Table 221Evaluation of applicability for individual randomized controlled trials evaluating catheter aspiration 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
Dudek, 2010Study Designation: Efficacy study

Composite Score: 1 of 7
Assessed final health outcomesPopulation, Intervention, Outcomes, SettingYounger population (58 y)
High male to female ratio (79-81%)
Only patients undergoing primary PCI
Short duration of followup (180 d)
Diver CE device no longer available
Adverse outcomes not reported
Small sample size (N= 196)
Use of ITT analysis not reported
Conducted in Europe
Liistro, 2009Study Designation: Efficacy study

Composite Score: 4 of 7
Enrolled primary care population
Assessed final health outcomes
Assessed adverse outcomes
Used intention to treat analysis
Population, SettingHigh male to female ratio (77-78%)
Only patients undergoing primary PCI
Short duration of followup (180 d)
Small sample size (N =111)
Conducted in Europe
Lipiecki, 2009Study Designation: Efficacy study

Composite Score: 1 of 7
Enrolled primary care populationPopulation, Outcomes, SettingYounger population (59 y)
Final health outcomes not reported
Short duration of followup (7 d)
Adverse outcomes not reported
Small sample size (N =44)
Use of ITT analysis not reported
Conducted in Europe
Moura, 2009Study Designation: Efficacy study

Composite Score: 2 of 7
Less stringent eligibility criteria
Assessed final health outcomes
Population, Intervention, Outcomes, SettingBaseline characteristics not reported
Only patients undergoing primary PCI
IRA not reported
Use of antiplatelets and antithrombotic not reported
Short duration of followup (270 d)
Device name not reported
Adverse outcomes not reported
Small sample size (N =152)
Use of ITT analysis not reported
Conducted in South America
Sardella, 2009Study Designation: Efficacy study

Composite Score: 3 of 7
Enrolled primary care population
Assessed final health outcomes
Adequate study duration with clinically relevant treatments
Population, Outcomes, SettingOnly patients undergoing primary PCI
Adverse outcomes not reported
Small sample size (N =175)
Use of ITT analysis not reported
Chao, 2008Study Designation: Efficacy study

Composite Score: 3 of 7
Enrolled primary care population
Assessed final health outcomes
Assessed adverse outcome
Population, SettingHigh male to female ratio (83.78 - 86.49%)
Only patients undergoing primary PCI
Short duration of followup (180 d)
Small sample size (N =74)
Use of ITT analysis not reported
Conducted in Asia
Chevalier, 2008Study Designation: Effectiveness study

Composite Score: 5 of 7
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Assessed adverse outcome
  4. Adequate sample size
  5. Used intention to treat analysis
Population, Setting
  • High male to female ratio (80-81%)
  • Only patients undergoing primary PCI
  • Short duration of followup (30 d)
  • Conducted in Europe and India
Ciszewski, 2008Study Designation: Efficacy study

Composite Score: 2 of 7
  1. Assessed final health outcomes
  2. Used intention to treat analysis
Population, Intervention, Outcomes, Setting
  • Only patients undergoing primary PCI
  • IRA not reported
  • Use of antiplatelets and antithrombotic not reported
  • Short duration of followup (8 d)
  • Rescue and Diver devices no longer available
  • Adverse outcomes not reported
  • Small sample size (N =135)
  • Conducted in Europe
Ikari, 2008Study Designation: Effectiveness study

Composite Score: 5 of 7
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Assessed adverse outcome
  4. Adequate sample size
  5. Used intention to treat analysis
Population, Intervention, Setting
  • High male to female ratio (77.7-80.6%)
  • Only patients undergoing primary PCI
  • Short duration of followup (240 - 720 d)
  • TVAC device is not FDA approved
  • Conducted in Asia
Svilaas, 2008Study Designation: Effectiveness study

Composite Score: 6 of 7
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Adequate study duration with clinically relevant treatments
  4. Assessed adverse outcome
  5. Adequate sample size
  6. Used intention to treat analysis
Population, Setting
  • High male to female ratio (67.9-73.1%)
  • Only patients undergoing primary PCI
  • Conducted in Europe
DeLuca, 2006Study Designation: Efficacy study

Composite Score: 2 of 7
  1. Assessed final health outcomes
  2. Assessed adverse outcome
Population, Intervention, Setting
  • High male to female ratio (55.3- 71%)
  • Only patients undergoing primary PCI
  • Majority of IRAs were LAD (97.4-100%)
  • Short duration of followup (180 d)
  • Diver CE device no longer available
  • Small sample size (N =76)
  • Use of ITT analysis not reported
  • Conducted in Europe
Kaltoft, 2006Study Designation: Effectiveness study

Composite Score: 5 of 7
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Assessed adverse outcome
  4. Adequate sample size
  5. Used intention to treat analysis
Population, Intervention, Setting
  • High male to female ratio (76- 80%)
  • Only patients undergoing primary PCI
  • Short duration of followup (30 d)
  • Rescue device no longer available
  • Conducted in Europe
Lee, 2006Study Designation: Efficacy study

Composite Score: 2 of 7
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
Population, Outcomes, Setting
  • Only patients undergoing primary PCI
  • Use of antiplatelets and antithrombotic not reported
  • Final health outcomes not reported
  • Short duration of followup (in-hospital)
  • Adverse outcomes not reported
  • Small sample size (N =133)
  • Use of ITT analysis not reported
  • Conducted in Asia
Silva-Orrego, 2006Study Designation: Efficacy study

Composite Score: 4 of 7
  1. Less stringent eligibility criteria
  2. Assessed final health outcomes
  3. Assessed adverse outcome
  4. Used intention to treat analysis
Population, Setting
  • Younger population (57.3- 58.0 y)
  • High male to female ratio (76- 84%)
  • Only patients undergoing primary PCI
  • Short duration of followup (180 d)
  • Small sample size (N =148)
  • Conducted in Europe
Burzotta, 2005Study Designation: Efficacy study

Composite Score: 4 of 7
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Assessed adverse outcome
  4. Used intention to treat analysis
Population, Intervention, Setting
  • High male to female ratio (77.6-90%)
  • Short duration of followup (30 d)
  • Diver CE device no longer available
  • Small sample size (N =99)
  • Conducted in Europe
Noel, 2005Study Designation: Efficacy study

Composite Score: 1 of 7
  1. Assessed final health outcomes
Population, Outcomes, Setting
  • Baseline characteristics not reported
  • Percentage of primary PCI versus rescue PCI not reported
  • IRA not reported
  • Use of antiplatelets and antithrombotic not reported
  • Short duration of followup (1 hr)
  • Adverse outcomes not reported
  • Small sample size (N =50)
  • Use of ITT analysis not reported
  • Conducted in Europe
Dudek, 2004Study Designation: Efficacy study

Composite Score: 1 of 7
  1. Less stringent eligibility criteria
Population, Intervention, Outcomes, Setting
  • Younger population (56.7- 59.1 y)
  • High male to female ratio (69-80%)
  • Only patients undergoing primary PCI
  • IRA not reported
  • Suboptimal use of anti-thrombotics
  • Final health outcomes not reported
  • Short duration of followup (90 d)
  • Rescue device no longer available
  • Small sample size (N =72)
  • Use of ITT analysis not reported
  • Conducted in Europe

Abbreviations: d=days; FDA=Food and Drug Administration; IRA=infarct related artery; ITT=intent to treat; LAD=left anterior descending artery; 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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