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April2013 Vol.50 Issue:      2 Table of Contents
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Aggressive Medical Treatment versus Carotid Artery Stenting in Management of Carotid Artery Stenosis: An Egyptian Study

Mohamed Khaled Elewa, Mahmoud Hemeda, Nahed Salah El-din,

Hany M Zakieldine, Samia Ashour Helal

Department of Neurology, Ain Shams University; Egypt



ABSTRACT

Background: Carotid revascularization is superior to medical treatment in stroke prevention in patients with severe symptomatic or asymptomatic atherosclerotic carotid artery stenosis. However, integrated aggressive medical treatment should be tested against revascularization. Objective: To compare CAS under protection device with aggressive medical treatment. Methods: Seventy-five patients with significant carotid stenosis were divided into three groups; double antiplatelets (DAP) group (acetyl-salicylic acid 150 mg/day + clopidogrel 75 mg/day), oral anticoagulation (OAC) group (INR level between 2-2.5 plus acetyl-salicylic acid 150 mg/day) and carotid artery stenting (CAS) group. All patients were followed for at least 6 months. End point was ipsilateral transient ischemic attack (TIA), ipsilateral ischemic stroke, intra-cranial hemorrhage and vascular death. Results: The study was done on two stages. The 2nd stage decision was based on results of 1st stage (patients who had new ischemic event on certain modality were shifted to another one). In the 1st stage, 57 patients were treated conservatively (39 on DAP and 13 on OAC) and 17 patients underwent CAS. CAS group was associated with significantly (p=0.01) better outcome. Twenty-six (45%) patients of medical group had new ipsilateral cerebral vascular event, while 2 (12%) patients of CAS group developed new ipsilateral vascular event (periprocedural TIAs). The 2nd decision included 29 patients; 22 patients underwent CAS, 5 patients were shifted to OAC and 2 patients to DAP. Among patients in CAS group, one (4.5%) developed ischemic stroke while among the 7 patients on medical management, one patient (14.2%) developed new ischemic stroke. Conclusion: CAS under protection device is associated with better outcome than aggressive medical treatment. [Egypt J Neurol Psychiat Neurosurg.  2013; 50(2): 113-120]

 Key Words: carotid artery stenting, double antiplatelets, oral anticoagulant.

Correspondence to Hany M Zakieldine, Department of Neurology, Ain Shams University; Egypt. Tel.: +201001069930   e-mail: zakieldine.hany@yahoo.com

 





INTRODUCTION

 

Stroke is the third leading cause of death in the U.S.1 Extra-cranial carotid stenosis accounts for about 15–20% of cerebral ischemic events.2,3 An Egyptian study had showed that among 100 acute stroke patients, 16% had internal carotid artery (ICA) stenosis (>50%).4

With the evolution and maturation of carotid artery stenting (CAS), many nonrandomized and randomized CAS clinical trials had compared carotid stenting with the use of an embolic-protection device with carotid endarterectomy (CEA). Recently the CREST trial concluded that among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly between carotid-artery stenting and endarterectomy5.

 

Antiplatelet therapy and strict control of vascular risk factors are the mainstays of medical therapy. New modalities of aggressive medical treatment were not tested again after the old large randomized studies comparing conventional medical treatment (aspirin only) against CEA. Despite the large number of studies on carotid disease management, there are no available studies comparing new modalities of medical treatment against CEA or CAS.

In this work, we compared CAS under protection device with aggressive medical treatment.

 

SUBJECTS AND METHODS

 

Seventy five patients were included according to the following inclusion criteria; symptomatic stenosis > 70% and asymptomatic stenosis >80% (accidentally discoverted during pre-operative assessment for CABG and during full assessment for irrelevant stroke). Exclusion criteria were; major functional impairment (modified Rankin Scale >3), significant cognitive impairment (demented patients) or major stroke within 4 weeks, contraindication to aspirin or clopidogrel (allergy, thrombocytopenia, GIT hemorrhage of <3 months), or inability to achieve safe vascular access, intracranial aneurysm >2mm or AVM requiring treatment, visible fresh thrombus on the lesion, chronic total occlusion or long subtotal occlusion (string sign).

All patients underwent; formal neurological assessment and modified Rankin Scale scoring6, carotid duplex ±MRA or CTA (neck vessels) at day zero and after 6 months, MRA or CTA brain at day zero, MRI Brain at day zero and with new cerebrovascular events, and laboratory investigations (complete blood count, PT, PTT, liver and renal function tests, random blood sugar, lipid profile and serum uric acid), ECG and trans-thoracic echocardiography.

