Soluble CD40 Ligand's Predictability of Ischemic Stroke and
Myocardial Infarction in Patients With Nonvalvular Atrial Fibrillation
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Status:
Completed. Results published October 2007.
Purpose:
To assess whether soluble CD40 ligand (sCD40L) is a predictor of stroke or myocardial infarction (MI) in patients with nonvalvular AF.
Year Started:
2001
Year Finished:
2006
Design:
Non-randomized, observational, intervention study.
Inclusion Criteria
Patients with nonvalvular atrial fibrillation (AF)—paroxysmal, persistent, or permanent (lasting >6 months).
Exclusion Criteria
Patients with rheumatic AF; echocardiographic evidence of intracardiac thrombosis or tumor; left ventricular aneurysm, severe congestive heart failure (New York Heart Association functional class >3), or the presence of prosthetic valves; acute myocardial infarction or unstable angina during the previous month; carotid endarterectomy or coronary or peripheral revascularization procedures performed during the previous 6 months; acquired or congenital valvular disease (except mitral valve prolapse or mitral annulus calcification). The neurological exclusion criteria included CT brain scan evidence of cerebral hemorrhage, documented arteriovenous malformation or tumor, severe involutive cerebral disease, or the presence of a carotid lesion requiring surgical intervention.
Patient Involvement:
Patients were classified as having low, moderate, or high risk for ischemic stroke. Based on this classification 172 patients (74.4%) were treated with oral anticoagulants and 55 (23.8%) with aspirin (100 mg/d). All patients' medical history was taken at baseline, along with a physical examination, and the following diagnostic procedures were also performed: routine blood laboratory tests, baseline 12-lead ECG, M-mode, and 2-dimensional echocardiography with
echocolor-doppler, echocolor-doppler of the supra-aortic trunks, and chest roentgenography. Patients were monitored every 3 months to assess compliance and clinical status, ECG, and laboratory tests. Patients were divided into 2 groups on the ground of the median value of sCD40L (4.76 ng/mL). Antiplatelet and anticoagulant drugs were equally distributed between the 2 groups. Statin treatment was more frequent in the group with high level of sCD40L.
Primary Outcome:
Nonfatal and fatal stroke, fatal and nonfatal myocardial infarction.
Secondary Outcome:
Mortality rate.
Results:
Of the 231 patients recruited, 177 (77%) had permanent or
persistent AF, and 54 (23%) had paroxysmal AF. During the follow-up 35 patients (15.1%) experienced cardiovascular and cerebrovascular events; 19 (8.2%) had ischemic stroke, and 16 (6.9%) had myocardial infarction (MI). 6 out of 116 patients (5.1%) with low levels of sCD40L had vascular events (2 nonfatal MI and 4 nonfatal ischemic strokes), and 29 of 115 patients (25.2%) with high levels of sCD40L had vascular events (11 fatal and 3 nonfatal MI; 3 fatal and 12 nonfatal ischemic strokes). Levels of sCD40L above the median were significantly associated with shorter time to ischemic events (P<0.001), with the incidence rate of vascular events being 0.93 and 0.18 per 100 months of observation in patients with sCD40L levels above and below the median, respectively.
Source of Information:
Arterioscler Thromb Vasc Biol. 2007;27:000-000.
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This information last updated on: 10/5/2007
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