Abstract TP132: Intensive Medical Management and Life-Style Modifications Can Be Successfully Applied in Combination With Indirect Surgical Revascularization for Symptomatic Intracranial Atherosclerotic Disease

Abstract

Introduction: We present the results of using the strict model of intensive medical management (IMM) and life-style modification of SAMMPRIS in a phase 2 study of EDAS revascularization in patients with symptomatic intracranial atherosclerosis (ERSIAS). Methods: ERSIAS was a mid-development, single surgical arm trial that enrolled patients closely matched to those recruited in SAMMPRIS with the exception of including also individuals with occlusions of the intracranial arteries. In addition to surgery, primary and secondary risk factors were strictly managed and a life-style modification program with monthly phone calls to encourage adherence to medication, diet, physical activity, and smoking cessation was applied. Every 3 months, patients were clinically evaluated and data of adherence to medical regimen was collected. Results: As previously reported, the rate of recurrent stroke in ERSIAS at one year was 7.7%. ERSIAS required patients to have ceased smoking for at least 6 months before enrollment. Of the 52 patients enrolled only 5 had a relapse in their smoking habit (9.6%). At the end of the study four stopped smoking, representing a failure on smoking control of only 2%. Patient’s engagement in vigorous physical activity increased from 43% at baseline to 84% at follow-up (p=0.03). Median LDL values at baseline, 6 months, and 12 months were 83.9 (IQR 65.2), 70.9 (IQR 38.8), and 77 (IQR 78.25), respectively. At an individual level 75.6% of patients had improvement in LDL control. The SBP goal (<160mmHg) was achieved in 91% of patients, and a reduction of SBP was observed in 65.9% at either 6 or 12 months. Median HbA1c values in diabetic (DM2) patients were 6.3% (QR 2.5) at baseline, 5.1% (IQR 2.5) at 6 months, and 5.9% (IQR 2.8) at 12 months, accounting for an improvement in 60% of patients at either 6 or 12 months. Conclusion: A dedicated follow-up program optimized medical adherence and results in ERSIAS. The surgery did not affect the ability of patients to engage in exercise or adhere to medical management. The IMM model of SAMMPRIS was successfully applied in this surgical trial. Strict observance of the improvements in medical management should be integrated in future interventional studies for ICAD.