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Der Nuklearmediziner 2017; 40(01): 48-53
DOI: 10.1055/s-0042-123628
Update Herz / Lunge
© Georg Thieme Verlag KG Stuttgart · New York

ISCHEMIA-Studie – Rationale, Design und bisheriger Randomisierungsstatus

ISCHEMIA Trial – Rationale, Design, and Current Randomization Status
Rolf Dörr
1   Studienleiter der ISCHEMIA- und ISCHEMIA-CKD-Studien in Deutschland
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Publication History

Publication Date:
25 April 2017 (online)

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Zusammenfassung

Bislang gibt es noch eine große Lücke in der wissenschaftlichen Evidenz für eine invasive Strategie und die Notwendigkeit einer koronaren Revaskularisation bei Patienten mit chronisch stabiler KHK und einer moderaten oder schwerwiegenden Myokardischämie in einem nicht invasiven kardialen Stress-Test. Die ISCHEMIA-Studie der US National Institutes of Health (NIH), die diese wichtige Frage klären soll, ist eine vom US National Heart, Lung, and Blood Institute (NHLBI) finanziell unterstützte, weltweite Studie zur Klärung der optimalen Therapiestrategie für Patienten mit einer chronisch stabilen KHK, einer moderaten bis schwerwiegenden Myokardischämie und Symptomen, die medikamentös noch kontrollierbar sind. In dieser Studie werden stabile KHK-Patienten mit wenigstens moderater Ischämie in einem kardialen Stress-Test (>10% Ischämie oder äquivalente Kriterien) im Verhältnis 1:1 in 2 therapeutische Studienarme randomisiert. In einem Studienarm erfolgt die Behandlung nach einer invasiven Strategie mit Herzkatheter, PCI/Stent oder Bypass-OP und einer begleitenden optimierten medikamentösen Therapie (OMT). Im anderen Studienarm erfolgt eine nicht invasive Strategie mit einer alleinigen OMT und einer Herzkatheteruntersuchung nur bei Patienten, bei denen eine alleinige medikamentöse Therapie nicht zur Stabilisierung führt. Der primäre klinische Endpunkt ist die Kombination aus kardiovaskulärem Tod und nichttödlichem Myokardinfarkt in einem Zeitraum von 4 Jahren. Die parallel laufende ISCHEMIA-CKD-Substudie vergleicht die beiden therapeutischen Strategien bei Patienten mit fortgeschrittener chronischer Niereninsuffizienz einschließlich Dialysepatienten. Bis zum 05.01.2017 wurden weltweit 3 725 Patienten in der ISCHEMIA-Hauptstudie randomisiert. In ISCHEMIA läuft die Patientenrekrutierung noch bis zum 30.12.2017. Eine Präsentation der Studienergebnisse mit gleichzeitiger Publikation wird bei den Scientific Sessions der American Heart Association (AHA) im November 2019 erwartet. Die Studie wird mit Sicherheit einen maßgeblichen Einfluss auf die internationalen Leitlinien von ACC/AHA und ESC und das zukünftige Management von Patienten mit chronisch stabiler KHK haben.

Abstract

So far, there is still an important gap in scientific evidenve regarding the need for an invasive strategy and the value of coronary revascularization in patients with stable ischemic heart disease (SIHD) and moderate or severe myocardial ischemia. The ISCHEMIA trial of the US National Institutes of Health (NIH) is a study funded by the US National Heart, Lung and Blood Institute (NHLBI) that seeks to determine the optimal management strategy for patients with SIHD, moderate to severe myocardial ischemia and symptoms that can be controlled with medication. In this study, SIHD patients with at least moderate ischemia on a cardiac stress test (≥10% ischemia or equivalent criteria) are randomized 1:1 into 2 treatment strategies. In the invasive strategy cardiac catheterization is performed followed by PCI/stent or bypass surgery and concomitant optimal medical therapy (OMT). The conservative strategy is OMT alone, and cardiac catheterization and revascularization is performed only for whom medical therapy fails. The primary clinical endpoint is the combination of cardiovascular death and non-fatal myocardial infarction during an average follow-up of 4 years. The parallel ISCHEMIA-CKD substudy compares the two therapeutic strategies in patients with advanced kidney disease, including dialysis patients. By January 5th, 2017, a total of 3 725 patients worldwide had been randomized in the ISCHEMIA main trial. ISCHEMIA patient recruitment is projected to run through December 30th, 2017. Final results of the ISCHEMIA trial are espected to be presented and published at the AHA Scientific Sessions in November 2019. The ISCHEMIA trial will certainly have an important impact on the international guidelines of ACC/AHA and ESC and the future management of patients with SIHD.

Schlüsselwörter

ISCHEMIA-Studie - Ischämie - optimierte medikamentöse Therapie - koronare Revaskularisation - perkutane koronare Intervention - koronare Bypass-Operation

Key words

ISCHEMIA trial - ischemia - optimal medical therapy - coronary revascularization - percutaneous coronary intervention - coronary artery bypass graft
 

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