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Journal of Vascular Surgery. Venous and... Jan 2024The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice... (Meta-Analysis)
Meta-Analysis
The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine.
The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice guidelines on varicose veins. Recommendations were based on the latest scientific evidence researched following an independent systematic review and meta-analysis of five critical issues affecting the management of patients with lower extremity varicose veins, using the patients, interventions, comparators, and outcome system to answer critical questions. Part I discussed the role of duplex ultrasound scanning in the evaluation of varicose veins and treatment of superficial truncal reflux. Part II focuses on evidence supporting the prevention and management of varicose vein patients with compression, on treatment with drugs and nutritional supplements, on evaluation and treatment of varicose tributaries, on superficial venous aneurysms, and on the management of complications of varicose veins and their treatment. All guidelines were based on systematic reviews, and they were graded according to the level of evidence and the strength of recommendations, using the GRADE method. All ungraded Consensus Statements were supported by an extensive literature review and the unanimous agreement of an expert, multidisciplinary panel. Ungraded Good Practice Statements are recommendations that are supported only by indirect evidence. The topic, however, is usually noncontroversial and agreed upon by most stakeholders. The Implementation Remarks contain technical information that supports the implementation of specific recommendations. This comprehensive document includes a list of all recommendations (Parts I-II), ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with appropriate, up-to-date management of patients with lower extremity varicose veins.
Topics: Humans; United States; Venous Insufficiency; Radiology, Interventional; Sclerotherapy; Saphenous Vein; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures; Lower Extremity; Cardiology
PubMed: 37652254
DOI: 10.1016/j.jvsv.2023.08.011 -
The Cochrane Database of Systematic... Feb 2018The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the third update of a review first published in 2007.
OBJECTIVES
To assess the efficacy and safety of topical, medical, and surgical treatments for ST of the leg in improving local symptoms and decreasing thromboembolic complications.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (March 2017), CENTRAL (2017, Issue 2), and trials registries (March 2017). We handsearched the reference lists of relevant papers and conference proceedings.
SELECTION CRITERIA
Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the legs that included people with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in a superficial vein.
DATA COLLECTION AND ANALYSIS
Two authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We identified three additional trials (613 participants), therefore this update considered 33 studies involving 7296 people with ST of the legs. Treatment included fondaparinux; rivaroxaban; low molecular weight heparin (LMWH); unfractionated heparin (UFH); non-steroidal anti-inflammatory drugs (NSAIDs); compression stockings; and topical, intramuscular, or intravenous treatment to surgical interventions such as thrombectomy or ligation. Only a minority of trials compared treatment with placebo rather than an alternative treatment and many studies were small and of poor quality. Pooling of the data was possible for few outcomes, and none were part of a placebo-controlled trial. In one large, placebo-controlled RCT of 3002 participants, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.04 to 0.50; moderate-quality evidence), ST extension (RR 0.08, 95% CI 0.03 to 0.22; moderate-quality evidence), and ST recurrence (RR 0.21, 95% CI 0.08 to 0.54; moderate-quality evidence) relative to placebo. Major bleeding was infrequent in both groups with very wide CIs around risk estimate (RR 0.99, 95% CI 0.06 to 15.86; moderate-quality evidence). In one RCT on 472 high-risk participants with ST, fondaparinux was associated with a non-significant reduction of symptomatic VTE compared to rivaroxaban 10 mg (RR 0.33, 95% CI 0.03 to 3.18; low-quality evidence). There were no major bleeding events in either group (low-quality evidence). In another placebo-controlled trial, both prophylactic and therapeutic doses of LMWH (prophylactic: RR 0.44, 95% CI 0.26 to 0.74; therapeutic: RR 0.46, 95% CI 0.27 to 0.77) and NSAIDs (RR 0.46, 95% CI 0.27 to 0.78) reduced the extension (low-quality evidence) and recurrence of ST (low-quality evidence) in comparison to placebo, with no significant effects on symptomatic VTE (low-quality evidence) or major bleeding (low-quality evidence). Overall, topical treatments improved local symptoms compared with placebo, but no data were provided on the effects on VTE and ST extension. Surgical treatment combined with elastic stockings was associated with a lower VTE rate and ST progression compared with elastic stockings alone. However, the majority of studies that compared different oral treatments, topical treatments, or surgery did not report VTE, ST progression, adverse events, or treatment adverse effects.
