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Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transradial approach | Active Comparator | Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125). |
|
| Transfemoral approach | Active Comparator | Transfemoral approach primary percutaneous coronary intervention using a vascular closure device to obtain hemostasis (n=125). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transradial primary percutaneous coronary intervention | Procedure | Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Major vascular access site complications | Major vascular complications related to arterial access site will be evaluated during hospitalization by physical examination and duplex ultrassonography and include major bleeding, retroperitoneal hemorrhage, compartment syndrome, pseudoaneurysm, arteriovenous fistula, limb ischemia or need for vascular surgery repair. | 48 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | The success of the device is defined as the attainment of adequate hemostasis at the end of the procedure, without the need to apply other compression methods. | 48 hours post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro B Andrade, phD | Irmandade SCMM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pedro Beraldo de Andrade | MarÃlia | São Paulo | 17515900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24345099 | Background | de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435. |
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|
| Transfemoral primary percutaneous coronary intervention | Procedure | Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes. |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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