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Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

Slide: 17 of 39

CER Outcomes of Interest for Studies on Adjunctive Devices for Patients With ACS Undergoing PCI on Native Vessels

For each outcome, separate analyses were conducted of studies that compared each individual adjunctive device type (e.g., catheter aspiration, mechanical thrombectomy, distal filter embolic protection, distal balloon embolic protection, proximal balloon embolic protection) with control and studies in which different adjunctive device types were compared with each other. Separate analyses were conducted for studies that enrolled patients experiencing only STEMI, studies that enrolled patients experiencing NSTEMI or UA, and studies that enrolled patients with mixed ACS (STEMI or NSTEMI or UA). Meta-analyses were conducted when two or more RCTs that were adequate for data pooling were available for any outcome. Observational studies were not pooled with RCTs and were assessed in a qualitative fashion only. For intermediate outcomes depicting the extent of myocardial reperfusion (MBG, TIMI blood flow, and ST-segment resolution), attainment of optimal myocardial reperfusion was defined as a MBG-3 or TIMI-3 blood flow (or a MBG or TIMI blood flow of at least two in studies not reporting the other end point) and complete ST-segment resolution as 70 percent resolution in peak ST-segments (or at least 50 percent resolution in studies not reporting the other end point). When possible, results for ST-segment resolution reported at 60 minutes were used, although when unavailable, data reported immediately after the procedure or up to 90 minutes after were utilized. For studies with multiple time points, the time closest to 60 minutes was used. For final health outcomes, the maximum duration of followup (defined as the longest time point from the procedure where the occurrence of a final health outcome is reported) was used as the base case analysis.