AUTHORS' CONCLUSIONS
Prophylactic dose fondaparinux given for 45 days appears to be a valid therapeutic option for ST of the legs for most people. The evidence on topical treatment or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE. Further research is needed to assess the role of rivaroxaban and other direct oral factor-X or thrombin inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment in people at various risk of recurrence; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Factor Xa Inhibitors; Fondaparinux; Hemorrhage; Heparin, Low-Molecular-Weight; Humans; Polysaccharides; Randomized Controlled Trials as Topic; Rivaroxaban; Stockings, Compression; Thrombectomy; Thromboembolism; Thrombophlebitis; Venous Thromboembolism
PubMed: 29478266
DOI: 10.1002/14651858.CD004982.pub6 -
Sexual Medicine Reviews Jul 2022Penile Mondor's Disease (PMD) is a rare illness that causes thrombophlebitis in the superficial veins of the penis that is manifested by transient pain and swelling. PMD... (Review)
Review
INTRODUCTION
Penile Mondor's Disease (PMD) is a rare illness that causes thrombophlebitis in the superficial veins of the penis that is manifested by transient pain and swelling. PMD often is associated with trauma to the penis, prolonged or vigorous sexual intercourse, and has been linked to genetics.
OBJECTIVES
Our aim is to review the current literature on PMD.
METHODS
A comprehensive literature search of English and Turkish publications on PMD was found through PubMed and Web of Science using various keywords. It is a systematic review.
RESULTS
PMD might be an uncommon, harmless condition that normalizes with moderate therapy or potentially clinical therapy. Its pathogenesis has not yet been completely explained; however, different etiological variables are known. The current studies on PMD are summarized.
CONCLUSION
Analyses are frequently made with a fair history and actual assessment. In any case, education on the illness is needed. Furthermore, the identification should be supported by ultrasonography. In a greater part of the patients, results are acquired with 2 months of clinical treatment. In exceptionally uncommon cases, careful thrombectomy or expulsion of the superficial vein is required. Özkan B, Coşkuner ER. What We Know About Penile Mondor's Disease. Sex Med Rev 2022;10:396-401.
Topics: Coitus; Humans; Male; Penile Diseases; Penis; Thrombophlebitis
PubMed: 35249861
DOI: 10.1016/j.sxmr.2021.12.006 -
Journal of Vascular Surgery. Venous and... Jul 2023We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency.
METHODS
We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points.
RESULTS
We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA.
CONCLUSIONS
Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.
Topics: Humans; Network Meta-Analysis; Bayes Theorem; Paresthesia; Treatment Outcome; Venous Insufficiency; Saphenous Vein; Pain
PubMed: 37030442
DOI: 10.1016/j.jvsv.2023.03.011 -
Journal of Vascular Surgery. Venous and... Jan 2021Compression after sclerotherapy is commonly used, although the evidence base for this practice is unclear. This study aims to summarize and assess the evidence for...
BACKGROUND
Compression after sclerotherapy is commonly used, although the evidence base for this practice is unclear. This study aims to summarize and assess the evidence for compression therapy after sclerotherapy to inform clinical practice.
METHODS
A systematic review was performed according to PRISMA guidelines via Medline and EMBASE databases (1946 to December 31, 2019) by two reviewers. Full-text, English-language studies comparing compression type and/or duration in adult chronic venous disease patients undergoing liquid or foam sclerotherapy were included.
