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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB | Treatment with Paclitaxel drug-coated balloon angioplasty (DCB) |
| |
| POBA | Treatment with plain old balloon angioplasty (POBA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCB | Device |
| ||
| POBA | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) | Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms) | 12 months |
| Freedom from (clinical driven) Target Lesion Revascularisation (FfTLR) | Freedom from repeated intervention of the index lesion (due to binary restenosis > 50% and/or recurrent symptoms) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency (PP) | 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.] | 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with intermittent claudication due to de novo femoropopliteal peripheral arterial disease.
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Teichgräber, Prof. | University Hospital Jena | Principal Investigator |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| Secondary Patency (SP) | freedom from binary restenosis after
| 12 and 24 months |
| Late Lumen Loss (LLL) | Difference of minimal lumen diameter at follow-up compared to minimal lumen diameter after index procedure | 6 and 12 months |
| ABI | Ankle-Brachial-Index | 12 and 24 months |
| Rutherford-Becker Classification | Clinical stage of disease according to Rutherford-Becker Classification | 12 and 24 months |
| Functional outcome | Functional result eg. Walking Impairment Questionnaire (WIQ) or treadmill test | 12 and 24 months |
| Quality of Life (QoL) | Quality of Life outcome eg. EQ5D | 12 and 24 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |