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      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

      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:

       DCB
      n = 45
      DES
      n = 22
      p-value
      9-month follow-up
      LLL0.05 ± 0.27 mm

      0.40 ± 0.54 mm0.022
      FFR0.85 ± 0.080.85 ± 0.050.973
      12-month follow-up
      MI0 patients1 patient-
      TLR0 patients1 patient-

      [1] Cutlip D et al. Circulation 2007; 115: 2344-51.