By Ed Susman
CHICAGO -- April 3, 2008 -- Stenting does not appear to provide an advantage over medical therapy for patients with atherosclerotic renal vascular disease, according to results of the Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial.
Preliminary 1-year results of ASTRAL indicate no evidence for differences between percutaneous revascularisation and medical treatment for any secondary endpoints, including blood pressure reduction and major events.
Results also show no evidence of differences in treatment effects among any of the subgroups in the study, said investigator Philip A. Kalra, MD, Consultant Nephrologist, Hope Hospital, Salford, and Lecturer, University of Manchester, Manchester, United Kingdom.
About 3% of patients undergoing the percutaneous intervention experienced a serious procedural complication, including poorly positioned stents and perforation and dissection of the renal artery. One patient in the medical treatment group had a major complication.
"For 15 years we've had the wherewithal to fix renal artery stenosis and restore patency of the renal artery," said Dr. Kalra in his late-breaker presentation on April 1 here at the Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI 2008), held in conjunction with the American College of Cardiology Innovation in Intervention: i2 Summit. "Thousands of patients have had this procedure, but no one has ever demonstrated any benefit in randomised, controlled trial testing."
The primary endpoint of the study was serum creatinine level, with lower levels indicating an improvement of function. The study will continue until all 403 patients in each group have 4 years of follow-up. Of the patients who completed 1 year of follow-up, serum creatinine increased by 15 points both in the 284 patients who underwent revascularisation and in the 299 patients on medical management.
Patients in the study had an average age of 70 years, 63% were men, 53% were former smokers, 21% were current smokers, and 30% had diabetes. None of the revascularised patients were on dialysis, but 0.3% of the medical treatment group was on dialysis, a nonsignificant difference (P = .50).
At 1-year, both groups showed a decrease of 5 mm Hg in systolic blood pressure.
Patients on medical management showed a smaller decrease in diastolic blood pressure (-1 mm Hg) compared with revascularised patients (3 mm Hg), but that difference was not significant, Dr. Kalra said.
In both groups, 805 of patients were free of first myocardial infarction, stroke, vascular death, hospitalisation for angina, fluid overload, and cardiac failure.
[Presentation title: The Impact of Renal Artery Revascularisation in Atherosclerotic Renovascular Disease: The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) Trial. Abstract 2411-5]
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