Drug Coated Balloon DCB-only All-Comers Registry

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DCB-only All-Comers Registry

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

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. 

Secondary endpoints:

  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 %

0.5 %

1.9 %

1.0 % 0.278

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

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany