The GREAT Trial

The Grampian Region Early Anistreplase Trial Reference Zahringer M, Sapoval M, Pattynama PM, et al. 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. J Endovasc Ther 2007;14:460–468.

Background Atherosclerotic lesions of the renal arteries may cause renal ischemia leading to arterial hypertension and impaired renal function. Stent-facilitated restoration and maintenance of vessel patency reduces the progression of renal failure. Drug-eluting stents significantly reduces in-stent-restenosis in coronary arteries. Zahringer et al. evaluated a sirolimus eluting stent for similar effects in renal artery stenosis.

AIM To evaluate the patency of sirolimus-eluting stents (SES) over bare-metal stents (BMS) in the treatment of atherosclerotic renal artery stenosis.

Methods

Key Results The trial reported in-stent diameter stenosis of 23.9% ± 22.9% in the BMS group and 18.7% ± 15.6% in the SES group (p=0.39) Clinical patency at 6-month follow-up was 92.3% in the BMS and 98.1% in the SES group. At 1-year follow-up, the clinical patency was 88.5% in the BMS group and 98.1% in the SES group. Stent implantation was technically successful in all cases and without procedural complications, except for one patient in the SES arm. Blood pressure readings remained below the baseline value in both groups; these effects were not significantly different between groups. A reduction in the number of antihypertensive drugs was not significantly different between groups. Differences in creatinine levels were significantly different (p=0.03) between groups only at baseline (Fig. 1).

Conclusion 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. This study could not identify significant benefits of drug-eluting stents over bare metal stents in treating renal artery stenosis.