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Reduced Rate and Cost of Complications

12/07/2019 -  

​Comparison of Vascular Closure Devices vs Manual Compression after Femoral Artery Puncture.


Schulz-Schüpke et al. Comparison of VCD vs Manual Compression After Femoral Artery Puncture. The ISAR-CLOSURE Randomised Clinical Trial. JAMA, 312(19):1981-1987. 2014.


DESCRIPTION

  • Randomised controlled multicenter open-label clinical trial with 4.524 patients undergoing coronary angiography with 6 Fr sheath.

  • After angiography of the access site, patients were randomised to hemostasis with intravascular VCD (FemoSeal; n=1.509), Extravascular VCD (ExoSeal; n=1.506) or manual compression (n=1.509) in 1:1:1 ratio.

  • Primary endpoint: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin.

  • Secondary endpoints: time to hemostasis, repeat manual compression, and VCD failure.


KEY FINDINGS

  • The primary endpoint was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (p for non-inferiority <0.001).

  • Time to hemostasis was significantly shorter in patients with VCD (1 min) vs manual compression (10 min) (p<0.001).

  • Time to hemostasis was significantly shorter among patients with intravascular VCD (FemoSeal; 0.5 min) vs extravascular VCD (ExoSeal; 2 min) (p <0.001).

  • Closure device failure was also significantly lower among patients with intravascular vs extravascular VCD (80 patients (5.3%) vs 184 patients (12.2%); p <0.001).

  • VCD are non-inferior to Manual Compression (vascular access site complications & shorter time to hemostasis, and FemoSeal vs ExoSeal has faster hemostasis, less deployment failures and less complications


Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study.


Holm N. Randomised comparison of manual compression and FemoSeal™ vascular closure device for closure after femoral artery access coronary angiography: CLOSE-UP Study. EuroIntervention, 9:183-190. 2014.

DESCRIPTION

  • Single center randomised trial, conducted at the Aarhus University Hospital in Denmark.

  • Objective: compare the safety and efficacy of the FemoSeal VCD vs manual compression after femoral access coronary angiography (CAG).

  • 1001 consecutive patients, 501 patients had a FemoSeal closure device and 500 patients received manual compression.

  • Primary endpoint: in-hospital incidence of access-site haematoma >5 cm. Secondary endpoints included 14-day major bleeding, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, infection, other complications requiring surgery.


KEY FINDINGS

  • The primary endpoint was observed in 6.7% of the manual compression patients vs 2.2% for FemoSeal group (p=0.002).

  • Median closure time was 8.0 minutes for manual compression vs 1.0 minute with FemoSeal (p<0.0001).

  • Closure of femoral access after coronary angiography by FemoSeal was associated with significantly fewer in-hospital large haematomas and was haemostasis was significantly faster.


Network Meta-analysis of Randomised Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis.


Jun Jiang et al. Network Meta-analysis of Randomised Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis. Sci Rep.; 5:13761. 2015.


DESCRIPTION

Objective: Network meta-analysis comparing the safety of different VCDs.

  • 40 RCTs with 16.868 patients

  • Comparison of different VCDs vs MC with patients undergoing diagnostic and/or interventional femoral procedures

  • Traditional meta-analysis: no significant difference in the rate of Combined Adverse Vascular Events (CAVEs) between all the VCDs and manual compression (MC)


KEY  FINDINGS

Results

1. Direct meta-analysis:
  • Traditional meta-analysis: risk for CAVE is similar between VCDs and MC

  • Subgroup analysis: similar results, but FemoSeal showed significantly reduced risk of CAVE

  • Haematoma risk: significantly lower with VCDs vs MC (RR: 0.80, CI: 0.71-0.90)

  • Design improvements of VCDs & increased user experience -> decreases risk of CAVE


Table 1. Risk of combined adverse vascular events of different vascular closure devices versus manual compression. 

​Vascular closure devices

​ ​N° of studies

​Total Patients 

​M-H, random

Heterogeneity​

​Test for overal effect


​RR (95% CI)

​Chi2/I2

​Z value 

​P value

​Angio-Seal

​13

​3264

​0.69 [0.46, 1.03]

​44.41/0.73

​1.81

​0.07

​Vasoseal

​7

​1301

1.10 [0.75, 1.61]

​22.68/0.74

​0.46

​0.64

​Exoseal

​2

​3416

1.45 [0.55, 3.84]

​3.51/0.72

​0.75

​0.45

​QuickSeal

​2

​539

1.27 [0.48, 3.37]

​2.40/0.58

​0.49

​0.63

​FemoSeal

​2

​4019

0.75 [0.60, 0.94]

​0.00/0.00

​2.46

​0.01*

​Perclose

9​

​2311

1.00 [0.65, 1.52]

​14.89/0.46

​0.02

​0.99

​StarClose

​3

​1132

0.63 [0.29, 1.37]

​5.27/0.62

​1.17

​0.24

*Statistically significant.

2. Network analysis on CAVE:

  • Angio-Seal – reduced risk of CAVE vs MC (RR: 0.67, CI: 0.46–0.98)

  • Other VCDs: similar risk for CAVE vs MC. No difference in risk for CAVE between different VCDs.

CONCLUSION

  • The use of VCDs significantly decreased the risk of haematomas

  • The newly developed VCDs significantly reduced the rate of CAVE

  • FemoSeal also significantly reduced the risk of CAVE. Newer VCDs with advanced design might improve the safety of VCDs

  • Angio-Seal, which might be the best VCD among all included VCDs, reduced the rate of both CAVE and haematomas vs MC