Ayman Ahmed Gad, Mohamed Mohamed Ahmed Kamal Hal, Moustafa Ebrahim Mokarrab, Mohamed Adel Attia, Khaled Abouelmagd, Waseem Omar Ahmed
In patients with isolated Medina 0.0.1 bifurcation lesions, a DCB strategy following successful lesion preparation was associated with favorable angiographic and clinical outcomes at 1 year compared with a stenting strategy, including lower late lumen loss, reduced angiographic restenosis and repeat revascularization, and a lower incidence of MACE, driven primarily by fewer repeat revascularization events. However, because treatment allocation was largely determined by predilation response, these findings did not establish the comparative superiority of DCB over DES.
BACKGROUND: The optimal treatment for isolated side-branch coronary bifurcation lesions (Medina 0.0.1) remains debated. Drug-coated balloons (DCB) offer a "leave-nothing-behind" alternative to drug-eluting stents (DES), but comparative data for this specific lesion subset is limited.
AIMS: This study aimed to compare the 1-year clinical and angiographic outcomes of a DCB strategy versus a contemporary stenting strategy for Medina 0.0.1 lesions.
METHODS: This prospective, observational cohort study enrolled 161 patients with symptomatic ischemic heart disease and de novo Medina 0.0.1 bifurcation lesions. Patients were allocated to either a stenting strategy (Group A, n = 80) or a DCB strategy (Group B, n = 81) based on operator judgment. The primary endpoints were absolute late lumen loss (LLL), binary restenosis, target vessel revascularization (TVR), and a five-point composite of major adverse cardiac events (MACE) at 1-year follow-up.
RESULTS: Baseline characteristics were comparable between the two groups. At 1 year, the mean late lumen loss (LLL) was significantly lower in the DCB group compared with the stenting group (0.16 ± 0.12 mm vs. 0.48 ± 0.22 mm; p < 0.001). The DCB group demonstrated a significantly lower rate of binary restenosis compared with the stenting group (7.4% vs. 21.3%; RR 0.35, 95% CI 0.15-0.82; p = 0.014; ARR 13.9%; NNT 7). TVR was significantly reduced in the DCB group (4.9% vs. 15.0%; RR 0.33, 95% CI 0.11-0.96; p = 0.038; ARR 10.1%; NNT 10). The incidence of MACE was also markedly lower in the DCB group (7.4% vs. 18.7%; RR 0.40, 95% CI 0.17-0.93; p = 0.043; ARR 11.3%; NNT 9), primarily attributed to the reduction in TVR.
CONCLUSION: In patients with isolated Medina 0.0.1 bifurcation lesions, a DCB strategy following successful lesion preparation was associated with favorable angiographic and clinical outcomes at 1 year compared with a stenting strategy, including lower late lumen loss, reduced angiographic restenosis and repeat revascularization, and a lower incidence of MACE, driven primarily by fewer repeat revascularization events. However, because treatment allocation was largely determined by predilation response, these findings did not establish the comparative superiority of DCB over DES.