Background and Purpose
Enrollment in the SAMMPRIS trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting (PTAS) arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with peri-procedural cerebrovascular events in the trial.
Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed peri-procedural) in the PTAS arm.
Of 224 patients randomized to PTAS, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs (CITS) within the peri-procedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (p ≤ 0.05) with hemorrhagic stroke. Non-smoking, basilar artery stenosis, diabetes, and older age were associated (p ≤ 0.05) with ischemic events.
Peri-procedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for peri-procedural strokes could be identified, excluding patients with these features from undergoing PTAS to lower the procedural risk would limit PTAS to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice.