Drug Coated Balloon BASKET-SMALL 2

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BASKET-SMALL 2 (3-year data available – October 2020)

Basel Stent Kosten Effektivitäts Trial Drug Coated Balloons vs. Drug Eluting Stents in Small Vessel Interventions

Jeger R et al. The Lancet, August 2018. Trial Registration Number: NCT01574534 on www.clinicaltrials.gov.
Jeger R et al. The Lancet, October 2020. Same trial registration.

Key Findings

Largest randomized clinical trial with primary clinical endpoint, testing the efficacy of SeQuent® Please NEO (DCB) vs. 2nd generation DES for the treatment of small vessel coronary artery disease.
DCB-only treatment with SeQuent® Please NEO achieves clinical results comparable to 2nd generation DES implantation in de novo lesions up to 3 mm in reference vessel diameter.

Description

Design: Investigator initiated | Randomized | Open-label | Prospective | Multicenter | Non-inferiority

Indication: Ischemic coronary artery disease (CAD) in native de novo lesions

Main inclusion criteria:

  • Vessel diameter ≥ 2 mm to < 3 mm
  • Native vessel
  • Successful pre-dilation according to consensus recommendations for DCB-usage

Primary outcome:

  • MACE @ 12 months (MACE includes: TVR, non-fatal MI, cardiac death)
  • MACE @ 36 months (MACE includes: TVR, non-fatal MI, cardiac death)

Secondary outcomes:

  • TVR, non-fatal MI, cardiac death, stent thrombosis, bleeding

Dual Antiplatelet Therapy (DAPT):

  • 4 weeks of DAPT in stable patients treated with DCB or 6 months for DES. In patients with acute coronary syndrome (ACS) 12-month DAPT

Results

758 patients randomized after pre-dilation (86 % of 883 initially assessed patients)

  • 382 assigned for DCB-treatment, 376 for DES-treatment
  • Well-balanced demographic and procedural parameters between the treatment groups

Primary outcome: No statistical difference between groups

  • MACE @ 12 months 7.3% in the DCB group vs. 7.5% in the DES group (p=0.92)
  • The primary endpoint was met for non-inferiority at both time points (DCB not worse than DES)

Secondary outcome:

  • MACE @ 36 months 15% in both groups (p=0.95)
  • @ 12 months DCB vs. DES – cardiac death: 3.1 vs. 1.3 %, MI 1.6 vs. 3.5 % or TVR 3.4 vs. 4.5%
  • @ 36 months DCB vs. DES – cardiac death: 5 vs. 4 %, MI 6 vs. 6 % or TVR 9 vs. 9%

Other endpoints:

  • @ 12 months: Probable or definite thrombosis were low and comparable between DCB and DES patients (0.79 vs. 1.60 %). Rates of major bleeding were low and similar in DCB and DES patients (1.1 vs. 2.4 %).
  • @ 36 months: Probable or definite thrombosis (1% in DCB and 2% in DES, p=0.18). Rates of major bleeding (2% in DCB vs. 4% in DES, p=0.088) were numerically lower in the DCB group without statistical significance.

Conclusion

BASKET SMALL 2 is the largest randomized trial with primary clinical endpoint comparing DCB with 2nd generation DES in small vessel coronary artery disease – DCB is non-inferior to 2nd generation DES in the treatment of SVD.

Study Flowchart

12-month Follow-Up:
  DCB
n = 362
DES
n = 376
p-value
TVR 3.4 % 4.5 % 0.44
MI 1.6 % 3.5 % 0.11
Cardiac death 3.1 % 1.3 % 0.11
MACE 7.3 % 7.5 % 0.92
36-month Follow-Up:
B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany