Long-Term Safety and Efficacy Profiles of Drug-Coated Balloons vs Drug Eluting Stents

Treatment of de-novo coronary small vessel disease with drug-coated balloon (DCB) was found to be safe and efficacious for up to 3 years, according to study published in The Lancet.

This was a 3-year follow-up study of the randomized, non-inferiority Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (ClinicalTrials.gov Identifier: NCT01574534) conducted between 2012 and 2017 at 14 centers in Germany, Switzerland, and Austria. Patients (N=758; mean age, 67.79±10.34 years; 73% men) with small coronary vessels with a diameter between 2.0 and 3.0 mm and successful predilatation of the lesion, decreased blood flow, or residual stenosis, and an indication for percutaneous coronary interventions (PCI) were randomly assigned to receive DCB (n=382) or drug eluting stent (DES; n=376).

In this cohort, the average left ventricular ejection fraction was 60% (interquartile range [IQR], 53%-62%), 87% had hypertension, 63% had previous PCI, 60% had hypercholesterolemia, and 34% had diabetes. Randomized groups were well balanced for all baseline characteristics except for gender (a greater percentage of men received DCB, 77% vs DEB, 70%).

Clopidogrel therapy had a longer duration in patients receiving DES vs DCB (median, 336; IQR, 182-374 vs median, 209; IQR, 146-384 days, respectively). Treatment lengths of other dual antiplatelet therapies did not differ between groups.

Complete follow-up data was available for 91% and 92% of patients treated with DCB and DES, respectively. The risk for major adverse cardiac events was not significantly different (hazard ratio [HR], 0.99; 95% CI, 0.68-1.45; P =.95).

Patients receiving DCB vs DES cohorts had comparable rates of: cardiac death (5% vs 4%, respectively; HR, 1.29; 95% CI, 0.63-2.66; P =.49), nonfatal myocardial infarction (6% vs 6%, respectively; HR, 0.82; 95% CI, 0.45-1.51; P =.52), target vessel revascularization (9% vs 9%, respectively; HR, 0.95; 95% CI, 0.58-1.56; P =.83), probable or definite vessel or stent thrombosis (2% vs 1%, respectively; HR, 0.33; 95% CI, 0.07-1.64; P =.18), major bleeding (4% vs 2%, respectively; HR, 0.43; 95% CI, 0.17-1.13; P =.088), and all-cause mortality (8% vs 8%, respectively; HR, 1.05; 95% CI, 0.62-1.77; P =.87).

A bailout stent implantation was required in 5% of the patients in the DCB cohort.

Study limitations include the small sample size.

“On the basis of the current results, DCB represents a genuine alternative to DES for selected de-novo lesions in coronary arteries with an excellent long-term safety and efficacy profile,” concluded the study authors.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Jeger R V, Farah A, Ohlow M-A, et al. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020;396(10261):1504-1510. doi:10.1016/S0140-6736(20)32173-5