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


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.
Hospital Universitario Puerta De Hierro, Majadahonda, Spain.
Arturo
A
García-Touchard
Javier
J
Goicolea
Manel
M
Sabaté
Fernando
F
Alfonso
Rafael
R
Ruiz-Salmerón
Armando
A
Bethencourt
Nieves
N
Gonzalo
Faustino
F
Miranda
Bruno
B
García Del Blanco
Jesús
J
Jiménez-Mazuecos
Rafael
R
Melgares
Pedro
P
Martínez-Romero
Jose María
JM
Hernandez-García
Román
R
Lezaún
Juan Antonio
JA
Bullones
Javier
J
Fernández-Portales
Jose Ramón
JR
Rumoroso
Rosario
R
Ortas
Mariano
M
Valdés
Ramiro
R
Trillo
Salvatore
S
Brugaletta
Shuji
S
Otzuki
F J
FJ
Hernández Pérez
Luis
L
Alonso-Pulpón
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D017239:Paclitaxel / Q000627:therapeutic use*; D020123:Sirolimus / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D008670:Metals; D017239:Paclitaxel; D020123:Sirolimus