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Meta-Analysis
. 2012 Aug 15;2012(8):CD002071.
doi: 10.1002/14651858.CD002071.pub3.

Antiplatelet and anticoagulant drugs for prevention of restenosis/reocclusion following peripheral endovascular treatment

Lindsay Robertson  1 , Maaz A Ghouri, Flora Kovacs
Affiliations
Meta-Analysis

Antiplatelet and anticoagulant drugs for prevention of restenosis/reocclusion following peripheral endovascular treatment

Lindsay Robertson et al. Cochrane Database Syst Rev. .

Abstract

Background: Peripheral arterial disease (PAD) is frequently treated by balloon angioplasty. Restenosis/reocclusion of the dilated segments occurs often, depending on length of occlusion, lower leg outflow, stage of disease and presence of cardiovascular risk factors. To prevent reocclusion, patients are treated with antithrombotic agents. This is an update of a review first published in 2005.

Objectives: To determine whether any antithrombotic drug is more effective in preventing restenosis or reocclusion after peripheral endovascular treatment, compared to another antithrombotic drug, no treatment, placebo or other vasoactive drugs.

Search methods: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched 14 February 2012) and CENTRAL (2012, Issue 1).

Selection criteria: We selected randomised controlled trials (RCTs). Participants were patients with symptomatic PAD treated by endovascular revascularisation of the pelvic or femoropopliteal arteries. Interventions were anticoagulant, antiplatelet or other vasoactive drug therapy compared with no treatment, placebo or any other vasoactive drug. Clinical endpoints were reocclusion, restenosis, amputation, death, myocardial infarction, stroke, major bleeding and other side effects, such as minor bleeding, puncture site bleeding, gastrointestinal side effects and haematoma.

Data collection and analysis: We independently extracted and assessed details of the number of randomised patients, treatment, study design, patient characteristics and risk of bias. Analysis was based on intention-to-treat data. To examine the effects of outcomes such as reocclusion, restenosis, amputation and major bleeding, we computed odds ratios (OR) with 95% confidence intervals (CI) using a fixed-effect model.

Main results: Twenty-two trials with a total of 3529 patients are included (14 in the original review and a further eight in this update). For the majority of comparisons, only one trial was available so results were rarely combined in meta-analyses. Individual trials were generally small and risk of bias was often unclear due to limitations in reporting. Three trials reported on drug versus placebo/control; results were consistently available for a maximum follow-up of only six months. At six months post intervention, a statistically significant reduction in reocclusion was found for high-dose acetylsalicylic acid (ASA) combined with dipyridamole (DIP) (OR 0.40, 95% CI 0.19 to 0.84), but not for low-dose ASA combined with DIP (OR 0.69, 95% CI 0.44 to 1.10; P = 0.12) nor in major amputations for lipo-ecraprost (OR 0.89, 95% CI 0.44 to 1.80). The remaining trials compared different drugs; results were more consistently available for a longer period of 12 months. At 12 months post intervention, no statistically significant difference in reocclusion/restenosis was detected for any of the following comparisons: high-dose ASA versus low-dose ASA (OR 0.98, 95% CI 0.64 to 1.48; P = 0.91), ASA/DIP versus vitamin K antagonists (VKA) (OR 0.65, 95% CI 0.40 to 1.06; P = 0.08), clopidogrel and aspirin versus low molecular weight heparin (LMWH) plus warfarin (OR 0.31, 95% CI 0.06 to 1.68; P = 0.18), suloctidil versus VKA: reocclusion (OR 0.59, 95% CI 0.20 to 1.76; P = 0.34), restenosis (OR 1.87, 95% CI 0.66 to 5.31; P = 0.24) and ticlopidine versus VKA (OR 0.71, 95% CI 0.37 to 1.36; P = 0.30). Treatment with cilostazol resulted in statistically significantly fewer reocclusions than ticlopidine (OR 0.32, 95% CI 0.13 to 0.76; P = 0.01). Compared with aspirin alone, LMWH plus aspirin significantly decreased occlusion/restenosis (by up to 85%) in patients with critical limb ischaemia (OR 0.15, 95% CI 0.06 to 0.42; P = 0.0003) but not in patients with intermittent claudication (OR 1.73, 95% CI 0.97 to 3.08; P = 0.06) and batroxobin plus aspirin reduced restenosis in diabetic patients (OR 0.28, 95% CI 0.13 to 0.60). Data on bleeding and other potential gastrointestinal side effects were not consistently reported, although there was some evidence that high-dose ASA increased gastrointestinal side effects compared with low-dose ASA, that clopidogrel and aspirin resulted in fewer major bleeding episodes compared with LMWH plus warfarin, and that abciximab resulted in more severe bleeding episodes.

