Peripheral Arterial Disease, Intermittent Claudication
Conditions
Keywords
drug-coated balloon angioplasty, angioplasty, plain old balloon angioplasty, peripheral arterial disease, intermittent claudication, systematic review, meta-analysis, Paclitaxel
Brief summary
Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.
Detailed description
Peripheral arterial disease is the third leading entity of atherosclerosis. The femoropopliteal segment is affected in most patients. Endovascular revascularisation is one possible treatment option, but high rates of restenosis, especially in complex lesions, are a limiting factor. Bare-metal stents failed to show a long-term superiority in a Cochrane systematic review. Another approach to prevent restenosis is local delivery of an antiproliferative drug (e.g. Paclitaxel) via Drug-Coated Balloon Angioplasty. New studies did report their results since the publication of earlier meta-analyses. It's time for an up-to-date systematic review. Prior systematic reviews did not address risk of bias nor did they take differences in treatment strategy despite the used balloon catheter into consideration.Some previous reviews did compare results from different points in time, e.g. analysis of 6 months' results together with 24 months' results.
Sponsors
Jena University Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Randomized controlled trials * DCB vs. POBA * focus on de-novo femoropopliteal lesions * registration in a clinical trials registry * available study protocol (either in clinical trial registry or published)
Exclusion criteria
* non-randomized controlled trials * focus on below-the-knee interventions * focus on iliac artery interventions * focus on treatment of critical limb ischemia * focus on treatment of in-stent restenosis * usage of additional devices except for bare-metal stent (e.g. atherectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) | 12 months | Freedom from repeated intervention of the index lesion (due to binary restenosis \> 50% and/or recurrent symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Patency (SP) | 12 and 24 months | freedom from binary restenosis after 1. single repeated endovascular revascularization or 2. no repeated Intervention \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The secondary patency is another commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\] |
| Late Lumen Loss (LLL) | 6 and 12 months | Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure |
| ABI | 12 and 24 months | Ankle-Brachial-Index |
| Primary Patency (PP) | 12 and 24 months | freedom from repeated intervention (FfTLR) and freedom from binary restenosis \> 50% \[comment: The metaanalysis compares the endpoints of different trials comparing DCB vs. POBA. The primary patency is a commonly used efficacy endpoint in those trials; information on this endpoint will be extracted from already published trial data.\] |
| Functional outcome | 12 and 24 months | Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test |
| Quality of Life (QoL) | 12 and 24 months | Quality of Life outcome eg. EQ5D |
| Rutherford-Becker Classification | 12 and 24 months | Clinical stage of disease according to Rutherford-Becker Classification |
Outcome results
None listed