Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial

Weimar, Christian; Bilbilis, Konstantinos; Rekowski, Jan; Holst, T.; Beyersdorf, Friedhelm; Breuer, Martin

doi:10.1016/j.jvs.2017.11.047

Cited by 17 publications

(30 citation statements)

References 16 publications

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“…Search Results: Database searches identified 6,339 records and yielded 15 trials of 69,560 participants that were eligible for inclusion [26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] (Figure 1, see Supplementary material, Supplementary Table I). An additional 74 trials were potentially eligible, but did not report outcomes assessed by site investigators.…”

Section: Resultsmentioning

confidence: 99%

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials

Godolphin

Bath

Algra

et al. 2019

Stroke

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Background and Purpose— In randomized stroke trials, central adjudication of a trial’s primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in randomized trials. The aim of this review was to compare outcomes assessed by central adjudicators with outcomes assessed by site investigators. Methods— We included randomized stroke trials where the primary outcome had undergone an assessment by site investigators and central adjudicators. We searched MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, and Google Scholar for eligible studies. We extracted information about the adjudication process as well as the treatment effect for the primary outcome, assessed both by central adjudicators and by site investigators. We calculated the ratio of these treatment effects so that a ratio of these treatment effects >1 indicated that central adjudication resulted in a more beneficial treatment effect than assessment by the site investigator. A random-effects meta-analysis model was fitted to estimate a pooled effect. Results— Fifteen trials, comprising 69 560 participants, were included. The primary outcomes included were stroke (8/15, 53%), a composite event including stroke (6/15, 40%) and functional outcome after stroke measured on the modified Rankin Scale (1/15, 7%). The majority of site investigators were blind to treatment allocation (9/15, 60%). On average, there was no difference in treatment effect estimates based on data from central adjudicators and site investigators (pooled ratio of these treatment effects=1.02; 95% CI, [0.95–1.09]). Conclusions— We found no evidence that central adjudication of the primary outcome in stroke trials had any impact on trial conclusions. This suggests that potential advantages of central adjudication may not outweigh cost and time disadvantages in stroke studies if the primary purpose of adjudication is to ensure validity of trial findings.

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Section: Resultsmentioning

confidence: 99%

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials

Godolphin

Bath

Algra

et al. 2019

Stroke

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“…Authors from nine trials, comprising 25,436 participants, completed the questionnaire, and these nine trials are included in this study [4][5][6][7][8][9][10][11][12] (Table 1). All outcomes adjudicated were either stroke or a composite including stroke, with two trials including transient ischaemic attack as part of their outcome of stroke (see Supplementary Material, Supplementary Table I).…”

Section: Resultsmentioning

confidence: 99%

Cost-benefit of outcome adjudication in nine randomised stroke trials

et al. 2020

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Background Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. Methods We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators’ time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. Results The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). Conclusions Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.

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“…Gemäß den Ergebnissen der randomisierten, allerdings aufgrund mangelnder Rekrutierung vorzeitig beendeten CABACS Studie, kann eine simultane Thrombenarteriektomie im Zuge einer indizierten kardialen Bypass-Chirurgie bei asymptomatischer höhergradiger Karotisstenose nicht empfohlen werden [16]. Hingegen kann der Nutzen eines intensiven Blutdruckmanagements (Ziel mittlerer Blutdruck 80-100 mmHg) anhand einer randomisierten Studie belegt werden.…”

Section: Koronare Bypass-chirurgieunclassified

Schlaganfall als periprozedurale Komplikation kardialer Interventionen

Häusler¹

2020

Nervenheilkunde

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ZUSAMMENFASSUNGDer periprozedurale Schlaganfall gehört zu den relevantesten Komplikationen kardialer Interventionen und beeinflusst die Prognose der Betroffenen. Interventions-spezifische Faktoren, Patienten-spezifische Faktoren als auch die Erfahrung des Interventionalisten bzw. des intervenierenden Zentrums bestimmen das periprozedurale Schlaganfallrisiko. Anhand einer intensiven Auseinandersetzung mit möglichen Risikofaktoren für einen Schlaganfall, dem verstärkten Einsatz bildgebender Verfahren und technischer Weiterentwicklungen konnte in den letzten Jahren eine Senkung des periprozeduralen Schlaganfallrisikos erreicht werden, das nach kardialer Operation etwa 1 %, nach katheterbasiertem Verfahren zwischen 0,1–3 % und nach Kardioversion etwa 0,1 % beträgt.Relevant für die Therapie des periprozeduralen Schlaganfalls erscheint neben einer diesbezüglichen interdisziplinären Awareness die Vorhaltung von Standard Operating Procedures (SOPs), die neben präventiven Maßnahmen, das Blutdruckmanagement, die post-interventionelle Gerinnungshemmung als auch deren Antagonisierung im Falle einer (intrakraniellen) Blutung adressieren. Nach akuter zerebraler Ischämie mit behinderndem neurologischem Defizit kann im interdisziplinären Dialog auf der Basis einer Einzelfallentscheidung nach bestimmten kardialen Prozeduren eine systemische Thrombolyse und/oder eine mechanische Rekanalisation erwogen werden, auch wenn keine spezifischen Studien zur Effizienz und Sicherheit dieser Therapieverfahren für prozedurassoziierte Schlaganfälle vorliegen.

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Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial

Cited by 17 publications

References 16 publications

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials

Cost-benefit of outcome adjudication in nine randomised stroke trials

Schlaganfall als periprozedurale Komplikation kardialer Interventionen

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