Authors' conclusions: There is limited evidence suggesting that restenosis/reocclusion at six months following peripheral endovascular treatment is reduced by use of antiplatelet drugs compared with placebo/control, but associated information on bleeding and gastrointestinal side effects is lacking. There is also some evidence of variation in effect according to different drugs with cilostazol reducing reocclusion/restenosis at 12 months compared with ticlopidine and both LMWH and batroxobin combined with aspirin appearing beneficial compared with aspirin alone. However, available trials are generally small and of variable quality and side effects of drugs are not consistently addressed. Further good quality, large-scale RCTs, stratified by severity of disease, are required.

PubMed Disclaimer

Conflict of interest statement

None known.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 1: Immediate occlusion, at discharge
1.2
1.2. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 2: Primary occlusion, 1 month
1.3
1.3. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 3: Primary occlusion, 3 months
1.4
1.4. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 4: Primary occlusion, 6 months
1.5
1.5. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 5: Primary occlusion, 12 months
1.6
1.6. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 6: Primary occlusion, 6 months (ASA 330 mg)
1.7
1.7. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 7: Amputation, 1 month
1.8
1.8. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 8: Death, 1 month
1.9
1.9. Analysis
Comparison 1: ASA/DIP versus placebo, Outcome 9: Bleeding puncture site, 1 month
2.1
2.1. Analysis
Comparison 2: ASA versus ASA/DIP, Outcome 1: Early occlusion 14 days
3.1
3.1. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 1: Primary occlusion, 1 month
3.2
3.2. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 2: Primary occlusion, 3 months
3.3
3.3. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 3: Primary occlusion, 6 months
3.4
3.4. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 4: Primary occlusion, 12 months
3.5
3.5. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 5: Primary occlusion, 24 months
3.6
3.6. Analysis
Comparison 3: High‐dose ASA versus low‐dose ASA, Outcome 6: Gastrointestinal side effects
4.1
4.1. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 1: Primary occlusion, 1 month
4.2
4.2. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 2: Primary occlusion, 3 months
4.3
4.3. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 3: Primary occlusion, 6 month
4.4
4.4. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 4: Primary occlusion, 12 months
4.5
4.5. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 5: Primary occlusion, 24 months
4.6
4.6. Analysis
Comparison 4: ASA/DIP versus VKA (phenprocoumon), Outcome 6: Primary occlusion, 36 months
5.1
5.1. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 1: Reocclusion/restenosis, 24 hours
5.2
5.2. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 2: Reocclusion/restenosis, 1 month
5.3
5.3. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 3: Reocclusion/restenosis, 6 months
5.4
5.4. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 4: Reocclusion/restenosis, 12 months
5.5
5.5. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 5: Reocclusion/restenosis, 18 months
5.6
5.6. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 6: Reocclusion/restenosis, all
5.7
5.7. Analysis
Comparison 5: Clopidogrel plus aspirin versus LMWH followed by warfarin, Outcome 7: Major bleeding
6.1
6.1. Analysis
Comparison 6: Suloctidil plus VKA (phenprocoumon) versus VKA (phenprocoumon), Outcome 1: Primary occlusion/restenosis, 12 months
6.2
6.2. Analysis
Comparison 6: Suloctidil plus VKA (phenprocoumon) versus VKA (phenprocoumon), Outcome 2: Primary restenosis, 12 months
6.3
6.3. Analysis
Comparison 6: Suloctidil plus VKA (phenprocoumon) versus VKA (phenprocoumon), Outcome 3: Primary occlusion, 12 months
7.1
7.1. Analysis
Comparison 7: Ticlopidine versus VKA (phenprocoumon), Outcome 1: Primary occlusion, 12 months
7.2
7.2. Analysis
Comparison 7: Ticlopidine versus VKA (phenprocoumon), Outcome 2: Side effects
8.1
8.1. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 1: Occlusion/restenosis, 12 months
