Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurrent Pulmonary Embolism: A Randomized Clinical Trial

Abstract

6.9% vs 8.4% and declined to 0.2 to 0.3 percentage points difference by three years after the trial ended. Over follow-up of 9.8 years, the intensive therapy group had a significantly lower risk of the primary outcome than did the standard therapy group (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.70-0.99; P ¼ .04). There was an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person years but there was no reduced cardiovascular mortality benefit (HR, 0.88; 95% CI, 0.64-1.20; P ¼ .42). There was no reduction in total mortality in the intensive therapy group (HR, 1.05; 95% CI, 0.89-1.25; P ¼ .54) with the median follow-up of 11.8 years.Comment: With no reduction in total mortality, small to moderate reductions in rates of cardiovascular events need to be considered along with potential harms due to aggressive attempts to control glucose and side effects of treatment including weight gain and hypoglycemia. Patients and physicians need to decide together whether a reduction in cardiovascular events at the risk of complications of diabetes control and no improvement in mortality is a desired individual patient goal.

International clinical practice guidelines including guidance for direct oral anticoagulants in the treatment and prophylaxis of venous thromboembolism in patients with cancer

“…The 2013 CPGs with regard to use of IVCFs were based on 14 retrospective cohort studies (29-308 patients). Since the 2013 CPGs were published, one new randomised trial 39 has compared recurrence of pulmonary embolism in patients assigned to inferior vena cava fi lters plus anticoagulation (33 [16·5%] of 200 patients had active cancer) versus anticoagulant alone (29 [14·6%] of 199 patients had active cancer). The recurrence for pulmonary embolism was doubled with inferior vena cava fi lters compared with anticoagulant alone at 3-month and 6-month follow-ups, although not statistically signifi cantly (3·0% for inferior vena cava fi lter and anticoagulant at 3-month follow-up vs 1·5% anticoagulant alone at 3-month follow-up).…”

Outcomes After Vena Cava Filter Use in Noncancer Patients With Acute Venous Thromboembolism

“…In 2 relatively small, randomized, clinical trials, VCF use was studied in patients with acute deep vein thrombosis (DVT) 3 and acute PE 11 who also received standard anticoagulation therapy. VCF use provided no significant survival benefit and did not reduce the frequency of subsequent PE in patients who presented with PE.…”

Prevention of Venous Thromboembolism in Individuals with Spinal Cord Injury: Clinical Practice Guidelines for Health Care Providers, 3rd ed.

“…For patients with an acute proximal DVT and an absolute contraindication to therapeutic anticoagulation, placement of a temporary IVC filter is appropriate until the contraindication resolves, although there is actually no direct evidence to support this practice (Kearon, 2012;Mismetti, 2015).…”