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Background and Objectives: Whether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT., Methods: Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT., Results: Five-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up., Discussion: Based on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.

Importance: The Patent Foramen Ovale (PFO)-Associated Stroke Causal Likelihood classification system combines information regarding noncardiac patient features (vascular risk factors, infarct topography) and PFO features (shunt size and presence of atrial septal aneurysm [ASA]) to classify patients into 3 validated categories of responsiveness to treatment with PFO closure. However, the distinctive associations of shunt size and ASA, alone and in combination, have not been completely delineated., Objective: To evaluate the association of PFO closure with stroke recurrence according to shunt size and/or the presence of an ASA., Design, Setting, and Participants: Pooled individual patient data from 6 randomized clinical trials conducted from February 2000 to October 2017 that compared PFO closure with medical therapy. Patients in North America, Europe, Australia, Brazil, and South Korea with PFO-associated stroke were included. Analysis was completed in January 2022., Exposures: Transcatheter PFO closure plus antithrombotic therapy vs antithrombotic therapy alone, stratified into 4 groups based on the combination of 2 features: small vs large PFO shunt size and the presence or absence of an ASA., Main Outcomes and Measures: Recurrent ischemic stroke., Results: A total of 121 recurrent ischemic strokes occurred in the pooled 3740 patients (mean [SD] age, 45 [10] years; 1682 [45%] female) during a median (IQR) follow-up of 57 (23.7-63.8) months. Treatment with PFO closure was associated with reduced risk for recurrent ischemic stroke (adjusted hazard ratio [aHR], 0.41 [95% CI, 0.28-0.60]; P < .001). The reduction in hazard for recurrent stroke was greater for patients with both a large shunt and an ASA (aHR, 0.15 [95% CI, 0.06-0.35]) than for large shunt without ASA (aHR, 0.27 [95% CI, 0.14-0.56]), small shunt with ASA (aHR, 0.36 [95% CI, 0.17-0.78]), and small shunt without ASA (aHR, 0.68 [95% CI, 0.41-1.13]) (interaction P = .02). At 2 years, the absolute risk reduction of recurrent stroke was greater (5.5% [95% CI, 2.7-8.3]) in patients with large shunt and ASA than for patients in the other 3 categories (1.0% for all)., Conclusions and Relevance: Patients with both a large shunt and an ASA showed a substantially greater beneficial association with PFO closure than patients with large shunt alone, patients with small shunt and ASA, and patients with neither large shunt nor ASA. These findings, combined with other patient features, may inform shared patient-clinician decision-making.

Importance: Patent foramen ovale (PFO)-associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear., Objective: To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems., Design, Setting, and Participants: Investigators for the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) Consortium pooled individual patient data from all 6 randomized clinical trials that compared PFO closure plus medical therapy vs medical therapy alone in patients with PFO-associated stroke, and included a total of 3740 participants. The trials were conducted worldwide from 2000 to 2017., Exposures: PFO closure plus medical therapy vs medical therapy alone. Subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10-point scoring system in which higher scores reflect younger age and the absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) Classification System, which combines the RoPE Score with high-risk PFO features (either an atrial septal aneurysm or a large-sized shunt) to classify patients into 3 categories of causal relatedness: unlikely, possible, and probable., Main Outcomes and Measures: Ischemic stroke., Results: Over a median follow-up of 57 months (IQR, 24-64), 121 outcomes occurred in 3740 patients. The annualized incidence of stroke with medical therapy was 1.09% (95% CI, 0.88%-1.36%) and with device closure was 0.47% (95% CI, 0.35%-0.65%) (adjusted hazard ratio [HR], 0.41 [95% CI, 0.28-0.60]). The subgroup analyses showed statistically significant interaction effects. Patients with low vs high RoPE Score had HRs of 0.61 (95% CI, 0.37-1.00) and 0.21 (95% CI, 0.11-0.42), respectively (P for interaction = .02). Patients classified as unlikely, possible, and probable using the PASCAL Classification System had HRs of 1.14 (95% CI, 0.53-2.46), 0.38 (95% CI, 0.22-0.65), and 0.10 (95% CI, 0.03-0.35), respectively (P for interaction = .003). The 2-year absolute risk reduction was -0.7% (95% CI, -4.0% to 2.6%), 2.1% (95% CI, 0.6%-3.6%), and 2.1% (95% CI, 0.9%-3.4%) in the unlikely, possible, and probable PASCAL categories, respectively. Device-associated adverse events were generally higher among patients classified as unlikely; the absolute risk increases in atrial fibrillation beyond day 45 after randomization with a device were 4.41% (95% CI, 1.02% to 7.80%), 1.53% (95% CI, 0.33% to 2.72%), and 0.65% (95% CI, -0.41% to 1.71%) in the unlikely, possible, and probable PASCAL categories, respectively., Conclusions and Relevance: Among patients aged 18 to 60 years with PFO-associated stroke, risk reduction for recurrent stroke with device closure varied across groups classified by their probabilities that the stroke was causally related to the PFO. Application of this classification system has the potential to guide individualized decision-making.

