Sirolimus coated balloon for the management of coronary in-stent restenosis: long term clinical results from nanolute study

ABSTRACT

BACKGROUND: We sought to investigate the performance of Sirolimus coated balloon (SCB) MagicTouch (Concept Medicals) in patients with in-stent restenotic lesions in native coronary vessels. METHODS: NANOLUTE is prospective, multi-centre, all-comers registry enrolling real world patients from routine clinical practice. We analysed 211 consecutive patients treated with MagicTouch SCB for in-stent restenotic lesions in coronary arteries. The primary endpoint of the study is Major Adverse Cardiac Event (MACE) at 6-month and procedural success. MACE is comprised of Target Lesion/Vessel Revascularization (TLR/TVR), Target Vessel Myocardial Infarction (TV-MI) and cardiac death. Procedural success is defined as technical and angiographic success in the absence of MACE at the time of discharge. The secondary endpoint is MACE assessed at 1 -year. RESULTS: Among total 450 patients enrolled in NANOLUTE, 211 patients had in-stent restenotic lesions. We specifically analysed those patients. The average age of enrolled patients was 60.60 ± 9.58 years mainly dominated by male patients (80.1%). Almost half of the patients had diabetes mellitus (54%) and 46% patients were acutely presented. Left anterior descending accounted for majority of the treated lesions (47.6%). Among 225 ISR lesions treated, 44 % lesions were diffuse while 53.8% lesions were focal. At 6 months 100% patients completed the follow-up and MACE rate was found to be 3.8% [Cardiac death 0%, TV-MI 0.5%, TLR/TVR 3.3%]. At 1 year, 95.7% patients completed the follow-up and MACE rate was reported as 5.0% [Cardiac death 0%, TV-MI 0.5%, TLR/TVR 4.5%]. At 2 years, 84.4% patients completed the follow-up and the incidence of MACE was 6.2%. There was no cardiac death reported in this cohort. As NANOLUTE is on-going study the follow-up of rest of the patient is yet to come. CONCLUSION: Sirolimus coated balloon angioplasty is safe and feasible in in-stent restenotic setting and showed good clinical outcome at 1-year and 2-year. Therefore, use of a SCB is an attractive treatment option for coronary in-stent restenosis, withholding the need for additional stent implantation. (AU)