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Positionspapier der DGK zur Wirksamkeit und Sicherheit von Medikamente freisetzenden Koronarstents (DES)

Eine evidenzbasierte Analyse von 71 randomisierten Studien mit 28.984 Patienten

  • Positionspapier
  • Published:
Der Kardiologe Aims and scope

Zusammenfassung

Hintergrund

Die perkutane Koronarintervention (PTCA, PCI) ist die häufigste Art der myokardialen Revaskularisation. Da die routinemäßige Stentimplantation den klinischen Verlauf verbessert, ist sie heute Standard. Die aus Edelstahl gefertigten Koronarstents induzieren eine Gewebsreaktion im Sinn einer Intimahyperplasie. Diese ist oft überschießend und führt zu einer letztendlich iatrogenen Krankheit: der In-Stent-Restenose. Medikamente freisetzende Koronarstents (Drug-eluting-Stents, DES) reduzieren aufgrund ihrer Abgabe antiproliferativer Substanzen die Häufigkeit von In-Stent-Restenosen in einem klinisch relevanten Ausmaß und verhindern somit erneute Revaskularisationsmaßnahmen. Ziel des vorliegenden Positionspapieres ist es, einen Überblick über die aktuelle Studienlage zur Wirksamkeit und Sicherheit der DES zu geben.

Methodik

In die Analyse wurden alle verfügbaren randomisierten, kontrollierten klinischen Studien einbezogen und hierbei besonderer Wert auf einen primären klinischen Endpunkt gelegt, da nur dieser eine ausreichende statistische Aussagekraft („Power“) garantiert, um belastbare Rückschlüsse auf den klinischen Verlauf zuzulassen. Ferner wurden die randomisierten Studien nach weiteren Evidenzkriterien beurteilt, z. B. ob das gewählte Beobachtungsintervall für den primären Endpunkt adäquat gewählt wurde, eine – nach Möglichkeit doppelblinde – Multicenterstudie vorlag, ob der Anteil der nachbeobachteten Patienten ausreichte und ob externe, unabhängige Beurteilungsgremien involviert waren.

Ergebnis

Zehn Medikamente wurden klinisch in randomisierten DES-Studien geprüft: Actinomycin-D, Biolimus A9, Dexamethason, 17-β-Estradiol, Everolimus, Paclitaxel, QuaDDS (7-Hexanoyltaxol), Sirolimus (Rapamycin), Tacrolimus und Zotarolimus (ABT 578). Von den insgesamt 71 randomisierten DES-Studien waren 68 Wirksamkeitsstudien, 3 Studien dienten dem Vergleich verschiedener Implantationsstrategien. Aussagekräftige Sicherheitsstudien zu den DES liegen bislang nicht vor.

Wirksamkeit

Von den 68 randomisierten Studien an 28.394 Patienten hatten 24 einen primären klinischen Endpunkt, 11 davon hatten ihn zum Zeitpunkt von 6–9 Monaten erreicht. Bei Patienten mit stabiler KHK wurden De-novo-Stenosen in koronaren Nativgefäßen in 54 Studien an 24.207 Patienten untersucht, hiervon hatten 17 einen primären klinischen Endpunkt, den 7 Studien erreichten. In-Stent-Restenosen wurden in 4 Studien an 1230 Patienten untersucht, 2 Studien hatten einen primären klinischen Endpunkt, den diese beiden Studien erreichten. Für Patienten mit ST-Streckenhebungsmyokardinfarkt (STEMI) liegen 10 Studien an 2957 Patienten vor, 5 Studien hatten einen primären klinischen Endpunkt, den 2 Studien erreichten. Nur für die 3 am häufigsten verwendeten DES (Cypher, Taxus und Endeavor) liegen Langzeitergebnisse über 3–5 Jahre vor, die eine unvermindert anhaltende Wirksamkeit dieser 3 DES bei De-Novo-Koronarstenosen in Nativgefäßen belegten. Zum heutigen Zeitpunkt sind 19 DES CE-zertifiziert: Für den Cypher-Stent liegen 35 randomisierte Studien vor, davon 10 mit einem klinischen primären Endpunkt, für den Taxus-Stent 25 randomisierte Studien, davon 11 mit einem klinischen primären Endpunkt, und für den Endeavor-Stent 2 randomisierte Studien, davon 1 mit einem klinischen primären Endpunkt. Für den Xience V/Promus- und den Yukon-Stent liegen randomisierte Äquivalenzstudien mit einem primären Surrogatendpunkt vor. Für die übrigen CE-zertifizierten DES, die derzeit kommerziell erhältlich sind, gibt es bislang keine bzw. keine adäquaten randomisierten Studien. Aufgrund der aktuellen Studienlage kann man von den derzeit kommerziell erhältlichen DES folgende empfehlen: hohe Evidenz für Cypher (Sirolimus), Taxus (Paclitaxel), Endeavor (Zotarolimus) und mittlere Evidenz für Xience V/Promus (Everolimus) und Yukon (Sirolimus).

Sicherheit

Die gering erhöhte Rate an späten Stentthrombosen für Cypher und Taxus (ca. 1 Promille pro Jahr) bei den Standardindikationen wird durch die aufgrund von verminderten Restenosen verhinderten Herzinfarkte ausgeglichen, sodass die zunächst vermutete erhöhte Mortalität nicht nachgewiesen werden konnte. Aufgrund ihres antiproliferativen Wirkungsprinzips heilen DES langsamer ein als unbeschichtete Stents und benötigen daher eine längere als die sonst übliche 4-wöchige doppelte Thrombozytenaggregationshemmung. Für die optimale Dauer der notwendigerweise verlängerten dualen Plättchenhemmung (ASS und Clopidogrel) gibt es keine randomisierten Studien.

Schlussfolgerung

Die zu ASS zusätzliche Clopidogrelgabe sollte bei allen Patienten für mindestens 6 Monate fortgesetzt werden und kann dann individuell unter Abwägung des Risikos einer Stentthrombose und des Blutungsrisikos für 1 Jahr oder länger fortgeführt werden. DES sollten bevorzugt bei Patienten mit erhöhtem Risiko einer Restenose implantiert werden, also bei stabiler KHK mit zu einer Symptomatik/Myokardischämie führenden De-novo-Koronarstenose mit einem Gefäßdurchmesser ≤3,0 mm und/oder einer Stenosenlänge ≥15 mm, nach erfolgreicher Wiedereröffnung eines chronisch verschlossenen Koronargefäßes und bei In-Stent-Restenose eines unbeschichteten Koronarstents. DES sollten zurückhaltend bei Patienten mit erhöhtem Risiko einer Stentthrombose eingesetzt werden, also bei deutlich eingeschränkter LV-Funktion, Niereninsuffizienz oder bei diffuser KHK mit Mehrgefäß-PCI. DES sollten eher nicht verwendet werden, wenn die Möglichkeit einer bzw. Compliance zur verlängerten Clopidogrelgabe nicht gegeben oder nicht eruierbar ist, also bei hinsichtlich zu erwartender Compliance schwierig zu erhebender Anamnese, multimorbiden Patienten mit hoher Tablettenanzahl, bei einer demnächst geplanten Operation, bei erhöhtem Blutungsrisiko, bekannter Clopidogrelallergie und bei strikter Indikation zur Dauerantikoagulation.

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  1. S. Silber
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  2. M. Borggrefe
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  3. M. Böhm
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  4. H.M. Hoffmeister
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  5. R. Dietz
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  6. G. Ertl
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  7. G. Heusch
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Silber, S., Borggrefe, M., Böhm, M. et al. Positionspapier der DGK zur Wirksamkeit und Sicherheit von Medikamente freisetzenden Koronarstents (DES). Kardiologe 1, 84–111 (2007). https://doi.org/10.1007/s12181-007-0012-6

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