Pulmonary embolism · Thrombolysis in intermediate-risk PE
Management Strategies and Prognosis of Pulmonary Embolism Trial 3
| Design | Randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Heparin plus alteplase |
| Control | Heparin plus placebo |
| Population | 256 patients with acute submassive pulmonary embolism and right ventricular dysfunction but normal systemic blood pressure |
| Follow-up | 30 days |
| Primary endpoint | In-hospital death or escalation of treatment |
| Result | The primary endpoint occurred significantly more often with placebo (p=0.006) and 30-day event-free survival favoured alteplase (p=0.005). The difference was driven by escalation of treatment: 24.6% with placebo versus 10.2% with alteplase. |
| Secondary endpoints | 30-day event-free survival, bleeding |
When given in conjunction with heparin, alteplase can improve the clinical course of stable patients who have acute submassive pulmonary embolism and can prevent clinical deterioration requiring the escalation of treatment during the hospital stay.
The trial authors, in the published abstract
Drove a decade of enthusiasm for thrombolysing submassive PE that PEITHO later tempered. Its primary endpoint included escalation of treatment — a decision made by unblinded-in-practice clinicians — which is why the harder endpoints in PEITHO matter more.
Konstantinides S, Geibel A, Heusel G, et al. Heparin plus alteplase compared with heparin alone in patients with submassive pulmonary embolism. N Engl J Med 2002 Oct 10;347(15):1143-50.