Treatment of Very Small De Novo Coronary Artery Disease With 2.0 mm Drug-Coated Balloons Showed 1-Year Clinical Outcome Comparable With 2.0 mm Drug-Eluting Stents.

Objective: To evaluate the 1-year clinical outcomes of patients treated with 2.0 mm drug-coated balloon (DCB) vs 2.0 mm drug-eluting stent (DES) implantation in small-caliber vessel de novo coronary artery disease (CAD).
Methods: All patients treated with 2.0 mm DCB or 2.0 mm DES for very small vessel de novo CAD from July 2014 to June 2016 were included in this study. The primary endpoint was the occurrence of target-lesion failure (TLF) and time to TLF, defined as a combination of cardiac mortality, target-vessel myocardial infarction, and target-lesion revascularization (TLR).
Results: A total of 87 patients (96 lesions) were implanted with 2.0 mm DCBs and 200 patients (223 lesions) were implanted with 2.0 mm DESs during the study period. Mean reference vessel diameter was similar between the DCB and DES groups (1.88 ± 0.38 mm vs 1.95 ± 0.21 mm, respectively; P=.11). The 1-year TLF rates were 7.0% in the DCB group and 8.2% in the DES group (P=.73). TLF was driven by TLR in both groups. Bailout stenting was performed in 7 patients (8 lesions) who received a DCB. Stent thrombosis was seen in 4 patients (2.0%) who underwent DES implantation. There was no vessel thrombosis noted in the DCB group. Cardiogenic shock was identified as a direct and significant predictor for both the occurrence of TLF and time to TLF.
Conclusions: In this first report, treatment of very small vessel CAD with 2.0 mm DCB vs 2.0 mm DES was associated with similar 1-year TLF rates.