Objectives: We sought to understand the clinical outcomes of dissections left untreated after sirolimus drug-coated balloon (DCB) angioplasty.
Background: DCB may be a valuable alternative to stents for the treatment of native coronary lesions, but the risk of having a dissection after DCB-angioplasty is not negligible. While type A and B dissections can be safely treated conservatively, some debate exists regarding type C dissections. We previously showed the safety of dissections left untreated after second-generation paclitaxel-DCB. However, the fate of dissections after sirolimus-DCB angioplasty has not been investigated so far.
Methods: EASTBOURNE is a prospective, multicenter, international, investigator-driven study aiming to explore the safety and efficacy of a novel sirolimus-DCB. This study enrolled a consecutive, all-comer population of coronary artery disease patients and is the largest prospective study on DCB so far. Primary endpoints of the study, target-lesion revascularization (TLR), and other clinical endpoints at 12 months, have been presented elsewhere. This is a prespecified subgroup analysis of the patients left with not-flow limiting dissection after DCB angioplasty, with complete 12 months follow-up and comparison between patients left with a dissection versus patients with DCB used for de novo lesions.
Results: Between September 2016 and November 2020, a total of 2123 patients were enrolled at 38 study centers. Seventy-three patients were left with nonflow limiting dissections (43 type A, 27 type B, 3 type C) and underwent complete 1-year clinical follow-up. In the nondissection group, 1110 patients had de-novo coronary artery disease while 900 had in-stent restenosis. Baseline characteristics were similar between the groups, while the dissection group was associated with longer lesions (23.8 vs. 18.4 mm, p < 0.001) and more frequent use of predilation (100 vs. 91.4%, p = 0.016). At 12-month follow-up, no significant differences among the groups were found, with a total of 1.25% TLR in the dissection cohort versus 5.6% in the de-novo cohort (p = 0.13), and an overall rate of major adverse cardiovascular events of 4.4% versus 10.1% (p = 0.18). Total death (1.5 vs. 2.6, p = 0.87), cardiac death, myocardial infarction (0% vs. 2.5%, p = 0.35), and bleedings did not differ significantly among the groups as well.
Conclusions: In this subgroup analysis of the EASTBOURNE study of consecutive patients treated with new-generation sirolimus DCB, dissections left untreated after angioplasty did not lead to an increase in adverse events.
Keywords: EASTBOURNE registry; bailout stenting; drug-coated balloon; residual dissection.
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