PEERLESS Trial: Mechanical Thrombectomy vs CDT for Intermediate-Risk PE

PEERLESS Trial: Mechanical Thrombectomy vs CDT for Intermediate-Risk PE

The PEERLESS Trial investigated whether mechanical thrombectomy improved outcomes compared to catheter-directed thrombolysis in patients with acute intermediate-risk pulmonary embolism.

The study was a prospective, open label, randomized controlled trial conducted across 13 sites in the USA, involving 150 patients. Participants had acute pulmonary embolism confirmed by imaging, evidence of right ventricular dysfunction, elevated biomarkers (NT-proBNP or troponin), and symptoms present for less than 14 days. Patients with massive pulmonary embolism, high bleeding risk, or contraindications to heparin were excluded.

The interventions compared were:
1. **Mechanical Thrombectomy:** Using the FlowTriever system for aspiration of clot, without the use of thrombolytics.
2. **Catheter-Directed Thrombolysis:** Local delivery of 10 milligrams of alteplase per lung over 6 hours via the EkoSonic Endovascular System.

The primary endpoint was the reduction in the right ventricle to left ventricle diameter ratio at 48 hours, as assessed by CT. Secondary endpoints included all-cause mortality, pulmonary embolism recurrence, major bleeding, device related complications, and length of intensive care unit and hospital stay.

Results showed that both mechanical thrombectomy and catheter-directed thrombolysis significantly reduced the right ventricle to left ventricle ratio from baseline to 48 hours. The difference in reduction between the two groups was not statistically significant, indicating that mechanical thrombectomy was not superior to catheter-directed thrombolysis for this primary outcome.

Regarding secondary clinical outcomes, there were no significant differences in all-cause mortality or pulmonary embolism recurrence between the groups. However, major bleeding was significantly higher in the catheter-directed thrombolysis group (10.7 percent) compared to the mechanical thrombectomy group (1.3 percent). This included one intracranial hemorrhage in the catheter-directed thrombolysis arm. Device related complications were rare, with one wire perforation reported in the mechanical thrombectomy group. Patients treated with mechanical thrombectomy had shorter median intensive care unit stays (1 day versus 2 days) and shorter median hospital stays (3 days versus 4 days). Oxygen requirements at discharge did not significantly differ.

The trial’s limitations included its open label design, the use of a single device manufacturer for mechanical thrombectomy, and a relatively small sample size.

The study concluded that for intermediate-risk pulmonary embolism, mechanical thrombectomy using the FlowTriever system achieved similar improvements in right heart strain compared to catheter-directed thrombolysis, but with a significantly lower risk of major bleeding and shorter intensive care unit and hospital stays.

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