OPtimal TIming for Reperfusion in Acute Pulmonary Embolism: Rationale and design of the OPTIRAPE registry

Abstract

Background

The optimal timing of reperfusion therapy in acute pulmonary embolism (PE) remains uncertain, despite guideline recommendations supporting urgent intervention in high-risk and selected intermediate-high-risk presentations.

Objective

The OPTIRAPE registry (Optimal Timing for Reperfusion in Acute Pulmonary Embolism) aims to evaluate the association between reperfusion timing and in-hospital outcomes and to characterize real-world treatment patterns and system-related delays in patients undergoing systemic thrombolysis (ST) or catheter-directed therapies (CDTs).

Design and interventions

OPTIRAPE (NCT07436702) is a prospective, multicentre, observational registry enrolling consecutive adults with acute high-risk or intermediate-high-risk PE undergoing ST or CDTs reperfusion therapy across seven Italian hospitals with 24/7 access to advanced imaging and reperfusion strategies. Treatment decisions are based on the 2019 European Society of Cardiology guidelines and local practice, without protocol-mandated interventions.

Study outcomes

The primary exposure is time-to-reperfusion, defined as the interval from diagnostic confirmation of high-risk PE, or, in intermediate-high-risk patients, from clinical deterioration to initiation of reperfusion therapy. The primary endpoint is in-hospital mortality. Secondary endpoints include major bleeding, early haemodynamic deterioration, need for mechanical circulatory or respiratory support, recurrent venous thromboembolism, intensive care unit admission, and length of hospital stay.

Implication

OPTIRAPE will provide granular real-world data on reperfusion timing, treatment modality, and inter-hospital variability in severe PE management. It will quantify the relationship between treatment delays and in-hospital outcomes and explore potential time thresholds associated with improved survival, informing future guideline recommendations and supporting the implementation of standardized, time-sensitive reperfusion pathways in acute PE.