Is DCB angioplasty better than stenting for de novo CAD?

Drug-coated balloon (DCB) angioplasty with rescue stenting in patients with de novo coronary artery disease (CAD) results in a higher rate of device-oriented composite endpoint (DoCE) than intended drug-eluting stent (DES) implantation at 3 years, reports a study.

DoCE, the primary outcome, included cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR) assessed in the intention-to-treat population.

This open-label, randomized, noninferiority trial was conducted across 43 sites in China and included 2,272 patients with de novo CAD. After successful lesion predilatation, participants were randomized to paclitaxel-coated balloon angioplasty with the option of rescue stenting (DCB arm; n=1,133) or intended upfront deployment of second-generation thin-strut sirolimus-eluting stents (DES arm; n=1,139).

The median diameter of devices was 3.00 mm. Rescue DES implantation following an unsatisfactory DCB angioplasty was done in 106 patients (9.4 percent).

DoCE occurred in 92 patients (8.2 percent) in the DCB arm and 56 (5.0 percent) in the DES arm (difference, 3.21 percent, 95 percent confidence interval [CI], 1.17–5.26; p=0.002) at 3 years.

In landmark analyses, the rate of difference in DoCE was 1.69 percent (95 percent CI, 0.32–3.06) at 0 to 1 year, 1.10 percent (95 percent CI, –0.13 to 2.32) at 1 to 2 years, and 0.58 percent (95 percent CI, –0.51 to 1.66) at 2 to 3 years (p_trend=0.023).

“The extended follow-up is ongoing and will continue for up to 10 years,” the authors said.