Severity percentage stenosis was defined by an absolute increase in the peak systolic velocities > 230 cm/sec, peak systolic velocity ratio (between ICA & CCA) of 4, or an end diastolic ratio of more than 5.5.

Patients were divided into three groups according to modality of management; double antiplatelet (DAP) group (acetyl-salicylic acid 150 mg/day + clopidogrel 75mg/day), oral anticoagulation (OAC) group (oral anticoagulants targeting INR level between 2:2.5 plus acetyl-salicylic acid 150 mg/day) and CAS under protection device group. Controlling the associated modifiable atherogenic risk factors including statins was performed in all patients. All patients were followed for at least 6 months. End point was defined as ipsilateral transient ischemic attack (TIA), ipsilateral ischemic stroke, intra-cranial hemorrhage and vascular death.

 

Carotid Angioplasty and Stenting under Embolic Protection Device

Preoperative management

Antiplatelet therapy: aspirin 150-mg/d and clopidogrel 75-mg/day for ≥3 days prior to the procedure, and routine antihypertensive medications on the morning of the procedure will be holded.

 

Operative Details

Access phase

All procedures were carried out via puncture of the right or left femoral artery. The common carotid artery was selectively engaged by using a proper 8 F guiding catheter under systemic heparinization (ACT between 250 and 300 seconds)

A diagnostic angiogram was obtained with PA, lateral, and oblique images of the target vessel and quantitative measurements of the target vessel and stenotic lesion were made. A PA and lateral intracranial angiogram was done routinely.

 

Intervention phase

Advancement and deployment of the embolic protection device (EPD), pre-dilatation angioplasty in tight lesions, advancement and deployment of the stent across the lesion, post-dilatation angioplasty (if needed). Patient was routinely pre-treated with atropine, 1mg IV, retrieval of the EPD, and final angiographic images were obtained.

Procedural success was defined as; to be able to perform the procedure under EPD, in other words, successful passage of the EPD before stenting or predilatation, to succeed to cover the whole lesion by the use of a single stent, to achieve a less than 30% residual diameter stenosis of the treated lesion in at least two matched views on angiography and finally absence of distal embolization.

 

Postprocedure management

Aspirin 150-mg PO QD indefinitely, Clopidogrel 75-mg PO QD for three months after the procedure and Enoxaparin  40 units SC / 12h for 7days. Post CAS hypotension is usually self-limited and resolves within 1–2 days.

 

Statistical Methodology

Data was analyzed on an IBM personal computer, using Statistical Package for Special Science (SPSS) software computer program version 15. Data were described as mean ± standard deviation (SD) for quantitative (Numerical) variables and as frequency and percentage for qualitative (Categorical) variables. Chi-square test (or Fisher’s exact test when appropriate) was used for comparison of distribution of qualitative variables among different group. Significance level p-value was classified as follows; P>0.05 is insignificant (NS), P≤0.05 is significant (S), P≤0.01 is highly significant (HS), P ≤0.001 is very highly significant (VHS).

 

RESULTS

 

The study was conducted over 2 years (between 2008 and 2010).  It was done on two stages with mean follow up of 7.84±4.35 months for the 1st stage and 10.32±3.8 months for the 2nd stage (Table 1). The decisions of management in the 2nd stage of the study were based on the results of the previous stage. The demographic data, risk factors, clinical presentation and vascular assessment are reported in Tables 2, 3, 4 and 5. Both groups were matched as regards demographic data, risk factors, presentation, disability, carotid duplex and intracranial vascular assessment findings except for gender and diabetes mellitus distribution. Females were more prevalent among the medically conservative group (65%) while males were more prevalent among the CAS group (80%) (P= 0.004) and diabetes mellitus was more prevalent among the medically conservative group (75% of the medical group and 40% of the CAS group) (P=0.0001).   

 

Outcome and correlative analysis

Out of the 75 patients in the 1st stage; 57 patients were treated conservatively (39 on DAP and 13 on OAC), 17 patients underwent CAS. Eight patients dropped out during follow-up (6 of conservative and 2 of stenting group) in addition to 1 patient that turned out to have a totally occluded artery.

During 7.84 months mean follow up; stenting was associated with better outcome. Twenty six patients (45%) of conservative group had new ipsilateral cerebral vascular event [13 (22.4%) ipsilateral TIA, 11 (19%) ipsilateral ischemic CVS (9 patients major stroke and 2 patients minor stroke) and 2 (3.4%) ipsilateral hemorrhagic transformation]. Two patients (12%) of the CAS group developed new ipsilateral vascular event (periprocedural TIAs). There was significant difference between the two groups (p<0.01) (Table 6).    

