Basel Kosten Effektivitäts Trial–Drug-Coated Balloons versus Drug-Eluting Stents in Small Vessel Interventions 2 - BASKET-SMALL 2

Aug 28, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B. Braun Medical AG, Switzerland
Date Presented:
08/28/2018
Date Published:
08/28/2018
Date Updated:
08/28/2018
Original Posted Date:
08/28/2018
References

Contribution To Literature:

The BASKET-SMALL 2 trial showed that a drug-coated balloon strategy was noninferior at preventing major adverse cardiac events.

Description:

The goal of the trial was to evaluate drug-coated balloons versus drug-eluting stents in small coronary arteries.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with small coronary arteries undergoing percutaneous coronary intervention (PCI) were randomized to a drug-coated balloon (n = 382) versus a drug-eluting stent (n = 376). All lesions were pre-dilated before receiving treatment assignment. The drug-coated balloon was paclitaxel and the drug-eluting stent was everolimus.

Inclusion criteria:

  • All-comers cohort of patients undergoing PCI
  • Total number of enrollees: 758
  • Duration of follow-up: 12 months
  • Mean patient age: 67 years
  • Percentage female: 23%
  • Percentage with diabetes: 32%

Other salient features/characteristics:

  • Mean size of the device: 2.75 mm in the drug-coated balloon group vs. 2.57 mm in the drug-eluting stent group

Principal Findings:

The primary outcome of cardiac death, myocardial infarction, or target vessel revascularization at 12 months occurred in 7.6% of the drug-coated balloon group compared with 7.5% of the drug-eluting stent group (p for noninferiority = 0.022; p for superiority = 0.92).

Secondary outcomes:

  • Cardiac death: 3.1% in the drug-coated balloon group vs. 1.3% in the drug-eluting stent group (p = 0.11)
  • Nonfatal myocardial infarction: 1.6% in the drug-coated balloon group vs. 3.5% in the drug-eluting stent group (p = 0.11)
  • Target vessel revascularization: 3.4% in the drug-coated balloon group vs. 4.5% in the drug-eluting stent group (p = 0.44)
  • Major bleeding: 1.1% in the drug-coated balloon group vs. 2.4% in the drug-eluting stent group (p = 0.18)  

Interpretation:

Among patients undergoing PCI in small arteries, the use of a drug-coated balloon was noninferior to a drug-eluting stent. The drug-coated balloon was noninferior with regard to major adverse cardiac events.

References:

Jeger RV, Farah A, Ohlow MA, et al., on behalf of the BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomized non-inferiority trial. Lancet 2018;Aug 28:[Epub ahead of print].

Editorial Comment: Ho HH, Ong PJL. BASKET-SMALL 2: advancing DCB beyond in-stent restenosis. Lancet 2018;Aug 28:[Epub ahead of print].

Presented by Dr. Raban Jeger at the European Society of Cardiology Congress, Munich, Germany, August 28, 2018.

Keywords: ESC Congress, ESC18, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention


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