PURPOSE: To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL). METHODS:One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention. RESULTS:QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting. CONCLUSION: Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.
RCT Entities:
PURPOSE: To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL). METHODS: One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention. RESULTS: QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting. CONCLUSION: Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.
Authors: Paul P Heideman; Mohammad Reza Rajebi; Michael A McKusick; Haraldur Bjarnason; Gustavo S Oderich; Jeremy L Friese; Mark D Fleming; Andrew H Stockland; William S Harmsen; Jay Mandrekar; Sanjay Misra Journal: J Vasc Interv Radiol Date: 2016-06-16 Impact factor: 3.464
Authors: Warren J Gasper; Cynthia A Jimenez; Joy Walker; Michael S Conte; Kirk Seward; Christopher D Owens Journal: Circ Cardiovasc Interv Date: 2013-11-12 Impact factor: 6.546
Authors: Michael D Dake; Gary M Ansel; Michael R Jaff; Takao Ohki; Richard R Saxon; H Bob Smouse; Lindsay S Machan; Scott A Snyder; Erin E O'Leary; Anthony O Ragheb; Thomas Zeller Journal: Circulation Date: 2016-03-11 Impact factor: 29.690
Authors: Hans I V Lindgren; Peter Qvarfordt; Stefan Bergman; Anders Gottsäter Journal: Cardiovasc Intervent Radiol Date: 2018-03-08 Impact factor: 2.740