Out of 39 patients on DAP; 23 (59%) developed new ipsilateral cerebral vascular events [13 patients (33%) ipsilateral TIA and 10 patients (26%) ipsilateral ischemic CVS (8 patients major stroke and 2 patients minor stroke]. On the other hand, out of 13 patients on OAC; 3 (23%) developed new ipsilateral cerebral vascular events [1 patient (7.6%) ipsilateral ischemic CVS (major stroke) and 2 patients (15.3%) ipsilateral hemorrhagic transformation]. DAP group showed significantly higher percentages of new ipsilateral vascular event than OAC group (P<0.05) (Table 7).

When DAP group was compared with OAC group, a significant difference was found as regard our different endpoints (p<0.01). With further analysis, DAP showed significantly higher rate of ipsilateral TIA than OAC (p<0.01) and a higher rate of new ipsilateral ischemic stroke but the difference did not reach a significant level. OAC group showed a higher rate of ipsilateral hemorrhagic transformation than DAP group but the difference did not reach a significant level (Table 7).

Among the conservative medical group, new ipsilateral cerebral vascular events were significantly more in diabetics versus non-diabetics (63.2% versus 14.3%; p<0.05), in patients with ≥4 vascular risk factors versus those with <4 vascular risk factors (75% versus 42.5%; p<0.05), in patients with 99-100% versus 70-98% carotid stenosis (80% versus 42.8%; p<0.05). There was no significant difference between symptomatic versus asymptomatic stenosis as well as between different brain imaging findings [distribution of carotid infarction, type of carotid infarction (lacunar, territorial and watershed infarction), brain atrophy, leukoariosis and vertebro-basilar infarction]

After the 1st treatment decision, a second decision management was done based on the outcome of the 1st follow up period (occurrence of endpoint). The 2nd decision includes 26 patients: 19 patients underwent CAS, 5 patients were shifted to OAC and 2 patients were shifted to DAP. In addition, 3 patients underwent their 2nd stenting procedure for their other asymptomatic side.

Out of 22 patients in stenting group, 1 patient (4.5%) developed ischemic stroke (major stroke) after 12 months follow up. He was a 76 years old male patient, symptomatic, heavy smoker, hypertensive and dyslipidemic and had tandem M1MCA stenosis (>70%) that may be the explanation for such recurrence since no carotid restenosis was detected during follow-up. Out of 7 patients on medical conservative management one patient (14.2%) developed new ischemic CVS on OAC (minor stroke) (Table 8).

Among the CAS patients in both stages (37 patients), only one patient (2.7%) developed significant restenosis after 11 months that was asymptomatic. Restenting was performed without complications.


 

 

Table 1. The mean follow up periods.

 

 

Number of patients

Minimum follow up (months)

Maximum follow up period (months)

Mean period of follow up (months)

1st stage

75

6.0

12.00

7.84± 4.35

2nd stage

29

6.0

12.00

10.32±3.80

Table 2. Demographic data and risk factors.

 

 


Number

%

Age (years), mean, range

63.87±10.10, 38-87 years

53


Male/ Female

33/42

44.0/56.0

Hypertension

60

80.0

Dyslipidemia

53

70.7

Diabetes Mellitus

47

62.7

Smoking

34

45.3

Ischemic Heart Disease

31

41.3

Myocardial infarction (MI)

2

2.7

coronary artery bypass graft

5

6.7

Renal impairment (s Cr ≥1.4 less than ≤2.5)

4

5.3

Peripheral vascular disease

3

4.0

 

 

Table 3. Clinical presentation and disability.

 

Clinical presentation

Number

%

·        Symptomatic carotid patients

·        Symptomatic carotid patients presenting with Ischemic CVS

·        Symptomatic carotid patients presenting with hemispheric TIA

69

54

15

92.0

72.0

20

Asymptomatic carotid patients

6

8.0

mRS score at presentation

0

1 and 2

3

 

22

43

10

 

29.3

57.3

13.3

 

 

Table 4. Carotid duplex findings.

