{"id":3447,"date":"2014-04-14T13:00:00","date_gmt":"2014-04-14T13:00:00","guid":{"rendered":"http:\/\/www.emlitofnote.com\/?p=3447"},"modified":"2014-04-14T13:00:00","modified_gmt":"2014-04-14T13:00:00","slug":"a-positive-primary-outcome-for-peitho","status":"publish","type":"post","link":"https:\/\/www.emlitofnote.com\/?p=3447","title":{"rendered":"A “Positive” Primary Outcome for PEITHO"},"content":{"rendered":"

Yet, by “positive”, as we all too often see, the underlying data comes with a surprise twist.<\/p>\n

The Pulmonary Embolism Thrombolysis (PEITHO) trial evaluates single-dose tenecteplase added to conventional heparin therapy for the treatment of \u201cintermediate risk\u201d acute pulmonary embolism.  This includes patients with pulmonary embolism, right ventricular dysfunction on imaging, and elevated cardiac biomarkers.  For the primary endpoint of death or hemodynamic deterioration within 7 days, 2.6% of patients in the immediate thrombolysis group met this outcome vs. 5.6% of patients in the usual treatment arm (OR 0.44, p=0.02).<\/p>\n

Unfortunately, this composite outcome obfuscates the difference between treatment arms is limited solely to hemodynamic deterioration.  The downside to thrombolysis \u2013 major extracranial bleeding (11.5% by ISTH definition) and hemorrhagic stroke (2.0%) \u2013 occurred five times as frequently in the treatment arm.  As a result, the overall 7-day and 30-day mortality were statistically identical.  Ultimately, then, this study paints the treatment decision as a choice between cardiovascular instability and life-threatening bleeding complications.<\/p>\n

A couple interesting tidbits from the supplementary appendix:<\/p>\n