Selective Aspiration Thrombectomy in STEMI

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.

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: Aspiration thrombectomy

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.

• Study Type: Observational
• Enrollment (Actual): 9100

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ST elevation myocardial infarction who received primary percutaneous coronary intervention

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: 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.; Other Names: Percutaneous coronary intervention
PCI alone; In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ying-Chang Tung, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Mortality; ST-elevation myocardial infarction; Physician volume
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: CMRPG3E1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is encrypted and is not allowed to share based on the regulations of the National Health Insurance Research Database of Taiwan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No