8.2
8.2. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 2: Occlusion/restenosis, 24 months
8.3
8.3. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 3: Occlusion/restenosis, 36 months
8.4
8.4. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 4: Amputation, all
8.5
8.5. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 5: Death, all
8.6
8.6. Analysis
Comparison 8: Cilostazol plus aspirin versus ticlopidine plus aspirin, Outcome 6: Side effects
9.1
9.1. Analysis
Comparison 9: Taprostene versus ASA/DIP, Outcome 1: Early occlusion, 72 hours
9.2
9.2. Analysis
Comparison 9: Taprostene versus ASA/DIP, Outcome 2: Primary occlusion, 3 months (high‐dose and low‐dose taprostene)
10.1
10.1. Analysis
Comparison 10: Abciximab versus control, Outcome 1: Immediate occlusion, 24 hours
10.2
10.2. Analysis
Comparison 10: Abciximab versus control, Outcome 2: Early occlusion, 1 month
10.3
10.3. Analysis
Comparison 10: Abciximab versus control, Outcome 3: Primary occlusion, 3 months
10.4
10.4. Analysis
Comparison 10: Abciximab versus control, Outcome 4: Primary occlusion, 6 months
10.5
10.5. Analysis
Comparison 10: Abciximab versus control, Outcome 5: Amputation, 3 months
10.6
10.6. Analysis
Comparison 10: Abciximab versus control, Outcome 6: Severe bleeding 30 days
10.7
10.7. Analysis
Comparison 10: Abciximab versus control, Outcome 7: Bleeding at groin access site, 30 days
10.8
10.8. Analysis
Comparison 10: Abciximab versus control, Outcome 8: Major bleeding, 3 months
10.9
10.9. Analysis
Comparison 10: Abciximab versus control, Outcome 9: Minor bleeding, 6 months
11.1
11.1. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 1: Occlusion/restenosis more than 50%, 3 weeks, all
11.2
11.2. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 2: Occlusion/restenosis more than 50%, 3 weeks, by arteries
11.3
11.3. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 3: Occlusion/restenosis more than 50%, 3 months, all
11.4
11.4. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 4: Occlusion/restenosis more than 50%, 3 months, by arteries
11.5
11.5. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 5: Occlusion/restenosis more than 50%, 6 months, all
11.6
11.6. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 6: Occlusion/restenosis more than 50%, 6 months, by arteries
11.7
11.7. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 7: Haematoma more than 10 cm and spurious aneurysm, 3 weeks, all
11.8
11.8. Analysis
Comparison 11: LMWH (nadroparin calcium) versus UFH, Outcome 8: Amputation, 6 months, all
12.1
12.1. Analysis
Comparison 12: LMWH (dalteparin) plus aspirin versus aspirin alone, Outcome 1: Occlusion/restenosis more than 50%, 12 months
13.1
13.1. Analysis
Comparison 13: Lipo‐ecraprost versus placebo, Outcome 1: Major amputation, ≤ 6 months
13.2
13.2. Analysis
Comparison 13: Lipo‐ecraprost versus placebo, Outcome 2: Death, ≤ 6 months
13.3
13.3. Analysis
Comparison 13: Lipo‐ecraprost versus placebo, Outcome 3: Non‐fatal cardiovascular adverse events, ≤ 6 months
13.4
13.4. Analysis
Comparison 13: Lipo‐ecraprost versus placebo, Outcome 4: Adverse events, ≤ 6 months
14.1
14.1. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 1: Restenosis, 12 months
14.2
14.2. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 2: Restenosis at 12 months, femoral popliteal lesion
14.3
14.3. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 3: Restenosis at 12 months, infrapopliteal lesion
14.4
14.4. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 4: Restenosis at 12 months, lesion length < 10 cm
14.5
14.5. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 5: Restenosis at 12 months, lesion length > 10 cm
14.6
14.6. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 6: Amputation, 12 months
14.7
14.7. Analysis
Comparison 14: Batroxobin plus aspirin versus aspirin alone, Outcome 7: Death, 12 months
15.1
15.1. Analysis
Comparison 15: Candesartan versus quinapril, Outcome 1: Restenosis, 6 months
15.2
15.2. Analysis
Comparison 15: Candesartan versus quinapril, Outcome 2: Adverse events, 6 months
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References

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References to other published versions of this review

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