Table 222Evaluation of applicability for individual randomized controlled trials evaluating mechanical thrombectomy devices versus control in patients with ST-segment elevation myocardial infarction

Study, YearEffectiveness Study Designation and Composite ScoreEffectiveness Study Criteria MetApplicability Limitation CategorySpecific Factors Limiting Applicability
Migliorini, 2010Study Designation: Effectiveness study

Composite Score: 5 of 7
Enrolled primary care population
Assessed final health outcomes
Adequate study duration with clinically relevant treatments
Assessed adverse outcome
Adequate sample size
PopulationHigh male to female ratio (76- 81%)
Only patients undergoing primary PCI
Use of ITT analysis not reported
Ali, 2006Study Designation: Effectiveness study

Composite Score: 5 of 7
Enrolled primary care population
Assessed final health outcomes
Assessed adverse outcome
Adequate sample size
Used intention to treat analysis
PopulationHigh male to female ratio (74.2-75.8%)
Short duration of followup (30 -180 d)
Lefèvre, 2005Study Designation: Efficacy study

Composite Score: 4 of 7
Assessed final health outcomes
Assessed adverse outcome
Adequate sample size
Used intention to treat analysis
Population, SettingHigh male to female ratio (73-76%)
Only patients undergoing primary PCI
Suboptimal use of antiplatelets
Short duration of followup (180 d)
Conducted in Europe
Antoniucci, 2004Study Designation: Efficacy study

Composite Score: 4 of 7
Enrolled primary care population
Less stringent eligibility criteria
Assessed final health outcomes
Used intention to treat analysis
Outcome, SettingHigh male to female ratio (78-82%)
Only patients undergoing primary PCI
Short duration of followup (30 d)
Adverse outcomes not reported
Small sample size (N =100)
Conducted in Europe
Napodano, 2003Study Designation: Efficacy study

Composite Score: 3 of 7
Assessed final health outcomes
Assessed adverse outcomes
Used intention to treat analysis
Population, SettingHigh male to female ratio (71.7-82.6%)
Percentage of primary PCI versus rescue PCI not reported
IRA not reported
Short duration of followup (30 d)
Small sample size (N =92)
Conducted in Europe

Abbreviations: d=days; IRA=infarct related artery; ITT=intent to treat; N=total number of patients enrolled in the study; PCI=percutaneous coronary intervention; y=years

From: Appendix H, Applicability of Individual Studies and of the Body of Evidence

Cover of Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention [Internet].
Comparative Effectiveness Reviews, No. 42.
Sobieraj DM, White CM, Kluger J, et al.

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