RESULTS
Nine studies were identified: five using liquid sclerotherapy, three foam sclerotherapy and one using both. Studies had short follow-up periods (6-24 weeks) and reported on clinical outcomes, quality of life, side effects and complications. In C1 patients undergoing liquid sclerotherapy, any duration of stocking use significantly decreased telangiectasia and reticular vein number and size compared with no compression. No significant difference in clinical symptoms or quality of life was seen when comparing compression duration after liquid or foam sclerotherapy in tributary or truncal veins in C2 to C6 patients. Greater superficial vein resolution was seen with stockings compared with bandages in C2 patients undergoing liquid sclerotherapy to tributary veins. A comparison of stockings vs bandaging revealed differing thrombophlebitis rates but no significant difference in pigmentation. In C2 to C6 patients undergoing foam sclerotherapy, use of 35 mm Hg stockings significantly improved post-treatment symptoms compared with 23 mm Hg stockings. This review was limited by heterogeneity of outcome measurements and the variety of comparisons between compression types and durations.
CONCLUSIONS
Postsclerotherapy compression may have beneficial clinical outcomes at short-term follow-up; however, evidence is lacking regarding its type, class, length, and duration. Further trials are required to guide the optimal management of postsclerotherapy patients.
Topics: Adult; Aged; Aged, 80 and over; Chronic Disease; Compression Bandages; Female; Humans; Male; Middle Aged; Sclerosing Solutions; Sclerotherapy; Stockings, Compression; Treatment Outcome; Vascular Diseases
PubMed: 32791308
DOI: 10.1016/j.jvsv.2020.07.011 -
The Cochrane Database of Systematic... Nov 2015Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.
OBJECTIVES
To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.
SEARCH METHODS
The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.
SELECTION CRITERIA
RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).
DATA COLLECTION AND ANALYSIS
We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.
MAIN RESULTS
We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.
AUTHORS' CONCLUSIONS
The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
Topics: Anti-Inflammatory Agents; Anticoagulants; Catheterization, Peripheral; Dalteparin; Diclofenac; Drug Combinations; Drugs, Chinese Herbal; Escin; Gels; Heparin; Heparinoids; Humans; Ibuprofen; Nitroglycerin; Pentosan Sulfuric Polyester; Phospholipids; Polydeoxyribonucleotides; Randomized Controlled Trials as Topic; Thrombophlebitis; Upper Extremity
PubMed: 26588711
DOI: 10.1002/14651858.CD011015.pub2 -
Journal of Thrombosis and Haemostasis :... May 2016Essentials The association of superficial vein thrombosis (SVT) with venous thromboembolism (VTE) is variable. We performed a meta-analysis to assess the prevalence of... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Essentials The association of superficial vein thrombosis (SVT) with venous thromboembolism (VTE) is variable. We performed a meta-analysis to assess the prevalence of concomitant VTE in patients with SVT. Deep vein thrombosis was found in 18.1%, and pulmonary embolism in 6.9%, of SVT patients. Screening for VTE may be worthy in some SVT patients to plan adequate anticoagulant treatment.
SUMMARY
Background Some studies have suggested that patients with superficial vein thrombosis (SVT) have a non-negligible risk of concomitant deep vein thrombosis (DVT) or pulmonary embolism (PE) at the time of SVT diagnosis. Unfortunately, the available data on this association are widely variable. Objectives To perform a systematic review and meta-analysis of the literature in order to evaluate the prevalence of concomitant DVT/PE in patients with SVT of the lower limbs. Methods Studies reporting on the presence of DVT/PE in SVT patients were systematically searched for in the PubMed, Web of Science, Scopus and EMBASE databases. The weighted mean prevalence (WMP) of DVT and PE was calculated by use of the random effect model. Results Twenty-one studies (4358 patients) evaluated the prevalence of DVT and 11 studies (2484 patients) evaluated the prevalence of PE in patients with SVT. The WMP of DVT at SVT diagnosis was 18.1% (95%CI: 13.9%, 23.3%) and the WMP of PE was 6.9% (95%CI: 3.9%, 11.8%). Heterogeneity among the studies was substantial. Selection of studies including outpatients only gave similar results (WMP of DVT, 18.2%, 95% CI 12.2-26.3%; and WMP of PE, 8.2%, 95% CI 3.3-18.9%). Younger age, female gender, recent trauma and pregnancy were inversely associated with the presence of DVT/PE in SVT patients. Conclusions The results of our large meta-analysis suggest that the prevalence of DVT and PE in patients presenting with SVT is not negligible. Screening for a major thromboembolic event may be worthwhile in some SVT patients, in order to allow adequate anticoagulant treatment to be planned. Other high-quality studies are warranted to confirm our findings.
