February 8, 2026

The efficacy and safety of low-intensity statins for high bleeding risk patients after PCI in Asian populations

Q: What does this research mean for the field?

Low-intensity statins reduce the risk of revascularization by 46% compared to moderate-to-high-intensity statins in high bleeding risk patients after PCI. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

Low-intensity statins after PCI in high bleeding risk Asian patients reduced revascularization risk by 36% (aHR 0.639, P=0.014) with similar death, MACE, and bleeding risk.

Key Points

This study aims to evaluate the safety and efficacy of low-intensity statins in high bleeding risk patients after percutaneous coronary intervention (PCI).
Retrospective cohort study from 82 hospitals in China (2010-2024)
Patients were classified into low-intensity and moderate-to-high-intensity statin groups
Used propensity score matching to adjust for covariates at a 3:1 ratio
Utilized Cox regression analysis to assess outcomes such as death and major cardiovascular adverse events.
No significant difference in death rates between groups (3.6% vs. 2.5%; P=0.08)
Low-intensity statins reduced the risk of revascularization (6.6% vs. 11.7%; P=0.014)
No significant difference in major cardiovascular adverse events (13.5% vs. 20.1%; P=0.169)
Safety outcomes such as bleeding and cerebral hemorrhage were similar between groups.

Structured PICO

Does low-intensity statin therapy improve clinical outcomes or reduce bleeding compared to moderate-to-high-intensity statins in high bleeding risk patients after PCI?

Population

62,771 high bleeding risk patients after their first percutaneous coronary intervention (PCI) from 82 hospitals in China. High bleeding risk defined as meeting one of: age > 75 years, anemia, eGFR < 60 ml/min/1.73 m², platelet count < 100 × 10^9/L, history of cerebral infarction, or history of cerebral hemorrhage.

Intervention

Low-intensity statins

Comparator

Moderate-to-high-intensity statins

Outcome

Death and major cardiovascular adverse events (MACE) within one year, defined as the composite endpoint of death, myocardial infarction (MI), and revascularizationcomposite

In high bleeding risk patients undergoing PCI, low-intensity statins did not significantly alter 1-year MACE or bleeding risks compared to moderate-to-high-intensity statins, suggesting bleeding risk alone should not dictate statin intensity.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Abstract Background Statins are the most commonly used lipid-lowering drugs. However, previous studies have shown that statin dosage is associated with an increased risk of cerebral hemorrhage. For patients with a high bleeding risk following percutaneous coronary intervention (PCI), the optimal selection of statin dosage remains unclear. Purpose This study aims to assess the safety and efficacy of low-intensity statins in high bleeding risk patients after PCI in Asian populations. Methods The data for this study sourced from a retrospective cohort from 82 hospitals in China, from January 2010 to March 2024. We identified patients who underwent their first PCI within this period based on their surgical records. Patients with a high bleeding risk were defined by meeting one of the following criteria: age 75 years, anemia, eGFR 60 ml/min/1. 73 m², platelet count 100 × 10⁹/L, history of cerebral infarction, or history of cerebral hemorrhage. Patients were divided into two groups based on the statin intensity: the low-intensity statin group and the moderate-to-high-intensity statin group. Propensity score matching (PSM) was employed to balance the covariates between the two groups at a ratio of 3: 1. After PSM, Cox regression analysis was used to assess the association between statin intensity and clinical outcomes. The primary outcomes were death and major cardiovascular adverse events (MACE) within one year, defined as the composite endpoint of death, myocardial infarction (MI) and revascularization. The safety endpoints were bleeding academic research consortium types 3-5 bleeding (BARC3~5) and cerebral hemorrhage (ICH) within one year. The secondary endpoints included MI and revascularization within one year. Results The study included 62, 771 high bleeding risk patients after PCI. Among them, 563 patients received low-intensity statins (median age 71. 89 years, 61. 1% male) and 62, 208 patents received moderate-to-high-intensity statins (median age 68. 84 years, 61. 1% male). The low-intensity statin group had lower LDL-C (mean 2. 72mmol/L versus 2. 88mmol/L, p 0. 001) and total cholesterol (mean 4. 32mmol/L versus 4. 47mmol/L, p = 0. 004) levels. Following PSM, the low-intensity statin group consisted of 560 patients, while the moderate-to-high-intensity statin group included 1, 671 patients. The two groups had similar risk of death (3. 6% VS 2. 5%, aHR: 1. 626, 95% CI: 0. 944 to 2. 801, P = 0. 08) and MACE (13. 5% VS 20. 1%, aHR: 0. 836, 95% CI: 0. 649 to 1. 079, P = 0. 169), but it can reduced the risk of revascularization (6. 6% VS 11. 7%, aHR: 0. 639, 95% CI: 0. 448 to 0. 912, P = 0. 014). The MI was not statistically different. As for safety endpoint, the two groups also had similar risk of BARC3~5. (0. 5% VS 0. 3%, aHR: 1. 133, 95% CI: 0. 301 to 4. 271, P = 0. 854) and ICH (0. 4% VS 0. 4%, aHR: 1. 511, 95% CI: 0. 277 to 8. 252, P = 0. 633). Conclusions This study suggests that bleeding risk may not be a decisive factor in the selection of statin intensity.

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