Purpose: The aim of this study was to compare the efficacy of paclitaxel-coated balloon (PCB) with repeat drug-eluting stent (DES) implantation for the treatment of DES restenosis in an unselected, consecutive, patient cohort.

Methods: We analyzed data from a prospective registry including consecutive patients after re-revascularization for DES restenosis in our institute from 2004 to 2011. A total of 683 patients with 777 lesions were analyzed in the study (260 patients with 306 lesions treated with PCB (SeQuent Please) and 423 patients with 471 lesions treated with DES). All patients were...

Purpose: The aim of this study was to compare the efficacy of paclitaxel-coated balloon (PCB) with repeat drug-eluting stent (DES) implantation for the treatment of DES restenosis in an unselected, consecutive, patient cohort.

Methods: We analyzed data from a prospective registry including consecutive patients after re-revascularization for DES restenosis in our institute from 2004 to 2011. A total of 683 patients with 777 lesions were analyzed in the study (260 patients with 306 lesions treated with PCB (SeQuent Please) and 423 patients with 471 lesions treated with DES). All patients were scheduled to undergo repeat angiography 6 to 8 months after successful procedure. After matching propensity scores of the 777 lesions with DES restenosis, 276 matched pairs were selected and analyzed for binary restenosis, target lesion revascularization (TLR) and major adverse cardiac events. As for the angiographic endpoint of TLR, subgroup analysis was performed for several parameters.

Results: There was only an insignificant trend favoring PCB with respect to binary restenosis (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.47-1.10), TLR (HR, 0.70; 95% CI, 0.43-1.13) and major adverse cardiac events (HR, 0.74; 95% CI, 0.46-1.18). HRs with respect to TLR in several subgroups are illustrated in Figure. There was a significant trend favoring PCB with respect to TLR in diffuse in-stent restenosis lesions (HR, 0.48; 95% CI, 0.29-0.79) and bifurcation lesions (HR, 0.18; 95% CI, 0.06-0.52).

HRs with respect to TLR.

Conclusions: Angiographic and clinical outcomes were similar between the PCB group and the repeat DES group. The benefit of PCB was more prominent in diffuse in-stent restenosis lesions and bifurcation lesions.