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 trial. JAMA. doi:10.1001/jama.2014.15305 etable 1. Outcomes at 30 days in the Per Protocol Population etable 2. Baseline Clinical and Demographic Characteristics etable 3. Antithrombotic Medication on Admission etable 4. Angiographic and Procedural Characteristics etable 5. Outcomes at 30 Days This supplementary material has been provided by the authors to give readers additional information about their work.
etable 1. Outcomes at 30 days in the Per Protocol Population Primary Endpoint of Vascular Access Site Complications (the Composite of Hematoma 5 cm, Pseudoaneurysma, Arterio- Venous Fistula, Access-Site- Related Major Bleeding, Acute Ipsilateral Leg Ischaemia, Need for Vascular Surgical/Interventional Treatment or Local Infection) Vascular Closure Device (n=2984) Manual Compression Difference in Proportions (95% CI) 208 (7.0) 119 (7.9) -0.9% (-2.6%, 0.8%) P <0.001* - Hematoma 5 cm 145 (4.9) 102 (6.8) -1.9% 0.008 (-3.4%,-0.4%) - Pseudoaneurysma 53 (1.8) 23 (1.5) 0.3% 0.536 (-0.6%, 1.1%) - Arteriovenous Fistula 12 (0.4) 2 (0.1) 0.3% 0.126 (-0.1%, 0.6%) - Access-Site-Related 3 (0.1) 3 (0.2) -0.1% 0.394 Major Bleeding** (-0.4%, 0.2%) - Acute Ipsilateral Leg 0 0 Ischaemia - Need for Vascular 0 0 Surgical or Interventional Treatment - Local Infection 1 0 0.477 Data are shown as number (percentage) or median [interquartile range]; * P-value from the non-inferiority analysis ** based on REPLACE-2 criteria
etable 2. Baseline Clinical and Demographic Characteristics Intravascular VCD Extravascular VCD Age, years 66.6 [57.8-74.3] 68.1 [59.3-74.9] Female 469 (31) 448 (30) Arterial Hypertension 1299 (86.1) 1300 (86.3) Hypercholesterolemia 973 (64) 969 (64) Diabetes Mellitus 285 (18.9) 299 (19.9) - Insulin-requiring 71 (4.7) 71 (4.7) Family History of Premature 482 (32) 462 (31) Coronary Artery Disease Active or Former Smoker 628 (42) 621 (41) History of Prior MI* 408 (27) 405 (27) History of Prior PCI 885 (59) 900 (60) History of Prior CABG 114 (7.6) 141 (9.4) Body Mass Index, kg/m² 27.0 [24.5-29.8] 27.1 [24.5-29.9] Renal Failure - Not dialysis Dependent 154 (10.2) 158 (10.5) - Dialysis Dependent 7 (0.5) 4 (0.3) Platelet Count, x10 9 /Liter 208 [176-242] 208 [176-247] Data are shown as number (percentage) or median [interquartile range]; *MI denotes Myocardial Infarction; PCI denotes Percutaneous Coronary Intervention; CABG denotes Coronary Artery Bypass Graft
etable 3. Antithrombotic Medication on Admission Intravascular VCD Extravascular VCD Acetylsalicylic acid 1025 (68) 1047 (70) ADP-Receptor Blocker - Clopidogrel 512 (33.9) 546 (36.3) - Prasugrel 70 (4.6) 61 (4.1) - Ticagrelor 17 (1.1) 12 (0.8) Oral Anticoagulation - Coumadins 161 (10.7) 169 (11.2) - Rivaroxaban 20 (1.3) 22 (1.5) - Dabigatran 8 (0.5) 6 (0.4) - Apixaban 1 (0.1) 1 (0.1) Data are shown as number (percentage)
etable 4. Angiographic and Procedural Characteristics Intravascular VCD Extravascular VCD Ejection Fraction, %* 60 [52-62] 60 [52-62] No. of Diseased Vessels - No Obstructive Coronary Artery 518 (34.3) 478 (31.7) Disease - 1 248 (16.4) 274 (18.2) - 2 292 (19.4) 275 (18.3) - 3 451 (29.9) 479 (31.8) Multivessel Disease 743 (49) 754 (50) Arterial Blood Pressure - Systolic, mmhg 140 [128-160] 140 [130-160] - Diastolic, mmhg 75 [65-80] 73 [65-80] Data are shown as number (percentage) or median [interquartile range]; *available for 2577 patients
etable 5. Outcomes at 30 Days Primary Endpoint of Vascular Access Site Complications (the Composite of Hematoma 5 cm, Pseudoaneurysma, Arterio-Venous Fistula, Access-Site-Related Major Bleeding, Acute Ipsilateral Leg Ischaemia, Need for Vascular Surgical/Interventional Treatment or Local Infection) Intravascular VCD Extravascular VCD 90 (6.0) 118 (7.8) Difference in Proportions (95% CI) -1.8% (-3.7%, 0%) P 0.043 - Hematoma 5 cm 65 (4.3) 80 (5.3) -1.0% (-2.6%, 0.6%) 0.197 - Pseudoaneurysma 22 (1.5) 31 (2.1) -0.6% (-1.6%, 0.4%) 0.210 - Arteriovenous Fistula 4 (0.3) 8 (0.5) -0.2% (-0.8%, 0.2%) 0.246 - Access-Site-Related 0.1% 2 (0.1) 1 (0.1) Major Bleeding* (-0.2%, 0.3%) 0.565 - Acute Ipsilateral Leg Ischaemia 0 0 - Need for Vascular Surgical/Interventional 0 0 Treatment - Local Infection 1 (0.1) 0 0.318 Secondary Endpoint: Time to Hemostasis, minutes 0.5 [0.2-1.0] 2 [1.0-2.0] <0.001 Secondary Endpoint: Repeat Manual Compression 22 (1.5) 31 (2.1) 0.210 Secondary Endpoint: Closure Device Failure 80 (5.3) 184 (12.2) <0.001 Data are shown as number (percentage) or median [interquartile range]; * based on REPLACE-2 criteria