KNOCOUT PE
Prospective Cohort: 3-Month Data
Vascular Surgery / EKOS Endovascular System Overview / Clinical Evidence / KNOCOUT PE
Importance:
With 489 patients, the prospective KNOCOUT cohort represents the largest prospective body of evidence in the interventional PE space to-date. The registry included a wide range of patients with intermediate-high and high-risk PE, making it an accurate representation of patients with PE treated with EKOS every day. In addition, KNOCOUT captures the largest breadth of contemporary clinical practices with 83 centers enrolled across the United States and Europe between 2018 and 2020.
Take-away:
Results from KNOCOUT PE reflect contemporary clinical practice and demonstrated effective treatment of PE with EKOS with lower r-tPA dose and shorter infusion duration, and low major hemorrhagic complications and zero intracerebral hemorrhagic events.
Results
Safety
Major Bleeding within 30 days |
12 (2.5)* |
| Anemia | 1 (0.2) |
| Gastrointestinal Hemorrhage | 1 (0.2) |
| Peritoneal Hemorrhage | 1 (0.2) |
| Procedural Hemorrhage | 1 (0.2) |
| Laceration | 1 (0.2) |
| Compartment Syndrome | 1 (0.2) |
| Hematoma | 1 (0.2) |
| Lower Gastrointestinal Hemorrhage | 1 (0.2) |
| Retinal Hemorrhage | 1 (0.2) |
| Retroperitoneal Hemorrhage | 1 (0.2) |
| Subdural Hematoma (pre-existing) | 1 (0.2) |
| Vascular Access Site Hematoma | 1 (0.2) |
* Out of a pool of 489
Recurrent VTE Within 30 Days |
|
| Pulmonary Embolism | 4 (0.8) |
| Confirmed Post-Procedure DVT | 1 (0.2)* |
Evidence
KNOCOUT shows that contemporary clinical practices are moving to low-dose, short duration OPTALYSE protocols. It adds to the growing evidence that EKOS is effective at treating intermediate-risk and high-risk PE with lower lytic doses and shorter infusion durations compared to other thrombolytic therapies.
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Indications, Safety and Warnings
References:
1. KonstantinidesS, GeibelA, HeuselG, et al. Heparin plus alteplase compared with heparin alone in patients with submassivepulmonary embolism. N EnglJ Med. 2002;347:1143–1150.
2. Kuo W et al. CHEST 2015; 148(3):667 673.
3. Piazza G et al. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism. The SEATTLE II Study. J Amer Coll Cardiol: Cardiovasc Interventions 2015; 8(10):1382-1392.
4. 3-Month Prospective KNOCOUT Data Presentation at VIVA 2021.
5. TapsonVF, Sterling K, Jones N, et al. A randomized trial of the optimum duration of acoustic pulse thrombolysis procedure in acute intermediate-risk pulmonary embolism: the OPTALYSE PE trial. JACC Cardiovasc Interv. 2018;11:1401-1410. doi: 10.1016/j.jcin.2018.04.008