Key Points<\/p>\n\n\n\n
Acute pulmonary embolism (PE) remains a leading cause of cardiovascular morbidity and mortality, particularly in patients with intermediate-risk disease characterized by right ventricular dysfunction and elevated biomarkers. While systemic fibrinolysis reduces hemodynamic collapse, its use has been limited by bleeding risk. The HI-PEITHO trial (NCT04790370<\/a>) was designed to evaluate whether ultrasound-facilitated, catheter-directed fibrinolysis using low-dose alteplase could improve clinical outcomes while mitigating bleeding risk in this population. The trial was published in New England Journal of Medicine<\/a> simultaneously.<\/p>\n\n\n\n HI-PEITHO was a multinational, randomized, open-label trial sponsored by Boston Scientific, with blind endpoint adjudication that enrolled 544 patients with acute intermediate-risk PE across 59 sites. Patients were randomized 1:1 to receive USCDT plus anticoagulation (n=273) or anticoagulation alone (n=271). The primary endpoint was a composite of PE-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of PE within 7 days.<\/p>\n\n\n\n At 7 days, the primary composite outcome occurred in 11 patients (4.0%; 95% CI, 2.3\u20137.1) in the USCDT group compared with 28 patients (10.3%; 95% CI, 7.2\u201314.5) in the anticoagulation-alone group (relative risk 0.39; 95% CI, 0.20\u20130.77; p=0.005). This effect was largely driven by a reduction in cardiorespiratory decompensation or collapse (3.7% vs. 10.3%; relative risk 0.40; 95% CI, 0.20\u20130.70). Rates of PE-related death were low and not significantly different (1.1% vs. 0.4%; relative risk 3.0; 95% CI, 0.3\u201328.5), and recurrence of PE was rare in both groups (0.4% vs. 0.4%; relative risk 1.0; 95% CI, 0.1\u201315.8).<\/p>\n\n\n\n Safety outcomes showed no statistically significant increase in major bleeding. Within 7 days, major bleeding occurred in 4.1% of the USCDT group versus 2.2% in the control group (p=0.32), and at 30 days in 4.1% versus 3.0% (relative risk 1.4; 95% CI, 0.6\u20133.4; p=0.64). Importantly, no intracranial hemorrhage occurred in either group. Rates of death at 30 days (1.8% vs. 1.1%) and serious adverse events (14.8% vs. 16.2%; p=0.64) were similar between groups. Additional findings demonstrated lower use of rescue therapy in the intervention group (2.9% vs. 9.2%), consistent with improved early hemodynamic stability. Hospital length of stay and functional outcomes at 30 days were similar between groups, though there was a trend toward shorter hospitalization with USCDT.<\/p>\n\n\n\n Dr. Stavros V. Konstantinides, the study\u2019s lead investigator, stated: \u201cThis trial shows that a catheter intervention can indeed be effective and improve the prognosis for patients with severe PE and elevated risk of early death or life-threatening complications. If the right patients are selected, it can prevent deterioration at an acceptably low risk of bleeding.\u201d<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" Key Points Acute pulmonary embolism (PE) remains a leading cause of cardiovascular morbidity and mortality, particularly in patients with intermediate-risk disease characterized by right ventricular dysfunction and elevated biomarkers. While systemic fibrinolysis reduces hemodynamic collapse, its use has been limited by bleeding risk. The HI-PEITHO trial (NCT04790370) was designed to evaluate whether ultrasound-facilitated, catheter-directed fibrinolysis […]<\/p>\n","protected":false},"author":40616,"featured_media":139668,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"aside","meta":{"footnotes":""},"categories":[1074,8],"tags":[1075,45,47,185],"ppma_author":[1070],"class_list":{"0":"post-139667","1":"post","2":"type-post","3":"status-publish","4":"format-aside","5":"has-post-thumbnail","7":"category-acc-2026","8":"category-news","9":"tag-acc-2026","10":"tag-conference","11":"tag-featured","12":"tag-news","13":"post_format-post-format-aside","14":"author-joseph-kim-md"},"authors":[{"term_id":1070,"user_id":40616,"is_guest":0,"slug":"joseph-kim-md","display_name":"Joseph Kim MD","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/bf0879bf0ca450025acf71d7345cf24be4748f67f7b0c6423d186a5765c5cda9?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/139667","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/40616"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=139667"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/139667\/revisions"}],"predecessor-version":[{"id":139669,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/139667\/revisions\/139669"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/139668"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=139667"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=139667"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=139667"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=139667"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}