SeQuent® Please in small vessel de novo lesions

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.

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