Coronary Artery Disease Clinical Trial
Official title:
Subcutaneous Administration of Nitroglycerin to Facilitate Trans-radial Access in Coronary Procedures: a Randomized Clinical Trial (NITRAD-Sub Study).
Femoral artery approach to perform coronary procedures is considered the standard technique for vascular access due to optimal catheter control, lower thromboembolic complications and immediate access due to the large diameter of the artery. Trans-radial approach has been shown to reduce major bleeding complications, vascular complications related to the site of puncture, including death from all causes, and to prevent post-procedure limb rest, greater comfort for patients, immediate ambulation, early discharge and reduction of costs. Previous studies have shown that intravenous, topical and intraarterial use of nitroglycerin produces vasodilation of the radial artery. Extravascular (subcutaneous) administration of nitroglycerin is extremely effective in restoring the radial pulse, and allows adequate cannulation.
Unlike femoral access, the trans-radial approach to coronary angiography requires a greater
learning curve for the inexperienced interventionist, and demands a greater technical
challenge than the femoral approach, which leads to a high incidence of failures and
complications, mainly in the initial stages of their formation. Some explanations for
procedural failure include inability for radial artery puncture, vessel tortuosity, and
radial spasm. Radial spasm has been reported from 5 to 30% in experienced centers, with a
decrease to 2.5% when associated with the administration of nitrate added to local
anesthesia. Although radial spasm is infrequent and usually occurs once the artery is
cannulated or during manipulation of the catheters, it can sometimes occur before cannulation
due to multiple unsuccessful attempts to cannulate the artery, which can also produce pain in
the patient.
The investigators will conduct an experimental, placebo-controlled, longitudinal,
prospective, double-blind, parallel arm clinical trial. Patients will be randomized to
receive 1:1 an intervention or placebo. Intervention group will receive a subcutaneous
"cocktail" with 0.5 ml of 500 mcg of nitroglycerin + 1 ml of 2% simple lidocaine. Placebo
group will receive a subcutaneous injection with 0.5 ml of 0.9% saline solution + 1 ml of 2%
simple lidocaine.
The investigators hypothesize that the maneuver (subcutaneous infiltration of local
anesthetic together with nitroglycerin) will facilitate radial access in terms of fewer
punctures until the insertion of the arterial introducer, shorter access time, lower
incidence of radial spasm, and lower crossover rate to femoral access, compared with placebo.
In terms of safety, the investigators do not believe that the maneuver represents a risk to
the patient in terms of incidence of hypotension or headache. In fact, the investigators
believe that the maneuver will provide less pain at the site of puncture referred by the
patient due to the less number of unsuccessful punctures.
For the calculation of the required sample, since the incidence of our primary end-point of a
compound of crossover to femoral access and/or access site-related vascular complications has
not been reported so far, the sample will be calculated with the rate of events obtained in
our center at 6 months of recruiting patients. For this calculation, the proportional
difference formula with an alpha value of 0,05 and a beta value of 0,20 will be used to have
a statistical power of 80%. The investigators estimate that 1,500 patients will be required
in a 11-month period.
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