Study Supports Catheter-Based Therapy for PE

November 11, 2009 - The Society of Interventional Radiology (SIR) announced that a study published by William T. Kuo, MD, et al in SIR's Journal of Vascular and Interventional Radiology (JVIR) concluded that catheter-directed therapy and catheter-directed thrombolysis saves lives and should be considered as a first-line treatment option for massive pulmonary embolism (PE) (2009;20:1431–1440).

According to the investigators, systemic thrombolysis for the treatment of acute PE carries an estimated 20% risk of major hemorrhage, including a 3% to 5% risk of hemorrhagic stroke. In this study, the investigators used evidence-based methods to evaluate the safety and effectiveness of modern catheter-directed therapy (CDT) as an alternative treatment for massive PE.

As detailed in JVIR, the systematic review was initiated by electronic literature searches (Medline, Embase) for studies published from January 1990 through September 2008. Inclusion criteria were applied to select patients with acute massive PE treated with modern CDT. Modern techniques were defined as the use of low-profile devices (≤ 10 F), mechanical fragmentation and/or aspiration of emboli including rheolytic thrombectomy, and intraclot thrombolytic injection, if a local drug was infused. Relevant, non-English language articles were translated into English, and paired investigators assessed study quality and abstracted data. Meta-analysis was performed using random effects models to calculate pooled estimates for complications and clinical success rates across studies. Clinical success was defined as stabilization of hemodynamics, resolution of hypoxia, and survival to hospital discharge.

Five hundred ninety-four patients from 35 studies (six prospective, 29 retrospective) met the criteria for inclusion. The pooled clinical success rate from CDT was 86.5% (95% confidence interval [CI], 82.1%–90.2%). Pooled risks of minor and major procedural complications were 7.9% (95% CI, 5%–11.3%) and 2.4% (95% CI, 1.9%–4.3%), respectively. Data on the use of systemic thrombolysis before CDT were available in 571 patients; 546 of those patients (95%) were treated with CDT as the first adjunct to heparin without previous intravenous thrombolysis.

“In our study, we conclude that modern catheter-directed therapy is a relatively safe and effective treatment for acute massive pulmonary embolism and should be considered as a first-line treatment option,” commented Dr. Kuo. “Modern catheter-directed therapy for acute pulmonary embolism saves lives, and we need to raise awareness about its safety and effectiveness, not only among the general public, but also within the medical community. It's a matter of life and death.”

According to Dr. Kuo, the study addressed the use of catheter-directed therapy for treating “massive” PE. Additional studies are needed to see if the treatment should be initiated in those patients with less severe or “submassive” PE, he added. To answer these questions and to analyze further treatment outcomes, Dr. Kuo and the investigators are initiating the multicenter PERFECT (Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis) registry. In the meantime, the investigators advocate the use of catheter-directed therapy for massive PE as both an early and alternative treatment option at centers with the appropriate expertise.