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

Abstract

Background: 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.

Methods and results: 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.

Conclusions: 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.

Keywords: drug‐coated balloon; drug‐eluting stent; in‐stent restenosis; plain old balloon angioplasty; target‐lesion revascularization.

Figure 1. Flowchart.

Flowchart illustrating eligible lesions and patients. The final study population consisted of 10 561 lesions from 9062 patients. DCB indicates drug‐coated balloon; DES, drug‐eluting stent; ISR, in‐stent restenosis; and POBA, plain old balloon angioplasty.

Figure 2. Outcome.

Kaplan–Meier curves illustrating the event rate of (A) TLR, (B) all‐cause death, (C) cardiovascular death, (D) myocardial infarction, and (E) any PCI. DCB indicates drug‐coated balloon; DES, drug‐eluting stent; PCI, percutaneous coronary intervention; POBA, plain old balloon angioplasty; and TLR, target‐lesion revascularization.

Figure 3. Subgroup analysis.

Forest plot for subgroup analysis. The subgroups were analyzed on TLR using an adjusted* Cox proportional hazard model. *Adjusted for inclusion year, age, sex, smoking status, diabetes, hypertension, hyperlipidemia, previous heart failure, renal failure, previous myocardial infarction, previous coronary artery bypass graft surgery, indication, number of lesions with ISR, lesion location, use of IVUS or OCT, ACC/AHA lesion classification, ISR‐type (DES‐ISR vs BMS‐ISR), number of previous stents in target lesion (single vs multiple) and time to ISR (Early ISR [<31 days] vs late ISR [31–365 days] vs very late ISR [>365 days]). ACC/AHA indicates American College of Cardiology/American Heart Association; ACS, acute coronary syndrome; BMS, bare‐metal stent; CAD, coronary artery disease; DCB, drug‐coated balloon; DES, drug‐eluting stent; ISR, in‐stent restenosis; IVUS, intravascular ultrasound; OCT, optical coherence tomography; POBA, plain old balloon angioplasty; and TLR, target lesion revascularization.

Figure 4. DES‐ISR and BMS‐ISR stratification.

Kaplan–Meier curves illustrating the event rate of (A) TLR, (B) cardiovascular death, and (C) myocardial infarction. P value of interaction was also calculated using an adjusted* Cox proportional hazard model. *Adjusted for: inclusion year, age, sex, smoking status, diabetes mellitus, hypertension, hyperlipidemia, previous heart failure, renal failure, previous myocardial infarction, previous coronary artery by‐pass graft surgery, indication, number of lesions with ISR, lesion location, use of IVUS or OCT, ACC/AHA lesion classification, ISR type (DES‐ISR vs BMS‐ISR), number of previous stents in target lesion (single vs multiple) and time to ISR (Early ISR [<31 days] vs late ISR [31–365 days] vs very late ISR [>365 days]). ACC/AHA indicates American College of Cardiology/American Heart Association; BMS, bare‐metal stent; CAD, coronary artery disease; DCB, drug‐coated balloon; DES, drug‐eluting stent; HR, hazard ratio; ISR, in‐stent restenosis; POBA, plain old balloon angioplasty; and TLR, target lesion revascularization.