Drug Coated Balloon SVD Registry

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SVD Registry

SeQuent® Please in small vessel de novo lesions

Prospective "real world" registry for the use of the "PCB only" strategy in small vessel de novo lesions 
Zeymer U et al. Heart 2014; 100(4): 311-6

Key Findings

Treatment of SVD with SeQuent® Please had a very high procedural success rate. At 9-month clinical follow-up, TLR and MACE rates were low in real world patients. The authors conclude that DCBs might be an attractive alternative to DES for treating SVD.

Description

Design: Open-label | Prospective | Multicenter  

Indication: De novo

Main patient inclusion criterion: Reference vessel diameter ≤ 2.75 mm, ≥ 2.0 mm

Primary endpoint: TLR @ 9-month follow-up. Components of TLR:

  • Re-PCI
  • CABG

Secondary endpoints:

  • Procedural success rate
  • MACE @ 9-month follow-up. Components of MACE:
    Cardiac death: Death not clearly of extracardiac origin
    MI: ECG changes and/or cardiac enzyme elevations according to each institution’s routine diagnostic algorithms
    TLR
  • Definite lesion and vessel thrombosis @ 9-month follow-up: according to academic research consortium definition [1]

DAPT: 1, 3-6 or 12 months

Results

Patients: 447 patients with 471 lesions were enrolled in this registry. 420 patients were treated with DCB-only (94 %) and 27 patients with DCB + BMS (6 %).

Baseline characteristics: The two treatment groups were well balanced. Of note are the high rate of diabetics (36.7 %) and the moderate ACS rate (23.5 %) in the overall patient population. The only statistically significant difference between the DCB-only and DCB + BMS group were the incident of STEMI, with a higher percentage in the DCB + BMS group.

Primary endpoint: TLR rates at 9-month follow-up were low and comparable between both treatment groups.

  All patients
n = 447
DCB-only
n = 420
DCB + BMS
n = 27
p-value
TLR 3.6 % 3.6 % 4.0 % 0.922

Secondary endpoints: Procedural success was achieved in 99 % of cases. Remaining endpoints at 9-month follow-up:

  All patients
n = 447
DCB-only
n = 420
DCB + BMS
n = 27
p-value
MACE 4.7 % 4.7 % 4.0 % 0.866
Cardiac death 0.0 % 0.0 % 0.0 % -
MI 1.8 % 1.9 % 0.0 % 0.481
TLR 3.6 % 3.6 % 4.0 % 0.922
Thrombosis 0.8 % 0.6 % 4.2 % 0.054

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

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany