Introduction
Material and methods
Patient population
FVCD device
Study design
Endpoints
Outcome assessment
Interventional operators and method of access
Statistical analysis
Approval of the ethics committee
Results
Baseline clinical and demographic patient characteristics
Number of patients (n = 1923)a | % of study population | |
---|---|---|
Age (years), median (IQR) | 67.00 (58.00–74.00) | – |
Female sex | 609 | 31.7 |
Arterial hypertension | 1563 | 81.3 |
Hypercholesterolemia | 1227 | 63.8 |
Diabetes mellitus | 349 | 18.1 |
– On insulin treatment | 118 | 6.1 |
Positive family history for premature coronary artery disease | 580 | 30.2 |
Prior percutaneous coronary intervention | 703 | 36.6 |
Prior coronary artery bypass graft | 85 | 4.4 |
Body mass index, median (IQR) | 26.23 (24.11–29.06) | – |
Renal failure (GFR < 60 ml/min) | 550 | 28.6 |
– On dialysis treatment | 39 | 2.0 |
Peripheral artery disease (n = 1912)b (stage I, II, III, IV) | 106 (63, 35, 2, 6) | 5.5 (3.3, 1.8, 0.1, 0.3) |
Platelet count (109/L), median (IQR) | 207 (175–245) | – |
ACS on admission (n = 1916)b | 388 | 20.2 |
Arterial blood pressure during coronary angiography (mm Hg), median (IQR) | 147 (131–165) systolic | – |
74 (65–81) diastolic |
Number of patients | % of study population | |
---|---|---|
Acetylsalicylic acid (n = 1916)1 | 1501 | 78.3 |
P2Y12 receptor blocker (n = 1915)a | 914 | 47.8 |
– Clopidogrel | 575 | 30.0 |
– Prasugrel | 147 | 7.7 |
– Ticagrelor | 192 | 10.0 |
Oral anticoagulation (n = 1913)a | 261 | 13.6 |
– Vitamin K antagonists | 86 | 4.5 |
– Rivaroxaban | 127 | 6.6 |
– Dabigatran | 15 | 0.8 |
– Apixaban | 33 | 1.7 |
Others (n = 1915)a | 909 | 47.5 |
– Tirofiban | 14 | 0.7 |
– Abciximab | 50 | 2.6 |
– Heparin | 770 | 40.2 |
– Bivalirudin | 75 | 3.9 |
Clinical outcome
Number of patients (n = 1923) | % of study population | |
---|---|---|
Access site-related bleeding with need of manual compression | 30 | 1.6 |
Access site-related bleeding with need of FemoStop™ administration | 21 | 1.1 |
Pseudoaneurysm | 44 | 2.3 |
– Manual compression | 25 | 1.3 |
– Fibrin coagulation | 7 | 0.4 |
– Surgical treatment | 12 | 0.6 |
Arteriovenous fistula with surgical treatment | 1 | 0.05 |
Local infection | 0 | – |
Ipsilateral leg ischemia | 0 | – |
Any bleeding with need of manual compression or FemoStop™ administration, pseudoaneurysm, arteriovenous fistula, local infection or ipsilateral leg ischemia | 89 | 4.6 |
Number of patients with pre-existing condition | % of population | Number of patients without pre-existing condition | % of study population | p-value | |
---|---|---|---|---|---|
Peripheral artery disease (n = 1912)a | 106 | – | 1806 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 5 | 4.7 | 46 | 2.5 | 0.20 |
– Pseudoaneurysm | 0 | 0 | 44 | 2.4 | 0.17 |
Acute coronary syndrome on admission (n = 1916)a | 388 | – | 1528 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 11 | 2.8 | 40 | 2.6 | 0.86 |
– Pseudoaneurysm | 17 | 4.4 | 27 | 1.8 | <0.01 |
Readministration of the femoral closure device within 90 days at same puncture site (n = 1920)a | 117 | – | 1803 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 1 | 0.9 | 50 | 2.7 | 0.37 |
– Pseudoaneurysm | 2 | 1.7 | 42 | 2.3 | 1.00 |
Number of patients with pre-existing condition | % of population | Number of patients without pre-existing condition | % of study population | p-value | |
---|---|---|---|---|---|
Administration of P2Y12 receptor blockers (n = 1915)1 | 914 | – | 1001 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 21 | 2.3 | 30 | 3.0 | 0.39 |
– Pseudoaneurysm | 32 | 3.5 | 12 | 1.2 | <0.01 |
Administration of heparin or bivalirudin (n = 1915)a | 845 | – | 1070 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 22 | 2.6 | 29 | 2.7 | 1.00 |
– Pseudoaneurysm | 28 | 3.3 | 16 | 1.5 | <0.01 |
Patients with ACS in the cohort of patients receiving heparin or bivalirudin (n = 845) | 304 | – | 541 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 7 | 2.3 | 14 | 2.6 | 1.00 |
– Pseudoaneurysm | 15 | 4.9 | 13 | 2.4 | 0.07 |
Administration of heparin or bivalirudin in the cohort of patients without ACS (n = 1528) | 552 | – | 976 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 14 | 2.5 | 26 | 2.6 | 1.00 |
– Pseudoaneurysm | 14 | 2.5 | 13 | 1.3 | 0.11 |
Administration of GP IIb/IIIa inhibitors (n = 1915)a | 64 | – | 1851 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 1 | 1.6 | 50 | 2.7 | 1.00 |
– Pseudoaneurysm | 4 | 6.2 | 40 | 2.2 | 0.06 |
Administration of any P2Y12 blocker, heparin/bivalirudin or GP IIb/IIIa inhibitor (n = 1911)a | 1063 | – | 848 | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 29 | 2.7 | 22 | 2.6 | 0.89 |
– Pseudoaneurysm | 33 | 3.1 | 11 | 1.3 | <0.01 |
Administration of any P2Y12 blocker (prasugrel/ticagrelor vs. clopidogrel) (n = 914) | 339 (prasugrel/ticagrelor) | – | 575 (Clopidogrel) | – | – |
– Access site-related bleeding with need for compression (manual or FemoStop™) | 8 | 2.4 | 13 | 2.3 | 1.0 |
– Pseudoaneurysm | 6 | 1.8 | 22 | 3.8 | 0.11 |