Clinical Original
Major bleeding complicating contemporary primary percutaneous coronary interventions—incidence, predictors, and prognostic implications

https://doi.org/10.1016/j.carrev.2008.08.001Get rights and content

Abstract

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.

Introduction

Primary percutaneous coronary intervention (PCI) is a robust therapeutic approach for patients presenting with ST-elevation myocardial infarction (STEMI). The incidence of major bleeding among patients undergoing PCI varies between 2.2% and 17.6% [1], [2], [3], [4], [5], [6], [7]. Systemic bleeding may be affected by patients' characteristics and/or adjunctive antiplatelet and anticoagulation treatment used during the course of STEMI-related PCI [2], [8], [9]. Among those patients, baseline anemia was found to be a major predictor for adverse clinical outcomes [9]. The effect of peri-procedural bleeding on short- and intermediate-term prognosis in patients undergoing primary PCI was not fully elucidated. Accordingly, the current study aimed at evaluating the incidence, predictors, and prognostic impact of peri-procedural bleeding and blood transfusion in unselected “real-world” patient population who underwent primary PCI for STEMI using contemporary interventional approach.

Section snippets

Study population

We studied 831 consecutive patients who underwent primary PCI for STEMI between 1/2001 and 6/2005 at the Rabin Medical Center. Data was prospectively collected and entered into a uniform computerized registry format. All patients had to have baseline and post-procedure hemoglobin (Hb) levels. Patients who underwent emergent coronary artery bypass grafting surgery were excluded from the analysis.

Study definitions and follow-up data

Acute STEMI was defined as the presence for at least 30 min but less than 12 h of symptoms attributed

Baseline demographics

Major bleeding was observed in 27 (3.5%) of 831 acute STEMI patients who underwent primary PCI within 12 h of onset of chest pains. Patient demographics are described in Table 1. Patients who experienced major bleeding were older and 48% of them were above the age of 75 years. The proportion of women experiencing major bleeding (13/230, 5.7%) was 2.5 times higher than the proportion of men (14/601, 2.3%).

Angiographic and procedural results

Patients with major bleeding had similar procedural results and complications (Table 2).

Discussion

The current study main findings are as follows: (1) primary PCI for STEMI using contemporary intervention and adjunctive pharmacology is associated with relatively low rate of major bleeding; (2) major bleeding is associated with increased mortality rates; and (3) women are at increased risk for both major bleeding and blood transfusion.

In the current study, we observed a relatively low rate of major bleeding (3.5%). In comparison, the rate of peri-procedure major bleeding in a large cohort of

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