Clinical trial NCT03841487: Selective Aspiration Thrombectomy in STEMI
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Keywords: ST-elevation myocardial infarction
Thrombectomy
Mortality
Stroke
Physician volume
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 9100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ST elevation myocardial infarction who received primary percutaneous coronary intervention

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.

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

Primary outcomes:
measure: Incidence rate of all-cause mortality at 30 days
timeFrame: 30 days from the date of primary percutaneous coronary intervention
measure: Incidence rate of stroke at 30 days
timeFrame: 30 days from the date of primary percutaneous coronary intervention
measure: Incidence rate of all-cause mortality at 1 year
timeFrame: 1 year from the date of primary percutaneous coronary intervention
measure: Incidence rate of stroke at 1 year
timeFrame: 1 year from the date of primary percutaneous coronary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ying-Chang Tung
role: PRINCIPAL_INVESTIGATOR
References: