Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years.
OBJECTIVE
To evaluate the patency of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in the treatment of atherosclerotic renal artery stenosis (RAS).


METHODS
Between November 2001 to June 2003, 105 consecutive symptomatic patients (53 men; mean age 65.7 years) with RAS were treated with either a bare-metal (n=52) or a drug-eluting (n=53) low-profile Palmaz-Genesis peripheral stent at 11 centers in a prospective nonrandomized trial. The primary endpoint was the angiographic result at 6 months measured with quantitative vessel analysis by an independent core laboratory. Secondary endpoints were technical and procedural success, clinical patency [no target lesion revascularization (TLR)], blood pressure and antihypertensive drug use, worsening of renal function, and no major adverse events at 1, 6, 12, and 24 months.


RESULTS
At 6 months, the overall in-stent diameter stenosis for BMS was 23.9%+/-22.9% versus 18.7%+/-15.6% for SES (p=0.39). The binary restenosis rate was 6.7% for SES versus 14.6% for the BMS (p=0.30). After 6 months and 1 year, TLR rate was 7.7% and 11.5%, respectively, in the BMS group versus 1.9% at both time points in the SES group (p=0.21). This rate remained stable up to the 2-year follow-up but did not reach significance due to the small sample. Even as early as 6 months, both types of stents significantly improved blood pressure and reduced antihypertensive medication compared to baseline (p<0.01). After 6 months, renal function worsened in 4.6% of the BMS patients and in 6.9% of the SES group. The rate of major adverse events was 23.7% for the BMS group and 26.8% for the SES at 2 years (p=0.80).


CONCLUSIONS
The angiographic outcome at 6 months did not show a significant difference between BMS and SES. Renal artery stenting with both stents significantly improved blood pressure. Future studies with a larger patient population and longer angiographic follow-up are warranted to determine if there is a significant benefit of drug-eluting stents in treating ostial renal artery stenosis.
Zähringer
Markus
M
Department of Radiology, University Hospital Cologne, Germany. markuszaehringer@vinzenz.de
Sapoval
Marc
M
Pattynama
Peter M T
PM
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
Bérégi
Jean-Paul
JP
Veeger
Nic J G M
NJ
Stoll
Hans-Peter
HP
Talen
Aly
A
D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D007677:Kidney Function Tests; D008297:Male; D008670:Metals; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012077:Renal Artery / Q000000981:diagnostic imaging* / Q000503:physiopathology; D012078:Renal Artery Obstruction / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D051437:Renal Insufficiency / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D000959:Antihypertensive Agents; D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus