Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices: A Meta-Analysis study Short title: Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices

doi:10.21203/rs.3.rs-2995502/v1

Download PDF

Research Article

Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices: A Meta-Analysis study Short title: Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices

https://doi.org/10.21203/rs.3.rs-2995502/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Objective

This study has been designed to compare the rate of thromboembolic events during Carotid angioplasty and stenting (CAS) with and without embolic protection devices (EPDs). So we systematically reviewed the literature to find and select studies that compared the rate of embolic events during CAS with and without embolic protection devices and conducted a meta-analysis to find which way is better.

Methods

Embase, PubMed, and Web of Science databases were thoroughly searched. By using random-effects models, each estimation was executed. To assess the heterogeneity among the studies I² index was used. Egger and Begg’s tests were applied to evaluate publication bias. Stata version 14.2 was used for the statistical analysis.

Results

For 25% of patients, EPD was used during CAS, and for 75%, did not. The prevalence of hypertension, diabetes mellitus, coronary artery disease, and cigarette smoking was 77%, 37%, 40%, and 44%. 52% of included patients were symptomatic, and 48% of them were asymptomatic .The mortality rate reduced from 2% in the no_EPD subgroup to 1% among the EPD subgroup. The occurrence of all other complications was also reportedly higher in patients who did not receive EPD, including major stroke and MI, except for minor events, which were reported to be almost the same in both subgroups.

Conclusion

we found out that the use of EPD can help with reducing the occurrence of thromboembolic complications of CAS, including MI, major stroke, and death. Altogether, our results suggest that the benefits of using EPD during CAS outweigh its risks.

Carotid angioplasty

Carotid artery stenting

Protection Devices

Thromboembolic

Stroke is a prominent cause of mortality and hospitalization in the united states ¹. Also, in developed countries, after cancer and cardiac-related fatalities, it is the third most significant cause of mortality ². Ischemic and hemorrhagic strokes are the most common types. According to population-based studies, internal carotid artery stenosis due to atherosclerosis is responsible for 15–20% of ischemic strokes ^3,4. Only in the United States, almost 500000 new strokes occur each year; 20–30% of these occurrences are caused by carotid artery disease ⁵. The severity and symptomatic/asymptomatic nature of internal carotid artery atherosclerosis contribute to yearly stroke risk. Patients with asymptomatic stenosis (60 to 99%) had a 2-2.5% yearly stroke risk, while symptomatic carotid stenosis (more than 70%) raises the chance of stroke by 10 to 15% per year ^6–9.

Medical therapy is used to treat individuals with carotid artery disease to minimize emboli formation and regulate the progression of atherosclerosis. Revascularization should be considered in more severe cases ^10,11. Carotid angioplasty and stenting (CAS) have developed as an effective, minimally invasive method for the treatment of carotid stenosis in recent years. CAS is a possibility for treating individuals with significant comorbidities for whom endarterectomy would be a high-risk treatment ⁵. Regardless of advancements in stenting procedures and medical antiplatelet therapy, embolic neurologic events during CAS procedures are unavoidable ^12,13. The friable, ulcerated, and thrombotic material found in the carotid artery may embolize during the surgery ^14–16.

There are several protective methods available to reduce the risk of thromboembolic complications ¹⁷. Several cerebral protective devices have been manufactured to minimize the risk of pre-procedural problems ¹⁸. Distal filters (DF), proximal protection devices (P-EPD), particularly proximal balloon occlusion (PBO), and flow reversal devices (FRS) are some of them ^19–21. These gadgets’ popularity has recently soared, and they are now widely used in therapeutic settings ¹⁸. Although cerebral protection devices minimize the risk of overt perioperative stroke during CAS, the chance of silent cerebral embolism is still considerable, and the risk varies depending on the type of protection utilized ²².

Much previous research has found no significant differences in embolic problems in CAS patients who received EPD versus those who did not ^23–25. Some studies have shown that endovascular treatment of carotid artery stenosis without EPDs can yield acceptable outcomes in terms of safety and efficacy ^5,18,26,27. On the other hand, using EPDs during CAS has been shown in some studies to minimize embolic consequences ^28,29. Yusuf Inanc et al. reported that complication rates associated with embolization were as much as 5% lower when a protective device was used during stenting ³⁰. In the multicenter study by Dierk Scheinert et al. involving 120 patients, the combined 30-day endpoint of death and stroke was 2.5%, indicating that using an EPD during CAS may reduce the rate of embolic complications.³¹

In this research, we systematically reviewed the literature to find and select studies that compared the rate of embolic events during CAS with and without embolic protection devices and conducted a meta-analysis to find whether the use of EPD can reduce the occurrence of perioperative complications of CAS, including MI, major stroke, and death.

Search strategy

Systematic literature searches were performed in PubMed, Scopus, Web of Science, and Google Scholar databases. The keywords, keywords combination, and mesh terms that are used in these databases were as follows: carotid artery stenting, CAS, carotid artery stenting with devices, embolic protection devices, embolic events, and stenting without protection. An independent investigator performed the search, and then, after removing duplicate articles, two other authors screened the articles based on title and abstract, and unrelated articles were excluded and then they reviewed the remaining articles based on full text and included related articles in the study, and a third investigator resolved discrepancies. The literature lists of included studies were also manually reviewed to identify additional eligible articles.

Selection criteria

This meta-analysis includes studies that met one or more of the following predefined criteria:

Randomized controlled trials (RCTs) or retrospective observational studies that compared embolic complications during carotid stenting with and without protective devices

Studies that provided quantitative data on clinical outcomes of interest

Studies published in English

High-risk _of bias studies or studies that reported irrelevant results were excluded.

Data extraction

Two independent reviewers extracted the relevant data from the eligible studies. All disagreements were discussed, and the final decision was made through consensus with the third party. Then, data extraction was carried out for the predefined variables listed below:

First author, year of publication, country, sample size, patient characteristics (age, gender, smoking history, coronary artery disease, diabetes, hypertension, stenting with and without embolic protection, percentage of symptomatic and asymptomatic patients, number of minor embolic events, number of strokes, number of deaths (total and stroke-related), number of MI and follow-up duration.

Quality assessment

In the present study, the Newcastle-Ottawa Scale (NOS) was used to assess the quality of all selected articles ³². This scale comprises 8 elements for evaluating the quality of studies, such as “comparability”, “outcome”, and “selection”. Besides, the Ottawa checklist was employed for cross-sectional studies. According to the standard of scoring in NOS, cross-sectional studies can be classified as follows: low risk of bias (7–10), intermediate risk of bias (5–6), and high risk of bias (1–4) (Table 1).

Table 1

NEWCASTLE-OTTAWA quality assessment results for included studies
Author (ref.)	Selection				Comparability	Outcome		Total score	Risk of Bias
Author (ref.)	1	2	3	4	1	1	2	Total score	Risk of Bias
Yabalak et al. [23]	*			**		**	*	6	intermediate risk of bias
Dayama et al. [24]	*	*		**		**	*	7	low risk of bias
Deharo et al. [49]	*	*		**		**		6	intermediate risk of bias
Inanc et al. [29]	*	*		**		**		6	intermediate risk of bias
Nazari et al. [50]	*	*	*	**	**	**	*	10	low risk of bias
Garriboli et al. [25]	*	*		**		**		6	intermediate risk of bias
Cremonesi et al. [37]	*	*		**		**		6	intermediate risk of bias
Gray et al. [51]	*	*		**		**	*	7	low risk of bias
Al mobarak et al. [52]	*	*		**		**		6	intermediate risk of bias
Bastug et al. [53]	*	*		**		**		6	intermediate risk of bias
Scheinert et al. [30]	*	*		**	**	**	*	9	low risk of bias
Ghafari et al. [26]	*			**		**	*	6	intermediate risk of bias
Mansour et al. [27]	*	*		**		**	*	7	low risk of bias
Pandey et al. [5]	*			**		**	*	6	intermediate risk of bias
Reimers et al. [28]	*	*		**		**	*	7	low risk of bias
Ayman et al. [18]	*			**		**		5	intermediate risk of bias

Statistical analysis

Stata version 14.2 (Stata Corp, College Station, TX, USA) was utilized to perform a meta-analysis, asses the pooled prevalence and 95% confidence interval (CI) of main complications in patients experiencing CAS with or without EPD. The heterogeneity of included articles in this meta-analysis was measured by the heterogeneity index (I²). If the heterogeneity was statistically significant (P < 0.05 and/or I² > 50%), the random effects model was utilized to perform a meta-analysis. Else, the fixed-effect model was used. Besides, meta-regression analyses were performed to assess the impact of potential variables to discover the source of heterogeneity. Moreover, Egger’s test and Begg’s funnel plot were used to evaluate the publication bias. A significant publication bias is considered when P < 0.05.

Study selection

The present study has been conducted according to the PRISMA checklist ³³. In our initial search in the mentioned databases, 50 studies were identified. After removing 4 duplicates, we excluded 20 studies for the irrelevant titles and abstracts. By reviewing the full text of the remaining 26 articles, 10 articles were excluded due to a lack of relevant information. Finally, 16 studies published from March 2002 until December 2021 meet the eligibility criteria for final analysis (Fig. 1, Table 2).

Table 2

Baseline characteristics of the included studies.
Author	Country	Year	Embolic Protection Devices	Sample Size (N)	Demographics			Comorbidities				Complications and Outcomes
Author	Country	Year	Embolic Protection Devices	Sample Size (N)	Mean Age (SD)	Female (%)	Symptomatic (%)	hypertension (%)	coronary artery disease (%)	diabetes mellitus (%)	Smoking (%)	Major Stroke (%)	Minor Events (%)	MI (%)	Total Death (%)
Al mobarak et al.	Ireland	2002	EPD	162	68 (8)	13	48	0.8	0.54	0.31		0	0.012	0	0.012
Cremonesi et al.	Italy	2003	EPD	442	73 (8)	21	57					0.002	0.009	0	0
Reimers et al.	Italy	2004	EPD	753	70 (8)	36	28	0.772	0.629	0.208		0.008	0.02	0.004	0.005
Pandey et al.	USA	2007	no_EPD	94	68 (10)	45	63	0.689	0.33	0.31	0.329	0.019		0.019	0.019
Mansour et al.	Germany	2011	no_EPD	133	71 (10)	23	68	0.721	0.218	0.248		0.022	0.007	0	0.045
Dayama et al.	Germany	2017	EPD	200	68 (11)	38	0					0.035		0.015	0.005
Dayama et al.	Germany	2017	no_EPD	57	69 (9)	35	0					0.07		0.018	0.018
Scheinert et al.	Germany	2017	EPD	120	75 (8)	28	12	0.883	0.433	0.342	0.475	0.02	0	0.008	0
Gray et al.	USA	2017	EPD	250	75 (10)	39	15	0.944		0.348	0.724	0.004	0.024	0.004	0.008
Inanc et al.	Turkey	2018	no_EPD	171	67 (14)	36		0.654	0.339	0.385	0.56	0	0.058	0	0
de Haro et al.	Spain	2018	EPD	21	73 (7)	23	100	1	0.333	0.667	0.43	0	0	0	0.047
Garriboli et al.	Italy	2018	no_EPD	77	77	22	0	0.61	0.2	0.22		0.013	0	0	0
Ghaffari et al.	Iran	2020	no_EPD	36	65 (11)	44	75	0.611	0.111	0.139	0.083	0.056	0	0	0.028
El-Sudany et al.	Egypt	2021	no_EPD	91	63 (10)	37	100	0.824	0.253	0.659	0.374	0	0.01	0	0
Yabalak et al.	Turkey	2021	EPD	35	69 (9)	23	86	0.657	0.371	0.514		0.029	0	0.029	0.029
Yabalak et al.	Turkey	2021	no_EPD	16	70 (9)	25	81	1	0.563	0.5		0	0.12	0	0
Nazari et al.	USA	2021	no_EPD	277		31	51	0.805		0.339	0.285	0.065		0.025	0.022
Nazari et al.	USA	2021	EPD	923		36	46	0.842		0.343	0.282	0.021		0.021	0.011
Bastug et al.	Turkey	2021	EPD	17	76 (7)	24	100	1	0.882	0.823	0.882	0.058	0	0	0

Demographic characteristics of included studies

After merging all the extracted data, 3875 patients were covered by our study, 1171 (30%) being female (95% CI: 26–34; I² = 85.0%). Of the total participants, 952 of them EPD were used during CAS, and 2923 did not. Based on the average age reported by articles, the mean age of patients was 70.05 (95% CI: 68.55–71.54; I² = 93.7%). Furthermore, the full-text reviewed studies were mostly conducted in Europe (N = 13).

Risk factors, complications, and outcomes

Based on the primary analysis, the assessment of risk factors revealed hypertension (2548), diabetes mellitus (1011), coronary artery disease (817), and cigarette smoking (756) with 77% (95% CI: 0.72–0.82; I² = 91.86%), 37% (95% CI: 0.31–0.43; I² = 91.40%), 40% (95% CI: 0.28–0.51; I² = 95.90%), and 44% (95% CI: 0.30–0.58; I² = 97.46%) prevalence, respectively (Fig. 2). Among the patients underwent CAS, the total death rate was measured to be 1% (95% CI: 0.01–0.01; I² = 6.11%) (Fig. 3). After eliminating 3 studies, 52% of included patients were symptomatic (95% CI: 0.41–0.64; I² = 98.0%), and by eliminating 6 studies, 48% of patients were asymptomatic (95% CI: 0.36–0.60; I² = 97. 97%). The prevalence of minor events in a study population of included articles was about 2% (95% CI: 0.01–0.02; I² = 48.56%, P-value = 0.07). Besides, the prevalence of MI and major stroke was 1% (95% CI: 0.01–0.02; I² = 52.84%) and 2% (95% CI: 0.01–0.03; I² = 69.74%), respectively (Table 3).

Table 3

Statistical analysis of reviewed studies
Data	Variable	Number of studies	embolic protection device	Number of patients	ES (95% CI)	I² (%)
Demographic data	Mean age	13	EDP		71.80 (70.01–73.58)	94.7%
	Mean age	13	no_ EDP		67.59 (65.38–69.80)	84.2%
	Female	16	EDP	860	27% (22–33)	90.3%
	Female	16	no_ EDP	311	33% (27–38)	64.3%
	Symptomatic	15	EDP	1,086	41% (27–55)	98.4%
	Symptomatic	15	no_ EDP	430	68% (56–80)	86.1%
Comorbidities	hypertension	14	EDP	1,891	83% (77–90)	93.6%
	hypertension	14	no_ EDP	657	72% (65–78)	76.6%
	coronary artery disease	12	EDP	648	54% (42–65)	89.2%
	coronary artery disease	12	no_ EDP	169	26% (19–33)	75.3%
	Diabetes melitus	14	EDP	698	41% (32–49)	93.0%
	Diabetes melitus	14	no_ EDP	313	34% (25–44)	89.9%
	Smoking	9	EDP	513	59% (31–78)	98.7%
	Smoking	9	no_ EDP	243	33% (18–47)	94.2%
Complications and Outcomes	Major Stroke	16	EDP	38	1% (0–2)	66.0%
	Major Stroke	16	no_ EDP	30	3% (1–5)	49.1%
	Minor Events	12	EDP	29	2% (1–2)	35.6%
		12	no_ EDP	12	2% (0–5)	71.3%
	MI	14	EDP	28	1% (0–2)	59.1%
	MI	14	no_ EDP	10	2% (1–4)	0.0%
	Total Death	16	EDP	21	1% (0–1)	0.0%
	Total Death	16	no_ EDP	16	2% (1–4)	0.0%

Meta-regression

Since the heterogeneity in the assessment of the effects of using EPD in CAS was high, we used a meta-regression to assess the potential sources of heterogeneity. Results of the meta-regression analyses indicate that the association of death with either mean age or comorbidities, duration, smoking, being female, and symptoms of recently experiencing CVA accidents was not statistically significant. Moreover, Major adverse cardiovascular and cerebral events (MACCE) were not significantly related to any of the mentioned content in both groups. However, there was an exception, where we found that the prevalence of CAD as a risk factor was correlated with a higher mortality rate.

Subgroup analysis

The results of subgroup analysis showed that the patients who received EPD during CAS were mostly asymptomatic [Symptomatic: 41% (95% CI: 27–55; I² = 98.4%); Asymptomatic: 59% (95% CI: 45–73; I² = 98.4%)]; while in patients with no EPD, it was the opposite [Symptomatic: 68% (95% CI: 56–80; I² = 86.1%); Asymptomatic: 32% (95% CI: 21–44; I² = 85.0%)]. The mortality rate reduced from 2% (95% CI: 0.01–0.04; I² = 0.0%) in the no_EPD subgroup to 1% (0.00-0.01; I² = 0.0%) among the EPD subgroup. The occurrence of all other complications was also reportedly higher in patients who did not receive EPD, including major stroke [EPD subgroup: 1% (95% CI: 0–2; I² = 66.0%); no_EPD subgroup: 3% (95% CI: 1–5; I² = 49.1%)] and MI [EPD subgroup: 1% (95% CI: 0–2; I² = 59.1%); no_EPD subgroup: 2% (95% CI: 1–4; I² = 0.0%)], except minor events [EPD subgroup: 2% (95% CI: 1–2; I² = 35.6%); no_EPD subgroup: 2% (95% CI: 0–5; I² = 71.3%)], which were reported to be almost same in both subgroups (Fig. 4).

Publication bias

Figure 5 demonstrates Begg’s and Egger’s funnel plots for relevant studies. Considering that there were no significant symmetries in Begg’s (P = 0.047) and Egger’s (P = 0.003) test results, it can be concluded that there was publication bias among the included studies.

In this systematic review and meta-analysis, we compared the rate of probable embolic events during CAS with and without EPD. We found out that the use of EPD can help with reducing the occurrence of thromboembolic complications of CAS, including MI, major stroke, and death.

CAS is a less invasive treatment method compared to CEA and is usually recommended to poor surgical candidates ³⁴. In a meta-analysis, Sardar et al. showed that the rate of minor intraoperative strokes during CAS is higher than CAE ³⁵. Therefore, this increased risk of stroke in patients undergoing endovascular interventions for carotid artery disorders necessitates the use of a protective device during surgery. However, patients are not completely protected by EPDs against these thromboembolic complications. Also, the placement of such devices is inherently risky. One of the possible risks is the long duration of the operation, which increases the chance of thromboembolism.

Reasons and probable mechanisms for why EPDs fail to prevent the dislodgement of microemboli have been provided by previous studies. In a study conducted in the Netherlands, Vos et al. determined the presence of macro emboli, isolated microemboli, micro embolic showers, and distal thrombus with the transcranial Doppler ultrasound in two groups of patients who underwent CAS with and without EPD ³⁶. In their study, the number of microemboli in the group with EPD was higher than in the group without EPD. They have explained that by capturing macro emboli, the EPD filter causes macro embolies to disintegrate and generate more microemboli. Moreover, the laboratory data reported by them show that after EPD deployment, there is still a potential space for embolic particles between the device and the vascular wall. The results of a study by Pandey et al. ⁵ in the US showed that there is no additional risk associated with placing EPD during CAS, which is in line with the results of other studies, including Coward et al. ³⁷, Cremonesi et al. ³⁸, Gray et al. ³⁹, Mas et al. ⁴⁰, and White CJ et al. ⁴¹.

In a meta-analysis by Cho et al., including 25 articles, using EPD was significantly associated with a lower occurrence of stroke after CAS (P = 0.001). The prevalence of cerebrovascular events in protected and unprotected CAS was 2.0% (326) and 3.4% (142), respectively ⁴². Our results are almost similar to their findings, while we also included the latest studies, a larger sample size, and more complications.

Garg et al. compared the total incidence of stroke within 30 days postoperatively between protected and unprotected CAS by pooling the data from 24 studies. Their findings indicated that protected CAS reduced stroke with a relative risk of 0.59 (95% CI: 0.47–0.73) compared to unprotected CAS ⁴³. A 4.7% (95% CI: 4.1– 5.2) reduction risk of stroke after CAS was also reported by Touzé et al. ⁴⁴. By comparing long-term side effects between symptomatic and asymptomatic patients who underwent CAS, Kosowski et al. concluded that there was no statistically significant difference in stroke and death between the groups ⁴⁵.

