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临床试验/NCT03841487
NCT03841487已完成不适用

All-cause Mortality and the Risk of Stroke With Selective Aspiration Thrombectomy in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention - A Nationwide Retrospective Cohort Study

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 9,100 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9,100
试验地点
1
主要终点
Incidence rate of all-cause mortality at 30 days

研究概览

简要总结

Patients who were diagnosed with ST-elevation myocardial infarction (STEMI) and received primary percutaneous coronary intervention (PPCI) from July 2009 to December 2011 were identified from the National Health Insurance Research Database of Taiwan. The investigators compared the 1-year outcomes of patients with STEMI who received aspiration thrombectomy during PPCI vs. those who received PPCI alone.

详细描述

Data source and study population Using the National Health Insurance Research Database of Taiwan, STEMI patients from July 2009 to December 2011 who received aspiration thrombectomy during PPCI were defined as the thrombectomy group, and the remaining patients were defined as the PCI alone group. ICD-9-CM codes were used to identify underlying comorbidities. Data regarding the prescription of in-hospital and outpatient medications and the utilization of medical devices were also extracted from the NHIRD using ICD-9-CM procedure codes and pharmacology and device codes.

Study outcomes The primary endpoints of this study were all-cause mortality and stroke during hospitalization and at 30 days and 1 year of follow-up. Ischemic and hemorrhagic subtypes of stroke were further identified according to ICD-9-CM codes. All patientswere followed for 1 year or until the outcomes were achieved, whichever came first.

Statistical analysis Propensity score weighting was used to reduce potential differences between the two study groups. The incidence rates of all-cause mortality and stroke were estimated as the total number of events during the follow-up period divided by the person-months at risk. For all-cause mortality, a Cox proportional hazard model was used to obtain hazard ratios (HRs). For stroke, Fine and Gray's competing-risk regression was used to obtain sub-hazard ratios (SHRs). The cumulative incidence of stroke versus follow-up time was plotted rather than the event-free rate, because cumulative incidence function can take the competing risk of death into account. For the thrombectomy group, 95% confidence intervals (CIs) of the HRs and SHRs were calculated using the PCI alone group as the referent group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ST elevation myocardial infarction

排除标准

  • Missing data on sex or discharge date
  • Aged less than 18 years
  • Previous stroke
  • Patients receiving thrombolytic therapy
  • Patients who did not undergo PPCI

结局指标

主要结局

Incidence rate of all-cause mortality at 30 days

时间窗: 30 days from the date of primary percutaneous coronary intervention

The total number of death during the follow-up period divided by the person-months at risk

Incidence rate of all-cause mortality at 1 year

时间窗: 1 year from the date of primary percutaneous coronary intervention

The total number of death during the follow-up period divided by the person-months at risk

Incidence rate of stroke at 1 year

时间窗: 1 year from the date of primary percutaneous coronary intervention

The total number of stroke events during the follow-up period divided by the person-months at risk

Incidence rate of stroke at 30 days

时间窗: 30 days from the date of primary percutaneous coronary intervention

The total number of stroke events during the follow-up period divided by the person-months at risk

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying-Chang Tung

Principal Investigator

Chang Gung Memorial Hospital

研究点 (1)

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