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Published on: December 11, 2017
Major Bleeding and Mortality After Revascularization of Left Main Disease
Gennaro Giustino1, Joseph F Sabik2, Patrick W Serruys3
1Gagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA. Electronic address: https://twitter.com/g_giustinoMD.
Insights
Major bleeding (MB) rates were higher after coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI) for left main coronary artery disease. MB events after either revascularization procedure increased the risk of death within 5 years.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- Major bleeding (MB) incidence and prognostic impact after left main coronary artery disease (LMCAD) revascularization remain unclear.
- Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are primary treatments for LMCAD.
Purpose of the Study:
- To investigate the rates and outcomes of major bleeding (MB) following LMCAD revascularization with PCI versus CABG.
- To assess the association between MB and subsequent mortality.
Main Methods:
- Analysis of 1,905 patients from the EXCEL trial with unprotected LMCAD, randomized to PCI (n=948) or CABG (n=957).
- MB defined by TIMI major/minor, BARC types 3-5, or transfusion-requiring bleeding; follow-up for 5 years.
- Time-adjusted Cox regression models used to assess MB's association with mortality.
Main Results:
- At 5 years, 11.4% of patients experienced MB. CABG had higher 5-year MB rates (14.8%) compared to PCI (7.9%).
- In-hospital MB was lower with PCI (3.8%) versus CABG (13.5%), but post-discharge MB was higher with PCI (4.5%) versus CABG (2.0%).
- MB events within 5 years significantly increased the risk of all-cause mortality (HR: 2.71), driven by both cardiovascular and non-cardiovascular causes.
Conclusions:
- Coronary artery bypass grafting (CABG) is associated with higher overall and in-hospital major bleeding (MB) rates compared to percutaneous coronary intervention (PCI) for left main coronary artery disease.
- Post-discharge MB is more frequent after PCI than CABG.
- Major bleeding following either LMCAD revascularization strategy independently predicts increased cardiovascular and non-cardiovascular mortality within 5 years.
Background:
The incidence and prognostic impact of major bleeding (MB) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown.
Objectives:
The goal of this study was to investigate the rates and outcomes of MB after LMCAD revascularization.
Methods:
In the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with unprotected LMCAD were randomized to undergo PCI (n = 948) or CABG (n = 957) and followed up for 5 years. MB was defined as TIMI major or minor bleeding, BARC (Bleeding Academic Research Consortium) types 3 to 5 bleeding, or any overt bleeding requiring blood transfusion. The association between MB and subsequent mortality was assessed in time-adjusted Cox regression models.
Results:
At 5 years, 217 patients (11.4%) had at least 1 MB event. Rates of 5-year MB were 7.9% after PCI vs 14.8% after CABG (OR: 0.48; 95% CI: 0.36-0.65; P < 0.0001). However, in-hospital MB was lower after PCI (3.8% vs 13.5%; OR: 0.25; 95% CI: 0.17-0.37), whereas postdischarge MB was lower after CABG (4.5% vs 2.0%; OR: 2.33; 95% CI: 1.33-3.09; Pinteraction < 0.0001). All 41 postdischarge MB events after PCI occurred in patients receiving dual antiplatelet therapy. MB events within 5 years were associated with a higher subsequent risk of all-cause mortality (adjusted HR: 2.71; 95% CI: 1.95-3.77; P < 0.0001), whether in-hospital or postdischarge (Pinteraction = 1.00) and after both PCI and CABG (Pinteraction = 0.95), driven both by increased cardiovascular and non-cardiovascular mortality.
Conclusions:
In the EXCEL trial, CABG resulted in higher 5-year rates of all MB and in-hospital MB, although postdischarge MB was more frequent after PCI. MB after both procedures was associated with increased cardiovascular and noncardiovascular mortality within 5 years. (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).
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