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Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in
Freek W A Verheugt1, Steven R Steinhubl, Martial Hamon
1Radboud University Medical Centre, Nijmegen, the Netherlands. f.w.a.verheugt@olvg.nl
Insights
Nonaccess site bleeding after percutaneous coronary intervention (PCI) is common and significantly increases mortality risk. Bivalirudin therapy reduces both access and nonaccess site bleeding events post-PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Bleeding complications post-percutaneous coronary intervention (PCI) are linked to increased mortality.
- The distinct contributions of access site versus nonaccess site bleeding to prognosis are not well understood.
- The role of antithrombotic therapies in mitigating bleeding risk requires further investigation.
Purpose of the Study:
- To determine the frequency of access and nonaccess site bleeding after PCI.
- To assess the association between bleeding events and 1-year mortality.
- To evaluate the impact of randomized antithrombotic therapy on bleeding outcomes.
Main Methods:
- Analysis of a combined dataset from three major PCI trials (REPLACE-2, ACUITY, HORIZONS-AMI) involving 17,393 patients.
- Examination of the incidence and impact of Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding within 30 days.
- Comparison of outcomes between patients receiving bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor.
Main Results:
- Nonaccess site bleeds constituted approximately two-thirds of all TIMI bleeding events (3.3% of patients).
- TIMI bleeding was independently associated with a 3.17-fold increased risk of 1-year mortality.
- Nonaccess site bleeding carried a higher mortality risk (HR: 3.94) compared to access site bleeding (HR: 1.82).
- Randomization to bivalirudin led to significant relative reductions in TIMI major/minor bleeding (38%) and TIMI major bleeding (43%) compared to heparin plus a glycoprotein IIb/IIIa inhibitor.
Conclusions:
- Nonaccess site bleeding is a frequent complication after PCI and is a strong predictor of increased 1-year mortality.
- Bivalirudin therapy significantly reduces both access and nonaccess site bleeding events by approximately 40% compared to heparin plus a glycoprotein IIb/IIIa inhibitor.
Objectives:
The aim of this study was to evaluate the relative frequency of access and nonaccess site bleeding, the association of these events with 1-year mortality, and the impact of randomized antithrombotic therapy.
Background:
Post-percutaneous coronary intervention (PCI) bleeding has been strongly associated with subsequent mortality. The extent to which access versus nonaccess site bleeding contributes to this poor prognosis and the role of antithrombotic therapies remains poorly understood.
Methods:
The incidence and impact of Thrombolysis In Myocardial Infarction (TIMI) major/minor 30-day bleeding and randomized antithrombotic therapy were examined in a combined dataset from the REPLACE-2 (Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events), Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY), and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials in 17,393 PCI patients.
Results:
The TIMI major/minor bleeding occurred in 5.3% of patients, 61.4% of which (3.3%) were nonaccess site bleeds. After multivariable adjustment, TIMI bleeding was associated with an increased risk of 1-year mortality (hazard ratio [HR]: 3.17, 95% confidence interval [CI]: 2.51 to 4.00, p < 0.0001). The HR of a nonaccess site bleed was approximately 2-fold that of an access site bleed: HR: 3.94, 95% CI: 3.07 to 5.15, p < 0.0001 versus HR: 1.82, 95% CI: 1.17 to 2.83, p = 0.008, respectively. Randomization to bivalirudin versus heparin + a glycoprotein IIb/IIIa inhibitor resulted in 38% and 43% relative reductions in TIMI major/minor and TIMI major bleeding, respectively (p < 0.0001 for both), with significant reductions in both access and nonaccess site bleeding.
Conclusions:
Nonaccess site bleeding after PCI is common, representing approximately two-thirds of all TIMI bleeding events, and is associated with a 4-fold increase in 1-year mortality. Use of bivalirudin rather than heparin + a glycoprotein IIb/IIIa inhibitor significantly decreases both nonaccess site as well as access site bleeding events by approximately 40%.
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