Table BConclusion and strength of evidence evaluations for adverse events (KQ 2)

Population: device category outcomeaNumber of studies, N (RCT, OBS)Conclusion, RR/RD (95% CI)bStrength of evidence
STEMI: Catheter aspiration devices
Coronary dissection5 (4,1)Decreases risk; RR 0.30 (0.12 to 0.75),RD -0.02 (-0.12 to 0.10)High
Prolonged procedure time9 (8,1)No effectcHigh
STEMI: Mechanical thrombectomy devices
Prolonged procedure time3 (3,0)Prolongs timecHigh
STEMI: Distal balloon embolic protection devices
Coronary perforation1 (1,0)No effect; RR 5.11 (0.53 to infinity)Low
Prolonged procedure time3 (3,0)Prolongs timecLow
Side branch occlusion2 (2,0)No effect; RR 0.93 (0.61 to 1.42)Moderate
STEMI: Proximal balloon embolic protection devices
Prolonged procedure time1 (1,0)Prolongs timecModerate
STEMI: Combined embolic protection devices
Prolonged procedure time5 (5,0)Prolongs timecModerate
Mixed ACS: Distal balloon embolic protection devices
Prolonged procedure time1 (1,0)Prolongs timecModerate
Mixed ACS: Combined embolic protection devices
Prolonged procedure time1 (1,0)Prolongs timecModerate
a

Outcomes reported are those with the longest duration of followup. Adverse events 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; OBS = observational study; RCT= randomized controlled trial; RD = risk difference; RR = relative risk; STEMI = ST-segment elevation 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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