Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial.
OBJECTIVE
The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial.


OBJECTIVE
To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications. A secondary objective was the comparison of the 2 types of VCD.


METHODS
Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014.


METHODS
After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio.


METHODS
Primary end point: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons.


RESULTS
Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, -1.0% [1-sided 97.5% CI, 0.7%]; P for noninferiority<.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001).


CONCLUSIONS
In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis.


BACKGROUND
clinicaltrials.gov Identifier: NCT01389375.
Deutsches Herzzentrum München, Technische Universität, Munich, Germany2DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Stefanie
S
Schulz-Schüpke
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Sandra
S
Helde
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Senta
S
Gewalt
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Tareq
T
Ibrahim
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Maryam
M
Linhardt
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Katharina
K
Haas
Schön Klinik Starnberger See, Berg, Germany.
Katharina
K
Hoppe
Schön Klinik Starnberger See, Berg, Germany.
Corinna
C
Böttiger
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Philip
P
Groha
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Christian
C
Bradaric
Krankenhaus der Barmherzigen Brüder, Innere Medizin II, Munich, Germany.
Roland
R
Schmidt
Klinikum Landkreis Erding, Abteilung Kardiologie und Pneumologie, Erding, Germany.
Lorenz
L
Bott-Flügel
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Ilka
I
Ott
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Julia
J
Goedel
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Robert A
RA
Byrne
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Simon
S
Schneider
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Christof
C
Burgdorf
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Tanja
T
Morath
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Sebastian
S
Kufner
CVPath Institute Inc, Gaithersburg, Maryland.
Michael
M
Joner
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Salvatore
S
Cassese
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Petra
P
Hoppmann
Deutsches Herzzentrum München, Technische Universität, Munich, Germany2DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Christian
C
Hengstenberg
Schön Klinik Starnberger See, Berg, Germany.
Jürgen
J
Pache
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Massimiliano
M
Fusaro
DZHK, Partner Site Munich Heart Alliance, Munich, Germany8Medizinische Klinik und Poliklinik I, Klinikum der LMU, Munich, Germany.
Steffen
S
Massberg
DZHK, Partner Site Munich Heart Alliance, Munich, Germany8Medizinische Klinik und Poliklinik I, Klinikum der LMU, Munich, Germany.
Julinda
J
Mehilli
Deutsches Herzzentrum München, Technische Universität, Munich, Germany2DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Heribert
H
Schunkert
DZHK, Partner Site Munich Heart Alliance, Munich, Germany31. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Karl-Ludwig
KL
Laugwitz
Deutsches Herzzentrum München, Technische Universität, Munich, Germany2DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Adnan
A
Kastrati
D000368:Aged; D006328:Cardiac Catheterization; D017023:Coronary Angiography / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005263:Femoral Artery; D006487:Hemostasis; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D011677:Punctures; D013997:Time Factors; D065506:Vascular Closure Devices