Authors' recommendations: Despite almost 3,000 studied patients, no positive effects on patient-related outcomes have consistently been observed with drug eluting stents or balloons in the treatment of atherosclerotic disease of the lower extremities, compared with uncoated stents or balloons. Mortality rate within 12 months was reported to be between zero and 18 %, probably mainly related to the underlying general atherosclerotic disease. Commonly encountered SAEs are mortality, amputations, pseudo aneurysms and thrombosis. For patients with intermittent claudication (P1) due to below the knee lesions, it is uncertain whether there is little or no difference regarding mortality, restenosis or symptom severity with DES (sirolimus) compared with BMS. Very low certainty of evidence (GRADE +000). In patients with critical ischemia (P2) and lesions below the knee, DES (everolimus) may reduce restenosis compared with BMS. In the same patient group, DEB with paclitaxel compared with UCB may slightly reduce symptom severity (Rutherford score). Low certainty of evidence (GRADE ++00). Importantly, for patients with critical ischemia below the knee, in one RCT comparing DEB (paclitaxel) with UCB (ref), a significant increase in amputation rate (not reported in the RCT) was detected in the DEB group when all amputated patients from the study flowchart were included in the analysis. There was also a non-significant but numerically higher mortality in the DEB (paclitaxel) group compared with the UCB group. In a mixed population (P3) (i.e. intermittent claudication or critical ischemia patients) with lesions above the knee, DES (paclitaxel) compared with BMS may reduce restenosis. DES (sirolimus) compared with BMS in lesions below the knee, may reduce restenosis and may slightly reduce symptom severity. In the mixed population, with lesions above and/or below the knee, restenosis may be reduced with DEB (paclitaxel) compared with UCB. In all cases low certainty of evidence (GRADE ++00). In the studied patient populations (P1-P3), the effect estimates for all other studied outcomes were uncertain, non-significant or inconclusive. Very low-, or low certainty of evidence (GRADE +000 or ++00).

Project Status: Completed

Year Published: 2015

URL for published report: https://www2.sahlgrenska.se/upload/SU/HTA-centrum/HTA-rapporter/HTA-report%20Drug%20eluting%20balloons%20and%20stents%20for%20symptomatic%20peripheral%20peripheral%20arterial%20disease%202015-08-11.pdf

URL for additional information: http://www.sahlgrenska.se/sv/SU/Forskning/HTA-centrum/Hogerkolumn-undersidor/Publicerade-rapporter/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Organisation Name: The Regional Health Technology Assessment Centre

Contact Address: The Regional Health Technology Assessment Centre, Region Vastra Gotaland, HTA-centrum, Roda Straket 8, Sahlgrenska Universitetssjukhuset, 413 45 GOTHENBORG, Sweden

Contact Name: hta-centrum@vgregion.se

Contact Email: hta-centrum@vgregion.se

Copyright: The Regional Health Technology Assessment Centre (HTA-centrum), Region Vastra Gotaland