Acute Coronary Syndrome
Conditions
Keywords
Transradial Approach, Transfemoral Approach, Vascular Closure Device
Brief summary
Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.
Detailed description
Antithrombotic therapy and percutaneous or surgical myocardial revascularization procedures are the basis of the treatment of patients admitted with non-ST-segment elevation acute coronary syndrome. However, the desired reduction of the recurrence of ischemic events has as complication an increased incidence of bleeding. Since arterial puncture followed by the insertion of an introducer has become the standard method to perform invasive cardiovascular procedures, complications related to vascular access have become an important bleeding site. Among the strategies to decrease vascular complications, the transradial approach is a well stablished alternative to the transfemoral approach. For its part, vascular closure devices were introduced to decrease vascular complications, homeostasis time and ambulation time of patients submitted to invasive procedures by the transfemoral access. Rapidly incorporated to the clinical practice, such devices to date have shown conflicting results with regard to their safety and efficacy. The inconsistency of data proving its safety limits its routine adoption as strategy to prevent vascular complications, requiring evidences through adequately designed randomized studies for this end.
Interventions
DEVICEPercutaneous coronary intervention
Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines.
Sponsors
Irmandade Santa Casa Misericórdia Marília
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Occurrence of Access Site Related Ischemic or Bleeding Complication | 30 days | Vascular and systemic complications at arterial puncture site include major bleeding, retroperitoneal hemorrhage, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arteriovenous fistula, infection, limb ischemia, asymptomatic arterial occlusion, adjacent nerve injury or need for vascular surgery repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Ischemic or Bleeding Events | 30 days | Individual components of the primary objective, hematoma \< 5 cm, cardiovascular death, myocardial infarction, stroke, major bleeding unrelated to puncture site or to coronary artery bypass grafting, device success and crossover rate between techniques |
Other
| Measure | Time frame |
|---|---|
| Cardiovascular Death, Myocardial Infarction or Stroke | 12 months |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transradial Approach Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis
Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines. | 120 |
| Transfemoral Approach Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis
Percutaneous coronary intervention: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines. | 120 |
| Total | 240 |
Baseline characteristics
| Characteristic | Transradial Approach | Transfemoral Approach | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 53 Participants | 108 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 67 Participants | 132 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11.2 | 63.6 years STANDARD_DEVIATION 10.2 | 63.0 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 120 Participants | 120 Participants | 240 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 120 Participants | 120 Participants | 240 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Brazil | 120 participants | 120 participants | 240 participants |
| Sex: Female, Male Female | 40 Participants | 24 Participants | 64 Participants |
| Sex: Female, Male Male | 80 Participants | 96 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 120 | 2 / 120 |
| other Total, other adverse events | 2 / 120 | 2 / 120 |
| serious Total, serious adverse events | 3 / 120 | 9 / 120 |
Outcome results
Primary
First Occurrence of Access Site Related Ischemic or Bleeding Complication
Vascular and systemic complications at arterial puncture site include major bleeding, retroperitoneal hemorrhage, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arteriovenous fistula, infection, limb ischemia, asymptomatic arterial occlusion, adjacent nerve injury or need for vascular surgery repair.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transradial Approach | First Occurrence of Access Site Related Ischemic or Bleeding Complication | 16 Participants |
| Transfemoral Approach | First Occurrence of Access Site Related Ischemic or Bleeding Complication | 15 Participants |
Secondary
Adverse Ischemic or Bleeding Events
Individual components of the primary objective, hematoma \< 5 cm, cardiovascular death, myocardial infarction, stroke, major bleeding unrelated to puncture site or to coronary artery bypass grafting, device success and crossover rate between techniques
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transradial Approach | Adverse Ischemic or Bleeding Events | 11 Participants |
| Transfemoral Approach | Adverse Ischemic or Bleeding Events | 3 Participants |
Other Pre-specified
Cardiovascular Death, Myocardial Infarction or Stroke
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transradial Approach | Cardiovascular Death, Myocardial Infarction or Stroke | 2 Participants |
| Transfemoral Approach | Cardiovascular Death, Myocardial Infarction or Stroke | 3 Participants |