More than 80% of patients with lower-extremity deep venous thrombosis who underwent endovascular treatment with the Angiojet rheolytic thrombectomy system were free of rethrombosis a year later, based on final results from the PEARL registry study.
Almost 4% of patients had bleeding events after treatment, but none of these events was tied to use of the Angiojet system, reported Dr. Mark Garcia of Mount Sinai Medical Center in New York and his associates.
“PEARL registry data demonstrate that rheolytic pharmacomechanical catheter-directed thrombolysis treatment of deep venous thrombosis is safe and effective, and can potentially reduce the need for concomitant catheter-directed thrombolysis and intensive care,” the researchers wrote.
The rates of venous thromboembolism are rising, and the number of affected adults is expected to double in the next 40 years as the population ages and experiences recurrent episodes. Lower-extremity deep venous thrombosis (DVT) is especially likely to recur or to develop complications such as pulmonary embolism and post-thrombotic syndrome. For this reason, practice guidelines now advocate early removal of iliofemoral clots if patients are functional, have a good life expectancy, are within 14 days of symptom onset, and are unlikely to develop bleeding complications. Options for clot removal include catheter-directed thrombolysis (CDT) or pharmacomechanical CDT, which combines catheterization with intervention to break up or aspirate the clot while infusing it with a thrombolytic drug, said the investigators (J. Vasc. Interv. Radiol. 2015 Mar. 27 [doi:10.1016/j.jvir.2015.01.036]).
The PEARL registry study prospectively followed patients who underwent PCDT for arterial or venous thrombosis with the AngioJet thrombectomy catheter system. Researchers analyzed data from 329 patients with severe lower-extremity DVT who were treated at 32 sites in the United States and Europe between 2007 and 2013. Two-thirds of the patients underwent Angiojet thrombectomy within 2 weeks of symptom onset, while 19% were treated within 15 to 30 days and 14% were treated for chronic lesions. A total of 57% of patients were men, and the average age at onset was 52 years. The cohort’s most prevalent risk factors for thrombosis included a history of DVT, preexisting caval filters, past or current tobacco use, and prior pulmonary embolism, the investigators reported.
Grade III (100%) clot removal was possible without needing to use CDT in 39% of patients. Most of these patients underwent PCDT alone (lasting a median of 2 hours), while the rest underwent rheolytic thrombectomy without a lytic agent (median, 1.4 hours). However, just over half of patients underwent PCDT and catheter-directed thrombolysis, lasting a median of 22 hours, and 9% underwent rheolytic thrombectomy with CDT (median, 41 hours). About three-quarters of patients had procedures lasting under 24 hours, and about one in three were done within 6 hours. Also, 86% of procedures required no more than two catheter laboratory sessions.
Three months after treatment, 94% of patients were free from rethrombosis, and 87% and 83% of the cohort remained so at 6 and 12 months, respectively, the researchers added. Even patients with chronic thrombi improved so much on the 12-item Short-Form Health Survey that their scores approximated population norms with a year of treatment, they said.
A total of nine patients (2.7%) had adverse events possibly related to treatment, including one case of acute renal failure, said the investigators. Clinicians should follow recommendations for hydration and limit run time to four minutes in a free-flowing vessel to prevent that outcome, they added.
Dr. Garcia and his associates reported being paid consultants for Boston Scientific, which makes the Angiojet thrombectomy catheter system and funded the study. Dr. Garcia also reported grant funds and consulting fees from BTG/EKOS and Cook. Four coauthors reported receiving consulting fees from Cordis, Cook, Medtronic, AstraZeneca, and Covidien.