TVF was low for treatment of SVD with DCB. In addition, LLL was observed significantly more frequent in the DCB group in comparison to the POBA group.
Design: Randomized | Open-label | Prospective | Multicenter | Superiority (test for difference)
Indication: De novoMain patient inclusion criterion: Reference vessel diameter ≤ 2.75 mm, ≥ 2 mm
Primary endpoint: TVF @ 6-month follow-up. Components of TVF:
- Cardiac death: Death due to target vessel
- MI: Creatine phosphokinase (CPK) elevation C3 times the normal value in addition to continuous chest symptoms and electrocardiogram changes due to target vessel
- Composite events: Revascularization of target vessel (PCI or CABG)
- TLR @ 6-month follow-up: Ischemia-driven if the lesion revealed restenosis (DS ≥ 50) associated with symptom or presence of ischemia, or if lesion diameter stenosis > 70% (by core laboratory QCA), even in the absence of clinical or functional ischemia
- LLL @ 6-month follow-up
DAPT: 6 months
Patients: In total, 135 patients were enrolled and randomized into a DCB group and POBA group with a ratio of 2:1. Some patients were excluded from the trial due to unsuccessful treatment, consent withdrawal and protocol violation. Follow-up was performed in 88 patients from the DCB group and in 39 patients from the POBA group.
Baseline characteristics: The two treatment groups were well balanced. Apart from a higher proportion of diabetes mellitus in the DCB group, there were no statistically significant differences between the two treatment groups.
Primary endpoints: TVF was low in the DCB group