ST Elevation Myocardial Infarction Clinical Trial
Official title:
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
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.
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.
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