Standalone cutting balloon angioplasty for the treatment of stent-related restenosis: acute results and 3- to 6-month angiographic recurrent restenosis rates.

Abstract

Despite excellent acute reperfusion results, 20%-30% of patients who undergo coronary stent implantation will develop angiographic restenosis and may require same additional treatments. Cutting Balloon angioplasty (CBA) causes less histological damage outside of the incised area than a regular balloon. However, regular plain old balloon angioplasty is sometimes required before CBA, as is adjunctive stenting and adjunctive angioplasty. These adjunctive strategies may negate the advantages of CBA. There is little data available on CBA as a standalone therapy for stent-related restenosis (SRS). The aim of this study was to evaluate the acute and 3- to 6-month angiographic recurrent restenosis rates following standalone CBA in a patient population treated for SRS and in whom optimal acute results were obtained. In this study, 40 patients with SRS (54 lesions) underwent standalone CBA with optimal acute results. For all lesions, coronary angiography was conducted before and after a standalone CBA procedure for SRS and systematically during 3-6 months to assess recurrent angiographic restenosis rates in the study population. In the study lesions, SRS was either diffuse disease (> 15 mm; 52%) or focal type (48%). Cutting Balloon diameter was 3.20 +/- 0.44 mm and maximal inflation pressure 8.7 +/- 1.2 atm. Ratio of Cutting Balloon diameter to restenotic stent diameter was 0.996 +/- 0.487. Multiple inflations (6 +/- 3 times) were performed. Number of used Cutting Balloon was 1.02 +/- 0.14. Complications were as follows; one non-Q-wave MI (1.9%); 0 death (0%), and 17 repeat target lesion revascularizations (TLRs; 32%). Follow-up coronary angiography (CAG) was not attained for one patient. The angiographic recurrent restenosis rate was 34%, with a higher rate observed when the SRS was diffuse type, 50% vs. 16% for focal-type SRS (P < 0.01). The recurrent restenosis rate for smaller vessels (vessel diameter < or = 3.0 mm) was the same as for larger ones. At follow-up CAG, diffuse-type recurrent restenosis (56%) presented nearly as frequently as that presenting in the original SRS lesions (52%). But four diffuse-type SRS (29%) changed into focal-type recurrent stenosis. In this study, standalone CBA for SRS with optimal acute results was associated with an angiographic restenosis rate of 34%. Diffuse-type disease had a higher recurrent restenosis rate. When CBA achieves acute optimal results, adjunctive stenting or adjunctive PTCA are not always necessary, particularly when the SRS is focal. As a result of CBA, some diffuse-type SRS may change into focal-type recurrent stenosis by the time of the next intervention.