Filters are more predisposed to generate embolic events than proximal occlusion or flow reversal systems when passing through the lesion. Therefore, the proximal embolic protection device could be effective in preventing stroke during CAS. Giri et al. compared the clinical outcome of events between distal and proximal protective devices during CAS and concluded that the results were not significant based on the type of device (p = 0.07) ⁴⁶. Besides, Zhan et al. revealed that stroke or death was not statistically different between groups that used filter (1.8%) and distal occlusion (2.3%) embolic protection devices (OR 1.04, p = 0.958) ⁴⁷. Furthermore, prospective trials are needed to compare the specificity and efficacy of the protective device with larger sample sizes and generalizable information.

The results of our analysis showed no significant association between cardiovascular risk factors and long-term complications. This can be attributed to the small sample size of the included studies, the shorter follow-up period, or the longer follow-up not being reported. However, according to our meta-regression analysis, the higher prevalence of cardiovascular disease (CVD) was correlated with a higher mortality rate. This result can be justified by higher base-rate mortality in these patients and their higher susceptibility to endothelial injuries ^48,49.

The study of the Paraskevas KI referred to as The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), has been used to support the equivalence of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in the treatment of carotid stenosis in patients with symptoms or without symptoms. Initially, according to CREST data, there was no difference in outcomes between CAS and CEA, but subsequent subgroup analyses showed that CAS was associated with higher rates of stroke and mortality in symptomatic patients, women, and patients over 65 years of age compared with CEA. Thus, these data offer that CEA and CAS are not equivalent, and CAS, until now, has a higher risk of stroke and death rates compared with CEA. Of course, it is worth mentioning that CREST used CAS technology and indications that are now expired. .⁵⁰

. According to the study of the Schermerhorn ML, Transcarotid artery revascularization (TCAR) with flow reversal offers the lowest reported overall stroke rate for any prospective trial of carotid artery stenting and is a less invasive method for carotid revascularization in high-risk patients. But it needed to confirm the safety of TCAR

and in-hospital stroke/death rates were similar between TCAR and CEA; thus it needs more comparative studies with larger samples sizes to recognize the role of TCAR in extracranial carotid disease management.⁵¹

In this systematic review and meta-analysis, we compared the rate of probable embolic events during CAS with and without using EPD. We found out that the use of EPD can help with reducing the occurrence of perioperative complications of CAS, including MI, major stroke, and death. According to our meta-regression analysis, the prevalence of CAD as a risk factor was correlated with a higher mortality rate. Our results also showed that the patients who received EPD during CAS were mostly asymptomatic, while in patients with no EPD usage, it was the opposite. Altogether, our results suggest that the benefits of using EPD during CAS outweigh the risks of CAS.

Ethics approval statement : As our study is a meta-analysis and has no human participants, it does not require ethical approval

Consent for publication: not applicable

Availability of data and materials: all data generated or analysed during this study are included in table 2.

Competing interests:no

Funding:no

Authors contributions: all the authors collaborated in all the sections and reviewed the manuscript.

