Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings.
Percutaneous intervention for coronary bifurcation lesions has been associated with increased clinical complication rates compared with nonbifurcation lesions, primarily as a result of restenosis. Therefore, there is a need for new techniques. The purpose of this study was to evaluate a new drug-eluting stent and implantation technique for the treatment of de novo coronary bifurcation lesions. The Axxess Plus trial was a prospective multicenter single-arm study that enrolled 139 patients. Each patient received a self-expanding, conically shaped nickel-titanium Axxess Plus biolimus A9-eluting stent at the level of the carina. Depending on the lesion anatomy, additional nonstudy stents were placed distally if necessary. Clinical and angiographic follow-up were scheduled at 6 months after the procedure. The overall rate of target lesion revascularization was 7.5% at 6 months. A mean of 2.4 stents were implanted per patient; 51.2% of patients received a stent to the side branch, 29.4% received balloon angioplasty only, and 20.6% of side branches were not treated. In-stent late loss in the Axxess stents was 0.09 mm. Incidences of angiographic in-stent restenosis were 7.1% in the parent vessel stents and 9.2% in the group receiving stents in the side branch (7.9% excluding bare metal stents placed distal to the Axxess stent), compared with 25% for balloon angioplasty treatment and 12% for no treatment. Late stent thrombosis was observed in 3 cases, 2 of which were associated with confirmed premature cessation of antiplatelet therapy. In conclusion, the Axxess Plus conical stent effectively treats bifurcation lesions alone or in conjunction with other drug-eluting stents.
Grube
Eberhard
E
HELIOS Heart Center, Siegburg, Germany. grubee@aol.com
Buellesfeld
Lutz
L
Neumann
Franz J
FJ
Verheye
Stefan
S
Abizaid
Alexandre
A
McClean
Dougal
D
Mueller
Ralf
R
Lansky
Alexandra
A
Mehran
Roxana
R
Costa
Ricardo
R
Gerckens
Ulrich
U
Trauthen
Brett
B
Fitzgerald
Peter J
PJ
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000601:surgery; D003331:Coronary Vessels / Q000033:anatomy & histology / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015607:Stents
D000903:Antibiotics, Antineoplastic; C518022:umirolimus; D020123:Sirolimus