Topics: Aged; Anticoagulants; Data Collection; Female; Humans; Lower Extremity; Male; Middle Aged; Outpatients; Pregnancy; Pregnancy Complications, Cardiovascular; Prevalence; Pulmonary Embolism; Regression Analysis; Risk Factors; Venous Thromboembolism; Venous Thrombosis
PubMed: 26845754
DOI: 10.1111/jth.13279 -
Fertility and Sterility Apr 2018To systematically review and appraise the existing evidence in relation to the efficacy and safety of pulsatile gonadotropin-releasing hormone (pGnRH) for the treatment... (Meta-Analysis)
Meta-Analysis
Efficacy and safety of pulsatile gonadotropin-releasing hormone therapy among patients with idiopathic and functional hypothalamic amenorrhea: a systematic review of the literature and a meta-analysis.
OBJECTIVE
To systematically review and appraise the existing evidence in relation to the efficacy and safety of pulsatile gonadotropin-releasing hormone (pGnRH) for the treatment of women with hypothalamic amenorrhea (HA).
DESIGN
Systematic review and meta-analysis.
SETTING
Not applicable.
PATIENT(S)
A total of 35 studies (three randomized and 32 observational) encompassing 1,002 women with HA.
INTERVENTION(S)
None.
MAIN OUTCOME MEASURE(S)
Primary outcomes: ovulation rate (OvR), pregnancy per ovulatory cycle rate (POR), and live birth per ovulatory cycle rate (LBOR).
SECONDARY OUTCOMES
multiple gestation (MG), ovarian hyperstimulation syndrome (OHSS), and superficial thrombophlebitis (ST) rates. The summary measures were expressed as proportions and 95% confidence intervals (CI).
RESULT(S)
Pulsatile GnRH treatment appears to achieve high OvRs. A trend toward high PORs and LBORs among women with HA is demonstrated. SC pGnRH achieves comparable OvR compared with IV pGnRH. The incidence of OHSS is low and of mild severity. Treatment with pGnRH is associated with low but slightly higher MG rates compared with the general population. IV administered pGnRH is rarely associated with ST.
CONCLUSION(S)
The high OvRs leading to a high rate of singleton pregnancies and the low likelihood of OHSS render the pGnRH treatment modality both effective and safe for the treatment of women with HA of either primary or secondary origin.
Topics: Adolescent; Adult; Amenorrhea; Female; Fertility Agents, Female; Gonadotropin-Releasing Hormone; Humans; Hypothalamus; Infertility, Female; Live Birth; Ovulation; Ovulation Induction; Pregnancy; Pregnancy Rate; Pulse Therapy, Drug; Risk Assessment; Risk Factors; Treatment Outcome; Young Adult
PubMed: 29605411
DOI: 10.1016/j.fertnstert.2017.12.028 -
The Journal of Maternal-fetal &... May 2022Complication rates associated with peripherally inserted central catheters (PICCs) in the general population are variable, and rates specific to pregnant women are... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Complication rates associated with peripherally inserted central catheters (PICCs) in the general population are variable, and rates specific to pregnant women are unclear. We conducted a systematic review and meta-analysis to estimate the rate of PICC-associated complications in pregnant women.
METHODS
We searched published literature for records discussing PICC use in pregnant or postpartum women. We included studies with primary data regarding rates of maternal complications from PICC use. The primary outcomes were maternal infection (cellulitis, sepsis), venous thromboembolism (VTE), or combined major complication rate. Secondary outcomes were superficial thrombophlebitis or mechanical failure. Meta-analysis was performed using STATA 12 with the METAN and METAPROP software routines. Pooled estimates with 95%CI were calculated using random-effects models.
RESULTS
After the removal of duplicates, the primary search yielded 318 articles, with 5 being included for final analysis. The pooled rate of combined infectious and thromboembolic complications was 26% (95%CI = 6-53%). For secondary outcomes the pooled rate of infectious complications was 18% (95%CI = 4-39%), VTE 6% (95%CI = 0-18%), mechanical failure 7% (95%CI = 3-12%), and superficial thrombophlebitis 1% (95%CI = 0-3%). There was significant statistical heterogeneity between studies for all outcomes calculated.
