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

Key findings

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

Description

Design: Investigator initiated | Randomised | Open-label | Prospective | Multicentre | 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 randomised 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 randomised trial with primary clinical endpoint comparing DCB with 2^nd generation DES in small vessel coronary artery disease – DCB is non-inferior to 2^nd generation DES in the treatment of SVD.

Study flowchart

12-month follow-up:

36-month follow-up: