Preliminary study of the use of drug-eluting stents in atherosclerotic renal artery stenoses 4 mm in diameter or smaller.
ABSTRACT To describe restenosis and clinical outcomes with drug-eluting stents (DESs) and compare them to those of bare metal stents (BMSs) in the treatment of symptomatic atherosclerotic renal artery stenosis (RAS) in the same patients.
A retrospective study was performed of all patients with RAS treated with a DES (Taxus Express 2 or Cypher). DESs were used for RASs with luminal vessel diameters of 4 mm or smaller and BMSs were used for those larger than 4 mm.
Sixteen patients (eight women; mean age, 72 years +/- 8) underwent treatment of 27 RASs for worsening renal function (n = 10) and uncontrolled hypertension (n = 6). Eighteen RASs were treated with 23 DESs (Cypher, n = 12; Taxus, n = 11) and nine were treated with BMSs. The average follow-up was 22 months +/- 10. After the procedure, the mean systolic blood pressure decreased significantly (P < .05), with no change in the mean diastolic pressure, serum creatinine, or number of antihypertensive medications. By Kaplan-Meier estimates, the 1- and 2-year patency rates for DESs were 78% and 68%, respectively; and for BMSs, the respective rates were 58% and 47% (P = NS). The average diameters of RASs were 3.4 mm +/- 0.6 in the DES group and 5.3 mm +/- 0.6 in the BMS group (P < .05). There were two technical failures (7.7%) in the DES group. There was one minor complication and a non-flow-limiting dissection.
DESs were used to treat RASs with good technical results and low restenosis rates compared with BMSs despite the smaller artery diameters in the DES group.
- Nephrology Dialysis Transplantation 11/2006; · 3.37 Impact Factor
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ABSTRACT: We sought to describe the incidence of late angiographic stent thrombosis (LAST) events in an unselected drug-eluting stent (DES) population. Concerns have been raised that LAST may be a potential limitation of DES. We have previously reported the angiographic incidence of early stent thrombosis (1.0%) in this prospective cohort of 2,006 patients treated with either sirolimus-eluting stents (SES) (n = 1,017) or paclitaxel-eluting stents (PES) (n = 989). We continued long-term follow-up to determine the incidence of LAST events, defined as angiographically proven stent thrombosis associated with acute symptoms more than 30 days after DES implantation. All patients had at least 1 year of follow-up, mean duration 1.5 years. There were eight angiographically confirmed LAST events in seven patients: three with SES (at 2, 25, and 26 months) and five with PES (at 6, 7, 8, 11, and 14.5 months). Three cases were related to complete cessation of antiplatelet therapy, two cases occurred while patients were on aspirin therapy within one month of cessation of clopidogrel, and three cases occurred at a time when patients were apparently clinically stable on aspirin monotherapy. We observed no cases of LAST in patients who were on dual antiplatelet therapy. Two deaths occurred directly as a result of LAST. Angiographically proven late stent thrombosis occurs with an incidence of at least 0.35% (95% confidence limits 0.17% to 0.72%) in patients treated with DES. Importantly, it may also occur when patients are stable on antiplatelet monotherapy.Journal of the American College of Cardiology 07/2005; 45(12):2088-92. · 14.09 Impact Factor
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ABSTRACT: 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. 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. 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. 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.Journal of Vascular and Interventional Radiology 10/2005; 16(9):1195-202. · 2.00 Impact Factor