CONCLUSION
There are limited data regarding complication rates due to PICC use in pregnancy, with a high level of heterogeneity among existing studies. The risk of VTE appears comparable to PICC-associated VTE in the non-pregnant hospitalized population. The risk of infection associated with PICC use was the most variable, with rates ranging from 4% to 37%. This suggests that infection risk may be modifiable and further studies are needed to assess interventions that may lower this risk.
Topics: Catheter-Related Infections; Catheterization, Central Venous; Catheterization, Peripheral; Catheters; Central Venous Catheters; Female; Humans; Pregnancy; Retrospective Studies; Risk Factors; Sepsis; Venous Thromboembolism
PubMed: 32441173
DOI: 10.1080/14767058.2020.1769591 -
The Cochrane Database of Systematic... Jul 2014Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in women with unexplained recurrent miscarriage, with or without inherited thrombophilia.
OBJECTIVES
To evaluate the efficacy and safety of anticoagulant agents, such as aspirin and heparin, in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 October 2013) and scanned bibliographies of all located articles for any unidentified articles.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that assessed the effect of anticoagulant treatment on live birth in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia were eligible. Interventions included aspirin, unfractionated heparin (UFH), and low molecular weight heparin (LMWH) for the prevention of miscarriage. One treatment could be compared with another or with no-treatment (or placebo).
DATA COLLECTION AND ANALYSIS
Two review authors (PJ and SK) assessed the studies for inclusion in the review and extracted the data. If necessary they contacted study authors for more information. We double checked the data.
MAIN RESULTS
Nine studies, including data of 1228 women, were included in the review evaluating the effect of either LMWH (enoxaparin or nadroparin in varying doses) or aspirin or a combination of both, on the chance of live birth in women with recurrent miscarriage, with or without inherited thrombophilia. Studies were heterogeneous with regard to study design and treatment regimen and three studies were considered to be at high risk of bias. Two of these three studies at high risk of bias showed a benefit of one treatment over the other, but in sensitivity analyses (in which studies at high risk of bias were excluded) anticoagulants did not have a beneficial effect on live birth, regardless of which anticoagulant was evaluated (risk ratio (RR) for live birth in women who received aspirin compared to placebo 0.94, (95% confidence interval (CI) 0.80 to 1.11, n = 256), in women who received LMWH compared to aspirin RR 1.08 (95% CI 0.93 to 1.26, n = 239), and in women who received LMWH and aspirin compared to no-treatment RR 1.01 (95% CI 0.87 to 1.16) n = 322).Obstetric complications such as preterm delivery, pre-eclampsia, intrauterine growth restriction and congenital malformations were not significantly affected by any treatment regimen. In included studies, aspirin did not increase the risk of bleeding, but treatment with LWMH and aspirin increased the risk of bleeding significantly in one study. Local skin reactions (pain, itching, swelling) to injection of LMWH were reported in almost 40% of patients in the same study.
AUTHORS' CONCLUSIONS
There is a limited number of studies on the efficacy and safety of aspirin and heparin in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia. Of the nine reviewed studies quality varied, different treatments were studied and of the studies at low risk of bias only one was placebo-controlled. No beneficial effect of anticoagulants in studies at low risk of bias was found. Therefore, this review does not support the use of anticoagulants in women with unexplained recurrent miscarriage. The effect of anticoagulants in women with unexplained recurrent miscarriage and inherited thrombophilia needs to be assessed in further randomised controlled trials; at present there is no evidence of a beneficial effect.
Topics: Abortion, Habitual; Anticoagulants; Antiphospholipid Syndrome; Aspirin; Enoxaparin; Female; Heparin, Low-Molecular-Weight; Humans; Live Birth; Nadroparin; Pregnancy; Pregnancy Complications, Hematologic; Randomized Controlled Trials as Topic; Thrombophilia
PubMed: 24995856
DOI: 10.1002/14651858.CD004734.pub4