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Clinical Trials/NCT03841487
NCT03841487
Completed
Not Applicable

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 site in 1 country9,100 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ST Elevation Myocardial Infarction
Sponsor
Chang Gung Memorial Hospital
Enrollment
9100
Locations
1
Primary Endpoint
Incidence rate of all-cause mortality at 30 days
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ying-Chang Tung

Principal Investigator

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with ST elevation myocardial infarction

Exclusion Criteria

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

Outcomes

Primary Outcomes

Incidence rate of all-cause mortality at 30 days

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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