Drug-coated balloon (DCB) coronary angioplasty without stent implantation has become a well-established alternative in several clinical scenarios, particularly in patients at high bleeding risk or when avoiding a permanent metallic implant is desirable. One of its main advantages is the possibility of shortening the duration of dual antiplatelet therapy (DAPT); however, the safety of extremely short regimens (≤30 days) remains a matter of debate.
The aim of this study was to evaluate whether a DAPT strategy of ≤30 days following DCB angioplasty, performed after optimal lesion preparation, was associated with an increased risk of major adverse cardiovascular events (MACE) at 1 year.
The primary endpoint was the incidence of 1-year MACE, defined as the composite of cardiovascular death, myocardial infarction, and target lesion revascularization (TLR). Patients treated with short-duration DAPT (≤30 days) were compared with those receiving standard-duration DAPT (>30 days).
A total of 337 patients who underwent stentless DCB coronary angioplasty at Kakogawa Central City Hospital (Hyogo, Japan) between April 2021 and December 2024 were included after excluding those receiving oral anticoagulation. Of these, 153 patients (45.2%) received DAPT for ≤30 days, while 184 (54.8%) received DAPT for >30 days.
All procedures were guided by intravascular imaging (IVUS or OCT), and the stentless strategy was adopted only when optimal lesion preparation was achieved, defined as TIMI 3 flow, residual stenosis ≤30%, and the absence of flow-limiting dissection.
The antiplatelet regimen consisted of aspirin 100 mg/day plus prasugrel 3.75 mg/day, followed by single antiplatelet therapy (aspirin or prasugrel, at the operator’s discretion) after DAPT discontinuation. The short-DAPT group had a higher prevalence of hemodialysis (13.1% vs. 6.5%; p=0.04), lower hemoglobin levels (p=0.0008), and more frequent use of plaque-modification devices (rotational, orbital, directional, or laser atherectomy) (73.9% vs. 50.0%; p<0.0001), whereas acute coronary syndrome was more common in the standard-DAPT group (41.3% vs. 29.4%; p=0.02).
At 1-year follow-up, MACE occurred in 5.9% of patients in the short-DAPT group versus 6.5% in the standard-DAPT group (OR 0.90; 95% CI: 0.37–2.19; p=0.81). No significant differences were observed in the incidence of TLR (5.2% vs. 5.4%), myocardial infarction (0% in both groups), or cardiovascular death (0.7% vs. 1.1%). After propensity score adjustment, the findings remained consistent, with no association between DAPT ≤30 days and an increased risk of 1-year MACE. Likewise, Kaplan-Meier curves showed no significant differences between the two strategies (log-rank p=0.78).
Conclusion: DAPT ≤30 Days After DCB Angioplasty Did Not Increase 1-Year MACE
In patients undergoing drug-coated balloon coronary angioplasty without stent implantation after optimal lesion preparation, a dual antiplatelet therapy strategy of ≤30 days was not associated with an increased risk of major adverse cardiovascular events at 1 year.
