Clinical trial NCT00356044: Arterial Access for Coronary Intervention in Myocardial Infarction
Official title: Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Reperfusion
Keywords: Transradial access
Femoral access
Femoral vs radial access
Lead sponsor: Hospital Juan Canalejo
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms.

Exclusion Criteria:

* Patients in cardiogenic shock were excluded following operator criteria.
* Previous coronary surgery with mammary artery graft
* Coronary artery intervention in the previous month
* Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine \>3 mg/dl).
* Patients with absolute or relative contraindication for the use of the femoral route.
* Absence of informed consent from the patient

Primary outcomes:
measure: All cause mortality at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: New ST elevation acute myocardial infarction at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: Coronary revascularization as a result of recurrent ischemia at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: Major vascular complications at 30 days.
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary outcomes:
measure: Embolic stroke at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: Coronary revascularization at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: Cardiovascular mortality at 30 days
timeFrame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
measure: Procedural time
measure: Hospital stay
measure: Estimation of costs
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: A Coruña
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
state: Pontevedra
city: A Coruña
country: Spain
facility: Hospital Juan Canalejo
Study officials:
affiliation: Hospital Juan Canalejo
name: Jose M Vazquez-Rodriguez, MD
role: STUDY_CHAIR
affiliation: Hospital do meixoeiro
name: Jose A Baz, Alonso
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Meixoeiro
name: Andrés Iñiguez-Romo, MD
role: STUDY_DIRECTOR
affiliation: Hospital Juan Canalejo
name: Nicolás Vázquez-González, MD
role: STUDY_DIRECTOR
affiliation: Hospital Juan Canalejo
name: Ramón Calviño-Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: Antonio Amaro-Cendón, MD
role: STUDY_DIRECTOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: Ramiro Trillo, Nouche
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.