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.
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.
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
- MACE @ 12 months (MACE includes: TVR, non-fatal MI, cardiac death)
- MACE @ 36 months (MACE includes: TVR, non-fatal MI, cardiac death)
- 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
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)
- 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%
- @ 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.
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.
n = 362
n = 376
|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|