Angiographic performance of a novel sirolimus-coated balloon in native coronary lesions: the FAtebenefratelli SIrolimus COated NATIVES prospective registry.

Abstract

AIMS\nTo evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions.\n\n\nMETHODS\nOut of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization.\n\n\nRESULTS\nA total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52\u200a±\u200a6.88\u200amm. The reference vessel diameter was 2.32\u200a±\u200a0.44\u200amm and the percentage diameter stenosis was 67\u200a±\u200a12. Procedural success was obtained in all patients. After a median of 6.6\u200a±\u200a2.5 months, late lumen loss was 0.09\u200a±\u200a0.34\u200amm and the percentage diameter stenosis was 31\u200a±\u200a18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up.\n\n\nCONCLUSION\nThe use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.