In patients undergoing PCI for de novo small-vessel coronary artery disease (SV-CAD), paclitaxel-coated balloon (PCB) angioplasty was associated with a reduction in the primary endpoint of major adverse cardiac events (MACE) and a nonsignificant difference in target lesion failure (TLF) compared to drug-eluting stent (DES) implantation at three years, according to a new individual patient-data meta-analysis published in the European Heart Journal.

In the investigator-initiated ANDROMEDA study, Simone Fezzi, MD, et al., compared data on MACE, defined as all-cause mortality, myocardial infarction, target lesion thrombosis and target vessel revascularization, and other outcomes from 1,154 patients with 1,360 lesions from three trials: BELLO, BASKET-SMALL 2 and PICCOLETO II. Baseline clinical characteristics were similar between PCB and DES arms, except that patients assigned PCB were generally younger at the time of PCI.

Results showed that 103 MACE events occurred in 582 of the patients in the PCB angioplasty arm vs. 132 MACE events in the 572 patients in the DES arm in the one-stage analysis (18.5% vs. 24.5%; hazard ratio [HR], 0.67; 95% CI, 0.47-0.96; p=0.027. The difference remained significant after multivariable adjustment (HR, 0.75; 95% CI, 0.58-0.96; p=0.22), driven by a lower risk of myocardial infarction (4.7% vs. 7.8%) and target vessel revascularization (11.1% vs. 15.6%).

However, two-stage analysis, where individual trial estimates were computed using Cox proportional hazards regression and pooled using random-effects models, did not show a statistically significant difference (HR, 0.67; 95% CI, 0.43-1.04; p=0.074).

On TLF outcomes, investigators added reconstructed time-to-event information from a fourth trial, RESTORE SVD China, for a study population of 1,384 patients with 1,590 lesions.

TLF occurred in 13.2% of the PCB arm and 15.5% of the DES arm, a nonsignificant difference in both one- and two-stage models (one stage: HR, 0.87; 95% CI, 0.63-1.20; p=0.401; two stage: HR, 0.85; 95% CI, 0.60-1.19; p=0.347).

Comparison between PCB and second-generation DES alone did not reveal any significant differences at three years (HR, 1.03; 95% CI, 0.70-1.50).

"Despite substantial advances in stent technologies and procedural optimization, patients undergoing PCI with second-generation DES for SV-CAD continue to exhibit a one-year risk of TLF almost two-fold higher than those treated for lesions in coronary artery segments with larger diameter," write the investigators. "Against this background, the ANDROMEDA study strengthens previous evidence on SV-CAD by showing in the primary analysis a relative risk reduction in three-year MACE of up to 33% in patients treated with PCB compared with those treated with DES."