Die CALISTO-Studie

Zusammenfassung

Die oberflächige Venenthrombose (OVT) tritt häufiger als die tiefe Venenthrombose (TVT) auf und betrifft Frauen doppelt so häufig wie Männer. Bei Patienten mit einer isolierten OVT, d.h. ohne gleichzeitige TVT oder Lungenembolie (LE), besteht ein erhöhtes Risiko für thromboembolische Komplikationen. Bislang gab es nur wenige randomisierte Studien zur OVT, und keine einzige mit ausschließlich klinischen Endpunkten. Daher war das Ziel der CALISTO-Studie, mit einem randomisierten, doppelt-blinden, placebo-kontrollierten Design die Wirksamkeit und Sicherheit einer 45-tägigen Behandlung mit Fondaparinux bei 3 002 Patienten mit isolierter OVT zu untersuchen im Hinblick auf klinische thromboembolische Endpunkte (Kombination von Tod, symptomatischer VTE, symptomatische Ausdehnung der OVT in die Crosse oder symptomatische Rezidive). Der primäre Endpunkt trat bei 0,9 % unter Fondaparinux, und bei 5,9 % unter Plazebo auf (RRR 85 %; 74–92 %; P<0,001). Es gab in jeder Gruppe jeweils eine schwere Blutung, ernste unerwünschte Ereignisse waren in beiden Gruppen vergleichbar (0,7 versus 1,1 % unter Plazebo). Die einmal tägliche Gabe von 2,5 mg Fondaparinux über 45 Tage war effektiv und sicher in der Behand-lung von Patienten mit akuter, symptomatischer, isolierter OVT und hatte im Vergleich zu Placebo keine schwerwiegenden Nebenwirkungen. Es handelt sich damit um die erste evidenzbasierte antithrombotische Therapie der OVT.

Summary

Superficial vein thrombosis (SVT) of the legs is a common condition which occurs more frequently than deep vein thrombosis (DVT), and affects twice as many women than men. Patients with isolated SVT, i.e. without concomitant DVT or PE, are at risk for subsequent symptomatic VTE complications. There are only very few randomized studies on SVT, and none has assessed clinical endpoints. Therefore, the CALISTO study was conducted as a randomized, double-blind, placebo-controlled trial to assess the benefits of a 45 day treatment with 2.5 mg Fondaparinux in 3 002 patients with isolated SVT with respect to clinical thromboembolic endpoints (Composite of death or symptomatic VTE, or symptomatic extension into the sapheno-femoral junction or symptomatic recurrence at day 47). The main safety outcome was major bleeding. The primary efficacy outcome occurred in 13 of 1 502 patients (0.9 %) in the fondaparinux group and 88 of 1500 patients (5.9 %) in the placebo group (RRR 85 %; 74–92 %; P<0.001). Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7 % with fondaparinux and 1.1 % with placebo. Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, isolated, symptomatic SVT and did not have serious side effects.

Schlüsselwörter

oberflächliche Venenthrombose - Thrombo -phlebitis - Fondaparinux - placebo-kontrollierte Studie - venöse Thromboembolie

Keywords

superficial vein thrombosis - fondaparinux - thrombophlebitis - venous thromboembolism - placebo-controlled trial

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