Drug-coated balloon versus bare-metal stent for the treatment of symptomatic vertebral artery origin stenosis: a systematic review and meta-analysis.

BACKGROUND

Symptomatic vertebral artery origin stenosis (VAOS) is associated with high recurrent stroke risk despite medical therapy. While bare-metal stents (BMS) are established for endovascular treatment, in-stent restenosis remains common. Drug-coated balloons (DCB) offer a stent-free alternative, but comparative effectiveness is uncertain.

METHODS

We searched PubMed, Embase, the Cochrane Library, Web of Science, and Scopus for comparative studies of DCB vs. BMS in symptomatic VAOS. The primary outcome was imaging-confirmed restenosis; secondary outcomes included symptomatic restenosis, technical success, periprocedural complications, and follow-up cerebrovascular events. Subgroup (study type, VAOS severity, imaging modality: digital subtraction angiography [DSA]-based vs. non-DSA-based) and sensitivity analyses were performed.

RESULTS

Four studies (2 randomized controlled trials [RCTs], 2 cohort studies) involving 329 patients (165 DCB, 164 BMS) were included. DCB significantly reduced imaging-confirmed restenosis (risk ratio [RR] = 0.45; 95% confidence interval [CI]: 0.27-0.73), with benefits in RCTs (RR = 0.44, 95% CI: 0.25-0.77), severe VAOS (≥ 70%; RR = 0.39, 95% CI: 0.22-0.70), and DSA-based follow-up (RR = 0.36, 95% CI: 0.19-0.68). No between-group differences were observed in secondary outcomes. Sensitivity analysis indicated that the primary result was highly influenced by the largest RCT, with limited robustness.

CONCLUSIONS

In this hypothesis-generating meta-analysis, DCB is associated with lower rates of imaging-confirmed restenosis than BMS in symptomatic VAOS, with comparable safety. These are preliminary findings limited to four small-sample studies from a single country and should not be used to guide routine clinical selection. Large, multicenter, long-term follow-up RCTs are required to confirm these results.