Drug Coated Balloon BASKET-SMALL 2

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BASKET-SMALL 2

SeQuent® Please (NEO) vs. DES (EES/PES) in small vessel de novo lesions

Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomized non-inferiority trial 
Jeger R et al. The Lancet 2018; 392(10150): 849-56

Key Findings

SeQuent® Please and SeQuent® Please NEO are non-inferior to 2nd generation DES in an all-comers population regarding clinical endpoints. The authors conclude that after successful lesion preparation, small native coronary artery disease might be safely treated with the SeQuent® Please or SeQuent® Please NEO DCB.

Over 85 % of patients were randomized after successful lesion preparation and could have therefore been treated with DCB-only.

Description

Design: Investigator-Initiated | Randomized | Open-label | Prospective | Multicenter | Non-inferiority (test for difference)

Indication: De novo

Main patient inclusion criterion: Reference vessel diameter ≤ 3 mm

Primary endpoint: MACE @ 12-month follow-up. Components of MACE:

  • Cardiac death: Death not clearly of extracardiac origin
  • Non-fatal MI: According to guidelines [1]
  • TVR

Secondary endpoints:

  • Single components of primary endpoint
  • Probable or definite stent thrombosis @ 12-month follow-up: According to Academic Research Consortium definition [2]
  • Major bleeding @ 12-month follow-up: BARC ≥ 3 according to Bleeding Academic Research Consortium [3]
  • Net clinical benefit @ 12-month follow-up: Composite of MACE and major bleeding

DAPT:

  • Stable CAD: 1 month for DCB-only, ≥ 6 months for DES
  • ACS: 12 months for DCB-only and DES

Results

Patients: After lesion preparation, 758 patients were randomized into the treatment groups. In total, 376 patients were allocated into the DES group and 382 patients in the DCB group, 362 of which were treated with DCB-only.

Baseline characteristics: The two treatment groups were well balanced. Apart from a higher proportion of men in the DCB group, there were no statistically significant differences between the two treatment groups.

Primary endpoint: MACE was met for non-inferiority

Secondary endpoints:

  DCB
n = 382
DES
n = 376
p-value
Cardiac death 3.14 % 4.52 % 0.11
Non-fatal MI 1.57 % 3.46 % 0.11
TVR 3.4 % 4.52 % 0.44
Stent thrombosis 0.79 % 1.6 % -
Major bleeding 1.1 % 2.4 % -
Net clinical benefit 7.9 % 9.6 % -

[1] Thygesen K et al. J Am Coll Cardiol 2012; 60: 1581-98.
[2] Cutlip D et al. Circulation 2007; 115: 2344-51.
[3] Mehran R et al. Circulation 2011; 123: 2736-47.

 

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany