Background
Bleeding and vascular complications related to arterial access
Strategies to prevent bleeding and vascular complications
Radial technique
Percutaneous vascular closure devices
Methods
The ARISE study
Design
Outcomes
Primary outcome
Secondary outcomes
Term | Definition |
---|---|
Major bleeding | Type 3 ((3a) bleeding with hemoglobin drop ≥ 3 and < 5 g/dL, or packed red cells transfusion; (3b) bleeding with hemoglobin drop ≥ 5 g/dL, heart tamponade, bleeding requiring surgical intervention or bleeding requiring intravenous inotropic drugs; (3c) intracranial hemorrhage; subcategories confirmed by autopsy, imaging examinations or lumbar puncture; intraocular bleeding with vision impairment) or type 5 bleeding ((5a) possibly fatal bleeding, (5b) definitive fatal bleeding), according to the Bleeding Academic Research Consortium definition [30]. |
Retroperitoneal hematoma | Defined as building up of blood in the retroperitoneal space, caused by common femoral artery puncture above the inguinal ligament, not obtaining an adequate hemostasis with consequent hematoma formation. It is clinically manifested by dorsal, loin or inguinal pain, hypotension and/or hematocrit drop. Its diagnosis has to be confirmed by abdominal ultrasound and/or CT. |
Compartment syndrome | Defined as abnormal tissue pressure increase inside an osteo-fascial compartment (considering in this analysis the involvement of upper or lower limbs after arterial puncture), impairing nervous and muscular structure irrigation, characterized by paresthesia, continuous pain, hypoesthesia, edema and stiffening of the affected region, peaking with tissue necrosis and/or permanent functional injury if not adequately treated. |
Hematoma | Defined as localized collection of extravascular blood adjacent to the vessel, located in the topography of the punctured artery used to perform the procedure. |
Pseudoaneurysm | Defined as a neocavity delimited by tissues adjacent to the injured vessel, fed by continuous blood flow into and out, coming from the real lumen through a narrow neck connecting it to the inside of the cavity. Diagnosis is determined by the presence of a pulsating bulge close to the puncture hole and is confirmed by duplex scanning. |
Arterio-venous fistula | Defined as an abnormal and acquired communication between the arterial and venous surface caused by the inadvertent puncture of a vein adjacent to the femoral or radial artery. Diagnosis is determined by the presence of a continuous murmur or thrill at the puncture site and is confirmed by duplex scanning. |
Infection | Defined as the introduction and/or colonization of microorganisms in structures adjacent to the puncture site and/or blood flow, predisposed by difficult access, repeated punctures, long introducer stay, multiple catheters or a prolonged procedure. It is manifested by pain, hyperemia, local edema, adenopathy, fever and/or leukocytosis with a shift to the left in the blood count. |
Limb ischemia | Defined as the presence of signs and/or symptoms such as local pain, paresthesia, paresis, skin pallor, cyanosis, lack of pulse, cold extremities and/or muscle tenderness, caused by acute or sub-acute arterial occlusion and confirmed by duplex scanning and/or arteriography. |
Asymptomatic arterial occlusion | Defined by blockade of the arterial blood flow without manifestations of disturbance of the cell mechanism or insufficient tissue blood supply, not involving the terminal arterial segment (example: radial artery occlusion). |
Adjacent nerve injury | Defined by the presence of sensory and/or motor disorders in the limb through which the invasive coronary procedure was performed, with persistence of signs and/or symptoms for ≥ 24 hours, as a consequence of direct injury by inadvertent nerve puncture, excessive compression or extrinsic compression by a hematoma and/or a pseudoaneurysm. |
Vascular surgical repair | Defined by the presence of complications at the arterial puncture site requiring immediate or late (first 15 days) surgical intervention to prevent and/or minimize sequelae to the affected limb. |
Patient population
Inclusion criteria | Non-ST-segment elevation acute coronary syndrome patients (ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation or worsening of chest pain characteristic of ischemia at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST-segment depression of at least 1 mm, transient ST-segment elevation, ST-segment elevation ≤ 1 mm or T wave inversion > 3 mm in at least two contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis marker changes; however, with previous documentation of coronary atherosclerotic disease, confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant coronary atherosclerotic disease confirmed by coronary angiography or positive functional test for myocardial ischemia) |
Intention to submit patient to an early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission | |
Patient informed about the nature of the study and agreeing with its general terms and having signed the informed consent, as approved by the Research Ethics Committee of the respective center | |
Patient eligible for coronary angiography and both radial and femoral PCI with the following pre-requisites: (a) palpable radial artery with the Allen or normal oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) agreement of the operator to use the access route determined by the randomization process | |
Exclusion criteria | Less than 18 years of age |
Pregnancy | |
Chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists | |
Hypersensitivity to antiplatelet and/or anticoagulant drugs | |
Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100,000 mm3) | |
Uncontrolled systemic hypertension | |
Cardiogenic shock | |
Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft | |
Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique | |
Severe concomitant disease with life expectancy below 12 months | |
Participation in drug or device investigative clinical trials in the last 30 days | |
Indication of elective percutaneous coronary intervention to be performed at a moment different from immediately after coronary angiography | |
Medical, geographic or social conditions impairing participation in the study or inability to understand and sign the informed consent term |
Procedures
Arterial homeostasis
Radial approach
Femoral approach
Site | Emergency unit | Catheter lab | Coronary unit and/or ward | Home use duration |
---|---|---|---|---|
Drug | ||||
Aspirin | 300 mg orally | No | 100 mg per day orally | 100 mg per day orally, indefinitely |
Clopidogrel | 600 mg orally | No | 75 mg per day orally | 75 mg per day orally, 12 months |
Prasugrel | 60 mg orally | No | 10 mg per day orally | 10 mg per day orally, 12 months |
Ticagrelor | 180 mg orally | No | 90 mg twice daily orally | 90 mg twice daily orally, 12 months |
Enoxaparin | 1 mg per kg SC | 0.3 mg per kg IV if the last dose is 8 to 12 hours 0.5 to 0.75 mg per kg IV if the last dose is >12 hours | 1 mg per kg SC twice daily | No |
Fondaparinux | 2.5 mg SC | 85 UI per kg IV UFH or 60 UI per kg IV UFH if GPI is scheduled | 2.5 mg/SC/day | No |
Abciximab | No | Intravenous loading dose of 0.25 mg per kg | 0.125 mcg per kg per min for 12 hours, IV, without using HNF | No |
Tirofiban | No | Intravenous loading dose of 25 mcg per kg | 0.15 mcg per kg per min for 12 to 18 hours, IV, without using HNF | No |