Comparison of manual compression and vascular hemostasis devices after coronary angiography or percutaneous coronary intervention through femoral artery access: A meta-analysis of randomized controlled trials

Abstract

Objectives: To compare the efficacy and safety of manual compression (MC) with vascular hemostasis devices (VHD) in patients undergoing coronary angiography (CA) or percutaneous coronary intervention (PCI) through femoral artery access. Introduction: The use of femoral artery access for coronary procedures may result in access-related complications, prolonged immobility and discomfort for the patients. MC results in longer time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to VHDs but its role in access-related complications remains unclear in patients undergoing coronary procedures. Methods: We searched MEDLINE, EMBASE, Cochrane CENTRAL and relevant references for English language randomized controlled trials (RCT) from inception through September 30, 2016. We performed the meta-analysis using random effects model. The outcomes were time-to-hemostasis, time-to-ambulation, major bleeding, large hematoma > 5 cm, pseudoaneurysm and other adverse events. Results: The electronic database search resulted in a total of 44 RCTs with a total of 18,802 patients for analysis. MC, compared to VHD resulted in longer TTH [mean difference (MD): 11.21 min; 95% confidence interval (CI) 8.13–14.29; P < 0.00001] and TTA [standardized mean difference: 1.2 (0.79–1.62); P < 0.00001] along with excess risk of hematoma > 5 cm formation [risk ratio (RR): 1.38 (1.15–1.67); P = 0.0008]. MC resulted in similar risk of major bleeding [1.01 (0.64–1.60); P = 0.95] pseudoaneurysm [0.99 (0.75–1.29); P = 0.92], infections [0.52 (0.25–1.10); P = 0.09], need of surgery [0.60 (0.29–1.22); P = 0.16), AV fistula [0.93 (0.68–1.27); P = 0.63] and ipsilateral leg ischemia [0.95 (0.57–1.60); P = 0.86] compared to VHD. Conclusion: Manual compression increase time-to-hemostasis, time-to-ambulation and risk of hematoma formation compared vascular hemostasis devices.