Selective Aspiration Thrombectomy in STEMI

NCT ID: NCT03841487

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Aspiration thrombectomy

In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI).

Aspiration thrombectomy

Intervention Type: 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.

PCI alone

In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.

No interventions assigned to this group

Interventions

Aspiration thrombectomy

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.

Intervention Type: DEVICE

Other Intervention Names

Percutaneous coronary intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying-Chang Tung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying-Chang Tung

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CMRPG3E1051

Identifier Type: -

Identifier Source: org_study_id