 

 

Number

%

Laterality of carotid stenosis

·   unilateral stenosis

·   bilateral stenosis

·   unilateral stenosis with contralateral occlusion

·   unilateral occlusion

 

53

12

5

5

 

70.7

16.0

6.7

6.7

Degree of stenosis (according to the most severe lesion)

·   70-98%

·   99 (subtotal occlusion)

·   100 (occluded) (including unilateral stenosis with contralateral occlusion and unilateral occlusion)

 

60

5

10

 

80.0

6.7

13.3

 

Table 5. Intracranial vascular assessment by MRA ± CTA.

 

 

Number

%

Intra-cranial stenosis (>50%)

·        tandem carotid circulation stenosis

·        non-tandem carotid circulation stenosis

·        VB circulation stenosis

15

5

2

9

20

6.7

2.6

12

Intra-cranial occlusion

·        tandem carotid circulation occlusion

·        non-tandem carotid circulation occlusion

·        VB circulation occlusion

22

14

4

7

29.3

18.6

5.3

9.3

 

Table 6. Comparison between medical and CAS group at first stage.

 

 

Medical patients             

CAS patients

Total     

No

%

No

%

No

%

No new ipsilateral vascular event

26

44.8%

13

76.5%

39

52.0%

New ipsilateral TIA

13

22.4%

2

11.8%

15

20.0%

New ipsilateral ischemic CVS

11

19.0%

0

0%

11

14.7%

Ipsilateral hemorrhagic transformation

2

3.4%

0

0%

2

2.7%

Dropped out

6

10.3%

2

11.8%

8

10.7%

Total

58

100%

17

100%

75

100%

χ2= 6.67 P=0.01

 

 

Table 7. Comparison between types of medical treatment (DAP and OAC).

 

 

DAP patients

OAC patients

P-value

No

%

No

%

No new ipsilateral vascular event

16

41.0%

10

76.9%

 

P<0.05

New ipsilateral vascular event

23

59.0%

3

23.1%

New ipsilateral TIA

13

33.3%

0

0%

P<0.01

New ipsilateral ischemic CVS

10

25.6%

1

7.7%

Ipsilateral hemorrhagic transformation

0

0%

2

15.4%

 

 

Table 8. Comparison between medical and CAS group at second stage.

 

 

Medical patients  

CAS patients             

Total         

No

%

No

%

No

%

No new ipsilateral vascular event

6

85.7%

21

95.4%

27

93.1%

New ipsilateral vascular event

1

14.2%

1

4.5%

2

6.9%

 

 

Figure 1. (a and b) ICA origin showing subtotal occlusion (0.5 cm) with a stagnant distal flow before stenting.

(c) ICA after stenting with complete recanalization.

 

 

 

Figure 2. (a and b) ICA showing tight stenosis by a large heavily calcified plaque. (c) ICA after angioplasty using cutting balloon followed by stenting resulting in complete recanalization.

 

 


DISCUSSION

 

Carotid revascularization is superior to conventional medical treatment in stroke prevention in patients with severe symptomatic or asymptomatic atherosclerotic carotid artery stenosis. However, with the evolution of integrated aggressive medical treatment, we tried in this work to test such aggressive medical treatment against revascularization.

In our trial, stenting was associated with better outcome than the integrated aggressive medical treatment; 45% of the conservative medical group versus 12% of the stenting group had new cerebral vascular event.  In the NASCET7 and ECST8; the ipsilateral stroke rate at 2 and 3 years was 26% and 26.5% in the medical group. The NASCET and ECST trials did not include TIA as an end point. After exclusion of TIA as end point in the current study, its results (22.4% ipsilateral vascular insult) is not far from these large trials especially that most of the new ischemic event in these large trials occurred in the 1st year of follow up. In addition, we did not exclude high risk patients (5.3% of patients >79 yrs old, 22.7% had bilateral tight lesions and 49.3% had intracranial stenosis or occlusion). This may also explain the higher rate of new vascular events among patients treated conservatively in our study. Hence, in this study the use of double antiplatelet did not add benefit over aspirin alone. This is consistent with the CHARISMA trial9 which had concluded that the combination of clopidogrel plus aspirin was similar to aspirin alone. On the other hand, in the MATCH trial, the combination of aspirin plus clopidogrel increased the risk of systemic and intra-cerebral hemorrhage, but did not decrease the risk of stroke compared with clopidogrel alone10.

