Cutting balloon angioplasty vs. conventional balloon angioplasty in patients receiving intracoronary brachytherapy for the treatment of in‐stent restenosis

Abstract

The objective of this study was to evaluate the safety and efficacy of cutting balloon angioplasty (CBA) for the treatment of in-stent restenosis prior to intracoronary brachytherapy (ICB). Cutting balloon angioplasty may reduce the incidence of uncontrolled dissection requiring adjunctive stenting and may limit "melon seeding" and geographic miss in patients with in-stent restenosis who are subsequently treated with ICB. We performed a retrospective case-control analysis of 134 consecutive patients with in-stent restenosis who were treated with ICB preceded by either CBA or conventional balloon angioplasty. We identified 44 patients who underwent CBA and ICB, and 90 control patients who underwent conventional percutaneous transluminal coronary angioplasty (PTCA) and ICB for the treatment of in-stent restenosis. Adjunctive coronary stenting was performed in 13 patients (29.5%) in the CBA/ICB group and 41 patients (45.6%; P < 0.001) in the PTCA/ICB group. There was no difference in the injury length or active treatment (ICB) length. The procedural and angiographic success rates were similar in both groups. There were no statistically significant differences in the incidence of death, myocardial infarction, recurrent angina pectoris, subsequent target lumen revascularization, or the composite endpoint of all four clinical outcomes (P > 0.05). Despite sound theoretical reasons why CBA may be better than conventional balloon angioplasty for treatment of in-stent restenosis with ICB, and despite a reduction in the need for adjunctive coronary stenting, we were unable to identify differences in clinical outcome.

Angiographic and clinical outcomes at 8 months of cutting balloon angioplasty and β‐brachytherapy for native vessel in‐stent restenosis (BETACUT): Results from a stopped randomized controlled trial

“…To date, only the report from the RENO registry [11] describes a superiority of CB angioplasty over SB angioplasty, when combined with intracoronary brachytherapy for ISR treatment, in terms of statistically significantly reduced rates of target vessel revascularization and MACE at 6 months. Other studies [12, 18, 20] do not confirm these findings, nor does our study. The rate of TLRs observed in our CB study arm was lower than in the SB study arm (8.2% vs. 13.7%, respectively), but the relative reduction by 40% did not reach statistical significance.…”

“…The combination of CB angioplasty and vascular brachytherapy to treat ISR has been evaluated before, with three studies utilizing the Beta‐Cath system also employed in our study [11, 18, 19], one study utilizing γ‐radiation [12], and another recent study employing either β‐ or γ‐radiation [20]. Except for the study by Moustapha et al [19], all studies mentioned incorporated a control group of patients who underwent radiation therapy preceded by conventional angioplasty.…”

Preliminary Experience With Cutting Balloon Angioplasty for Iliac Artery In-Stent Restenosis

“…In contrast, conventional balloons tend to move forward and backward when inflated within these lesions because of the smooth, slippery surface of neointimal tissue; thus, they may cause unintentional injury to the vessel adjacent to the restenotic area and contribute to repeat restenosis. 33 We encoun-¤ ¤ tered only one case with clinically uneventful PCB slippage during initial inflation in a diffuse ISR lesion along the entire stent length. Application of PCB in non-coronary ISR is limited.…”

Cutting balloons for the treatment of vascular stenoses

“…The consequence of this directed intimal disruption and reduced wall tension is less intimal trauma, which may result in a decreased secondary restenosis rate [9,38]. CBA also has a practical advantage over conventional PTA for the treatment of ISR: conventional PTA balloons tend to move forwards and backwards when inflated within these lesions, because of the smooth, slippery surface of neointimal tissue, and may cause unintentional injury of the vessel outside the restenotic area thus contributing to repeat restenosis [39]. In contrast, the CB is anchored by its blades to the tissue during inflation, reducing the risk of dissection at the stent margins.…”