DCB may be noninferior to DES in setting of small-vessel CAD, regardless of PCI indication
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According to a prespecified analysis of the BASKET-SMALL 2 trial, reperfusion with a drug-coated balloon in patients with CAD and small vessels may be noninferior to a drug-eluting stent, regardless of the indication for PCI.
“PCI is the preferred reperfusion strategy in patients presenting with ACS with latest-generation DES recommended irrespective of patient- and lesion-related characteristics. However, DCBs have emerged as a viable alternative for specific patient subgroups including in-stent restenosis, high bleeding risk, and small vessel CAD,” Norman Mangner, MD, of the department of internal medicine and cardiology at Herzzentrum Dresden–Technische Universität Dresden in Germany, and colleagues wrote. “This study provides the opportunity to examine the clinical outcome of patients treated by DCB vs. DES in the setting of an ACS compared with patients receiving this treatment for a chronic coronary syndrome, which was a prespecified analysis of the BASKET-SMALL 2 trial.”
BASKET-SMALL 2
The BASKET-SMALL 2 trial was an multicenter, open-label, noninferiority trial for which researchers enrolled 758 patients with de novo lesions of less than 3 mm in diameter and randomly assigned them to angioplasty with a paclitaxel-coated balloon (SeQuent Please, B. Braun Medical) or a second-generation DES.
As Healio previously reported, among patients with small vessels and native CAD, a DCB was found to be noninferior to a DES for the primary outcome of MACE, defined as cardiac death, nonfatal MI and target vessel revascularization at 12 months.
For this prespecified analysis of the BASKET-SMALL 2 trial, published in Circulation: Cardiovascular Interventions, researchers evaluated the impact of clinical presentation on 1-year and 3-year outcomes in patients who underwent treatment with DCB or DES for ACS or chronic coronary syndrome.
DCB vs. DES stratified by PCI indication
Among 758 patients, 28.2% presented with ACS.
Researchers reported no significant difference between DCB compared with a DES for the incidence of the primary endpoint in patients with ACS (HR = 0.5; 95% CI, 0.19-1.26) or chronic coronary syndrome (HR = 1.29; 95% CI, 0.67-2.47), and reported no significant interaction between clinical presentation and treatment effect (P for interaction = .088).
However, researchers observed an interaction between clinical presentation and treatment and secondary outcomes at 1 year, with lower rates of cardiac death (P for interaction = .049) and nonfatal MI (P for interaction = .01) among patients with ACS treated with DCB.
According to the study, there were similar rates of MACE throughout across clinical presentation and treatment groups at 3 years, with no significant interaction between clinical presentation and treatment (P for interaction = .301).
Moreover, risk for all-cause death was higher among patients who presented with ACS compared with those with chronic coronary syndromes at 1 year (HR = 2.59; 95% CI, 1.13-5.91) and numerically higher at 3 years (HR = 1.71; 95% CI, 0.96-3.06); however, researchers observed no difference in all-cause death between patients treated with a DCB compared with a DES, regardless of clinical presentation.
“In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for PCI (ACS vs. chronic coronary syndrome) and treatment effect of DCB vs. DES in patients with small-vessel CAD,” the researchers wrote. “The results for the combined endpoint and its components must be interpreted as hypothesis-generating, and further studies in larger cohorts of ACS patients are required before definite conclusions can be drawn.”
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