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Randomized Controlled Trial
. 2025 Aug 5;14(15):e037214.
doi: 10.1161/JAHA.124.037214. Epub 2025 Jul 17.

Cost-Effectiveness of Drug-Coated Balloons in the Treatment of Coronary Small Vessel Disease: A Report From the BASKET-SMALL 2 Randomized Controlled Trial

Marco E G V Cattaneo  1 , Michael Coslovsky  1 , Samuel J P Malkin  2 , Gregor Fahrni  1   3 , Christoph Kaiser  4 , Nicole Gilgen  1 , Bruno Scheller  5 , Raban V Jeger  1   3
Affiliations
Randomized Controlled Trial

Cost-Effectiveness of Drug-Coated Balloons in the Treatment of Coronary Small Vessel Disease: A Report From the BASKET-SMALL 2 Randomized Controlled Trial

Marco E G V Cattaneo et al. J Am Heart Assoc. .

Abstract

Background: Drug-coated balloons (DCB) are noninferior to second-generation drug-eluting stents (DES) in the treatment of small vessel coronary artery disease regarding major adverse cardiac events (MACE). However, the economic implication of this finding is unclear.

Methods: In the BASKET-SMALL 2 study (Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions 2), 738 patients were treated with either DCB or DES and followed up regarding MACE, that is, target vessel revascularization, myocardial infarction, or cardiac death, over 3 years. A cost-effectiveness analysis was performed using German diagnosis-related group data to evaluate total expected costs and quality-adjusted life expectancy, expressed in quality-adjusted life-years, for the entire cohort and each treatment option.

Results: DCB led to fewer MACE than DES (14.5% versus 15.3%) but also reduced quality-adjusted life expectancy during the 3-year follow-up (2.35 versus 2.36 quality-adjusted life-years). Regarding direct costs, DCB was less expensive than DES: 5243 versus 5341 EUR during the first 3 years. The incremental cost-effectiveness ratio for DES versus DCB was 6863 EUR per quality-adjusted life-year gained, whereas DCB was more effective and less costly than DES in terms of MACE avoided. Sensitivity analyses emphasized the uncertainty in the results.

Conclusions: Despite reducing the probability of MACE, in terms of quality-adjusted life expectancy DCB was less cost effective than DES at 3 years in the treatment of small vessel coronary artery disease, although results varied substantially when accounting for uncertainty in model parameters.

Keywords: cost‐effectiveness analysis; drug‐coated balloons; major adverse cardiac events; percutaneous coronary intervention; quality‐adjusted life expectancy; second‐generation drug‐eluting stents; small vessel disease.

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Conflict of interest statement

Gregor Fahrni, and Raban V. Jeger received grants to the institution from Abbott, Amgen, AstraZeneca, Bayer, Biosense Webster, B. Braun Melsungen AG, Biotronik, Boston Scientific, Bristol‐Myers Squibb, Cardionovum, Cordis, Daiichi Sankyo, Edwards Lifesciences, GE Medical Systems, MCM Medsys, Medtronic, Novartis, Pfizer, Terumo, and Vascular Medical GmbH. Bruno Scheller is a shareholder of InnoRa GmbH, Berlin, Germany and has received lecture fees from B. Braun and Medtronic. Samuel J. P. Malkin is an employee of Ossian Health Economics and Communications GmbH, which received consulting fees from University Hospital Basel to support preparation of the analysis. The remaining authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. State‐transition graph of the Markov cohort discrete‐time model.
MI indicates myocardial infarction; and TVR, target vessel revascularization.
Figure 2
Figure 2. Breakdown of expected costs, in EUR.
DAPT indicates dual antiplatelet therapy; DCB, drug‐coated balloon; DES, drug‐eluting stent; EES, everolimus‐eluting stent; MI, myocardial infarction; PCI, percutaneous coronary intervention; and TVR, target vessel revascularization.
Figure 3
Figure 3. Probabilistic sensitivity analyses.
DCB vs DES over 3‐year (A) and 5‐year (B) time horizons, as well as DCB vs EES over 3‐year (C) and 5‐year (D) time horizons, respectively, with a cost‐effectiveness threshold of 30 000 EUR per QALY gained applied. Percentages give frequencies of samples in each quadrant (upper right of panels A, B, C, and D: DCB more effective but more expensive than DES/EES; upper left of panels A, B, C, and D: DCB dominated by DES/EES, because less effective and more expensive; lower left of panels A, B, C, and D: DCB less effective but less expensive than DES/EES; lower right of panels A, B, C, and D: DCB dominating DES/EES, because more effective and less expensive). DCB indicates drug‐coated balloon; DES, drug‐eluting stent; EES, everolimus‐eluting stent; and QALY, quality‐adjusted life‐year.
Figure 4
Figure 4. Probabilistic sensitivity analyses.
DCB vs DES over 3‐year (A) and 5‐year (B) time horizons, as well as DCB vs EES over 3‐year (C) and 5‐year (D) time horizons, respectively, with a cost‐effectiveness threshold example of 30 000 EUR per QALY gained. DCB indicates drug‐coated balloon; DES, drug‐eluting stent; EES, everolimus‐eluting stent; and QALY, quality‐adjusted life‐year.
Figure 5
Figure 5. One‐way deterministic sensitivity analyses.
Variability of the difference between DCB and DES in net monetary benefit at 3 years (in EUR), when the estimated event risks vary over their 95% CIs, favoring DCB (blue) or DES (orange). Net monetary benefit is the value of the quality‐adjusted life expectancy (at 30 000 EUR per QALY) minus the expected costs: at 3 years it is 330 EUR lower for DCB than for DES, according to the BASKET‐SMALL 2 event risks. BASKET‐SMALL 2 indicates Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons Versus Drug‐Eluting Stents in Small Vessel Interventions 2; DCB, drug‐coated balloon; DES, drug‐eluting stent; MI, myocardial infarction; QALY, quality‐adjusted life‐year; and TVR, target vessel revascularization.
See this image and copyright information in PMC

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