Key result
Paclitaxel-eluting balloon treatment after bare metal stent implantation significantly reduced median in-stent late luminal loss at 9 months compared to BMS alone (0.31 mm vs 0.80 mm; P<0.0001).
Why the study?
Does paclitaxel-eluting balloon treatment after bare metal stent implantation reduce in-stent late luminal loss in patients with ST-elevation myocardial infarction undergoing primary angioplasty?
RCT (n=223)
1:1
Does paclitaxel-eluting balloon treatment after bare metal stent implantation reduce in-stent late luminal loss in patients with ST-elevation myocardial infarction undergoing primary angioplasty?
Absolute Event Rate: 0.31% vs 0.8%
p-value: p=<0.0001
Using a paclitaxel-eluting balloon after bare metal stent implantation in STEMI significantly reduces late luminal loss and improves 1-year clinical outcomes compared to BMS alone.
Supports paclitaxel-eluting balloon after BMS in STEMI primary PCI; extends randomized evidence for reduced restenosis and MACE.
AIMS: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. METHODS AND RESULTS: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100±0.0% vs. 99.52±1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016). CONCLUSIONS: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts.
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García‐Touchard et al. (2017) conducted an RCT in ST-elevation myocardial infarction (n=223). Paclitaxel-eluting balloon (PTX-B) vs. Bare metal stent (BMS) only was evaluated on In-stent late luminal loss (LLL) at nine-month follow-up (p=<0.0001). Paclitaxel-eluting balloon treatment after bare metal stent implantation significantly reduced median in-stent late luminal loss at 9 months compared to BMS alone (0.31 mm vs 0.80 mm; P<0.0001).
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