Drug-coated balloons match stents in coronary disease

Clinical takeaway: Drug-coated balloon (DCB) angioplasty achieved rates of cardiovascular death and myocardial infarction comparable to drug-eluting stents (DES) across randomized trials of de novo coronary artery disease, supporting a "leave nothing behind" strategy in selected patients while longer-term evidence continues to mature.

Drug-eluting stents remain the standard PCI treatment for most de novo coronary lesions, but they leave a permanent metal implant that can complicate future interventions and carry long-term device-related risks. Drug-coated balloons deliver antiproliferative therapy and are then removed, raising the possibility that some patients could achieve similar outcomes without a permanent coronary implant.

In a systematic review and meta-analysis published in eClinicalMedicine, investigators pooled data from 10 randomized controlled trials involving 7,832 patients treated for de novo coronary artery disease. Four trials focused exclusively on small-vessel disease, while others enrolled broader coronary populations, including acute coronary syndrome patients and those with larger vessels. Follow-up ranged from 1 to 5 years.

Across all studies, DCB and DES strategies produced nearly identical rates of cardiovascular death and myocardial infarction. These findings held even after investigators excluded studies limited to small coronary vessels, suggesting similar protection against the most clinically important outcomes across a broader range of lesion types.

Repeat revascularization told a more nuanced story. Overall, rates were not significantly different between treatment approaches. However, when trials restricted to small vessels were excluded, patients treated with DCBs were about 80% more likely to undergo a repeat procedure. Investigators noted substantial variation among studies, and the signal was heavily influenced by one large trial. The excess risk also appeared less evident in studies with follow-up extending beyond 24 months.

A separate safety analysis found no significant difference in treated-lesion thrombosis, with results numerically favoring DCBs.

"Our work shows that there is no meaningful difference between these two treatments when it came to the most serious outcomes," lead author Dr Natasha Corballis said. "Rates of heart attack were also virtually identical between the two groups."

Source: Corballis N, et al. (2026 Oct 15) eClinicalMedicine. Drug coated balloons versus drug eluting stents for de novo coronary artery disease: a systematic review and meta-analysis of randomised controlled trials