Table AConclusion and strength of evidence evaluations for final health and intermediate outcomes (KQ 1)

Population: Device Category, OutcomeaNumber of Studies, N (RCT, OBS)Conclusion, RR/RD (95% CI) bStrength of Evidence
STEMI: Catheter aspiration devices
Mortality13 (10,3)No effect; RR 0.69 (0.47 to 1.02)Low
Myocardial infarction12 (10,2)No effect; RR 0.61 (0.36 to 1.04)Low
Target revascularization11 (9,2)No effect; RR 0.79 (0.61 to 1.02)Low
MACE13 (11,2)Decreased risk (favors device); RR 0.73 (0.61 to 0.88), RD -0.03 (-0.10 to 0.001)High
ST-segment resolution16 (15,1)Increased risk (favors device); RR 1.51 (1.32 to 1.73), RD 0.22 (0.15 to 0.30)Moderate
Ejection fraction12 (11,1)No effectcModerate
MBG-313 (13,0)Increased risk (favors device); RR 1.61 (1.41 to 1.84), RD 0.22 (0.16 to 0.28)Moderate
TIMI-315 (13,2)Increased risk (favors device); RR 1.08 (1.04 to 1.12), RD 0.06 (0.03 to 0.10)Moderate
Distal embolization11 (10,1)Decreased risk (favors device); RR 0.56 (0.39 to 0.79), RD -0.09 (-0.17 to -0.01)High
No reflow8 (8,0)Decreased risk (favors device); RR 0.52 (0.35 to 0.76), RD -0.07 (-0.11 to -0.03)High
STEMI: Mechanical thrombectomy devices
ST-segment resolution5 (5,0)No effect; RR 1.16 (0.99 to 1.36)Low
Ejection fraction2 (2,0)No effectcModerate
MBG-34 (4,0)No effect; RR 1.07 (0.80 to 1.43)Low
TIMI-35 (4,1)No effect; RR 0.98 (0.92 to 1.04)Moderate
Distal embolization3 (3,0)No effect; RR 0.44 (0.17 to 1.12)Moderate
STEMI: Distal filter embolic protection devices
Target revascularization2 (2,0)Increased risk (favors control); RR 1.61 (1.03 to 2.54), RD 0.04 (-0.0006 to 0.08)Low
MACE5 (5,0)No effect; RR 1.34 (0.97 to 1.86)Moderate
ST-segment resolution5 (5,0)No effect; RR 1.05 (0.97 to 1.15)Moderate
Ejection fraction2 (2,0)No effectcLow
MBG-32 (2,0)No effect; RR 0.97 (0.81 to 1.15)Moderate
TIMI-35 (5,0)No effect; RR 1.00 (0.90 to 1.11)Low
STEMI: Distal balloon embolic protection devices
ST-segment resolution4 (4,0)No effect; RR 1.08 (0.91 to 1.29)Moderate
Ejection fraction6 (6,0)No effectcModerate
MBG-36 (6,0)Increased risk (favors device); RR 1.39 (1.15 to 1.69), RD 0.15 (0.10 to 0.24)High
TIMI-38 (8,0)Increased risk (favors device); RR 1.11 (1.03 to 1.19), RD 0.08 (0.02 to 0.14)Low
STEMI: Combined embolic protection devices
MACE12 (11,1)No effect; RR 1.04 (0.84 to 1.29)Moderate
ST-segment resolution10 (10,0)No effect; RR 1.06 (1.00 to 1.13)Low
Ejection fraction9 (9,0)No effectcModerate
MBG-39 (9,0)Increased risk (favors device); RR 1.20 (1.02 to 1.40), RD -0.004 (-0.02 to 0.01)Moderate
TIMI-314 (14,0)Increased risk (favors device); RR 1.06 (1.01 to 1.12), RD 0.05 (0.01 to 0.10)Low
Distal embolization6 (6,0)No effect; RR 0.91 (0.64 to 1.30)Moderate
Mixed ACS: Catheter aspiration devices
MBG-31 (1,0)Increased risk (favors device); RR 4.45 (1.51 to 13.88), RD 0.30 (0.10 to 0.51)Low
Mixed ACS: Mechanical thrombectomy devices
ST-segment resolution1 (1,0)Increased risk (favors device); RR 1.58 (1.05 to 2.57), RD 0.30 (0.03 to 0.54)Moderate
Mixed ACS: Distal balloon embolic protection devices
ST-segment resolution1 (1,0)Increased risk (favors device); RR 1.58 (1.10 to 2.46), RD 0.29 (0.10 to 0.50)Moderate
MBG-32 (2,0)Increased risk (favors device); RR 3.22 (1.03 to 10.10), RD 0.51 (0.18 to 0.84)Moderate
No reflow1 (1,0)Decreased risk (favors device); RR 0.36 (0.20 to 0.59), RD -0.54 (-0.71 to -0.31)High
Mixed ACS: Combined embolic protection devices
ST-segment resolution1 (1,0)Increased risk (favors device); RR 1.58 (1.10 to 2.46), RD 0.29 (0.10 to 0.50)Moderate
MBG-32 (2,0)Increased risk (favors device); RR 3.22 (1.03 to 10.10), RD 0.51 (0.18 to 0.84)Moderate
No reflow1 (1,0)Decreased risk (favors device); RR 0.36 (0.20 to 0.59), RD -0.54 (-0.71 to -0.31)High
a

Outcomes reported are those with the longest duration of followup. Final health or intermediate outcomes graded as “insufficient” are not reported in this table but are listed in Table C.

b

Pooled RR and RD are based on data from RCTs only; observational studies were used qualitatively.

c

Based on qualitative evaluation of available data.

Note: ACS = acute coronary syndrome; CI = confidence interval; MACE = major cardiovascular adverse event; MBG = myocardial blush grade; OBS = observational study; RCT = randomized controlled trial; RD = risk difference; RR = relative risk; STEMI = ST-segment elevation myocardial infarction; TIMI = thrombolysis in myocardial infarction.

From: Executive Summary

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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