Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.
The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.
Abizaid
Alexandre
A
Instituto Dante Pazzanese de Cardiologia, Saõ Paulo, Brazil.
Lansky
Alexandra J
AJ
Fitzgerald
Peter J
PJ
Tanajura
Luis Fernando
LF
Feres
Fausto
F
Staico
Rodolfo
R
Mattos
Luiz
L
Abizaid
Andrea
A
Chaves
Aurea
A
Centemero
Marinella
M
Sousa
Amanda G M R
AG
Sousa
J Eduardo
JE
Zaugg
Margo J
MJ
Schwartz
Lewis B
LB
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D019917:Blood Vessel Prosthesis Implantation; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D017023:Coronary Angiography; D003326:Coronary Circulation; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010767:Phosphorylcholine / Q000627:therapeutic use*; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000503:physiopathology; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D010767:Phosphorylcholine; C489443:zotarolimus; D020123:Sirolimus