Low-profile stent system for treatment of atherosclerotic renal artery stenosis: the GREAT trial.
OBJECTIVE
The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly analyzed by a Core Lab.


METHODS
Fifty-two consecutive patients (mean age, 63.7 years) were successfully treated with the Palmaz Genesis Peripheral Stent (Cordis, Miami, FL) on the Slalom 0.018-inch Delivery System (Cordis Europe N.V., Oosteinde 8, NLO-9301 LJ Roden, The Netherlands) at 11 investigational centers. Patients with severe renal failure and > 8-mm renal artery were excluded. Primary endpoint was angiographic determination of in-stent percent diameter stenosis at 6 months. Fifty-one patients were treated with one stent, one patient was treated with two stents to cover the complete lesion.


RESULTS
Mean percentage diameter stenosis before renal angioplasty was 68.2% +/- 12.0%. No stent implantation failure, displacement, need for additional stent implantation, or procedural complication was observed. Six-month angiography was performed in 41 of 52 patients (79%) resulting in a mean in-stent percent diameter stenosis or Quantitative Vessel analysis (QVA) at 6 months of 23.9%. The in-stent binary (percent diameter stenosis > 50%) restenosis rate at 6 months was 14.3%. No fatal events occurred up to 6 months after implantation. Major adverse events occurred in five patients: four patients (7.7%) required a revascularization and one patient (1.9%) experienced a cerebrovascular event, which regressed spontaneously.


CONCLUSIONS
The Palmaz Genesis stent (Cordis) provides good results for renal artery stent placement, with an in-stent binary restenosis rate (percent diameter stenosis > 50%) at 6 months of 14.3% as determined with angiography.
Sapoval
Marc
M
Hôpital Européen Georges Pompidou, Clermont Ferrand, France. marc.spoval@egp.aphp.fr
Zähringer
Markus
M
Pattynama
Peter
P
Rabbia
Claudio
C
Vignali
Claudio
C
Maleux
Geert
G
Boyer
Louis
L
Szczerbo-Trojanowska
Malgorzata
M
Jaschke
Werner
W
Hafsahl
Geir
G
Downes
Mark
M
Beregi
Jean Paul
JP
Veeger
Nic
N
Talen
Aly
A
D000368:Aged; D000800:Angioplasty, Balloon; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D019917:Blood Vessel Prosthesis Implantation; D003404:Creatinine / Q000378:metabolism; D020878:Device Removal; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007668:Kidney / Q000378:metabolism / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009200:Myocardial Contraction / Q000187:drug effects / Q000502:physiology; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology; D011446:Prospective Studies; D011859:Radiography; D012078:Renal Artery Obstruction / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D015607:Stents; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects / Q000502:physiology
D000959:Antihypertensive Agents; D003404:Creatinine