Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention
Breakdown of Unique Trials Included in the CER
Overall, 53 RCTs and 9 controlled observational studies have evaluated the impact of thrombectomy or embolic protection devices in ACS. Catheter aspiration, mechanical thrombectomy, distal filter embolic protection, distal balloon embolic protection, and proximal balloon embolic protection devices have been evaluated for at least one end point, but no studies evaluating proximal filter embolic protection devices met the inclusion and exclusion criteria. One-hundred and twenty-seven publications of RCTs, which represent 43 unique trials (n = 8,185) met the inclusion criteria for the quantitative analysis. Of these 43 unique trials, 37 were of patients with STEMI and 6 were of patients with mixed ACS. Of these 37 trials, 17 trials (n = 3,355) evaluated the impact of catheter aspiration devices, 5 trials (n = 1,374) evaluated the impact of mechanical thrombectomy devices, 5 trials (n = 962) evaluated the impact of distal filter embolic protection devices, 9 trials (n = 1,479) evaluated the impact of distal balloon embolic protection devices, and 1 trial (n = 284) evaluated the impact of proximal balloon embolic protection devices. Of the six unique trials in patients with mixed ACS, two evaluated catheter aspiration devices, one evaluated a distal filter embolic protection device, and three evaluated distal balloon embolic protection devices.
Forty-eight publications met the inclusion criteria for the qualitative synthesis. Of these publications, 38 represented 20 unique studies (n = 14,771) and 21 publications represented 18 unique systematic reviews with meta-analysis (n = 80,181). Of the 20 unique studies, 1 was an RCT evaluating thrombectomy or embolic protection devices in patients with mixed ACS, 9 studies were controlled observational studies, 2 studies were RCTs evaluating thrombectomy or embolic protection devices in patients with UA or NSTEMI, 2 studies were direct comparative RCTs, 2 studies were RCTs with selective inclusion/exclusion criteria in patients with STEMI, 1 study was an RCT with a unique comparison in patients with STEMI, 2 studies were RCTs with a unique comparison in patients with mixed ACS, and 1 study was a pooled analysis in STEMI patients.
- Sobieraj DM, White CM, Kluger J, et al. Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Comparative Effectiveness Review No. 42 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; December 2011. AHRQ Publication No. 11(12)-EHC089-EF. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.
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