SeQuent® Please in de novo lesions, DES- and BMS-ISR
Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: The DCB-only All-Comers Registry
Rosenberg M et al. Catheter. Cardiovasc. Interv. 2019; 93(2): 181-8
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.
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:
- 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 
- DCB-only: 1 month
- DCB + stent: ≥ 6 months
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.
|All patients||De novo||BMS-ISR||DES-ISR||p-value|
|Patients with clinical follow-up||915 (89.3 %)||604 (88.0 %)||103 (95.4 %)||208 (90.0 %)||0.067|
|MACE||6.8 %||5.6 %||7.8 %||9.6 %||0.131|
|TLR||3.2 %||2.3 %||2.9 %||5.8 %||0.049|
|Cardiac death||1.3 %||1.0 %||1.9 %||1.9 %||0.499|
|MI||3.4 %||3.6 %||3.9 %||2.4 %||0.666|
|Definite vessel thrombosis||0.8 %||
 Cutlip D et al. Circulation 2007; 115: 2344-51.