Late Restenosis After Paclitaxel Balloon Angioplasty | Journal Scan

Study Questions:

What is the long-term safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty for in-stent restenosis (ISR) lesions?


Between September 2008 and December 2012, PCB angioplasty was performed in 468 patients with 550 ISR lesions (bare-metal stent restenosis [BMS-ISR]: 114 lesions, drug-eluting stent restenosis [DES-ISR]: 436 lesions). Two serial angiographic follow-ups were routinely planned for the patients (at 6 and 18 months after the procedure). The efficacy endpoint included late lumen loss, rate of binary restenosis, and rate of target lesion revascularization (TLR) at follow-up. The safety endpoint included major adverse cardiac events and a composite of cardiac death, myocardial infarction, or target lesion thrombosis at follow-up. Stepwise multivariable logistic regression analysis was applied to individuate the variables independently associated with recurrent restenosis.


Early follow-up (6 months) angiography was performed for 488 lesions (89%), and recurrent restenosis occurred in 13 lesions (14.9%) in the BMS-ISR group and in 82 lesions (21.1%) in the DES-ISR group. TLR was performed for seven lesions (7.0%) in the BMS-ISR group and 54 lesions (13.9%) in the DES-ISR group. Late follow-up (18 months) angiography was performed for 377 (88%) of the remaining 427 lesions (excluding TLR lesions), and late restenosis was found in two lesions (2.5%) in the BMS-ISR group and 50 lesions (16.8%) in the DES-ISR group. Delayed late lumen loss was significantly larger in the DES-ISR group. Previous stent size ≤2.5 mm, percentage diameter stenosis after the procedure, and in-stent occlusion lesion were independent predictors of early restenosis. DES-ISR, percentage diameter stenosis at early follow-up, and hemodialysis were independent predictors of late restenosis.


The authors concluded that late restenosis occurs after PCB angioplasty for DES-ISR lesions.


This retrospective single-center observational study suggests that late restenosis occurs after PCB angioplasty for DES-ISR lesions, but not for BMS-ISR lesions, and risk factors of recurrent restenosis after PCB angioplasty for ISR lesions vary depending on the period of time after the procedure. While this study provides some insight into longer-term outcomes after PCB angioplasty, additional prospective research is indicated to determine safety and efficacy of PCB angioplasty versus implantation of another DES for ISR.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Angiography, Angioplasty, Balloon, Coronary, Angioplasty, Balloon, Constriction, Pathologic, Coronary Restenosis, Drug-Eluting Stents, Logistic Models, Myocardial Infarction, Paclitaxel, Risk Factors, Stents, Thrombosis

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