Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity after Cataract Surgery during Infancy: A Randomized Clinical Trial

© 2020 American Medical Association. All rights reserved. Importance: Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy. Objective: To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy. Design, Setting, and Participants: This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019. Interventions: Intraocular lens implantation at the time of cataract surgery. Main Outcomes and Measures: Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis. Results: Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P =.82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was-0.54 to 0.47). Conclusions and Relevance: As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome

Intracranial Stenosis: Impact of Randomized Trials on Treatment Preferences of US Neurologists and Neurointerventionists

Medical and endovascular treatment options for stroke prevention in patients with symptomatic intracranial stenosis have evolved over the past several decades, but the impact of 2 major multi-center randomized stroke prevention trials on physician practices has not been studied. We sought to determine changes in US physician treatment choices for patients with intracranial atherosclerotic stenosis (ICAS) following 2 NIH-funded clinical trials that studied medical therapies (antithrombotic agents and risk factor control) and percutaneous transluminal angioplasty and stenting (PTAS)

Relationship Between Blood Pressure and Stroke Recurrence in Patients With Intracranial Arterial Stenosis

Background— Many clinicians allow blood pressure to run high in patients with intracranial stenosis to protect against hypoperfusion. We sought to determine whether higher blood pressure decreases the risk of stroke in these patients. Methods and Results— Data on 567 patients in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial were analyzed. Time to ischemic stroke and stroke in the same territory of the stenotic vessel was compared in patients grouped by mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) during the study. Additional analyses were based on severity and location of stenosis. Ischemic stroke risk increased with increasing mean SBP and DBP on univariate analysis ( P <0.0001, P <0.0001) and after adjustment for risk factors ( P =0.0008, P <0.0001). Elevated mean SBP and DBP also resulted in increased risk of stroke in the territory in univariate ( P =0.0065, P <0.0001) and adjusted ( P =0.0002, P =0.0005) analyses. The increased risk of stroke with increasing SBP was driven largely by patients in the highest SBP group. Patients with moderate (<70%) stenosis had increased risk of stroke ( P <0.0001, P =0.003) and stroke in the territory ( P =0.0002, P =0.010) with increased SBP and DBP. Patients with severe (≥70%) stenosis had increased risk of stroke and stroke in the territory with elevated DBP ( P =0.004, P =0.004). Conclusions— In patients with intracranial stenosis, higher blood pressure is associated with increased (not decreased) risk of ischemic stroke and stroke in the territory of the stenotic vessel. These findings argue strongly against the common clinical practice of maintaining high blood pressure in patients with intracranial stenosis

Abstract P569: Adherence to Preventive Therapy and Early Recurrent Cerebral Ischemia in Patients With Symptomatic Intracranial Atherosclerotic Disease: Analysis of the Myriad Study

Background: Intracranial atherosclerotic disease (IAD) is a common cause of stroke with high rate of early recurrence despite maximal medical therapy. We sought to determine adherence to secondary preventive therapy and its association with early recurrent ischemia in patients with symptomatic IAD. Methods: The Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD) study included patients with recent stroke or transient ischemic attack due to moderate-to-severe IAD. Although MyRIAD did not mandate treatment, patients were recommended to follow standard secondary preventive management including antiplatelet therapy, lipid-lowering medications, antihypertensives for blood pressure (BP) goal <140/90 mmHg, smoking cessation and regular physical activity. Patients underwent 6-8 weeks assessment for medication adherence, smoking status, and physical activity compliance. Adherence to preventive therapy was correlated with new infarcts in the affected vessel territory on brain MRI. Results: Eighty-nine out of 105 patients enrolled in MyRIAD completed 6-8 weeks clinical and brain MRI assessment (mean age 64 +/- 12 years; 57% men). During follow up, 99% were on antiplatelets, 89% on lipid-lowering medications, 81% on antihypertensives, 48% had systolic BP at goal, 79% had diastolic BP at goal, 93% were not active smokers, and 47% were compliant with physical activity. Overall, new infarcts on brain MRI were found in 25% patients. Although no significant differences were found, patients with uncontrolled BP, active smokers and those not compliant with physical activity had a higher frequency of new infarcts in the affected vessel territory (Table). Conclusions: Medication adherence was high after IAD-related stroke. However, a noteworthy fraction of patients had uncontrolled BP, continue to smoke, and were not compliant with physical activity. The latter may represent important therapeutic targets to prevent early recurrent ischemia

Risk Factors Control and Early Recurrent Cerebral Infarction in Patients with Symptomatic Intracranial Atherosclerotic Disease

