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Safety of drug-eluting stent in Chinese population with or without diabetes: a multi-center registry study
Shining Cao1, Meirong Ling2, Xun Zhang1
1Guizhou Provincial Center for Drug Evaluation and Adverse Reaction Monitoring, Guizhou Medical Products Administration, Guiyang, Guizhou Province, 550081, China.
Insights
Drug-eluting stents (DES) show a low 1-year adverse event rate in China. Diabetes did not significantly increase major adverse cardiovascular events (MACE) risk after DES implantation in this study.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Device Safety
Background:
- Limited data exists on drug-eluting stent (DES) safety in China.
- Percutaneous coronary intervention (PCI) is a common procedure for coronary artery disease (CAD).
- Understanding adverse outcomes post-PCI with DES is crucial for patient care.
Purpose of the Study:
- To evaluate the 1-year safety and adverse outcomes of DES in a large Chinese registry.
- To compare outcomes between patients with and without diabetes mellitus (DM).
Main Methods:
- Retrospective cohort study using a multicenter observational registry.
- Inclusion of 12,448 patients undergoing PCI with DES.
- Primary endpoint: Major Adverse Cardiovascular Events (MACE) including cardiovascular death, myocardial infarction, or revascularization.
- Multivariable logistic regression to assess the impact of diabetes on MACE.
Main Results:
- The overall 1-year MACE rate was 0.92%.
- Patients with diabetes (26.98%) showed a non-significant trend towards higher MACE rates (1.01% vs. 0.88%).
- Diabetes was not an independent risk factor for MACE after adjusted analysis (OR: 1.67; P=0.452).
Conclusions:
- DES implantation in China is associated with a low and acceptable 1-year MACE rate.
- Diabetes does not appear to be an independent predictor of adverse outcomes post-DES.
- Further research with rigorous endpoint ascertainment is needed, especially for high-risk groups.
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.
