Sedation Plus Analgesia Improves Transradial PCI by Decreasing Spasm

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Routine administration of sedation and opioid analgesia at the beginning of transradial percutaneous coronary intervention (PCI) reduces the incidence of radial spasm, improving procedure-related patient comfort and lessening the need for access site crossover. Results from a randomized trial were published in the March 2013 issue of JACC: Cardiovascular Interventions.

Researchers led by Georgios Giannopoulos, MD, of Athens General Hospital (Athens, Greece), looked at 2,013 patients at 3 Greek referral hospitals undergoing transradial PCI randomized to receive sedation and analgesia (fentanyl 0.5 µg/kg and midazolam 1 mg slow IV push over 2 min at the beginning of the procedure during preparation of the access site) or no intraprocedural sedation/analgesia. The goal was to see if such treatment would reduce the incidence of arterial spasm.

The overall incidence of spasm (primary endpoint) was 5.4%, with sedation/analgesia reducing the risk by 68.7%, and the risk of access site crossover by 34%. TIMI major bleeding was equivalent between groups (table 1).

Table 1.  Primary, Secondary Endpoints

 

Sedation/Analgesia
(n = 1,007)

No Sedation/Analgesia
(n = 1,006)

P Value

Radial Spasm

2.6%

8.3%

< 0.001

Access Site Crossover

9.9%

15%

0.001

TIMI Major Bleeding

1.1%

1.0%

0.812


The number needed to treat to avoid 1 incidence of spasm was 18 (95% CI 12.9-26.6). In the majority of patients with radial artery spasm (81.7%), the operator had to forgo the transradial route, with spasm being the most frequent cause (35.5%) of access site crossover.

Factors associated with spasm included shorter stature, lower BMI, female sex, and smoking. Spasm was more common in patients undergoing combined coronary angiography and PCI as opposed to PCI alone. On multivariable analysis, sedation/analgesia was an independent predictor of reduced radial spasm (HR 0.140; 95% CI 0.073-0.271; P < 0.001).

Self-reported patient discomfort according to the 100-point visual analogue scale (VAS) was lower in the treatment group (18.8 ± 12.5 vs. 27.4 ± 17.4; P < 0.001), with patients reporting almost double VAS scores if spasm occurred (55.7 ± 13.8 vs. 21.2 ± 13.6; P < 0.001).

The safety endpoint of death or repeat hospital stay at 30 days was similar between the sedation/analgesia and control groups (4.6% vs. 4.5%; P = 0.918).

Spasm a Valid Target

According to Dr. Giannopoulos and colleagues, access site crossover seems to be more frequent with the transradial approach, often due to severe arterial spasm, which leads to inability to further advance guidewires and catheters through the radial artery. The reported frequency of spasm during transradial procedures ranges from 4% to over 20% in published literature, they add.

A low-dose opioid and benzodiazepine may lower spasm incidence just by their sedative and analgesic action, but they may also exert a direct vasoactive effect on the radial artery, the authors theorize.

Although the reduction in spasm did not translate to an improvement in hard outcomes, radial artery spasm “in itself is a valid target,” the authors note, “because when it happens, it complicates and usually prolongs the procedure, frustrates the interventionalist, increases the possibility of discomfort, and essentially nullifies the advantages of the transradial approach.”

As a result of the study, Dr. Giannopoulos and colleagues suggest that “routine administration of moderate procedural sedation during transradial procedures could be useful in everyday practice.”

Study Details

There were no serious adverse events related to the administration of fentanyl and midazolam. Operators in the study had performed at least 100 transradial PCI procedures per year. Spasm was identified by the appearance of marked resistance to the movement of or inability to further advance catheters, with or without accompanying forearm pain reported by the patient, and was confirmed arteriographically as severe constriction of the radial artery lumen.

 


Source:
Deftereos S, Giannopoulos G, Raisakis K, et al. Moderate procedural sedation and opioid analgesia during transradial coronary interventions to prevent spasm. A prospective randomized study. J Am Coll Cardiol Intv. 2013;6:267-273.

Disclosures:

  • Dr. Giannopoulos reports no relevant conflicts of interest.


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