panthera Lux and Restore DEB; p<0.05). Multivariable analysis revealed that first-generation PCB without a carrier (hazard ratio [HR] 2.50, 95% confidence interval [CI] 0.96-6.50; p=0.06) and recurrent ISR (HR 7.76, 95% CI 1.56-38.66; p=0.01) correlated with subsequent TLR.

CONCLUSIONS

Our results confirm the safety and efficacy of PCB for ISR treatment both within BMS and DES. PCB type and recurrent ISR correlate with subsequent TLR.