Impact of heart failure severity and major bleeding events after percutaneous coronary intervention on subsequent major adverse cardiac events

Background Heart failure (HF) is one of high bleeding risk after percutaneous coronary intervention (PCI). Furthermore, major bleeding events increase the risk of subsequent cardiovascular events. However, it is unknown whether HF severity and bleeding events are associated with major adverse cardiac events (MACE). Purpose The aim of this study was investigating the impact of HF severity or bleeding events on subsequent MACE. Methods Clinical Deep Data Accumulation System (CLIDAS), a multicenter database with 7 tertiary medical hospitals, was developed to collect data directly for patient characteristics, medications, laboratory test, physiological test, cardiac catheterization and PCI treatment in electronic medical records. This retrospective analysis included 7,160 patients with PCI between April 2014 and March 2020 and have completed 3-year follow-up. The patients were divided into two groups: HF with high BNP (HF-hBNP) (>100 pg/ml) (n=384) and non-HF-hBNP (HF with low BNP and non-HF) (n=6,776). Furthermore, both groups were re-classified into two groups according to presence of major bleeding events in 30 days: HF-hBNP with 30-day bleeding (n=14), without 30-day bleeding (n=370), non-HF-hBNP with 30-day bleeding (n=74) and without 30-day bleeding (n=6,702). Primary endpoint was defined as MACE. Results HF with high BNP was an independent risk factor of MACE (hazard ratio [HR], 2.21; 95% confidence interval [CI], 1.64-2.98) compared with non-HF. Among the HF-hBNP patients, MACE incidence tended to be increased by 30-day bleeding (p=0.075). In addition, among the non-HF-hBNP patients, the bleeding events increased the risk of MACE (p=0.003). The multivariable Cox regression model revealed that other three groups were associated with a high risk compared with non-HF-hBNP without 30-day bleeding group: non-HF-hBNP with 30-day bleeding (HR, 3.90; 95% CI, 1.59-9.54), HF-hBNP without 30-day bleeding (HR, 2.19; 95% CI, 1.56-3.07) and HF-hBNP with 30-day bleeding (HR, 8.33; 95% CI, 2.57-27.0). Conclusion The real-world database CLIDAS revealed that HF with high BNP and major bleeding events in 30 days might be associated with MACE. Those results suggest that management of HF and prevention of bleeding complication in early days after PCI could be important to prevent MACE.