On the other hand the Stroke Prevention in Reversible Ischemia Trial (SPIRIT), oral anticoagulation (INR =3.0-4.5) was tested against daily 30 mg aspirin as a secondary prevention for ischemic stroke. The trial was stopped due to higher rate of major bleeding complication in OAC group11. In the Warfarin Aspirin Recurrent Stroke Study (WARSS), warfarin (INR =1.4-2.8) was tested against aspirin in preventing recurrent ischemic stroke in patients with non-cardioembolic infarcts. Warfarin did not show additional benefit over aspirin12. The Warfarin versus Aspirin for Symptomatic Intracranial Disease (WASID) study revealed that warfarin (INR of 2.0 to 3.0) was associated with significantly higher rates of adverse events (major hemorrhage) and did not provide a benefit over aspirin13. In contrast, the ESPRIT trial concluded that anticoagulation with achieved INR of 2.0 to 3.0 is reasonably safe concerning the risk of developing intracranial hemorrhage in patients with cerebral ischemia of arterial origin14. In our study, OAC group received oral anticoagulation targeting INR level between (2-2.5) which is reasonably safe plus acetyl-salicylic acid 150 mg /day. This combination succeeded in decreasing the rate of new ischemic events significantly than DAP. Yet it was associated with higher rate of hemorrhagic events (15.3%).

The outcomes with CAS have continued to improve and the results reported in recent registries have been superior to the old studies. The average 30-day rate for stroke or death was 7.3% in a meta-analysis, which included 11 randomized studies between 1998-200915. In the CREST trial5 (2502 patients), the Emboshield and Xact Post Approval Carotid Stent Trial registry (2145 high surgical risk patients) and the Carotid Acculink/Accunet Post Approval Trial (4175 patients) the 30 day rates for ipsilateral stroke or death was only 4.4%, 4.1% and 3.4%, respectively16. This may be attributed to a learning curve in the emerging technique of CAS with improvement in equipment design, optimization of patient selection, adequate training of operators, and better attention to pharmacotherapy. Randall et al in a recent prospective study that analyzed collected data of 563 carotid stenting procedures in a single center found that ipsilateral stroke rates for all patients were 4.8%, 7.0%, and 9.5% at 30 days, 1 year, and 4 years, respectively. The rates improved to 2.7%, 4.1%, and 4.5% when patients were treated with optimal therapy (clopidogrel plus aspirin and statins and the use of EPD). 17

What is also important to mention is that out of 5 patients who had unilateral carotid occlusion based on duplex, this apparently occluded artery turned out to be a high grade stenosis in 4 patients using CT angiography (2 patients) or digital subtraction angiography (2 patients). Thus, more sensitive modalities should be used in those patients with apparently occluded carotids on duplex to confirm the diagnosis.18

Finally we can conclude that in our trial, CAS under protection device is associated with better outcome than aggressive medical treatment (either DAP or OAC) and it appears to be a safe procedure.

 

[Disclosure: Authors report no conflict of interest]

 

REFRENCES

 

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2.      Woo D, Gebel J, Miller R, Kothari R, Brott T, Khoury J, et al. Incidence rates of first-ever ischemic stroke subtypes among blacks: a population-based study. Stroke. 1999; 30(12): 2517-22.

3.      Grau A, Weimar C, Buggle F, Heinrich A, Goertler M, Neumaier S, et al. Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German Stroke Data Bank. Stroke. 2001; 32(11): 2559-66.

4.      Zaki-eldine HM, Saleh M, Hassaan A, Abdulghani MO, Zaki AA, El-Etribi MA. Assessment of cerebral atherosclerosis and novel strategies of management of brain attack [MD thesis]. Cairo: Ain Shams University; 2002.

5.      Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, et al. The CREST Investigators. Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis. N Engl J Med. 2010; 363(1): 11-23.

6.      Bonita R, Beaglehole R. Modification of Rankin Scale: Recovery of motor function after stroke. Stroke. 1988; 19(12): 1497-500.

7.      North American Symptomatic Carotid Endarterectomy Trial (NASCET) Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991; 325: 445-53.

8.      Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998; 351: 1379-87.

9.      Bhatt D, Fox K, Hacke W, Berger PB, Black HR, Boden WE, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006; 354: 1706-17.

10.    Diener H, Bogousslavsky J, Brass L, Cimminiello C, Csiba L, Kaste M, et al. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004; 364: 331-7.

11.    The Stroke Prevention in Reversible Ischemia Trial (SPIRIT) Study Group. A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. Ann Neurol. 1997 Dec;42(6):857-65.

12.    Hankey G. Warfarin-Aspirin Recurrent Stroke Study (WARSS) trial: is warfarin really a reasonable therapeutic alternative to aspirin for preventing recurrent noncardioembolic ischemic stroke? Stroke. 2002; 33(6): 1723-6.

