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.