Vascular Closure Devices Versus Manual Compression After Femoral Artery Access
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1 Vascular Closure Devices Versus Manual Compression After Femoral Artery Access the ISAR-CLOSURE Randomized Trial Stefanie Schüpke (Schulz) 1, Sandra Helde 1, Senta Gewalt 1, Tareq Ibrahim 2, Roland Schmidt 3, Lorenz Bott-Flügel 4, Andreas Stein 3, Nadar Joghetai 4, Maryam Linhardt 1, Katharina Haas 1, Katharina Hoppe 5, Philipp Groha 1, Christian Bradaric 2, Ilka Ott 1, Iva Simunovic 1, Robert Byrne 1, Tanja Morath 1, Sebastian Kufner 1, Salvatore Cassese 1, Petra Hoppmann 2, Massimiliano Fusaro 1, Julinda Mehilli 6, Heribert Schunkert 1, Karl-Ludwig Laugwitz 2, Adnan Kastrati 1 1 Deutsches Herzzentrum München, Munich, Germany, 2 1. Medizinische Klinik, Klinikum rechts der Isar, Munich, Germany, 3 Krankenhaus der Barmherzigen Brüder, Innere Medizin II, Munich, Germany, 4 Klinikum Landkreis Erding, 5 Schoen Klinik Starnberger See, Berg, Germany, 6 Klinikum der Universität München, Medizinische Klinik und Poliklinik I, Munich, Germany
2 Disclosure Statement of Financial Interest I, Stefanie Schüpke, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
3 All faculty disclosures are available on the CRF Events App and online at
4 Background The role of vascular closure devices (VCD) for the achievement of hemostasis after femoral artery puncture remains controversial Increased efficacy, i.e. reduced time to hemostasis and earlier ambulation, has been a consistent finding across different trials of VCDs However, meta-analyses suggest an increased risk of vascular complications with VCD compared to manual compression Koreny et al. JAMA 2004;1:
5 Background Size of most RCTs has generally been modest, permitting evaluation of efficacy but precluding definitive assessment of safety Moreover, comparative efficacy studies between devices used in contemporary practice remain a scientific gap
6 Primary objective Objectives Comparison of 2 hemostasis strategies: Vascular closure device (VCD) vs. manual compression Secondary objective Comparison of 2 types of VCD: Femoseal vs. Exoseal in pts undergoing transfemoral coronary angiography
7 Hypothesis In patients undergoing transfemoral coronary angiography, VCD are noninferior to manual compression to terms of vascular access site complications
8 Design Investigator-initiated, randomized, large-scale, multicenter, open-label trial Recruitment period: 04/ /2014
9 Study Organisation Participating Centers: Deutsches Herzzentrum Munich Klinikum rechts der Isar, Munich Krankenhaus der Barmherzigen Brüder, Munich Klinikum Landkreis Erding Steering Committee: Adnan Kastrati (Study Chair) Maryam Linhardt (PI) Tareq Ibrahim Julinda Mehilli Coordinating Center: ISAResearch Center Munich Event Adjudication Committee: Olga Bruskina (Chair) Gjin Ndrepepa Andreas Stein Imaging Core Lab: Corinna Böttiger
10 Eligibility Criteria Major Inclusion Criteria: Pts undergoing coronary angiography with a 6 French sheath via the common femoral artery Diameter of common femoral artery of > 5 mm Major Exclusion Criteria: Implantation of a VCD within the last 30 days Symptomatic leg ischemia Prior TEA or patch plastic of the common femoral artery Planned invasive diagnostic/interventional procedure in the following 90 days Heavily calcified vessel Active bleeding or bleeding diathesis Severe arterial hypertension (>220/110 mmhg) Local infection Autoimmune disease Allergy to resorbable suture Pregnancy
11 Endpoints Primary endpoint: Vascular access site complications at 30 days after randomisation i.e. the composite of hematoma 5 cm, arteriovenous fistula, pseudoaneurysm, access-site related bleeding*, acute ipsilateral leg ischemia, need for vascular surgical or interventional treatment or local infection Secondary endpoints: - Time to hemostasis - Repeat manual compression - VCD failure *Adapted from REPLACE-2 criteria: Hb drop 3 g/dl with evident bleeding, Hb drop 4 g/dl with/without evident bleeding or bleeding requiring blood transfusion
12 Sample Size Calculation Assumptions: - Incidence of the primary endpoint in the manual compression group: 5% - Margin of non-inferiority: 2% (absolute) - Power 80% - 1-sided α-level Enrolment of 4,500 patients required
13 Study Flow Patients undergoing diagnostic coronary angiography via the common femoral artery (after angiography of access site) n=4,524 1:1:1 open-label Femoseal VCD n=1,509 Exoseal VCD n=1,506 Manual Compression n=1,509 Follow-up: Duplex sonography prior to hospital discharge Clinical follow-up at 30 days
14 Baseline Characteristics (1/2) Vascular Closure Device (n=3015) Manual Compression (n=1509) Age, years 67.4 [ ] 68.4 [ ] Female 917 (30) 478 (32) Arterial Hypertension 2599 (86.2) 1319 (87.4) Hypercholesterolemia 1942 (64) 997 (66) Diabetes Mellitus 584 (19.4) 321 (21.3) - Insulin-Requiring 142 (4.7) 65 (4.3) Family History 944 (31) 471 (31) Active or Former Smoker 1249 (41) 602 (40)
15 Baseline Characteristics (2/2) Vascular Closure Device (n=3015) Manual Compression (n=1509) History of Prior MI 813 (27.0) 393 (26.0) History of Prior PCI 1785 (59) 882 (58) History of Prior CABG 255 (8.5) 135 (8.9) Body Mass Index, kg/m² 27.1 [ ] 27.0 [ ] Renal Failure - Not Dialysis Dependent 312 (10.3) 161 (10.7) - Dialysis Dependent 11 (0.4) 3 (0.2) Platelet Count, x10 9 /Liter 208 [ ] 206 [ ]
16 Antithrombotic Medication On Admission Vascular Closure Device (n=3015) Manual Compression (n=1509) Acetylsalicylic acid 2072 (67) 1025 (68) ADP-Receptor Blocker - Clopidogrel 1058 (35.1) 503 (33.3) - Prasugrel 131 (4.3) 48 (3.2) - Ticagrelor 29 (1.0) 16 (1.1) Oral Anticoagulation - Coumadins 330 (10.9) 175 (11.6) - Rivaroxaban 42 (1.4) 33 (2.2) - Dabigatran 14 (0.5) 6 (0.4) - Apixaban 2 (0.1) 2 (0.1)
17 Angiographic And Procedural Characteristics Vascular Closure Device (n=3015) Manual Compression (n=1509) Ejection Fraction, % 60 [52-62] 60 [52-62] No. of Diseased Vessels - No Obstructive CAD 996 (33.0) 516 (34.2) (17.3) 269 (17.8) (18.8) 272 (18.0) (30.8) 452 (30.0) Multivessel Disease 1497 (49.7) 724 (48.0) Arterial Blood Pressure - Systolic, mmhg 140 [ ] 140 [ ] - Diastolic, mmhg 75 [65-80] 75 [65-80]
18 % Primary Endpoint: the Composite of Vascular Access Site Complications 6.9% VCD 7.9 % Manual Compression
19 Primary Endpoint: the Composite of Vascular Access Site Complications % % VCD 7.9 % Manual Compression Infection Bleeding AV-Fistula Pseudoaneurysm Pseudoaneuryma Haematoma
20 Primary Endpoint - Individual Components - Vascular Closure Device (n=3015) Manual Compression (n=1509) P* Primary Composite Endpoint 208 (6.9) 119 (7.9) Hematoma 5 cm 145 (4.8) 102 (6.8) Pseudoaneurysm 53 (1.8) 23 (1.5) Arteriovenous Fistula 12 (0.4) 2 (0.1) Access Site-Related Major Bleeding 3 (0.1) 3 (0.2) Acute Ipsilateral Leg Ischaemia Need for Vascular Surgical or Interventional Treatment Local Infection *Conventional superiority testing with a significance level of p<0.025
21 Primary Endpoint Margin of Non-inferiority Versus Manual Compression 1-sided 97.5 % Limit P Noninferiority < Difference in Primary Endpoint (%)
22 Secondary Endpoints Vascular Closure Device (n=3015) Manual Compression (n=1509) P* Time to Hemostasis, minutes 1 [ ] 10 [10-15] <0.001 Repeat Manual Compression 53 (1.8) 10 (0.7) *Conventional superiority testing with a significance level of p<0.025
23 Secondary Comparison: Femoseal vs. Exoseal
24 Secondary Comparison: Femoseal vs. Exoseal Femoseal (n=1509) Exoseal (n=1506) Primary Endpoint of Vascular Access Site Complications 90 (6.0) 118 (7.8) Hematoma 5 cm 65 (4.3) 80 (5.3) Pseudoaneurysm 22 (1.5) 31 (2.1) Arteriovenous Fistula 4 (0.3) 8 (0.5) Access-Site-Related Major Bleeding* 2 (0.1) 1 (0.1) Acute Ipsilateral Leg Ischaemia Need for Vascular 0 0 Surgical/Interventional Treatment - Local Infection 1 (0.1) P* *Conventional superiority testing with a significance level of p<0.025
25 Secondary Comparison: Femoseal vs. Exoseal Femoseal (n=1509) Exoseal (n=1506) P* Time to Hemostasis 0.5 [ ] 2 [ ] <0.001 Repeat Manual Compression 22 (1.5) 31 (2.1) Closure Device Failure 80 (5.3) 184 (12.2) <0.001 *Conventional superiority testing with a significance level of p<0.025
26 Summary And Conclusion (1/2) In patients undergoing transfemoral coronary angiography, VCD are non-inferior to manual compression in terms of vascular access site complications and reduce time-to-hemostasis The increase in efficacy of VCD with no tradeoff in safety provides a sound rationale for the use of VCD over manual compression in daily routine
27 Summary And Conclusion (2/2) The use of the intravascular Femoseal VCD was associated with a tendency towards less vascular access-site complications as compared to the extravascular Exoseal VCD Time-to-hemostasis was shorter and device deployment failures were less frequent with the Femoseal VCD compared to the Exoseal VCD
28 Thanks for your attention!
Supplementary Online Content
Supplementary Online Content Schulz Schüpke S, Helde S, Gewalt S; et al. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical
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