Key findings
FFR-guided DCB treatment with SeQuent® Please is safe and effective in de novo lesions. MLD was comparable in the DCB and DES group at 9-month follow-up, and LLL was significantly lower in the DCB group.
Description
Design: Open-label | Prospective | Single center
Indication: De novo
Main patient inclusion criterion: Reference vessel diameter ≤ 3.5 mm, ≥ 2.5 mm
Endpoints:
- LLL @ 9-month follow-up
- FFR @ 9-month follow-up
- MI @ 12-month follow-up
DAPT:
- DCB-only: 1.5 months
- BMS: ≥ 6 months
- DES: ≥ 12 months
Additional information: Method of treatment was determined through FFR measurements
- FFR ≥ 0.85: DCB angioplasty
- FFR < 0.85: Stent implantation
Results
Patients: 67 lesions were included in this trial due to successful lesion preparation and FFR. All patients with FFR ≥ 0.85 and some additional lesions with FFR ≤ 0.85 were treated with a DCB, in total 45 lesions (67.2 %). Lesions with FFR ≤ 0.85 were chosen for DCB angioplasty if measurements were close to the limit or patients were not able to receive long-term DAPT. The remaining 22 lesions (32.8 %) with FFR ≤ 0.85 were treated with a stent.
Baseline characteristics: The two treatment groups were well balanced, there were no statistically significant differences between the groups.
Endpoints:
[1] Cutlip D et al. Circulation 2007; 115: 2344-51.
