A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study)

作者：Garcia Touchard Arturo^*; Goicoleal Javier; Sabate Manel; Alfonso Fernando; Ruiz Salmeron Rafael; Bethencourt Armando; Gonzalo Nieves; Miranda Faustino; Garcia del Blanco Bruno; Jimenez Mazuecos Jesus; Melgares Rafael; Martinez Romero Pedro; Maria Hernandez Garcia Jose; Lezaun Roman; Antonio Bullones Juan; Fernandez Portales Javier; Ramon Rumoroso Jose; Ortas Rosario; Valdes Mariano; Trillo Ramiro; Brugaletta Salvatore; Otzuki Shuji; Jose Hernandez Perez Francisco

来源：Eurointervention, 2017, 12(13): 1587-1594.

DOI：10.4244/EIJ-D-16-00128

• myocardial infarction
• paclitaxel-eluting balloon
• primary angioplasty
• stent
• ST-segment elevation

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. PEBSI trial (NCT 01839890)

• 出版日期2017-1