Angiographic and Clinical Outcomes After Stent-less Coronary Intervention Using Rotational Atherectomy and Drug-Coated Balloon in Patients with De Novo Lesions.

Objectives: We investigated angiographic and clinical outcomes in patients with de novo lesions undergoing rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation (RA/DCB).

Background: Implantation of drug-eluting stent (DES) has been a mainstay of the interventional treatment of coronary artery disease (CAD); however, there still remain several DES-unsuitable clinical/lesion conditions. Nowadays DCB for de novo lesions has attracted more attention, and RA, which tends not to cause major dissection but to debulk intima, might be one of suitable pre-treatments before DCB.

Methods And Results: Thirty patients (34 lesions) undergoing RA/DCB for de novo lesions were enrolled. Clinical/lesion background included severe calcification, calcified nodule, inlet/outlet of aneurysm, ostial lesion, severe thrombocytopenia, bleeding tendency, and/or sequelae of Kawasaki disease. The largest burr size used was 1.83 ± 0.23 mm, and the mean DCB diameter was 2.71 ± 0.47 mm. Angiographic success was obtained in 94% of the lesions. No acute closure but 1 no reflow occurred. Repeat angiography (mean, 6.6 months after procedure) was performed for 19 lesions. Frequency of binary restenosis was 21.1%, and late lumen loss was 0.34 ± 0.30 mm. During a mean follow-up period of 13.1 months, 6 deaths (2 sudden deaths, 1 cardiac death, 3 non-cardiac deaths), 2 strokes, and 2 target lesion revascularizations were observed.

Conclusions: Stent-less PCI using RA/DCB might be an alternative revascularization therapy for CAD patients complicated with DES-unsuitable conditions.