Major bleeding complicating contemporary primary percutaneous coronary interventions-incidence, predictors, and prognostic implications

Background: Major bleeding is one of the most frequent procedural-related complications of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infraction (STEMI). We investigated the incidence, predictors, and prognostic impact of peri-procedural bleeding in a cohort of unselected patients undergoing contemporary primary PCI. Methods: A total of 831 consecutive patients who underwent primary PCI between 1/2001 and 6/2005 were studied. Major bleeding was defined as hemorrhagic stroke, hemoglobin (Hb) drop of >5 g%, or 3-5 g% with a need for blood transfusion. Clinical outcomes were evaluated at 30 days and 6 months. Results: Major bleeding occurred in 27 patients (3.5%). Those who experienced major bleeding were older (66±15 vs. 61±13, P=.02), more frequently female gender (48% vs. 27%, P=.0001), presented more often with cardiogenic shock (37% vs. 8%, P=.0001), and had higher CADILLAC score (7.8±4.5 vs. 5.1±4.0, P=.002) and activated clotting time (ACT) levels (284±63 vs. 248±57 s, P=.007). In multivariate analysis, significant predictors of major bleeding were female gender (OR 5.1, 95% CI 1.7-15.2, P=.004), ACT levels >250 s (OR 3.6, 95% CI 1.1-12.1, P=.04), and use of intra-aortic balloon pump (IABP) (OR 3.5, 95% CI 1.0-12.1, P=.047). Major bleeding was associated with increased 6-month mortality rates (37% vs. 10%, P=.0001), which remained significant after adjustment for baseline CADILLAC score (37% vs. 19.4%, P=.05). Conclusions: Major bleeding complicating primary PCI is associated with increased 6-month mortality. Women and those who need IABP support are at particularly high risk. Tight monitoring of anticoagulation may reduce the risk of bleeding.