Arterial Access for Coronary Intervention in Myocardial Infarction

Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Reperfusion
• Intervention / Treatment: Procedure: Coronary angioplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Hospital Juan Canalejo
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Complexo Hospitalario Universitario De Santiago
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Hospital Do Meixoeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital stay
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
Cardiovascular mortality at 30 days	within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Procedural time
Estimation of costs

Collaborators and Investigators

• Sponsor: Hospital Juan Canalejo
• Investigators: Study Chair: Jose M Vazquez-Rodriguez, MD, Hospital Juan Canalejo; Principal Investigator: Jose A Baz, Alonso, Hospital Do Meixoeiro; Study Director: Andrés Iñiguez-Romo, MD, Hospital Do Meixoeiro; Study Director: Nicolás Vázquez-González, MD, Hospital Juan Canalejo; Principal Investigator: Ramón Calviño-Santos, MD, Hospital Juan Canalejo; Study Director: Antonio Amaro-Cendón, MD, Complejo Hospitalario Universitario De Santiago; Principal Investigator: Ramiro Trillo, Nouche, Complejo Hospitalario Universitario De Santiago

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: July 24, 2006
• First Submitted That Met QC Criteria: July 24, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): July 11, 2007
• Last Update Submitted That Met QC Criteria: July 10, 2007
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Transradial access; Femoral access; Femoral vs radial access
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CEICG 2004/063