Original title: Moderate Procedural Sedation and Opioid Analgesia During Transradial Coronary Interventions to Prevent Spasm. A Prospective Randomized Study. Reference: Spyridon Deftereos et al. J Am Coll Cardiol Intv 2013;6:267–73.
The trans-radial approach has become the preferred diagnostic and therapeutic study for evidence of minor vascular complications, shorter hospital stays, less blood loss and better outcomes in acute coronary syndromes.
One limitation of this access is the spasm that may require changing to femoral access thus increasing procedure time and risk of complications, especially vascular. Several strategies have been proven to prevent spasm, including sedation, however to date this has not been systematically tested in a study that endorses its use in daily practice. The aim of this study was to test the hypothesis that routine sedation administration and analgesia at the beginning of the therapeutic procedure for radial access could reduce spasm.
This prospective study randomized 2,013 patients who underwent trans-radial coronary angioplasty with the administration of 0.5 mg/kg of fentanyl plus 1 mg of midazolam versus non administration, (the control group). All patients were under local anesthesia with lidocaine used together with the administration of 100 µg of nitroglycerine and 2.5 mg of verapamil. The primary end point was the occurrence of spasm that was objectified with angiography. The secondary end points were the incidence of bleeding, level of discomfort for patients, re-hospitalization or death at 30 days.
Periprocedural death was low and similar in both groups, (0.35% overall). There were no cases of respiratory depression requiring mechanical ventilation. Allergic reactions, (rash or pruritus), following administration of fentanyl and midazolam, (and before contrast), reached 1.1%. The paradoxical reaction to midazolam was also uncommon at 0.8%. Spasm was observed in 2.6% of the group receiving sedation and analgesia versus 8.3% in the control group, (p <0.001). The relative reduction in spasm risk was 68.7%. The need for femoral crossover with sedation was also lower, (9.9% versus 15%, P = 0.001). The incidence of spasm was associated with short stature, low body mass index, female sex, smoking, increased exchange of catheters, increased procedure time and contrast volume. The procedure was significantly more comfortable for those who received sedation, (p <0.001). Unlike the foregoing, death or re-hospitalization at 30 days and major bleeding were identical between groups.
Conclusion:
Routine administration of moderate doses of midazolam and fentanyl prior to a radial access intervention is associated with a significant reduction in spasm, the need for femoral crossover and a feeling of discomfort by patients.
Commentary:
This is a widespread strategy but now with the evidence of a multicenter randomized study it can be definitively adopted into daily practice. On the other hand, the relatively high number needed to treat (18) and the identical result in safety end points, also make this selective strategy reasonable and non-routine.
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