Drug-Coated Balloons Versus Drug-Eluting Stents or Plain Old Balloon Angioplasty: A Long-Term in-Stent Restenosis Study

Balloon angioplasty with drug-coated balloons (DCBs) is frequently used during percutaneous coronary intervention for in-stent restenosis. Despite its frequent use, there is a lack of long-term data on the efficacy of DCB angioplasty. We conducted an investigation on the long-term efficacy outcome of in-stent restenosis, comparing DCBs, drug-eluting stents, and plain old balloon angioplasty. We conducted a nationwide analysis from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) including in-stent restenosis lesions undergoing coronary angiography between June 11, 2013, and January 14, 2022. The primary outcome of this study was target-lesion revascularization within a 5-year follow-up. Secondary outcomes included all-cause death, cardiovascular death, myocardial infarction, and any percutaneous coronary intervention. The outcomes were analyzed using a multivariable Cox proportional hazard model or Poisson regression, as appropriate. A total of 10 561 lesions from 9062 patients were included. Compared with plain old balloon angioplasty, the use of DCB angioplasty was associated with less target-lesion revascularization (risk ratio, 0.69 [95% CI, 0.57-0.82]), all-cause death (risk ratio, 0.72 [95% CI, 0.59-0.88]), and cardiovascular death (hazard ratio [HR], 0.59 [95% CI, 0.45-0.78]). No difference was observed for myocardial infarction or any percutaneous coronary intervention. Compared with drug-eluting stents, the use of DCBs was associated with higher rates of target-lesion revascularization (HR, 1.20 [95% CI, 1.06-1.37]). No difference was observed for all-cause death, cardiovascular death, myocardial infarction, or any percutaneous coronary intervention. In this long-term nationwide analysis, the use of DCB angioplasty showed superior outcomes compared with plain old balloon angioplasty within 5 years but higher rates of repeat revascularizations compared with drug-eluting stents.