Trans Radial Versus Transfemoral Route for Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.

Detailed Description
-----------------
Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly. The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.

Official Title
-----------------
Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: transradial
* Procedure: Transfemoral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnostic angiography of coronary vessels, PCI Exclusion Criteria: Patients with impaired renal function tests. Lack of informed consent. Severe infection. Previous contrast allergy. Severe intrinsic/iatrogenic caogulopathy INR>2. Abnormal modified Allen's test.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transfemoral<br>in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route. | Procedure: transradial<br>* transradial route for coronary angiography and PCI<br>Procedure: Transfemoral<br>* transfemoral route for coronary angiography and PCI<br>|
| Active Comparator: Transradial<br>Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance. | Procedure: transradial<br>* transradial route for coronary angiography and PCI<br>Procedure: Transfemoral<br>* transfemoral route for coronary angiography and PCI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access time | Access time for the procedures | 4 years | 
| Fluoroscopy time | measure of radiation exposure | 4 years | 
| Procedure time | time taken to do the full procedure | 4 years | 
| hospital stay | time period the patient stayed in the hospital | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematoma | hematoma development at the site of puncture | 4 years | 
| pseudoaneurysm | local complication at the access site | 4 years | 
| bleeding | at the access site | 4 years | 
| Access site failure | failure to gain access for the procedure | 4 years |