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

Slide: 35 of 39

Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With Mixed ACS: All Outcomes and Adverse Events

In RCTs, the use of distal balloon embolic protection devices did not impact the risk of mortality when using the maximal duration of followup. Neither trial was determined to be of higher methodological quality.

In RCTs, the use of a distal balloon embolic protection device significantly increased the risk of attaining a MBG-3 and did not impact the risk of attaining TIMI-3 blood flow. Given the risk difference for attaining MBG-3 [RD 0.51 (0.18, 0.84), (CER 0.14 to 0.37)], two people would need to be treated with a distal balloon embolic protection device in order to cause one to achieve a MBG-3. The use of a distal balloon embolic protection device also led to a significantly increased chance of resolving ST-segment elevation (one trial), significantly higher ejection fraction (one trial), and a significantly reduced risk of no reflow (one trial). No trials or studies evaluated distal embolization. For ST-segment resolution, given the risk difference [RD 0.29 (0.10, 0.50), (CER 0.50)], three people would need to be treated with a distal balloon embolic protection device to have one patient experience an ST-segment resolution. For the no reflow outcome, [RD -0.54 (-0.71, -0.31), CER 0.02 to 0.05)], two people would need to be treated with a distal balloon embolic protection device to prevent one person from experiencing no reflow.