Effects of High Dose of Atorvastatin for Preventing Periprocedural Ischemic Brain Damage in Patients Undergoing Carotid Artery Stenting (PICAS) in China: A Randomized Controlled Clinical Trial

Haipeng Wang, Junjie Wang, Jun Lu, Daming Wang, Haipeng Wang, Junjie Wang, Jun Lu, Daming Wang

Abstract

Background: Research conducted in Western countries has suggested that high-dose statin therapy can lead to the regression of carotid atherosclerotic plaques and can reduce periprocedural ischemic complication rates in individuals undergoing carotid artery stenting (CAS). However, whether this same therapeutic approach is of value in patients of Chinese ethnicity is not as well-established. Methods: This is a single-center, prospective, parallel-controlled, intervention-based efficacy study that will enroll a total of 130 Chinese patients with cervical carotid stenosis who are scheduled to undergo CAS. These patients will be randomly divided into a routine treatment group and a high-dose atorvastatin group. Individuals in the routine treatment group will be administered standard of care 20 mg/day atorvastatin treatment. Individuals in the high-dose atorvastatin group will be administered 80 mg/day atorvastatin for 3 days prior to and following CAS. The primary outcome of this study will be the cumulative incidence of new cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) within 5 days following CAS, and of transient ischemic attacks (TIAs) or ischemic stroke within 30 days after CAS. Discussion: This study is the first to assess whether high-dose atorvastatin treatment is capable of reducing the incidence of perioperative cerebral ischemic injury in patients of Chinese ethnicity undergoing CAS. These results will offer evidence regarding which statin treatment regimens are more appropriate when treating Chinese patients undergoing CAS in an effort to minimize their risk of any perioperative cerebral ischemic injury. Trial Registration: ClinicalTrials.gov NCT03079115; registered March 14, 2017.

Keywords: Chinese ethnicity; carotid artery stenting; clinical trials; high-dose statin therapy; periprocedural ischemic complication.

Copyright © 2020 Wang, Wang, Lu and Wang.

Figures

Figure 1
Figure 1
Study design. CAS, carotid artery stenting; MRI, magnetic resonance imaging; DW-MRI, diffusion-weighted magnetic resonance imaging.

References

    1. Huibers A, Calvet D, Kennedy F, Czuriga-Kovács KR, Featherstone RL, Moll FL, et al. . Mechanism of procedural stroke following carotid endarterectomy or carotid artery stenting within the International Carotid Stenting Study (ICSS) randomised trial. Eur J Vasc Endovasc Surg. (2015) 50:281–8. 10.1016/j.ejvs.2015.05.017
    1. Hill MD, Brooks W, Mackey A, Clark WM, Meschia JF, Morrish WF, et al. . stroke after carotid stenting and endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). Circulation. (2012) 126:3054–61. 10.1161/CIRCULATIONAHA.112.120030
    1. Gargiulo G, Sannino A, Stabile E, Perrino C, Trimarco B, Esposito G. New cerebral lesions at magnetic resonance imaging after carotid artery stenting versus endarterectomy: an updated meta-analysis. PLoS ONE. (2015) 10:e0129209. 10.1371/journal.pone.0129209
    1. Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, et al. . Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. (2015) 62:521–9. 10.1016/j.jacc.2014.11.038
    1. Capoccia L, Speziale F, Gazzetti M, Mariani P, Rizzo A, Mansour W, et al. . Comparative study on carotid revascularization (endarterectomy vs stenting) using markers of cellular brain injury, neuropsychometric tests, and diffusion-weighted magnetic resonance imaging. J Vasc Surg. (2010) 51:584–91.e583. 10.1016/j.jvs.2009.10.079
    1. Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al. . 2011 ASA/ACCF/AHA/AANN/ AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: a report of the American college of cardiology foundation/American heart association task force on practice guidelines, and the American stroke association, American association of neuroscience nurses, American association of neurological surgeons, American college of radiology, American society of neuroradiology, congress of neurological surgeons, society of atherosclerosis imaging and prevention, society for cardiovascular angiography and interventions, society of interventional radiology, society of neurointerventional surgery, society for vascular medicine, and society for vascular surgery developed in collaboration with the American academy of neurology and society of cardiovascular computed tomography. J Am Coll Cardiol. (2011) 57:1002–44. 10.1016/j.jacc.2010.11.005
    1. Patti G, Tomai F, Melfi R, Ricottini E, Macrì M, Sedati P, et al. . Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting: results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. (2013) 61:1379–87. 10.1016/j.jacc.2013.01.015
    1. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, et al. . Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. (2005) 352:1425–35. 10.1056/NEJMoa050461
    1. Amarenco P, Bogousslavsky J, Callahan A, III, Goldstein LB, Hennerici M, Rudolph AE, et al. . High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. (2006) 355:549–59. 10.1056/NEJMoa061894
    1. Reiff T, Amiri H, Rohde S, Hacke W, Ringleb PA. Statins reduce peri-procedural complications in carotid stenting. Eur J Vasc Endovasc Surg. (2014) 48:626–32. 10.1016/j.ejvs.2014.08.010
    1. Takayama K, Taki W, Toma N, Nakahara I, Maeda M, Tanemura H, et al. . Effect of pitavastatin on preventing ischemic complications with carotid artery stenting: a multicenter prospective study - EPOCH-CAS study. Cardiovasc Intervent Radiol. (2013) 37:1436–43. 10.1007/s00270-013-0813-x
    1. Stern RH, Yang BB, Hounslow NJ, MacMahon M, Abel RB, Olson SC. Pharmacodynamics and pharmacokinetic-pharmacodynamic relationships of atorvastatin, an HMG-CoA reductase inhibitor. J Clin Pharmacol. (2000) 40:616–23. 10.1177/00912700022009396
    1. Cilla DD, Jr, Whitfield LR, Gibson DM, Sedman AJ, Posvar EL. Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clin Pharmacol Ther. (1996) 60:687–95. 10.1016/S0009-9236(96)90218-0

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