13.    Chimowitz M, Lynn M, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005; 352(13):1305–16.

14.    ESPRIT. Oral anticoagulation in patients after cerebral ischemia of arterial origin and risk of intracranial hemorrhage. Stroke. 2003; 34(6): e45-6.

15.    Meier P, Knapp G, Tamhane U, Chaturvedi S, Gurm HS. Short term and intermediate term comparison of endarterectomy versus stenting for carotid artery stenosis: systematic review and meta-analysis of randomised controlled clinical trials. BMJ 2010; 340: c467.

16.    Gray W, Chaturvedi S, Verta P. Thirty-day outcomes for carotid artery stenting in 6320 patients from 2 prospective, multicenter, high-surgical-risk registries. Circ Cardiovasc Interv. 2009; 2(3): 159-66.

17.    Randall MS, McKevitt FM, Kumar S, Cleveland TJ, Endean K, Venables GS, et al. Long-term results of carotid artery stents to manage symptomatic carotid artery stenosis and factors that affect outcome. Circ Cardiovasc Interv. 2010 Feb 1;3(1):50-6.

18.    Dillon E, van Leeuwen M, Fernandez M, Eikelboom B, Mali W. CT angiography: application to the evaluation of carotid artery stenosis. Radiology. 1993; 189(1): 211-9.


 

الملخص العربى

 

 

علاج ضيق الشريان السباتى : دراسة مصرية مقارنة العلاج الدوائى المكثف وتركيب الدعامة للشريان السباتى

 

إن التوسيع لمرضى ضيق الشريان السباتى الشديد يوفر حماية أفضل من العلاج الدوائى التقليدى للوقاية من الأزمات المخية ولكن يتبقى اختبار العلاج المكثف مقارنة بالتوسيع. ولقد قسمنا 75 مريضاً يعانون من ضيق الشريان السباتى الشديد الى ثلاث مجموعات من حيث نوع العلاج: المجموعة الأولى حصلت على مضادين للصفائح الدموية (حمض الأستيل ساليسيليك 150 مج + كلوبيدوجريل 75 مج) والمجموعة الثانية حصلت على مضادات لعوامل التجلط (آى إن آر 2-2.5) بالإضافة لحمض الأستيل ساليسيليك ( 150 مج) و للمجموعة الثالثة تم إجراء توسيع وتركيب دعامة للشريان السباتى. وقد تمت متابعة المرضى لمدة 6 اشهر على الأقل وفى النهاية تم تسجيل من أصيبوا بقصور مؤقت فى الدورة المخية أو بأزمة مخية فى نفس ناحية الضيق أو نزيف بالمخ أو الوفاة. وقد تمت تلك الدراسة على مرحلتين حيث كان القرار بالمرحلة الثانية معتمدا على نتيجة المرحلة الأولى (فى حالة فشل نوع من العلاج تم الانتقال الى نوع آخر من العلاج). فى المرحلة الأولى تم علاج 57 مريضا بالعلاج الدوائى المكثف (39 فى المجموعة الأولى و 13 فى المجموعة الثانية)  كما تم إجراء توسيع وتركيب دعامة للشريان السباتى لسبعة عشر مريضا. كانت نتائج مجموعة توسيع وتركيب الدعامة للشريان السباتى أفضل: حيث أصيب ستة وعشرون مريضا (45%) من مرضى العلاج الدوائى المكثف بقصور مؤقت فى الدورة المخية أو بأزمة مخية فى نفس ناحية الضيق بينما أصيب مريضان  (12%) من مرضى توسيع وتركيب الدعامة للشريان السباتى بقصور مؤقت فى الدورة المخية وفقد 9 مرضى. فى المرحلة الثانية تم علاج 29 مريضا: تم إجراء توسيع وتركيب دعامة للشريان السباتى لـ 22 مريضا وتم تحويل 5 مرضى من علاج المجموعة الأولى الى علاج الثانية وتم تحويل 2 مرضى من علاج المجموعة الثانية إلى علاج الأولى. فى هذه المرحلة أصيب  مريض واحد (14.2%) من مرضى العلاج الدوائى المكثف بأزمة مخية فى حين أن مريض واحد (4.5%) من مرضى توسيع وتركيب الدعامة للشريان السباتى أصيب بأزمة مخية. ونستنتج من هذا أن توسيع الشريان السباتى وتركيب الدعامة له باستخدام الوقاية المخية يوفر حماية أفضل من العلاج الدوائى المكثف.



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