DCB remains noninferior to DES at 3 years for PCI in small coronary vessels
At 3 years, a paclitaxel-coated balloon was noninferior to drug-eluting stents for treatment of CAD in patients with small coronary vessels, according to new data from the BASKET-SMALL 2 trial.
As Healio previously reported, the drug-coated balloon (SeQuent Please, B. Braun Medical) was noninferior to DES for MACE at 1 year in 758 patients with de novo lesions in coronary vessels < 3 mm in diameter.
“The study shows the maintained efficacy and safety of DCBs in de novo lesions of small coronary vessels up to 3 years, without any evidence of increased all-cause or cardiac mortality in patients treated with DCBs,” Raban V. Jeger, MD, interventional cardiologist at the University Hospital Basel in Basel, Switzerland, and colleagues wrote in The Lancet.
For this randomized, open label, noninferiority trial, investigators assigned 382 patients in Germany, Switzerland and Austria to receive treatment for with de-novo small vessel disease with the DCB and 376 to be treated with a second-generation DES. Patients were followed over 3 years and evaluated for the composite outcome of MACE, defined as cardiac death, nonfatal MI and target vessel revascularization. Additional outcomes included all-cause death, probable or definite stent thrombosis and major bleeding.
The protocol called for patients to receive dual antiplatelet therapy for 1 month after therapy with the DCB and for 6 months if they were treated with a DES and were stable to 12 months if they were treated with a DES and had ACS.
The researchers reported the estimated of the rate of MACE was 15% among both groups (HR = 0.99; 95% CI, 0.68-1.45).
The groups were also similar regarding the individual components of MACE:
- cardiac death (5% vs. 4%; HR = 1.29; 95% CI 0.63-2.66);
- nonfatal MI (6% for both; HR = 0.82; 95% CI, 0.45-1.51); and
- target vessel revascularization (9% for both; HR = 0.95; 95% CI, 0.58-1.56).
The incidence of all-cause death was also similar between the groups (8% for both; HR = 1.05, 95% CI, 0.62-1.77).
Patients in the DCB group experienced lower estimated rates of probable or definite stent thrombosis (1% vs. 2%; HR = 0.33, 95% CI, 0.07-1.64) and major bleeding (2% vs. 4%; HR = 0.43; 95% CI 0.17-1.13) compared with those who received a DES, but the finding was not statistically significant.
“A stent-free treatment of small coronary artery disease using DCB shows a maintained long-term efficacy and safety profile without increased mortality but numerically lower rates of stent thrombosis and major bleeding,” the researchers wrote. “Therefore, the use of DCB for this indication might be a safe alternative to DES.”