Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism
| Autor: | Gerard Stansby, Daniel J. Reddy, Ioannis Ntouvas, Joseph A. Caprini, Andrew N. Nicolaides, George Geroulakos, Stavros K. Kakkos |
|---|---|
| Rok vydání: | 2023 |
| Předmět: |
Venous Thrombosis [prevention & control]
Anticoagulants [therapeutic use] Deep vein 030204 cardiovascular system & hematology TOTAL HIP-ARTHROPLASTY law.invention TOTAL KNEE ARTHROPLASTY 0302 clinical medicine Randomized controlled trial Venous Thromboembolism [prevention & control] law ABDOMINAL-SURGERY Pharmacology (medical) DEEP-VEIN THROMBOSIS 030212 general & internal medicine THROMBOPROPHYLAXIS Incidence (epidemiology) Anticoagulant DISEASE PROPHYLAXIS MOLECULAR-WEIGHT HEPARIN 11 Medical And Health Sciences Venous Thromboembolism Pulmonary embolism medicine.anatomical_structure LOW-DOSE HEPARIN Cardiology and Cardiovascular Medicine Life Sciences & Biomedicine Medicine General & Introductory Medical Sciences medicine.medical_specialty PULMONARY-EMBOLISM medicine.drug_class Hemorrhage 03 medical and health sciences Medicine General & Internal General & Internal Medicine Internal medicine GYNECOLOGIC ONCOLOGY medicine Humans Leg [blood supply] cardiovascular diseases Intermittent Pneumatic Compression Devices Combined Modality Therapy [methods] Leg Science & Technology business.industry Anticoagulants Guideline Odds ratio medicine.disease Clinical trial Pulmonary Embolism [prevention & control] Physical therapy Surgery Controlled Clinical Trials as Topic business Pulmonary Embolism |
| Zdroj: | The Cochrane Library Cochrane Database Syst Rev |
| ISSN: | 1469-493X |
| Popis: | BACKGROUND: It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is the second update of the review first published in 2008. OBJECTIVES: The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis compared to single modalities in preventing VTE. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 January 2021. We searched the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE compared to either intervention individually. DATA COLLECTION AND ANALYSIS: We independently selected studies, applied Cochrane's risk of bias tool, and extracted data. We resolved disagreements by discussion. We performed fixed‐effect model meta‐analyses with odds ratios (ORs) and 95% confidence intervals (CIs). We used a random‐effects model when there was heterogeneity. We assessed the certainty of the evidence using GRADE. The outcomes of interest were PE, DVT, bleeding and major bleeding. MAIN RESULTS: We included a total of 34 studies involving 14,931 participants, mainly undergoing surgery or admitted with trauma. Twenty‐five studies were RCTs (12,672 participants) and nine were CCTs (2259 participants). Overall, the risk of bias was mostly unclear or high. We used GRADE to assess the certainty of the evidence and this was downgraded due to the risk of bias, imprecision or indirectness. The addition of pharmacological prophylaxis to IPC compared with IPC alone reduced the incidence of symptomatic PE from 1.34% (34/2530) in the IPC group to 0.65% (19/2932) in the combined group (OR 0.51, 95% CI 0.29 to 0.91; 19 studies, 5462 participants, low‐certainty evidence). The incidence of DVT was 3.81% in the IPC group and 2.03% in the combined group showing a reduced incidence of DVT in favour of the combined group (OR 0.51, 95% CI 0.36 to 0.72; 18 studies, 5394 participants, low‐certainty evidence). The addition of pharmacological prophylaxis to IPC, however, increased the risk of any bleeding compared to IPC alone: 0.95% (22/2304) in the IPC group and 5.88% (137/2330) in the combined group (OR 6.02, 95% CI 3.88 to 9.35; 13 studies, 4634 participants, very low‐certainty evidence). Major bleeding followed a similar pattern: 0.34% (7/2054) in the IPC group compared to 2.21% (46/2079) in the combined group (OR 5.77, 95% CI 2.81 to 11.83; 12 studies, 4133 participants, very low‐certainty evidence). Tests for subgroup differences between orthopaedic and non‐orthopaedic surgery participants were not possible for PE incidence as no PE events were reported in the orthopaedic subgroup. No difference was detected between orthopaedic and non‐orthopaedic surgery participants for DVT incidence (test for subgroup difference P = 0.19). The use of combined IPC and pharmacological prophylaxis modalities compared with pharmacological prophylaxis alone reduced the incidence of PE from 1.84% (61/3318) in the pharmacological prophylaxis group to 0.91% (31/3419) in the combined group (OR 0.46, 95% CI 0.30 to 0.71; 15 studies, 6737 participants, low‐certainty evidence). The incidence of DVT was 9.28% (288/3105) in the pharmacological prophylaxis group and 5.48% (167/3046) in the combined group (OR 0.38, 95% CI 0.21 to 0.70; 17 studies; 6151 participants, high‐certainty evidence). Increased bleeding side effects were not observed for IPC when it was added to anticoagulation (any bleeding: OR 0.87, 95% CI 0.56 to 1.35, 6 studies, 1314 participants, very low‐certainty evidence; major bleeding: OR 1.21, 95% CI 0.35 to 4.18, 5 studies, 908 participants, very low‐certainty evidence). No difference was detected between the orthopaedic and non‐orthopaedic surgery participants for PE incidence (test for subgroup difference P = 0.82) or for DVT incidence (test for subgroup difference P = 0.69). AUTHORS' CONCLUSIONS: Evidence suggests that combining IPC with pharmacological prophylaxis, compared to IPC alone reduces the incidence of both PE and DVT (low‐certainty evidence). Combining IPC with pharmacological prophylaxis, compared to pharmacological prophylaxis alone, reduces the incidence of both PE (low‐certainty evidence) and DVT (high‐certainty evidence). We downgraded due to risk of bias in study methodology and imprecision. Very low‐certainty evidence suggests that the addition of pharmacological prophylaxis to IPC increased the risk of bleeding compared to IPC alone, a side effect not observed when IPC is added to pharmacological prophylaxis (very low‐certainty evidence), as expected for a physical method of thromboprophylaxis. The certainty of the evidence for bleeding was downgraded to very low due to risk of bias in study methodology, imprecision and indirectness. The results of this update agree with current guideline recommendations, which support the use of combined modalities in hospitalised people (limited to those with trauma or undergoing surgery) at risk of developing VTE. More studies on the role of combined modalities in VTE prevention are needed to provide evidence for specific patient groups and to increase our certainty in the evidence. |
| Databáze: | OpenAIRE |
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