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Nonfatal Adverse Events and Risk for Subsequent Mortality in Patients Undergoing Percutaneous Coronary Intervention
Takahiro Suzuki1, Yasuyuki Shiraishi2, Shun Kohsaka2
1Department of Cardiology, Keio University School of Medicine, Tokyo, Japan; Department of Cardiovascular Medicine, St. Luke's International Hospital, Tokyo, Japan.
Insights
Heart failure hospitalization (HFH) poses a greater mortality risk after percutaneous coronary intervention (PCI) than acute coronary syndrome (ACS) or major bleeding. These findings suggest a need to re-evaluate how adverse events are weighted in clinical practice and endpoint definitions.
Area of Science:
- Cardiology
- Clinical Research
- Public Health
Background:
- Current percutaneous coronary intervention (PCI) quality metrics often equally weight diverse nonfatal adverse events.
- Events like heart failure hospitalization (HFH), acute coronary syndrome (ACS), and major bleeding are frequently grouped in composite endpoints.
Purpose of the Study:
- To quantify and compare the associations of HFH, ACS, and major bleeding with subsequent mortality after PCI.
- To inform clinical decision-making and endpoint definitions by differentiating the prognostic impact of these adverse events.
Main Methods:
- Analysis of a Japanese multicenter prospective PCI registry (2008-2021) with 2-year outcomes.
- Utilized Cox proportional hazards models and population attributable fractions to assess time-varying exposures (HFH, ACS, major bleeding) and their association with all-cause mortality.
- Adjusted for conventional cardiovascular risk factors.
Main Results:
- Among 10,482 patients, 2-year cumulative incidence rates were 4.7% for HFH, 3.4% for ACS, and 2.5% for major bleeding.
- HFH demonstrated the strongest association with mortality (adjusted HR: 6.11), followed by ACS (aHR: 3.22) and major bleeding (aHR: 2.62).
- HFH accounted for a significantly larger proportion of the mortality burden (20.1%) compared to ACS (4.3%) and major bleeding (2.9%).
Conclusions:
- Heart failure hospitalization is more strongly associated with mortality post-PCI than acute coronary syndrome or major bleeding.
- This highlights the need to move beyond equally weighted composite endpoints.
- Clinical decision-making and quality metric development should prioritize events based on their differential impact on mortality.
Background:
Current guidelines and quality metrics after percutaneous coronary intervention (PCI) often assign equal weight to nonfatal adverse events, including heart failure hospitalization (HFH), acute coronary syndrome (ACS), and major bleeding, within composite endpoints.
Objectives:
The aim of this study was to quantify and compare the associations of HFH, ACS, and major bleeding with subsequent mortality following PCI.
Methods:
A Japanese multicenter prospective PCI registry (2008-2021) with 2-year postprocedural outcomes was analyzed. The primary outcome was all-cause mortality, with HFH, ACS, and major bleeding as time-varying exposures. Cumulative incidence was estimated with death as a competing risk. Cox proportional hazards models and population attributable fractions were used to assess associations between time-varying events and mortality, adjusting for conventional risk factors.
Results:
Among 10,482 patients (mean age 69 years, 77.5% men) followed for a median of 730 days (Q1-Q3: 730-730 days), 1,021 (9.7%; 95% CI: 9.2%-10.3%) experienced adverse events. Two-year cumulative incidence rates were 4.7% (95% CI: 4.2%-5.1%) for HFH, 3.4% (95% CI: 3.0%-3.7%) for ACS, and 2.5% (95% CI: 2.2%-2.8%) for major bleeding. Cox analysis showed that HFH was associated with mortality (adjusted HR [aHR]: 6.11; 95% CI: 4.76-7.85), followed by ACS (aHR: 3.22; 95% CI: 2.14-4.84) and major bleeding (aHR: 2.62; 95% CI: 1.71-4.02). Population attributable fraction analysis demonstrated that HFH accounted for 20.1% (95% CI: 19.0%-21.0%) of mortality burden, higher than ACS (4.3%; 95% CI: 3.3%-4.9%) and major bleeding (2.9%; 95% CI: 1.9%-3.5%).
Conclusions:
HFH shows stronger associations with mortality than ACS or major bleeding following PCI, suggesting that adverse events should not be weighted equally and underscoring the need to reconsider prioritization in clinical decision-making and endpoint definitions.
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