In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).
Conclusion:In patients with a hemodialysis access graft and an asymptomatic central venous stenosis (CVS) of Ͼ50%, treatment of the CVS results in more rapid stenosis progression compared with a nontreatment approach.Summary: The authors evaluated the natural history of Ͼ50% asymptomatic CVSs in hemodialysis patients. Outcome of serial treatment of CVS with percutaneous catheter-based techniques (PTA) was also evaluated. All patients in this study required maintenance procedures for their dialysis access.Between 1998 and 2004, 35 patients (19 men, 16 women), with a mean age of 58.7 years, were found to have asymptomatic CVS of Ͼ50%. CVS was measured by using venograms obtained before and after PTA. Patients with arm swelling, multiple CVSs, or indwelling catheters, were excluded. CVS progression was calculated by comparing degrees of stenoses with serial venographic examinations.The mean severity of CVSs before intervention was 71% (range, 50% to 100%), with 62% of lesions having associated collateral vessels. Twenty eight percent of CVSs were not treated. The mean degree of stenosis in the untreated group was 72% (range, 30% to 100%). Mean progression of stenosis in the untreated group was -0.8% point per day. No untreated CVS progressed to symptoms, stent placement, or developed additional CVS.PTA was used to treat 62 CVS lesions (72%). The mean degree of stenosis in the treated group was 74% (range, 50% to 100%) before and 40% (range, 0% to 75%) after treatment. In the treated group, mean progression of CVS was 0.21% per day after treatment. Six of the 62 treated CVS lesions were monitored, with symptomatic escalation of the CVS as manifested by arm swelling, need for stent placement, or development of additional CVS lesions.Comment: Treatment of an asymptomatic CVS in a dialysis patient is not a good thing. One is reminded of the old adage that it is wise to avoid poking a skunk. A major weakness of this study is that the patients were undergoing maintenance procedures for their dialysis access. We do not know if the CVS contributed to the need for the dialysis access maintenance. It would be interesting to know if there was a higher rate of repeat procedures for maintenance of dialysis access in patients with treated vs untreated CVS.
At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.
Intermediate-term in-stent restenosis remains a major problem even with current nitinol stent technology; however, clinical deterioration seems no matter of serious concern with SMART and Dynalink/Absolute stents. Stent fractures may be lower with Dynalink/Absolute stents, but randomized head-to-head comparisons are needed to validate these data.
In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.
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