Drug Coated Balloon FFR-Guided DCB-Angioplasty

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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
LLL 0.05 ± 0.27 mm 0.40 ± 0.54 mm 0.022
FFR 0.85 ± 0.08 0.85 ± 0.05 0.973
12-month follow-up
MI 0 patients 1 patient -
TLR 0 patients 1 patient -

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

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany