Drug-coated balloon noninferior to DES for small CAD lesions
Drug-coated balloons (DCB) are noninferior to drug-eluting stents (DES) for the management of small native coronary artery disease (CAD), according to results of the BASKET-SMALL 2 trial presented at the European Society of Cardiology (ESC) Congress 2018.
In the multicentre, open-label, noninferiority trial, patients with de novo coronary artery lesions smaller than 3 mm in diameter who underwent with percutaneous coronary intervention (PCI) with DCB implantation had similar rates of major adverse cardiac events (MACE; cardiac death, nonfatal MI, and target vessel revascularization) compared with those who underwent PCI with implantation of second-generation DES. [Lancet 2018, doi: 10.1016/S0140-6736(18)31719-7]
“At 1 year, the rate of MACE was 7.5 percent in 382 patients who received the paclitaxel-iopromide-coated DCB compared with 7.3 percent in 376 patients who received the everolimus-eluting or paclitaxel-eluting stent, with a hazard ratio [HR] of 0.97 [95 percent confidence interval (CI), 0.58 to 1.64; p=0.9180],” reported investigator Professor Raban Jeger of the University Hospital Basel, Switzerland.
Rates of cardiac death (3.1 percent vs 1.3 percent for DCB vs DES; HR, 2.33; 95 percent CI, 0.82 to 6.61; p=0.1131), nonfatal MI (1.6 percent vs 3.5 percent; HR, 0.46; 95 percent CI, 0.17 to 1.20; p=0.1123), and target vessel revascularization (3.4 percent vs 4.5 percent; HR, 0.75; 95 percent CI, 0.36 to 1.55; p=0.4375) were also not significantly different between the groups.
In the study, conducted at 14 centres in an all-comer population, patients were randomized to receive angioplasty with DCB or second-generation DES after successful predilatation only (no flow-limiting dissections, no residual stenosis >30 percent). Dual antiplatelet therapy (DAPT) was given according to current guidelines.
According to the investigators, rigorous lesion preparation as per established recommendations was mandatory before DCB use to achieve an acceptable angiographic result and avoid complications.
The most common adverse events reported in the study were probable or definite stent thrombosis (0.8 percent in the DCB group vs 1.1 percent in the DES group; HR, 0.73; 95 percent CI, 0.16 to 3.26) and major bleeding (1.1 percent vs 2.4 percent; HR, 0.45; 95 percent CI, 0.14 to 1.46).
The rates of cardiac mortality (3.1 percent in the DCB group vs 1.3 percent in the DES group; HR, 2.33; 95 percent CI, 0.82 to 6.61; p=0.1131), nonfatal MI (1.6 percent vs 3.5 percent; HR, 0.46; 95 percent CI, 0.17 to 1.20; p=0.1123), and target vessel revascularization (3.4 percent vs 4.5 percent; HR, 0.75; 95 percent CI, 0.36 to 1.55; p=0.4375) did not differ significantly between the two groups.
“Although second-generation DES are the standard treatment for CAD, their efficacy in small vessels is limited due to increased rates of in-stent restenosis,” explained Jeger. “DCB are an established treatment option for in-stent restenosis of both bare metal stents and DES. Potential benefits of its use include the absence of thrombotic events, and the possibility of shortening DAPT duration if bail-out stenting is not necessary.”
“Our findings suggest that small native CAD may safely be treated with DCB after successful predilatation,” he concluded. “Because no permanent material is implanted in the coronary artery, a reduced number of very late adverse events can be expected, but long-term follow up is needed.”