Intracoronary beta-irradiation prevents excessive in-stent neointimal proliferation in de novo lesions of patients with high plasma ACE levels. The BetAce randomized trial.
BACKGROUND
This study evaluated vascular brachytherapy (VBT) as a potent antiproliferative treatment to prevent in-stent restenosis (ISR) after coronary angioplasty of de novo lesions in patients carrying the D allele of the I/D polymorphism of the ACE gene and high ACE plasma levels (>34 U/l).


METHODS
A prospective randomized trial was designed to detect a 30% improvement in the minimal lumen diameter (MLD) of the stenotic artery, as measured by quantitative coronary analysis (QCA), 6 months following VBT at the time of stented angioplasty. All patients were carriers of the D allele of the ACE gene, with plasma ACE levels >34 U/l.


RESULTS
Thirty-one patients (33 stenoses) were allocated to stent implantation (control group) and 30 patients (31 stenoses) to VBT and stented angioplasty. After angioplasty, in-stent MLD was similar in the two groups. At 6 months in the control group, in-stent MLD had decreased to 1.74+/-0.8 versus 2.25+/-1.05 mm in the VBT group (P=.04). The mean in-stent diameter was 2.3+/-0.8 mm in the control group versus 2.9+/-1.05 mm after VBT (P=.02), and the restenosis rate was 37.5% versus 17.9%, respectively (P=.08). At 6 months, a higher need for target vessel revascularization (TVR) was observed in the control group: 35.5% versus 13.3% (P=.04).


CONCLUSIONS
This randomized study confirms that patients with high plasma ACE concentrations are exposed to an increased risk for ISR after coronary stenting. The preventive use of VBT in these patients reduced neointimal formation by 65% such that the MLD at follow-up was increased by 29% compared with the control group.
Ribichini
Flavio
F
Division of Cardiology, Università del Piemonte Orientale, Ospedale Maggiore della Carita', Novara, Italy. flavio.ribichini@med.unipmn.it
Ferrero
Valeria
V
Piessens
Marleen
M
Heyndrickx
Guy R
GR
de Bruyne
Bernard
B
Verbeke
Luc
L
Matullo
Giuseppe
G
Büchi
Martin
M
Piazza
Alberto
A
Guarrera
Simonetta
S
Lüscher
Thomas F
TF
Wijns
William
W
D000483:Alleles; D017130:Angioplasty / Q000379:methods; D001610:Beta Particles / Q000627:therapeutic use; D001918:Brachytherapy / Q000379:methods*; D003131:Combined Modality Therapy; D003324:Coronary Artery Disease / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D006083:Graft Occlusion, Vascular / Q000235:genetics / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D007703:Peptidyl-Dipeptidase A / Q000097:blood* / Q000235:genetics; D011110:Polymorphism, Genetic / Q000502:physiology; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D015607:Stents; D017539:Tunica Intima / Q000503:physiopathology / Q000528:radiation effects*; D014654:Vascular Patency / Q000528:radiation effects
D007703:Peptidyl-Dipeptidase A