• In BOSS study, bail-out stenting in case of de novo DCB PCI is associated with higher rate of 1-year target vessel revascularization. • The observed effect on the primary endpoint is predominantly attributable to target vessel-myocardial infarction. • Patients enrolled in the study predominantly received small vessel PCI. The median reference vessel diameter was indeed 2.5 mm in both groups. • The use of imaging-guided PCI was modest, but no events related to the primary endpoint occurred in patients with BOS who received it. In BOSS study, bail-out stenting in case of de novo DCB PCI is associated with higher rate of 1-year target vessel revascularization. The observed effect on the primary endpoint is predominantly attributable to target vessel-myocardial infarction. Patients enrolled in the study predominantly received small vessel PCI. The median reference vessel diameter was indeed 2.5 mm in both groups. The use of imaging-guided PCI was modest, but no events related to the primary endpoint occurred in patients with BOS who received it. Drug-coated balloon (DCB) percutaneous coronary intervention (PCI) for de-novo lesions represents a valid alternative to drug-eluting-stents in different settings. Bail-out stenting (BOS) might be applied to manage acute vessel recoil or dissections, however, its impact on clinical endpoints remains unclear. This study sought to investigate the 1-year outcomes of BOS compared to DCB-only PCI. The present study was a multicenter, ambispective, investigator-initiated all-comer study enrolling PCI patients treated with DCB at 11 hospitals. Patients were divided into two groups: those who received DCB-only treatment and those who required BOS. Primary endpoint was 12-month target-vessel-failure (TVF) defined as a composite of target-vessel-myocardial infarction (TV-MI) and ischemia driven-target vessel revascularization (ID-TVR). The study included 1085 patients and 1236 lesions. BOS occurred in 11.1% of patients. The two study groups were well balanced in terms of clinical characteristics and angiographic features. Most of the lesions involved small vessels (median RVD 2.5 mm IQR 2.0–2.5 mm) and were classified as intermediate-high anatomical complexity (41% type B2/C). At 12-month, the occurrence of TVF was 3.2%. The primary endpoint occurred more frequently in BOS group (6.7% vs 2.8%, p -value = 0.02;), mostly due to TV-MI (4.2% vs 0.9%, p-value = 0.01). On multivariable analysis, BOS was still independently associated with the risk of the primary endpoint. (HR 2.70; 95%CI: 1.22–5.98: p-value = 0.015). After DCB-PCI the need for bail-out stenting is an independent risk factor of TVF at 1 year. Operators should anticipate BOS as a higher-risk scenario, imaging optimization may mitigate risks.
Ghetti et al. (Sun,) studied this question.
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