Safety and efficacy of the treatment of in-stent restenosis and de novo complex lesions with the novel paclitaxel-coated scoring balloon (Angiosculpt X)

Abstract

Background The AngioSculpt X (Spectranetics) is a novel paclitaxel-coated scoring balloon with encouraging preliminary data for the treatment of in-stent restenosis or de novo complex lesions. Purpose To assess the safety and efficacy of real-world patients with in-stent restenosis (ISR) or de novo complex lesions (vessels <2.5 mm, calcified lesions, bifurcation lesions...) treated with the novel paclitaxel-coated scoring balloon. Methods A “real-world”, prospective registry from two centers was performed including consecutive patients presenting with ISR or de novo complex lesions and treated with AngioSculpt X. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, stent thrombosis, nonfatal myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR). Results Overall, 87 real-world patients and 93 lesions (73% male, 68±10 years, 46% smoker, 83% hypertensive, 62% diabetic, 71% hyperlipidemic, 35% LVEF <60% impairment) were enrolled in the study. Clinical presentation was stable angina in 19%, unstable angina in 33%, NSTEMI in 29% and STEMI in 5%. Radial access account 84%. The median fluoroscopy time was 17 (IQ range 10,0 - 37.5) min. De novo complex lesions were treated in 35% (n=32) while ISR in 63% (n=57), (Prior BMS 19%; Sirolimus DES 9%; Everolimus DES 26%; Biolimus/Anfilimus DES 20%; Zotarolimus DES 26%) with a median time to ISR of 3.6 (IQ range 1.1 - 10.7) years. Total stent length was 28±18 mm, with an overlap spot affected in 18%, and 27% had >1 treatment for ISR. The most frequent artery treated was left anterior descending (41%) followed by left circumflex (35%) and right coronary artery (17%). Quantitative coronary angiography reference diameter of lesions was 2.7±0.5 mm and length 9.0±4.8 mm, with a % stenosis of 75±20. Predilatation/postdilatation was performed in 60/24% respectively. Device diameter was 2.9±0.4 mm and length 13.6±3.9 mm, deployed at 16±3 atmospheres, with an inflation time of 33±16 seconds. The balloon/artery ratio was 0.99±0.03. Crossover was decided on 18 cases (19%) due to remaining intimal flap, but the success rate (residual stenosis <30%) was 100%. Intracoronary imaging technique was performed in 12% (OCT=7, IVUS=4). At 7±6 month follow-up, there were 10 MACE (cardiac death=1, nonfatal myocardial infarction =4, TLR=4 and TVR=1). Conclusions Paclitaxel-coated scoring balloon offers a safe and valuable treatment option for ISR and de novo complex lesions. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Juan Ramόn Jiménez University Hospital