Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis

Completed

• Conditions: Acute Coronary Syndromes; Myocardial Infarction
• Interventions: Device: Manual Aspiration Thrombectomy

• Registration Number: NCT02552407
• Lead Sponsor: Population Health Research Institute

Brief Summary

During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.

Detailed Description

An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-17
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18000

Inclusion Criteria

• Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015.
• Large trials randomizing more than 1000 patients.
• Trials must have had at least 30 day follow up.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Manual Aspiration Thrombectomy with PCI	Manual Aspiration Thrombectomy	Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to Manual Aspiration Thrombectomy followed by percutaneous coronary intervention (PCI).

Primary Outcome Measures

Name	Time	Method
Occurrence of Cardiovascular death	up to 30 days	time to event analysis

Secondary Outcome Measures

Name	Time	Method
Occurrence of Cardiovascular death	up to 180 days	time to event analysis