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Safety Analysis of Spironolactone Use in Patients Undergoing Percutaneous Coronary Intervention with High Bleeding
Junyan Zhang1, Ting Yan1,2, Ran Liu3
1Department of Cardiology, West China Hospital of Sichuan University, 37 Guo Xue Xiang, Chengdu, China.
Insights
Spironolactone does not increase gastrointestinal bleeding risk in patients undergoing high bleeding risk percutaneous coronary intervention (PCI-HBR). This study found comparable bleeding rates between spironolactone and non-spironolactone groups, suggesting its use is safe in this population.
Area of Science:
- Cardiology
- Pharmacology
- Gastroenterology
Background:
- Spironolactone is a medication with potential associations with upper gastrointestinal bleeding.
- Patients undergoing percutaneous coronary intervention with high bleeding risk (PCI-HBR) often require careful medication management.
Purpose of the Study:
- To validate the reported increased risk of gastrointestinal bleeding associated with spironolactone use.
- To investigate the safety of spironolactone in patients with high bleeding risk undergoing PCI.
Main Methods:
- A prospective cohort study including 1616 PCI-HBR patients.
- Propensity score matching was used to create comparable spironolactone and non-spironolactone groups (n=927).
- Cox regression and Kaplan-Meier analyses evaluated gastrointestinal bleeding events (BARC 2-5 and 3-5).
Main Results:
- No significant difference in BARC 2-5 gastrointestinal bleeding (5.4% vs. 6.3%, p=0.689) or BARC 3-5 bleeding (2.3% vs. 3.6%, p=0.410) was observed between groups.
- Spironolactone use did not show a statistically significant interaction with factors like acute coronary syndrome, diabetes, or chronic kidney disease regarding bleeding risk.
- The study provides robust data on spironolactone's safety profile in a high-risk cardiovascular population.
Conclusions:
- Spironolactone use is not associated with an increased risk of gastrointestinal bleeding in patients undergoing PCI-HBR.
- Cardiologists can consider spironolactone for appropriate patients without routine concern for drug-induced bleeding.
- Further large-scale randomized trials are recommended to confirm these findings.
Purpose:
Spironolactone has been reported to increase the risk of upper gastrointestinal bleeding in patients. We aimed to validate this perspective in a population of patients undergoing percutaneous coronary intervention with high bleeding risk (PCI-HBR).
Methods:
We prospectively included a total of 1616 PCI-HBR patients who were treated at West China Hospital of Sichuan University from May 2022 to July 2024. These patients were divided into a spironolactone treatment group (n = 301) and a non-spironolactone treatment group (n = 1315). A propensity score matching was performed at a 1:4 ratio, and Cox regression analysis was conducted on the matched data. Additionally, Kaplan-Meier curves were plotted to evaluate the direct correlation between spironolactone use and gastrointestinal bleeding. And the subgroup analysis is used to assess the robustness of the results.
Results:
In this study, after propensity score matching, a total of 927 patients were included in the outcome analysis, with 259 in the spironolactone group and 668 in the non-spironolactone group. Throughout the follow-up period, 14 (5.4%) and 42 (6.3%) patients experienced BARC 2-5 gastrointestinal bleeding events in the spironolactone and non-spironolactone groups, respectively, while 6 (2.3%) and 24 (3.6%) patients experienced BARC 3-5 gastrointestinal bleeding. The incidence of BARC 2-5 gastrointestinal bleeding was comparable between the groups (14/259 [5.4%] vs. 42/668 [6.3%]; HR 0.88 [0.48-1.62], p = 0.689), as was the incidence of BARC 3-5 gastrointestinal bleeding (6/259 [2.3%] vs. 24/668 [3.6%]; HR 0.69 [0.28-1.68], p = 0.410). No statistically significant interactions were found between spironolactone use and clinical variables such as acute coronary syndrome, diabetes, and chronic kidney disease concerning the risk of gastrointestinal bleeding.
Conclusions:
In summary, our prospective cohort study, which used propensity score matching, represents the first comprehensive investigation of spironolactone usage in PCI-HBR patients. Our results underscore that cardiologists need not routinely consider the risk of spironolactone-induced bleeding when making decisions about its use in patients. Larger randomized trials or analyses from existing randomized trials on spironolactone are warranted to draw definitive conclusions about the potential association between spironolactone and bleeding.
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