Key findings
DCB-only angioplasty with SeQuent® Please in de novo lesions is associated with low MACE and TLR rates. The authors conclude that DCBs appear to be an attractive alternative for the interventional, stent-less treatment of suitable de novo coronary lesions.
Description
Design: Open-label | Prospective | Multicenter
Indication: De novo, ISR
Primary endpoint: TLR @ 9-month follow-up
Secondary endpoints: MACE @ 9-month follow-up. Components of MACE:
- TLR
- Cardiac death: Death not clearly of extracardiac origin
- MI: Typical clinical symptoms, relevant ECG changes and/ or elevated troponin T or troponin I increases (3 × the upper limit of normal)
- Definite vessel thrombosis: According to Academic Research Consortium definition [1]
DAPT:
- DCB-only: 1 month
- DCB + stent: ≥ 6 months
Results
Patients: A total of 1,025 patients were enrolled. 686 of these patients (66.9 %) were treated in de novo lesions, 231 (22.6 %) in DES-ISR and 108 (10.5 %) in BMS-ISR.
Baseline characteristics: The different patient groups were well balanced. Statistically significant differences were observed with regards to the history of smoking and STEMI. The percentage of patients with a history of smoking was highest in the BMS-ISR group, while the percentage of STEMI was highest in the de novo group.
Primary endpoint: TLR rates at 9-month follow-up were low across all treatment groups, with a lower rate for the de novo group.
[1] Cutlip D et al. Circulation 2007; 115: 2344-51.
