Selective Aspiration Thrombectomy in STEMI

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Aspiration thrombectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspiration thrombectomy<br>In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). | Device: Aspiration thrombectomy<br>* In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.<br>* Other names: Percutaneous coronary intervention;|
| PCI alone<br>In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of all-cause mortality at 30 days | The total number of death during the follow-up period divided by the person-months at risk | 30 days from the date of primary percutaneous coronary intervention | 
| Incidence rate of stroke at 30 days | The total number of stroke events during the follow-up period divided by the person-months at risk | 30 days from the date of primary percutaneous coronary intervention | 
| Incidence rate of all-cause mortality at 1 year | The total number of death during the follow-up period divided by the person-months at risk | 1 year from the date of primary percutaneous coronary intervention | 
| Incidence rate of stroke at 1 year | The total number of stroke events during the follow-up period divided by the person-months at risk | 1 year from the date of primary percutaneous coronary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation myocardial infarction, Thrombectomy, Mortality, Stroke, Physician volume