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Background <p>The safety of drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) remains largely lacking in China. This study aimed to determine the 1-year adverse outcomes in a large registry of patients undergoing PCI with DES for coronary artery disease (CAD) in China. We also examined clinical outcomes in patients with versus without diabetes.</p> Methods <p>This study employs a retrospective cohort design. Data were obtained from the Monitoring Reevaluation Platform for Key Medical Device Adverse Events—the multicenter, observational registry that includes patients undergone PCI in Beijing, Guangdong province, and Guizhou province. The primary outcome measure was the composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or any clinically indicated revascularisation procedure. Multivariable logistic regression was used to assess the association between MACE and diabetes, estimating adjusted odds ratios (ORs) and 95% confidence intervals.</p> Results <p>A total of 12,448 patients were included in the final analysis. There were 3,359 (26.98%) patients with DM and 9,089 (73.02%) without DM, respectively. The crude incidence rate of MACE was 0.92% (95% CI: 0.68–1.17%) over 12 months following PCI. Patients with diabetes had a slightly higher rate of MACEs than those without DM, but this difference did not reach statistical significance (1.01% vs. 0.88%; <i>P</i> = 0.625). After adjustment for baseline characteristics, patients with DM were not at higher risk of MACEs than those without diabetes (OR: 1.67; 95% CI: 0.44–6.34; <i>P</i> = 0.452).</p> Conclusions <p>In this large, multicenter Chinese registry, DES use was associated with a low and acceptable 1-year MACE rate. Diabetes may not be an independent risk factor for adverse outcomes following DES implantation. However, given the high attrition rate in the observational registry and the potential for underestimation of events, further studies with stricter endpoint ascertainment are warranted, particularly among high-risk subgroups such as elderly patients and those with multiple comorbidities.</p>

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Safety of drug-eluting stent in Chinese population with or without diabetes: a multi-center registry study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月23日

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  • Shining Cao,
  • Meirong Ling,
  • Xun Zhang,
  • Wei Wu,
  • Man Luo,
  • Bin Jiang,
  • Jing Yuan

摘要

Background

The safety of drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) remains largely lacking in China. This study aimed to determine the 1-year adverse outcomes in a large registry of patients undergoing PCI with DES for coronary artery disease (CAD) in China. We also examined clinical outcomes in patients with versus without diabetes.

Methods

This study employs a retrospective cohort design. Data were obtained from the Monitoring Reevaluation Platform for Key Medical Device Adverse Events—the multicenter, observational registry that includes patients undergone PCI in Beijing, Guangdong province, and Guizhou province. The primary outcome measure was the composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or any clinically indicated revascularisation procedure. Multivariable logistic regression was used to assess the association between MACE and diabetes, estimating adjusted odds ratios (ORs) and 95% confidence intervals.

Results

A total of 12,448 patients were included in the final analysis. There were 3,359 (26.98%) patients with DM and 9,089 (73.02%) without DM, respectively. The crude incidence rate of MACE was 0.92% (95% CI: 0.68–1.17%) over 12 months following PCI. Patients with diabetes had a slightly higher rate of MACEs than those without DM, but this difference did not reach statistical significance (1.01% vs. 0.88%; P = 0.625). After adjustment for baseline characteristics, patients with DM were not at higher risk of MACEs than those without diabetes (OR: 1.67; 95% CI: 0.44–6.34; P = 0.452).

Conclusions

In this large, multicenter Chinese registry, DES use was associated with a low and acceptable 1-year MACE rate. Diabetes may not be an independent risk factor for adverse outcomes following DES implantation. However, given the high attrition rate in the observational registry and the potential for underestimation of events, further studies with stricter endpoint ascertainment are warranted, particularly among high-risk subgroups such as elderly patients and those with multiple comorbidities.