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

Slide: 22 of 39

Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With STEMI: Intermediate Health Outcomes

In RCTs evaluating patients with STEMI undergoing PCI and comparing a catheter aspiration thrombectomy device versus a control, the use of catheter aspiration devices significantly increased the occurrence of ST-segment resolution and achieved a MBG-3 and TIMI-3 blood flow while significantly reducing the risk of distal embolization and the occurrence of no reflow versus a control. For ST-segment resolution [RD 0.22 (0.15, 0.30), (CER 0.11 to 0.65)], five people would need to be treated with a catheter aspiration device to allow one person to experience ST-segment resolution. For MBG-3 [RD 0.22 (0.16, 0.28), (CER 0.12 to 0.71)], five people would need to receive the catheter aspiration device to cause one person to experience a MBG-3. For TIMI-3 blood flow [RD 0.06 (0.03, 0.10), (CER 0.68 to 0.88)], 17 people would need to be treated with a catheter aspiration device to cause 1 person to achieve TIMI-3 blood flow. For a decreased risk of distal embolization [RD -0.09 (-0.17, -0.01), (CER 0.03 to 0.66)], 12 people would need to be treated with a catheter aspiration device to prevent 1 person from experiencing distal embolization. In RCTs, ejection fraction was not significantly impacted by catheter aspiration use versus a control in most trials (9 of 11), while one controlled observational study found a decreased ejection fraction in the catheter aspiration group versus a control. For the no-reflow outcome [RD -0.07 (-0.11, -0.03), (CER 0.05 to 0.27)], 15 people would need to be treated with a catheter aspiration device in order to prevent 1 no reflow event from occurring.

Two direct comparative randomized trials compared the use of catheter aspiration devices to distal balloon embolic protection devices in patients undergoing STEMI. In these RCTs, no significant differences were found between groups for ST-segment resolution (one trial), ejection fraction (two trials), MBG-3 (one trial), TIMI-3 blood flow (one trial), or no reflow (one trial) with insufficient data for other intermediate end points. One direct comparative randomized trial compared the use of one catheter aspiration device to another catheter aspiration device in patients with STEMI. In this controlled trial, no significant differences in ST-segment resolution, MBG-3, or TIMI- 3 blood flow occurred with insufficient data for other intermediate end points.