Randomized Trial of Optimal Treatment Strategies for In-Stent Restenosis After Drug-Eluting Stent Implantation

Study Questions:

What is the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis?


Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall, 62 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled.


In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: -0.01 to 0.68 mm vs. 0.06 mm, IQR: - 0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow-up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: -0.02 to 0.30 mm; vs. 0.00 mm, IQR: -0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between the SES group (n = 32) and the EES group (n = 34).


The authors concluded that for lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty.


This study suggests that in the cases of focal type DES restenosis, repeat implantation of SES showed a more effective trend for preventing late luminal loss compared to cutting balloon angioplasty. However, in the cases of diffuse-type DES restenosis, SES and EES implantation showed similar angiographic and clinical outcomes. Given the small sample size in this analysis, larger studies are required to compare efficacy of diverse treatment modalities for DES restenosis.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Drug-Eluting Stents, Sirolimus, Angioplasty, Balloon, Coronary, Stents

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