•Only one-fifth on patients with symptomatic intracranial atherosclerosis (IAD) had optimal stroke risk factors control during early follow-up.•Uncontrolled systolic blood pressure and physical inactivity were frequent during early follow-up in patients with symptomatic IAD.•None of the participants with optimal risk factors control had early recurrent cerebral infarction, thus suggesting that lifestyle modifications and pharmacotherapy are important in reducing risk of recurrent ischemia in patients with symptomatic IAD. The risk of early recurrent cerebral infarction (RCI) is high in patients with symptomatic intracranial atherosclerotic disease (IAD). We sought to determine the relationship between risk factor control and early RCI risk among patients with symptomatic IAD. We analyzed participants with symptomatic IAD in the multi-center prospective observational MYRIAD study. Risk factor control was assessed at 6-8-week follow-up. Optimal risk factor control was defined by target systolic blood pressure, being non-smoker, target physical activity, and antiplatelet and antilipidemic therapy compliance. Age-adjusted associations were calculated between risk factor control and RCI determined by MRI-evident new infarcts in the territory of the stenotic vessel at 6-8 weeks from the index event. Among 82 participants with clinical and brain MRI information available 6-8 weeks after the index event (mean age 63.5 ±12.5 years, 62.2% men), RCI occurred in 21 (25.6%) cases. At 6-8-week follow-up, 37.8% had target systolic blood pressure, 92.7% were non-smokers, 51.2% had target physical activity, and 98.8% and 86.6% were compliant with antiplatelet and antilipidemic therapy, respectively. Optimal risk factor control increased from 4.9% at baseline to 19.5% at 6-8-week follow-up (p=0.01). None of the participants with optimal risk factor control at follow-up had RCI (0% vs. 31.8%, p<0.01). Only one-fifth of MYRIAD participants had optimal risk factor control during early follow-up. Approximately half and two-thirds had physical inactivity and uncontrolled systolic blood pressure, respectively. These risk factors may represent important therapeutic targets to prevent early RCI in patients with symptomatic IAD

Abstract MP48: Intracranial Dolichoectasia in Patients With Symptomatic Intracranial Atherosclerotic Disease: The Myriad Study

Background: It is unknown whether intracranial atherosclerotic disease (IAD), in addition to vessel narrowing, also contributes to the abnormal dilation and increased tortuosity of intracranial vessels, a condition known as intracranial dolichoectasia (IDE). We aim to determine the degree to which these two arteriopathies coexist and whether IDE correlates with subsequent ischemic events in patients with recently symptomatic moderate-to-severe IAD. Methods: The study included 99 patients (mean age 6311 years; 57% men) enrolled in the Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD) study. Intracranial vessels diameter, length, and tortuosity were determined by semiautomatic vessel segmentation and were considered abnormal if ≥2 standard deviations from the study population mean. Either ectasia (increased diameter) or dolichosis (increased tortuosity) defined IDE. We assessed the correlation of IDE in the symptomatic vessel with the composite outcome of either new infarcts in the territory of the affected vessel on brain MRI performed at 6-8 weeks from the index event or stroke recurrence during 12-month follow up. Results: IDE prevalence was 34% (isolated ectasia 8%, isolated dolichosis 18%, and both ectasia and dolichosis 8%) and 14% of symptomatic vessels. Patients with and without IDE had similar demographics and vascular risk factors prevalence (Table). I Twenty-two out of 85 (26%) patients with brain MRI at 6-8 weeks had new infarct(s) in the territory and 9% of the entire cohort had stroke recurrence during follow-up. Coexistence of IAD and IDE in the target vessel was not associated to subsequent ischemic events (21.4% versus 29.4%; P=0.54). Conclusion: IDE is a common finding in patients with moderate-to-severe IAD. Superimposed IDE did not increase the already heightened risk of subsequent ischemic events in patients with symptomatic IAD. ClinicalTrials.gov Identifier: NCT0212102

Failure of Antithrombotic Therapy and Risk of Stroke in Patients With Symptomatic Intracranial Stenosis

BACKGROUND AND PURPOSE: We sought to determine if patients with intracranial stenosis who have a TIA or stroke on antithrombotic therapy are at particularly high risk for recurrent stroke. METHODS: We compared baseline features and the rates of stroke or vascular death and stroke in the territory of the symptomatic artery between patients ON (n=299) vs. OFF (n=269) antithrombotics at the time of their qualifying event for the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial. RESULTS: In univariate analyses, there was no difference in the rates of stroke or vascular death (21 vs. 23%, HR (ON/OFF) = 0.91 (95%CI: 0.64–1.29), p= 0.59) or stroke in territory (13 vs. 14%, HR (ON/OFF) = 0.90 (95%CI: 0.57–1.39), p=0.61) between patients ON vs. OFF antithrombotics at the time of their qualifying event. A multivariable analysis adjusted for the difference in risk factors between patients ON and OFF antithrombotic therapy also showed no significant differences in the combined endpoint of stroke or vascular death (HR (ON/OFF) = 0.86, 95%CI: 0.55–1.34, p=0.51) or stroke in territory (HR (ON/OFF) = 1.01., 95%CI: 0.58–1.77, p=0.97) between patients ON vs. OFF antithrombotic therapy at the time of qualifying event. CONCLUSIONS: Intracranial stenosis patients who fail antithrombotic therapy are not at higher risk of stroke than those who do not fail antithrombotic therapy. Given our finding that patients ON and OFF antithrombotic therapy are both at high risk for stroke in the territory, intracranial stenting trials should not be limited to just those who fail antithrombotic therapy