Acknowledgements: no

Collaborators* NASCET. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325(7):445–53.
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics—2011 update: a report from the American Heart Association. Circulation. 2011;123(4):e18–e209.
Bastug S. Carotid Artery Stenting Using the Double Embolic Protection Technique. Ejournal of Cardiovascular Medicine. 2021;9(4):200–7.
Chaturvedi S, Bruno A, Feasby T, et al. Carotid endarterectomy—an evidence-based review: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005;65(6):794–801.
Pandey AS, Koebbe CJ, Liebman K, Rosenwasser RH, Veznedaroglu E. Low incidence of symptomatic strokes after carotid stenting without embolization protection devices for extracranial carotid stenosis: a single-institution retrospective review. Neurosurgery. 2008;63(5):867–73.
Halliday A, Harrison M, Hayter E, et al. 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. The Lancet. 2010;376(9746):1074–84.
Barnett HJ, Taylor DW, Eliasziw M, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. N Engl J Med. 1998;339(20):1415–25.
Fisher C, Ojemann R. A clinico-pathologic study of carotid endarterectomy plaques. Rev Neurol. 1986;142(6–7):573–89.
Toole JF. Endarterectomy for Asymptomatic Carotid Artery Stenosis-Reply. JAMA. 1995;274(19):1506–7.
Furie KL, Kasner SE, Adams RJ, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42(1):227–76.
Panagos TSR, Rosenwasser RH, Taylor AJ, Thomas G, Brott JL, Halperin et al. Suhny Abbara, J. Michael Bacharach, John.
Wholey MH, Wholey M, Mathias K, et al. Global experience in cervical carotid artery stent placement. Catheter Cardiovasc Interv. 2000;50(2):160–7.
Roubin GS, New G, Iyer SS, et al. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001;103(4):532–7.
Imparato AM, Riles TS, Gorstein F. The carotid bifurcation plaque: pathologic findings associated with cerebral ischemia. Stroke. 1979;10(3):238–45.
Angelini A, Reimers B, Barbera MD, et al. Cerebral protection during carotid artery stenting: collection and histopathologic analysis of embolized debris. Stroke. 2002;33(2):456–61.
Ohki T, Roubin GS, Veith FJ, Iyer SS, Brady E. Efficacy of a filter device in the prevention of embolic events during carotid angioplasty and stenting: an ex vivo analysis. J Vasc Surg. 1999;30(6):1034–44.
Al-Mubarak N, Roubin GS, Vitek JJ, Iyer SS, New G, Leon MB. Effect of the distal-balloon protection system on microembolization during carotid stenting. Circulation. 2001;104(17):1999–2002.
El-Sudany AH, Georgy SS, Zaki AS, Bedros RY, El-Bassiouny A. Non-protected carotid artery stenting for symptomatic carotid stenosis in low resource settings. Egypt J Neurol Psychiatry Neurosurg. 2021;57(1):1–5.
Varbella F, Gagnor A, Rolfo C, et al. Feasibility of carotid artery stenting with double cerebral embolic protection in high-risk patients. Catheter Cardiovasc Interv. 2016;87(3):432–7.
de Castro-Afonso LH, Abud LG, Rolo JG, et al. Flow reversal versus filter protection: a pilot carotid artery stenting randomized trial. Circulation: Cardiovasc Interventions. 2013;6(5):552–9.
Plessers M, Van Herzeele I, Hemelsoet D, et al. Transcervical carotid stenting with dynamic flow reversal demonstrates embolization rates comparable to carotid endarterectomy. J Endovasc Ther. 2016;23(2):249–54.
Bijuklic K, Wandler A, Hazizi F, Schofer J. The PROFI Study (Prevention of Cerebral Embolization by Proximal Balloon Occlusion Compared to Filter Protection During Carotid Artery Stenting) A Prospective Randomized Trial. J Am Coll Cardiol. 2012;59(15):1383–9.
Yabalak A, Yilmaz M. Carotid artery stenting with or without distal filter-type embolic protection device: A single center experience. J Bionic Memory. 2021;1(2–3):41–9.
Dayama A, Foroutan S, Matolo N, Tsilimparis N. IP113. Results From a Nationwide Registry on Carotid Artery Stenting With Cerebral Protection Device vs Carotid Artery Stenting Alone in Asymptomatic Carotid Stenosis Patients. J Vasc Surg. 2017;65(6):86S.
Giri J, Yeh RW, Kennedy KF, et al. Unprotected carotid artery stenting in modern practice. Catheter Cardiovasc Interv. 2014;83(4):595–602.
Garriboli L, Pruner G, Miccoli T, Recchia A, Tamellini P, Jannello AM. Carotid artery stenting without embolic protection device: a single-center experience. J Endovasc Ther. 2019;26(1):121–7.
Ghaffari S, Hokmabadi ES, Rikhtegar R, et al. Is carotid artery stenting without protection safe?-A single center experience: case series. J Res Clin Med. 2020;8(1):46–6.
Mansour O, Weber J, Niesen W, Schumacher M, Berlis A. Carotid angioplasty and stenting without protection devices. Clin Neuroradiol. 2011;21(2):65–73.
Reimers B, Schlüter M, Castriota F, et al. Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients. Am J Med. 2004;116(4):217–22.
Inanç Y, Mete A, Giray S, Inanç Y. Carotid artery stenting without using any embolic protective device. Ann Ital Chir. 2018;89(6):556–61.
Scheinert D, Reimers B, Cremonesi A, et al. Independent modular filter for embolic protection in carotid stenting. Circulation: Cardiovasc Interventions. 2017;10(3):e004244.
Wells G. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analysis. http://www, ohri ca/programs/clinical_epidemiology oxford htm. 2004;
Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1–e34.
Coutts SB, Wein TH, Lindsay MP, et al. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J stroke. 2015;10(3):282–91.
Sardar P, Chatterjee S, Aronow HD, et al. Carotid artery stenting versus endarterectomy for stroke prevention: a meta-analysis of clinical trials. J Am Coll Cardiol. 2017;69(18):2266–75.
Vos JA, van den Berg JC, Ernst SM, et al. Carotid angioplasty and stent placement: comparison of transcranial Doppler US data and clinical outcome with and without filtering cerebral protection devices in 509 patients. Radiology. 2005;234(2):493–9.
Coward LJ, McCabe DJ, Ederle J, Featherstone RL, Clifton A, Brown MM. Long-Term Outcome After Angioplasty and Stenting for Symptomatic Vertebral Artery Stenosis Compared With Medical Treatment in the C arotid A nd V ertebral A rtery T ransluminal A ngioplasty S tudy (CAVATAS) A Randomized Trial. Stroke. 2007;38(5):1526–30.
Cremonesi A, Manetti R, Setacci F, Setacci C, Castriota F. Protected carotid stenting: clinical advantages and complications of embolic protection devices in 442 consecutive patients. Stroke. 2003;34(8):1936–41.
Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg. 2006;44(2):258–68.
Mas J-L, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355(16):1660–71.
White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME. Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv. 2006;67(4):503–12.
Cho YD, Kim S-E, Lim JW, Choi HJ, Cho YJ, Jeon JP. Protected versus unprotected carotid artery stenting: meta-analysis of the current literature. J Korean Neurosurg Soc. 2018;61(4):458–66.
Garg N, Karagiorgos N, Pisimisis GT, et al. Cerebral protection devices reduce periprocedural strokes during carotid angioplasty and stenting: a systematic review of the current literature. J Endovasc Ther. 2009;16(4):412–27.
Touzé E, Trinquart L, Chatellier G, Mas J-L. Systematic review of the perioperative risks of stroke or death after carotid angioplasty and stenting. Stroke. 2009;40(12):e683–93.
Kosowski M, Zimoch W, Gwizdek T, et al. Safety and efficacy assessment of carotid artery stenting in a high-risk population in a single-centre registry. Adv Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2014;10(4):258–63.
Giri J, Parikh SA, Kennedy KF, et al. Proximal versus distal embolic protection for carotid artery stenting: a national cardiovascular data registry analysis. JACC: Cardiovasc Interventions. 2015;8(4):609–15.
Zahn R, Ischinger T, Mark B, et al. Embolic protection devices for carotid artery stenting: is there a difference between filter and distal occlusive devices? J Am Coll Cardiol. 2005;45(11):1769–74.
Bemanalizadeh M, Farajzadegan Z, Golshiri P. Estimation of cardiovascular disease risk factors in the undefined participants of campaign in isfahan in 2017. Int J Prev Med. 2021;12.
Alfaddagh A, Martin SS, Leucker TM, et al. Inflammation and cardiovascular disease: From mechanisms to therapeutics. Am J Prev Cardiol. 2020;4:100130.
Paraskevas K, Mikhailidis D, Liapis C, Veith F. Critique of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): flaws in CREST and its interpretation. Eur J Vasc Endovasc Surg. 2013;45(6):539–45.
Schermerhorn ML, Liang P, Dakour-Aridi H, et al. In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative. J Vasc Surg. 2020;71(1):87–95.

No competing interests reported.

Download PDF

Version 1

posted

You are reading this latest preprint version

Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices: A Meta-Analysis study Short title: Comparison of Thromboembolic Complications After Carotid Artery Stenting with and without Using Protection Devices

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusion

Figures

Introduction

Methods

Search strategy

Selection criteria

Data extraction

Quality assessment

Statistical analysis

Results

Study selection

Demographic characteristics of included studies

Risk factors, complications, and outcomes

Meta-regression

Subgroup analysis

Publication bias

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1