Background: Diagnosing stroke in dizzy patients remains a challenge in emergency medicine. The accuracy of the neuroophthalmologic examination HINTS performed by emergency physicians (EPs) is unknown. Our objective was to determine the accuracy of the HINTS examination performed by trained EPs for diagnosing central cause of acute vertigo and unsteadiness and to compare it with another bedside clinical tool, STANDING, and with the history-based score ABCD2., Methods: This was a prospective diagnostic cohort study among patients with isolated vertigo and unsteadiness seen in a single emergency department (ED). Trained EPs performed HINTS and STANDING tests blinded to attending physicians. ABCD2 ≥ 4 was used as the threshold and was calculated retrospectively. The criterion standard was diffusion-weighted brain magnetic resonance imaging (MRI). Peripheral diagnoses were established by a normal MRI, and etiologies were further refined by an otologic examination., Results: We included 300 patients of whom 62 had a central lesion on neuroimaging including 49 strokes (79%). Of the 238 peripheral diagnoses, 159 were vestibulopathies, mainly benign paroxysmal positional vertigo (40%). HINTS and STANDING tests reached high sensitivities at 97% and 94% and NPVs at 99% and 98%, respectively. The ABCD2 score failed to predict half of central vertigo cases and had a sensitivity of 55% and a NPV of 87%. The STANDING test was more specific and had a better positive predictive value (PPV; 75% and 49%, respectively; positive likelihood ratio [LR+] = 3.71, negative likelihood ratio [LR-] = 0.09) than the HINTS test (67% and 44%, respectively; LR+ = 2.96, LR- = 0.04). The ABCD2 score was specific (82%, LR+ = 3.04, LR- = 0.56) but had a very low PPV (44%)., Conclusions: In the hands of EPs, HINTS and STANDING tests outperformed ABCD2 in identifying central causes of vertigo. For diagnosing peripheral disorders, the STANDING algorithm is more specific than the HINTS test. HINTS and STANDING could be useful tools saving both time and costs related to unnecessary neuroimaging use., (© 2021 by the Society for Academic Emergency Medicine.)

Background and Purpose: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial., Methods: This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists., Results: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up., Conclusions: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura., (© 2021 European Academy of Neurology.)

Background: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with PFO-associated cryptogenic stroke., Methods and Results: We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I 2 =59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I 2 =42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I 2 =12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I 2 =77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I 2 =14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I 2 =12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference., Conclusions: PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.

Background: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy., Methods: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3., Results: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone., Conclusions: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).

Background: Results from randomised controlled trials have shown a higher short-term risk of stroke associated with carotid stenting than with carotid endarterectomy for the treatment of symptomatic carotid stenosis. However, these trials were underpowered for investigation of whether carotid artery stenting might be a safe alternative to endarterectomy in specific patient subgroups. We therefore did a preplanned meta-analysis of individual patient data from three randomised controlled trials., Methods: Data from all 3433 patients with symptomatic carotid stenosis who were randomly assigned and analysed in the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS) were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. The intention-to-treat (ITT) analysis included all patients and outcome events occurring between randomisation and 120 days thereafter. The per-protocol (PP) analysis was restricted to patients receiving the allocated treatment and events occurring within 30 days after treatment., Findings: In the first 120 days after randomisation (ITT analysis), any stroke or death occurred significantly more often in the carotid stenting group (153 [8·9%] of 1725) than in the carotid endarterectomy group (99 [5·8%] of 1708, risk ratio [RR] 1·53, [95% CI 1·20-1·95], p=0·0006; absolute risk difference 3·2 [1·4-4·9]). Of all subgroup variables assessed, only age significantly modified the treatment effect: in patients younger than 70 years (median age), the estimated 120-day risk of stroke or death was 50 (5·8%) of 869 patients in the carotid stenting group and 48 (5·7%) of 843 in the carotid endarterectomy group (RR 1·00 [0·68-1·47]); in patients 70 years or older, the estimated risk with carotid stenting was twice that with carotid endarterectomy (103 [12·0%] of 856 vs 51 [5·9%] of 865, 2·04 [1·48-2·82], interaction p=0·0053, p=0·0014 for trend). In the PP analysis, risk estimates of stroke or death within 30 days of treatment among patients younger than 70 years were 43 (5·1%) of 851 patients in the stenting group and 37 (4·5%) of 821 in the endarterectomy group (1·11 [0·73-1·71]); in patients 70 years or older, the estimates were 87 (10·5%) of 828 patients and 36 (4·4%) of 824, respectively (2·41 [1·65-3·51]; categorical interaction p=0·0078, trend interaction p=0·0013]., Interpretation: Stenting for symptomatic carotid stenosis should be avoided in older patients (age ≥70 years), but might be as safe as endarterectomy in younger patients., Funding: The Stroke Association., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background and Purpose: Carotid angioplasty and stenting (CAS) has not been shown to be as safe as carotid endarterectomy (CEA) with regard to the risks of periprocedural complications, but beyond the perioperative period, the risks are comparable, suggesting that CAS may be an acceptable option in selected patients. However, risk factors for perioperative stroke and death have not been clearly established. We aimed to estimate the 30-day absolute risks of stroke or death after CAS and investigate sources of heterogeneity., Methods: We sought articles published between January 1990 and June 2008 by using MEDLINE, EMBASE, the COCHRANE databases, hand-searching, abstract books from conferences, and official websites. Two reviewers independently and in duplicate selected articles on the risks of CAS, irrespective of the type of treatment, study design, setting, or language. The 2 reviewers abstracted data and assessed the quality of the studies., Results: Two hundred six independent studies (with 54 713 patients) were included. The overall 30-day risk of stroke or death was 4.7% (95% CI, 4.1 to 5.2) with substantial heterogeneity across studies. Symptomatic patients were about twice as likely as those with asymptomatic stenoses to have complications. The 30-day risk of stroke or death was 7.6% (6.3 [corrected] to 9.1) in symptomatic and 3.3% (2.6 to 4.1) in asymptomatic patients. Risks increased with age, hypertension, and history of coronary artery disease; were unrelated to sex and the presence of contralateral carotid occlusion; and were lower in patients who had carotid restenosis after CEA and in those treated with the use of a cerebral protection device. Risks have also decreased over time., Conclusions: Risks of CAS vary substantially across studies. Risks are overall higher than those of CEA in symptomatic patients. Some factors are likely to help select good candidates for CAS.

Background: Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years., Methods: In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov, number NCT00190398., Findings: 262 patients were randomly assigned to endarterectomy and 265 to stenting. The cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke after 4 years of follow-up was higher with stenting than with endarterectomy (11.1%vs 6.2%, hazard ratio [HR] 1.97, 95% CI 1.06-3.67; p=0.03). The HR for periprocedural disabling stroke or death and non-procedural fatal or disabling ipsilateral stroke was 2.00 (0.75-5.33; p=0.17). A hazard function analysis showed the 4-year differences in the cumulative probabilities of outcomes between stenting and endarterectomy were largely accounted for by the higher periprocedural (within 30 days of the procedure) risk of stenting compared with endarterectomy. After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups. For any stroke or periprocedural death, the HR was 1.77 (1.03-3.02; p=0.04). For any stroke or death, the HR was 1.39 (0.96-2.00; p=0.08)., Interpretation: The results of this study suggest that carotid stenting is as effective as carotid endarterectomy for middle-term prevention of ipsilateral stroke, but the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy in patients with symptomatic carotid stenosis.

Background and Purpose: Since publication of previous meta-analyses comparing endovascular and surgical treatment of patients with carotid artery stenosis, two further large-scale trials have been conducted, almost doubling the number of patients available for analysis. Therefore, it is justified to update these meta-analyses., Methods: Relevant trials were identified by a search of the literature using an electronic database. Trials with a nonrandomized patient allocation were not included. We focused on events within 30 days after intervention and made two sets of analysis: one with all trials and one with large trials exclusively including symptomatic patients., Results: Only Endartérectomie Versus Angioplastie chez les patients ayant une Sténose carotide Symptomatique Serrée (EVA3S) and Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) were identified to be included in the updated meta-analysis. In total, 2985 patients were included in eight trials of which 89% were symptomatic. In contrast to previous analyses, this meta-analysis found a significant difference between the odds ratios of any stroke or death within 30 days after treatment with a disadvantage of endovascular treatment when analysing all trials (odds ratio [OR], 1.38; 95% confidence interval [CI] 1.04-1.83; P = .024). Significant heterogeneity was found for this analysis (P = .03). The increase of the odds of suffering from disabling stroke or death in the endovascular compared with the surgical group was not significant in the analysis of all trials (OR, 1.37; 95% CI, 0.92-2.04; P = .12); no heterogeneity was found for this analysis (P = .27). In the analysis of the large trials with symptomatic patients, the OR for the endpoint any stroke or death was 1.29 (95% CI 0.94-1.76; P = .11); with a hint for heterogeneity (P = .10). For the endpoint disabling stroke or death, the OR was 1.33 (95% CI 0.89-1.93; P =.17) without any heterogeneity (P = .58)., Conclusion: The expressiveness of this meta-analysis is limited by the heterogeneity of some tests. The main result is that surgical treatment still remains the gold standard for treatment of patients with symptomatic carotid artery stenosis, who do not have an increased surgical risk. Carotid artery stenting is neither safer than nor as safe as carotid endarterectomy in large clinical trials when short-term stroke and death rates are taken into account. Further recruitment into ongoing randomized trials is strongly recommended.

Background: Whether stroke patients should be investigated for asymptomatic coronary artery disease remains matter of debate. Absolute risks of myocardial infarction (MI) and vascular death after a stroke have not been accurately assessed. We performed a systematic review and a meta-analysis to determine the risk of MI and nonstroke vascular death after transient ischemic attack (TIA) and ischemic stroke. Cohort studies of TIA or ischemic stroke patients were included if they were published between 1980 and March 2005, reported risk of MI and nonstroke vascular death, enrolled >100 patients, and had at least 1 year of follow-up. We included 39 studies in a total of 65,996 patients with mean follow-up of 3.5 years. Two reviewers independently carried out data extraction using a standardized form. Absolute annual risks were estimated through weighted meta-regressions with a random effect. To test the predictions of expected event rates derived from our analysis, we used individual patient data., Summary of Review: The annual risks were 2.1% (CI 95%: 1.9 to 2.4) for nonstroke vascular death, 2.2% (1.7 to 2.7) for total MI, 0.9% (0.7 to 1.2) for nonfatal MI and 1.1% (0.8 to 1.5) for fatal MI. The time course of risk was linear. Estimated risks fitted well with observed risks at the individual level. There was no heterogeneity in the absolute risks according to baseline study characteristics., Conclusions: Patients with TIA or stroke have a relatively high risk of MI and nonstroke vascular death. Additional research is needed to identify the determinants of coronary artery disease in stroke patients.

Background and Purpose: Whether cerebral protection during carotid angioplasty and stenting (CAS) is associated with a lower risk of periprocedural stroke or death remains to be established. We report on 80 patients randomized in the CAS arm of the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis trial comparing CAS (with or without cerebral protection) with carotid surgery in patients with recently symptomatic, severe carotid stenosis., Summary of Report: The Safety Committee recommended stopping unprotected CAS, because the 30-day rate of stroke was 3.9 (0.9 to 16.7) times higher than that of CAS with cerebral protection (4/15 versus 5/58)., Conclusions: Although this result was not based on a randomized comparison of unprotected versus protected CAS, it suggests that the use of cerebral protection devices during CAS reduces periprocedural strokes.

Background: The SHEAF (Self-Measurement of Blood Pressure at Home in the Elderly: Assessment and Follow-up) study is an observational study (from February 1998 to early 2002) designed to determine whether home blood pressure (BP) measurement has a greater cardiovascular prognostic value than office BP measurement among elderly (> or =60 years) French patients with hypertension. The objective of this present work is to describe the baseline characteristics of the treated patients in the SHEAF study from February 1998 to March 1999, placing special emphasis on "isolated office" and "isolated home" hypertension., Methods: Baseline office BP measurement was assessed using a mercury sphygmomanometer. Home BP measurement was performed over a 4-day period. A 140/90-mm Hg threshold was chosen to define office hypertension, and a 135/85-mm Hg threshold to define home hypertension., Results: Of the 5211 hypertensive patients in the SHEAF study with a valid home BP measurement, 4939 received treatment with at least 1 antihypertensive drug. Patients with isolated office hypertension represented 12.5% of this population, while patients with isolated home hypertension represented 10.8%. The characteristics of the patients with isolated office hypertension were similar to those of patients with controlled hypertension. However, patients with isolated office hypertension had fewer previous cardiovascular complications. In contrast, rates of cardiovascular risk factors and history of cardiovascular disease in patients with isolated home hypertension resembled those in patients with uncontrolled hypertension., Conclusions: This retrospective analysis suggests that patients with isolated home hypertension belong to a high-risk subgroup. The 3-year follow-up of these patients will provide prospective data about the cardiovascular prognosis of these subgroups.

The main cause of death and long-term disability of patients undergoing carotid artery surgery is coronary artery disease. To identify the prognostic value of the status of the contralateral artery, we studied the course of 224 consecutive patients in whom one or both carotid arteries were operated on at our institution between 1985 and 1995. The 224 patients were divided into three groups: group I (n = 56) had an occluded contralateral carotid artery, in group II (n = 56) both carotids were operated on, and group III (n = 112) had a normal contralateral carotid artery. The clinical status of all patients except one was ascertained by one of us. We found that the status of the contralateral artery does not influence the long-term prognosis of patients undergoing carotid artery surgery. A periodic cardiological and vascular follow-up of these patients seems warranted to improve their survival.

It is well demonstrated that the antihypertensive treatment is effective, particularly for the primary prevention of stroke. However, benefits of treatment are rather small in certain groups of patients. The explicit assessment of absolute cardiovascular risks and likely treatment benefits in patients with hypertension can usefully guide treatment decisions and provide a more rational basis for initiating therapy than blood pressure levels alone. This approach highlights the generally greater cardiovascular risk and potential treatment benefits in older compared with younger hypertensive patients. Some specific questions remain still unanswered. Evidence is accumulating concerning protective effect of antihypertensive treatment against dementia. Trials are in progress to investigate the effect of treatment on stroke incidence in hypertensive patients over the age of 80 years. Finally, despite the worldwide use of calcium antagonists and converting enzyme inhibitors, solid evidence of their safety and efficacy compared with the references drugs (beta-blockers and diuretics) is still lacking.