Konzept der unterstützten Sekundärprävention nach Schlaganfall

Zusammenfassung

Hintergrund: Patienten mit einem akuten Schlaganfall oder einer transitorischen ischämischen Attacke (TIA) haben ein hohes Risiko für neue vaskuläre Ereignisse. Mehrere evidenzbasierte Strategien zur Sekundärprävention sind verfügbar, vermutlich aber noch nicht ausreichend genutzt. Bislang wurden Unterstützungsprogramme, die auf eine multifaktorielle Modifikation der Risikofaktoren abzielen, zwar bei anderen Erkrankungen wie Diabetes mellitus oder koronarer Herzkrankheit aber noch nicht beim Schlaganfall in prospektiven kontrollierten Studien untersucht. INSPiRE-TMS ist eine multizentrische, randomisierte offene Interventionsstudie für intensivierte Sekundärprävention nach leichtem Schlaganfall und TIA. Methoden: An den teilnehmenden Zentren werden geeignete Patienten mit TIA oder leichtem Schlaganfall rekrutiert und 1:1 in einen Interventions- und einen Kontrollarm randomisiert. 2 082 Patienten sollen eingeschlossen werden. Das Unterstützungsprogramm beinhaltet die Messung der kardiovaskulären Risikofaktoren und Feedback, das Monitoring der Adhärenz, Beratung bezüglich einer Lebensstiländerung und die aktive Einbeziehung der Angehörigen. Standardisiertes „Motivational Interviewing“ soll die Patienten motivieren und in dieser Motivation stärken. Primäres Studienziel ist die Reduktion vaskulärer Ereignisse (Hirninfarkt, Myokardinfarkt, vaskulärer Tod). Die Beobachtungszeit soll für jeden Patienten mindestens zwei Jahre betragen. Diskussion: Aufgrund des hohen Rezidivrisikos nach einem akuten Schlaganfall und zugleich bekannten effektiven sekundärpräventiven Strategien, hat die INSPiRE-TMS-Intervention das Potenzial, zu einer relevanten Reduktion von erneuten vaskulären Ereignissen und einer verlängerten ereignisfreien Überlebenszeit zu führen. Die Studie wird mit zu der Entscheidung beitragen, ob ein Programm zur intensivierten Sekundärprävention nach Schlaganfall in die Regelversorgung übernommen werden sollte. Zusätzlich wird die Kosteneffektivität mitbeurteilt.

Summary

Background: Patients with recent stroke or transient ischemic attack (TIA) have a high risk for recurrent vascular events. Multiple evidence-based strategies in secondary prevention are recommended but presumably not sufficiently utilized. Support programmes targeting vascular risk factors have been evaluated in prospective randomized trials for other diseases like diabetes mellitus or coronary heart disease. However, no such support programme has been investigated in patients after stroke. INSPiRE-TMS is a multicentre, prospective and randomized intervention trial for intensified secondary prevention after TIA or minor stroke. Methods: Patients with recent TIA or minor stroke are randomized in a 1:1 manner into an intervention (usual care plus support programme) and a control (usual care) arm. The trial will include 2 082 patients. The support programme consists of the following components: measurement of the vascular risk parameters, monitoring of the adherence to medication, counselling concerning lifestyle-modification and involvement of the relatives. Using standardized “motivational interviewing”, the patients’ motivation shall be consolidated and strengthened. Patients will be followed up for at least 2 years. Discussion: Through systematic implementation of available evidence-based strategies in secondary prevention, INSPiRE-TMS has the potential to reduce recurrent vascular events and to extend the event-free survival time in acute stroke patients. As a result, it will contribute to the decision, whether an intensified secondary prevention support programme after stroke should be implemented into regular care.

Schlüsselwörter

TIA - Schlaganfall - Sekundärprävention - Interventionsstudie

Keywords

TIA - stroke secondary prevention - intervention trial

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