MUNICH — In patients with small vessels with native CAD, a drug-coated balloon was noninferior to drug-eluting stents for major adverse cardiac events, according to the BASKET-SMALL 2 trial presented at the European Society of Cardiology Congress.
Raban V. Jeger, MD, from University Hospital Basel, University of Basel, Switzerland, and colleagues conducted an open-label noninferiority trial and randomly assigned 758 patients with de novo lesions < 3 mm in diameter to receive angioplasty with a paclitaxel-coated balloon (SeQuent Please, B. Braun Medical) or a second-generation DES. BASKET-SMALL 2 was conducted at 14 centers in Austria, Germany and Switzerland. All patients were enrolled after successful predilatation, Jeger said during a press conference.
“The rationale of the study is that second-generation drug-eluting stents work very well in coronary lesions and are the preferred treatment strategy for de novo stenosis, but the efficacy of these drug-eluting stents are somewhat limited in small vessels because in-stent restenosis is quite frequent in this population,” Jeger said. “DCB are an established strategy for in-stent restenosis of bare-metal and drug-eluting stents, but we don’t know their efficacy in de novo stenosis.”
The DES group was initially implanted with a paclitaxel-eluting stent (Taxus Element, Boston Scientific), but about one-quarter of the way through enrollment, that stent was pulled from the German market because of a lawsuit, and subsequent patients in the DES group received an everolimus-eluting stent (Xience, Abbott Vascular), Jeger said during the press conference.
The primary outcome was major adverse cardiac events, defined as cardiac death, nonfatal MI and target vessel revascularization at 12 months.
The trial was designed for noninferiority. The noninferiority margin was absolute difference of 4% in major adverse cardiac events. The results were simultaneously published in The Lancet.
At 12 months, the primary outcome occurred in 7.5% of the DCB group and 7.3% of the DES group (HR = 0.97; 95% CI, 0.58-1.64). Jeger said noninferiority was proven because the 95% CI of the absolute difference in the per-protocol population (–3.83% to 3.93%) was below the predefined margin (P for noninferiority = .0217).
Cardiac death was numerically higher in the DCB group (3.1% vs. 1.3%; HR = 2.33; 95% CI, 0.82-6.61), but nonfatal MI (1.6% vs. 3.5%; HR = 0.46; 95% CI, 0.17-1.2) and target vessel revascularization (3.4% vs. 4.5%; HR = 0.75; 95% CI, 0.36-1.55) were numerically lower in the DCB group, according to the researchers.
The most common adverse events were vessel thrombosis and major bleeding, but they did not differ between the groups (vessel thrombosis: DCB, 0.8%; DES, 1.1%; HR = 0.73; 95% CI, 0.16-3.26; major bleeding: DCB, 1.1%; DES, 2.4%; HR = 0.45; 95% CI, 0.14-1.46), Jeger and colleagues found.
“Native CAD in small vessels can be treated with DCB after successful predilatation,” Jeger said. “We have the potential benefit of leaving behind an intact vessel without a stent. Therefore, no prolonged antiplatelet therapy is necessary; only 4 weeks of dual antiplatelet therapy. We expect a reduced number of late events in the DCB group because they don’t have stents so they won’t get in-stent restenosis or stent thrombosis, but we will need long-term results to prove this hypothesis.”
“The investigators should be commended for doing this study because, in daily practice, at least 30% of PCI involve small coronary vessels. It is also not easy to recruit patients for a trial like this one, especially when the interventional cardiology community’s predominant practice is to stent,” Hee Hwa Ho, MBBS, and Paul Jau Lueng Ong, MB BChir, both from the department of cardiology at Tan Tock Seng Hospital, Singapore, wrote in a related editorial in The Lancet. “This finding supports the use of DCB beyond in-stent restenosis (ie, in small native coronary artery disease).” – by Erik Swain
Jeger RV, et al. Hot Line Session 4. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.
Ho HH, et al. Lancet. 2018;doi:10.1016/S0140-6736(18)31926-3.
Jeger RV, et al. Lancet. 2018;doi:10.1016/S0140-6736(18)31719-7.
Disclosure: The study was funded in part by B. Braun Medical. Jeger reports he has received lecture honoraria and travel support from B. Braun Medical. Ho and Ong report no relevant financial disclosures. Please see the full study for a list of the other authors’ relevant financial disclosures.