ABSTRACT
Emicizumab has been approved in several countries for regular prophylaxis in patients with congenital haemophilia A and FVIII inhibitors because it substantially reduces their bleeding risk and improves quality of life. However, although significantly less frequent, some breakthrough bleeds may still occur while on emicizumab, requiring treatment with bypassing or other haemostatic agents. Thrombotic complications have been reported with the associated use of activated prothrombin complex concentrates. In addition, when surgery/invasive procedures are needed while on emicizumab, their management requires multidisciplinary competences and direct supervision by experts in the use of this agent. Given this, and in order to expand the current knowledge on the use of emicizumab and concomitant haemostatic agents, and reduce the risk of complications in this setting, the Italian Association of Haemophilia Centres (AICE) here provides guidance on the management of breakthrough bleeds and surgery in emergency situations in patients with haemophilia A and inhibitors on emicizumab prophylaxis. This paper has been shared with other National Scientific Societies involved in the field.
Subject(s)
Antibodies, Bispecific/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Hemophilia A/prevention & control , Hemostatics/therapeutic use , Antibodies, Bispecific/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Factor VIII/antagonists & inhibitors , Hemorrhage/prevention & control , Hemostatics/adverse effects , Humans , Italy , Quality of LifeABSTRACT
OBJECTIVES: Periprocedural bleedings, often related to vascular access site, represent an important drawback of percutaneous coronary procedures and are associated with worse outcomes. Radial access (RA) and, potentially, femoral access (FA) with vascular closure device (VCD) are useful strategies in order to mitigate periprocedural bleedings; nevertheless, their relative efficacy is largely undetermined. We aimed to perform a systematic review and meta-analysis of available studies comparing the efficacy of RA and FA with hemostasis by VCD (FA + VCD) on the reduction of access-site complications and/or periprocedural bleedings. METHODS: Published studies reporting outcomes on access-site complications and periprocedural bleedings were included in the analysis. Data were extracted by two independent reviewers; odds ratio (OR) and 95% confidence interval (CI) were calculated by random-effects model and were used as summary statistics. RESULTS: We included in the analysis 13 studies, of which 5 were randomized. Access-site complications were reported by 11 studies, amounting to 157,031 patients (77,713 in the RA group and 79,318 in the FA + VCD group), whereas periprocedural bleedings were reported by 12 studies, amounting to 600,196 patients (137,277 in the RA group and 462,919 in the FA + VCD group). RA was associated with a significant reduction in access-site complications (OR, 0.25; 95% CI ,0.21-0.31; P<.001) and periprocedural bleedings (OR, 0.40; 95% CI, 0.34-0.48; P<.001) as compared with FA + VCD; the results were consistent among randomized and observational studies. CONCLUSIONS: This meta-analysis shows that RA is superior to FA + VCD in the reduction of access-site complications and periprocedural bleedings.
Subject(s)
Cardiac Catheterization/methods , Catheterization, Peripheral , Femoral Artery , Hemorrhage , Hemostasis, Surgical , Percutaneous Coronary Intervention/methods , Radial Artery , Vascular Closure Devices , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/methods , Comparative Effectiveness Research , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Hemorrhage/etiology , Hemorrhage/surgery , Hemostasis, Surgical/instrumentation , Hemostasis, Surgical/methods , Humans , Radial Artery/diagnostic imaging , Radial Artery/surgeryABSTRACT
Cardiac catheterization through the radial artery approach (RA) has been shown to significantly reduce access-site complications compared with the femoral artery approach (FA) in many clinical settings. However, in the subset of patients with previous coronary artery bypass grafting (CABG), optimal vascular access site for coronary angiography and intervention is still a matter of debate. We aimed to perform a systematic review and meta-analysis of available studies comparing RA with FA in patients with previous CABG. Data were extracted by two independent reviewers; weighted mean differences and 95% confidence interval (CI) were calculated for continuous outcomes, whereas odds ratio (OR) and 95% CI were calculated for dichotomous outcomes. Summary statistics were calculated by random-effects model using Review Manager 5.3 software. The meta-analysis included 1 randomized and 8 nonrandomized studies, with a total of 2,763 patients. Compared with FA, RA required similar procedural time (mean difference 3.24 minutes, 95% CI -1.76 to 8.25, p = 0.20), fluoroscopy time (mean difference 0.62 minutes, 95% CI -0.83 to 2.07, p = 0.40), and contrast volume (mean difference -2.58 ml, 95% CI -18.36 to 13.20, p = 0.75) and was associated with similar rate of procedural failure (OR 1.32, 95% CI 0.63 to 2.80, p = 0.46), higher rate of crossover to another vascular access (OR 7.0, 95% CI 2.74 to 17.87, p <0.0001), and lower risk of access-site complications (OR 0.46, 95%CI 0.26 to 0.80, p = 0.006). In conclusion, the present meta-analysis suggests that in patients with previous CABG undergoing coronary procedures, RA, compared with FA, is associated with increased crossover rate but may reduce access-site complications.
