Multicenter Randomized Trial to Prevent Pulmonary Vein Stump Thrombus After Left-Sided Anatomical Lung Resection.

BACKGROUND

Pulmonary vein stump thrombosis (PVST) is frequently detected on follow-up computed tomography in patients who have undergone left-sided anatomical pulmonary resection. In particular, a floating thrombus in the pulmonary vein stump has been identified as a potential cause of several postoperative systemic embolic complications, including cerebral infarction, highlighting the unmet need to improve postoperative outcomes in general thoracic surgery.

METHODS

This randomized trial aims to confirm the efficacy of postoperative heparin administration in preventing PVST and postoperative cerebral infarction, focusing exclusively on left-sided anatomical pulmonary resections. The primary end point is the frequency of PVST on contrast-enhanced computed tomography scans at postoperative day 5 ± 2. The secondary end point is the frequency of systemic thromboembolic events, including cerebral infarction. The study expects to enroll 250 patients from 26 institutions over 2.5 years.

RESULTS

The PV STUDY (Postoperative heparin administration to prevent pulmonary vein stump thrombus after left side anatomical pulmonary resection: Multicenter Randomized Phase II trial) has been open since October 2024, and the trial registration is now ongoing.

CONCLUSIONS

The primary analysis is scheduled for spring 2027.