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Completed

NCT Number: NCT03841487

Selective Aspiration Thrombectomy in STEMI

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspiration thrombectomy

Device

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.

Other names: Percutaneous coronary intervention

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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