Protection Systems Reduce Stroke and Mortality in Carotid Artery Stenting

So far, the main controlled randomized studies have almost exclusively been aimed at comparing the efficacy and safety of carotid artery stenting vs. endarterectomy. Almost all of them have left at operator discretion the choice of the devices to be used during the procedure, which is why there is few direct information to help us make a decision on the cerebral protection system to use, stent material or design, the need for intraprocedural neurophysiological monitoring, and the type of antiplatelet therapy.

The aim of this study was to analyze the association between intraprocedural and periprocedural variables and in-hospital stroke and death rates after carotid artery stenting.

This trial enrolled a total of 13,086 patients who underwent carotid artery stenting procedures for asymptomatic (63.9%) or symptomatic disease.

Read also: “Estudio SENTINEL: Protección cerebral durante el TAVI”.

The following variables were analyzed: stent design, stent material, neurophysiological monitoring, antiplatelet medication, and use of a cerebral protection system. The primary endpoint was the rate of in-hospital stroke or death.

The primary outcome occurred in 2.4% of the population (1.7% in asymptomatic and 3.7% in symptomatic patients).

A multivariable analysis showed an independent association between the use of a cerebral protection system and lower in-hospital rates of stroke or death (relative risk [RR]: 0.65; 95% confidence interval [CI]: 0.50 to 0.85), disabling stroke or death (RR: 0.60; 95% CI: 0.43 to 0.84), and stroke (RR: 0.57; 95% CI: 0.43 to 0.77). In the analysis of death rates, no association was found between this event and the use of a cerebral protection system (RR: 0.78; 95% CI: 0.46 to 1.35).

Read also: “La endarterectomía precoz parece superior a la angioplastia carotidea en pacientes sintomáticos”.

There was no significant association between stent design, stent material, neurophysiological monitoring, or antiplatelet medication and events such as stroke or death.

Conclusion

The use of a cerebral protection system was the only technical variable in carotid artery stenting associated with lower rates of in-hospital stroke and death.

Editorial

Retrospective and indirect evidence, plus rationality in the use of cerebral protection systems during carotid artery stenting, resulted in the non-existence of randomized studies testing the usefulness of these devices. We simply adopt them, almost without asking questions. This work with over 13,000 patients is the largest study supporting the idea of always using cerebral protection systems.

As regards stent design, this work showed a trend of lower event rates with closed-cell stents, while featuring a wide confidence interval. There is evidence in favor and against both designs. Furthermore, no study has considered parameters such as plaque morphology or vessel anatomy. The most likely scenario is for different patients to benefit from different designs (e.g., open-cell stents for tortuous arteries or closed-cell stents for soft and unstable plaque).

Stent material (nitinol or stainless steel) was not associated with events.

Antiplatelet medication was not associated with events either, which is both surprising and suspicious. This could be easily explained by the fact that only 2% of patients did not receive antiplatelet medication. Conclusion: Physicians will always indicate dual-antiplatelet therapy.

Neurophysiological monitoring showed a trend towards higher rates of stroke and death, but the clear problem here is that the indication was at operator discretion. Neurophysiological monitoring was very probably indicated for those who were suspected of being high-risk patients.

Original title: The Use of Embolic Protection Devices Is Associated with a Lower Stroke and Death Rate After Carotid Stenting.

Reference: Christoph Knappich et al. J Am Coll Cardiol Intv 2017;10:1257-65.

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