PURPOSE: To compare long-term cardiovascular morbidity and mortality and their determinants in a population initially treated with one of two endovascular treatment strategies for stenosis or short occlusion of an iliac artery. MATERIALS AND METHODS: A total of 279 symptomatic patients with stenosis or short (< or =5-cm) occlusion of the iliac arteries were randomly assigned to undergo either primary stent placement or primary angioplasty followed by selective stent placement (in case of a residual mean pressure gradient greater than 10 mm Hg at the treated site). Follow-up data for all 279 patients were provided by the general practitioners and referring clinicians. Events of interest were arterial interventions, reinterventions in the iliac arteries, cardiovascular events (myocardial infarction, stroke, or extracranial bleeding), and death. Regression analysis was performed to identify predictors of reintervention and of cardiovascular morbidity and mortality. RESULTS: The mean follow-up period was 5.6 years +/- 1.3 (+/- standard deviation). There were no significant differences between primary stent placement and primary angioplasty treatment groups in regard to number of reinterventions in the treated iliac arteries (33 [18%] of 187 segments and 33 [20%] of 169 segments, respectively) or in the ipsilateral legs (45 [25%] of 181 legs and 50 [30%] of 164 legs, respectively). The risk of other cardiovascular events in primary stent placement and primary angioplasty groups was 13% (18 of 143) and 11% (15 of 136), and the risk of death was 15% (21 of 143 patients) and 16% (22 of 136 patients), respectively. Sex, presence of critical ischemia, and length of stenosis were predictors of whether a patient would require iliac reintervention. Myocardial infarction, stroke, and vascular death were predicted on the basis of a patient's creatinine level and walking distance as tested at the time of inclusion. CONCLUSION: No difference was found in the number of reinterventions between the two treatment groups 5 years after treatment. Patients with iliac artery disease are at high risk of cardiovascular morbidity and mortality. Copyright RSNA, 2004
RCT Entities:
PURPOSE: To compare long-term cardiovascular morbidity and mortality and their determinants in a population initially treated with one of two endovascular treatment strategies for stenosis or short occlusion of an iliac artery. MATERIALS AND METHODS: A total of 279 symptomatic patients with stenosis or short (< or =5-cm) occlusion of the iliac arteries were randomly assigned to undergo either primary stent placement or primary angioplasty followed by selective stent placement (in case of a residual mean pressure gradient greater than 10 mm Hg at the treated site). Follow-up data for all 279 patients were provided by the general practitioners and referring clinicians. Events of interest were arterial interventions, reinterventions in the iliac arteries, cardiovascular events (myocardial infarction, stroke, or extracranial bleeding), and death. Regression analysis was performed to identify predictors of reintervention and of cardiovascular morbidity and mortality. RESULTS: The mean follow-up period was 5.6 years +/- 1.3 (+/- standard deviation). There were no significant differences between primary stent placement and primary angioplasty treatment groups in regard to number of reinterventions in the treated iliac arteries (33 [18%] of 187 segments and 33 [20%] of 169 segments, respectively) or in the ipsilateral legs (45 [25%] of 181 legs and 50 [30%] of 164 legs, respectively). The risk of other cardiovascular events in primary stent placement and primary angioplasty groups was 13% (18 of 143) and 11% (15 of 136), and the risk of death was 15% (21 of 143 patients) and 16% (22 of 136 patients), respectively. Sex, presence of critical ischemia, and length of stenosis were predictors of whether a patient would require iliac reintervention. Myocardial infarction, stroke, and vascular death were predicted on the basis of a patient's creatinine level and walking distance as tested at the time of inclusion. CONCLUSION: No difference was found in the number of reinterventions between the two treatment groups 5 years after treatment. Patients with iliac artery disease are at high risk of cardiovascular morbidity and mortality. Copyright RSNA, 2004
Authors: Alexander M de Vos; Annemarieke Rutten; Hester J van de Zaag-Loonen; Michiel L Bots; Riksta Dikkers; Robert A Buiskool; Willem P Mali; Daniel D Lubbers; Arend Mosterd; Mathias Prokop; Benno J Rensing; Maarten J Cramer; H Wouter van Es; Frans L Moll; Eric D van de Pavoordt; Pieter A Doevendans; Birgitta K Velthuis; Albert J Mackaay; Felix Zijlstra; Matthijs Oudkerk Journal: Trials Date: 2008-08-01 Impact factor: 2.279