AngioSeal Versus Radial Approach in Acute Coronary Syndrome

Inclusion Criteria

• Non-ST-segment elevation ACS 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 of 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, or transient ST segment elevation, or ST segment elevation ≤ 1 mm, or T wave inversion > 2 mm in at least 2 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 markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia];
• Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission;
• Signed informed consent;
• Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and 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 or direct thrombin inhibitors, or oral Xa-factor 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 disease preventing the use of the femoral technique;
• Severe concomitant disease with life expectancy below 12 months;
• Participation in drug or devices investigative clinical trials in the last 30 days;
• Indication of elective percutaneous coronary intervention to be performed in a moment different from immediately after coronary angiography;
• Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.