Key result
Agent paclitaxel-coated balloon yields ~6% 1-year MACE, with higher event rates in in-stent restenosis.
Why the study?
The Agent paclitaxel-coated balloon is a new DCB with few available real-world data regarding its safety and efficacy during PCI across different coronary lesion types.
What is the real-world safety and efficacy of the Agent paclitaxel-coated balloon during percutaneous coronary intervention across different coronary lesion types?
Cohort (n=354)
Yes
What is the real-world safety and efficacy of the Agent paclitaxel-coated balloon during percutaneous coronary intervention across different coronary lesion types?
In a real-world multicenter Italian registry, the Agent paclitaxel-coated balloon demonstrated high procedural lesion success (92%) and a low 1-year MACE rate (5.7%) across diverse coronary lesion types, though event rates were higher in in-stent restenosis compared to small-vessel disease.
Answers are grounded in this paper and cite their sources.
Adds early registry data on Agent DCB across lesions; leaves open its role in PCI pending randomized trials.
BACKGROUND: The Agent paclitaxel-coated balloon is a new drug-coated balloon (DCB) with few available real-world data. Our study sought to assess the safety and efficacy of the Agent DCB during percutaneous coronary intervention (PCI) in different coronary lesion types in a prospective registry. METHODS AND RESULTS: All patients undergoing PCI with the Agent DCB at three Italian centers between September 2014 and March 2018 were included in this registry. Major adverse cardiac event (MACE) rate was defined as the composite of cardiac death, recurrent non-fatal myocardial infarction (MI), and target-lesion revascularization (TLR). Procedural success was also evaluated. Among the 354 patients included in the registry (450 lesions treated with 508 DCBs), Agent DCBs were used for the treatment of in-stent restenosis (ISR) in 34%, small-vessel disease (SVD) in 29%, bifurcation lesions in 26%, and "stent-like result" (SLR) lesions obtained after balloon predilation in 11%. The implantation of Agent DCBs was safe and had a high DCB lesion success rate of 92%. One-year MACE rate was 5.7% in the overall population. A higher MACE rate was observed in the ISR group (8.3%) vs the SVD group (3.6%; P=.03), with a trend toward higher event rates vs both BL (3.7%; P=.09) and SLR patients (5.5%; P=.54). CONCLUSIONS: The use of Agent DCBs during PCI appears safe and effective in a large real-world registry. These results were maintained in all subgroups, with a slightly higher trend of events rates in the ISR setting, consistent with the higher-risk nature of this patient subset.
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Iannopollo et al. (2020) conducted a cohort in Coronary artery lesions (in-stent restenosis, small-vessel disease, bifurcation lesions, and stent-like result lesions) (n=354). Agent paclitaxel-coated balloon during PCI was evaluated on 1-year major adverse cardiac events (MACE: composite of cardiac death, recurrent non-fatal myocardial infarction, and target-lesion revascularization). PCI with the Agent paclitaxel-coated balloon achieved a 92% lesion success rate and a 5.7% 1-year MACE rate, with higher MACE in in-stent restenosis vs small-vessel disease (8.3% vs 3.6%; P=.03).