Drug Coated Balloon
FFR-Guided DCB-Angioplasty

SeQuent® Please and DES (ZES/EES/BMS) in de novo lesions

Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions

Shin E et al. Catheter. Cardiovasc. Interv. 2016; 88(2): 193-200

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. 

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

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.}