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We thank Dr. Alfonso for his comments about our study (1). His observations provide an opportunity: 1) to analyze the implications of the procedural finding of balloon slippage in patients with in-stent restenosis (ISR) treated by conventional balloon angioplasty; 2) to report whether a specific subgroup of patients benefited from cutting balloon angioplasty; and 3) to discuss the possible benefit of lesion pre-dilation using the cutting balloon in patients with ISR treated with drug-eluting stenting.
First, analysis of the Restenosis Cutting Balloon Evaluation Trial (RESCUT) database shows that in the group treated with conventional balloon angioplasty, balloon slippage was associated with a higher percentage, although not statistically significant, of residual dissections (11.1% vs. 6,9%; p = 0.35), and a higher percentage of additional stent implantation (9.5% vs. 3.5%; p = 0.21) mainly due to type D, E, and F dissections. However, recurrent restenosis rate at six months was not higher when balloon slippage was observed.
Second, the analysis performed with the multivariate technique to determine whether any specific subset of ISR patients/lesions benefited from the cutting balloon treatment (i.e., short vs. long lesions, small vs. large vessel, diabetics vs. nondiabetics, short time vs. long time by previous implanted stent, first vs. >1 prior ISR on the same vessel) did not uncover any significant effect.
Third, although a recent study failed to demonstrate long-term benefits after the use of cutting balloon in ISR patients undergoing adjunctive gamma brachytherapy (2), in the Registry Novoste (RENO) (3) where brachytherapy was performed using beta-radiation, pretreatment with cutting balloon significantly reduced six-month target-vessel revascularization compared with conventional angioplasty (10.2% vs. 16.6%; p = 0.04).
However, we do not believe that the use of cutting balloon will translate into clinical or angiographic benefit for patients with ISR treated with drug-eluting stents (DES), as a result of the procedural differences in the treatment of ISR using adjunctive brachytherapy compared with restenting with a DES. In the first case, before adjunctive brachytherapy, it is recommended to optimally treat ISR by conventional/cutting balloon angioplasty or atherectomy, avoiding additional stenting to reduce the risk of late stent thrombosis, whereas in the case of restenting with a DES, an optimal balloon pretreatment of ISR is not necessary, nor is the use of cutting balloon to avoid balloon slippage, because the operator can reduce the risk of vessel injury at the stent edges, even in the event of balloon slippage, by simply predilating the ISR lesion using an undersized noncompliant conventional balloon.
- American College of Cardiology Foundation