The Effects of Antithrombotic Medication on Patients Enrolled in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial Open Access

Hong, Mindy Rui (2014)

Permanent URL: https://etd.library.emory.edu/concern/etds/m900nt67v?locale=en
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Abstract

Intracranial arterial stenosis is an imperative cause of stroke that can be treated with percutaneous transluminal angioplasty and stenting (PTAS) in patients who have experienced a recent transient ischemic attack (TIA) or stroke. The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial aimed to determine whether angioplasty and stenting is beneficial to aggressive medical management in preventing a primary end point. The clinical trial discovered that the 30-day rate of stroke or death was much higher in the PTAS group (14.7%) than the medical management group (5.8%), and concluded that aggressive medical management was superior to PTAS in patients with intracranial stenosis. Because there has not yet been a treatment proven to be more effective than medical therapy, interventionalists hope to find an effective alternative method to treating patients with intracranial stenosis, especially in those who have failed medical management. Since patients who were taking antithrombotic medication at the time of the qualifying event can be considered to have failed medical therapy, we are interested in observing whether or not angioplasty and stenting can provide any potential benefit to these patients. In this study, we used the log-rank test and Cox proportional hazards regression to see whether or not there was a statistical difference in overall time to primary endpoint between patients who were on antithrombotic medication and patients who were not. Product-limit estimates for both medication groups were obtained through Kaplan-Meier curves. Our results showed that within the group of patients taking antithrombotic medication, the probability of experiencing a primary endpoint was significantly higher in patients assigned to the PTAS group compared to those in the medical management group (p = 0.0428). Furthermore, multivariate analysis regression results showed that the effect of treatment was not statistically different in the two antithrombotic medication groups. Therefore, our results emphasized that PTAS does not provide a benefit over aggressive medical management alone in patients who were taking antithrombotic medication at the time of the qualifying event.

Table of Contents

Introduction .... 1
Background .... 1
Treatments .... 2
SAMMPRIS .... 4

Methods .... 7

Results .... 9
Demographic and Clinical Characteristics .... 9
Analysis for Primary Endpoint .... 12

Discussion.... 13

Appendix.... 16

Table 1: Baseline Characteristics .... 16

Table 2: Event Rates in Patients on Antithrombotic Medication .... 17

Table 3: Event Rates in Patients Not on Antithrombotic Medication .... 17
Table 4: Cox Proportional Hazard Regression .... 18
Figure 1: Kaplan-Meier Curve in Patients on Antithrombotic Medication .... 19
Figure 2: Kaplan-Meier Curve in Patients Not on Antithrombotic Medication .... 20

References .... 21

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