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The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.
Some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. The advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. The radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.The patients with ST elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.On the other hand, the time and success of the procedure are significant prognostic issues.In this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. For this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angioplasty | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | |
| New ST elevation acute myocardial infarction at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | |
| Coronary revascularization as a result of recurrent ischemia at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | |
| Major vascular complications at 30 days. | within the first 30 days (plus or minus 5 days) after the index myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Embolic stroke at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | |
| Coronary revascularization at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Vazquez-Rodriguez, MD | Hospital Juan Canalejo | Study Chair |
| Jose A Baz, Alonso | Hospital do meixoeiro | Principal Investigator |
| Andrés Iñiguez-Romo, MD | Hospital do Meixoeiro | Study Director |
| Nicolás Vázquez-González, MD | Hospital Juan Canalejo | Study Director |
| Ramón Calviño-Santos, MD | Hospital Juan Canalejo | Principal Investigator |
| Antonio Amaro-CendĂłn, MD | Complejo Hospitalario Universitario de Santiago | Study Director |
| Ramiro Trillo, Nouche | Complejo Hospitalario Universitario de Santiago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juan Canalejo | A Coruña | A Coruña | 15006 | Spain | ||
| Complexo Hospitalario Universitario de Santiago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12720237 | Background | Saito S, Tanaka S, Hiroe Y, Miyashita Y, Takahashi S, Tanaka K, Satake S. Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the test for myocardial infarction by prospective unicenter randomization for access sites (TEMPURA) trial. Catheter Cardiovasc Interv. 2003 May;59(1):26-33. doi: 10.1002/ccd.10493. | |
| 14691415 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Cardiovascular mortality at 30 days | within the first 30 days (plus or minus 5 days) after the index myocardial infarction |
| Procedural time |
| Hospital stay |
| Estimation of costs |
| Santiago de Compostela |
| A Coruña |
| 15706 |
| Spain |
| Hospital do Meixoeiro | Vigo | Pontevedra | 36200 | Spain |
| Background |
| Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J. 2004 Jan;147(1):31-4. doi: 10.1016/j.ahj.2003.07.019. |
| Result | Vazquez Rodriguez JM, Calvino Santos R, Baz Alonso JA, Trillo Nouche R, Salgado Fernandez J, Sanmartin Fernandez M, et al. Radial vs. Femoral access in emergent coronary interventions for acute myocerdial infarction with ST segment elevation (abstract). Innovation in Intervention: i2 Summit 2007 Abstract Sessions. 10.1016/j.jacc.2007.01.048. J Am Coll Cardiol 2007;49(9_Suppl_B):12B. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |