For the critical outcome of 30-day mortality, we have identified moderate-quality evidence (downgraded for imprecision) from 5 RCTs(Kurihara 2004, E14; Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators 2006, 569-578; Thiele 2006, 1132-1139; Ellis 2008, 2205-2217; Itoh 2010, 1625-1634) enrolling 3533 patients showing no benefit when fibrinolytic administration is combined with immediate PCI versus immediate PCI alone (OR, 1.29; 95% CI, 0.96–1.74) (Figure 8).
For the critical outcome of intracranial hemorrhage, we have identified moderate-quality evidence (downgraded for imprecision) from 3 RCTs(Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators 2006, 569-578; Ellis 2008, 2205-2217; Itoh 2010, 1625-1634) enrolling 3342 patients showing harm when fibrinolytic administration is combined with immediate PCI versus immediate PCI alone (OR, 7.75; 95% CI, 1.39–43.15) (Figure 9).
For the important outcome of nonfatal myocardial infarction, we have identified low-quality evidence (downgraded for bias, inconsistency, and imprecision) from 5 RCTs(Kurihara 2004, E14; Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators 2006, 569-578; Thiele 2006, 1132-1139; Ellis 2008, 2205-2217; Itoh 2010, 1625-1634) enrolling 3498 patients showing no benefit when fibrinolytic administration is combined with immediate PCI versus immediate PCI alone (OR, 1.15; 95% CI, 0.73–1.81).
For the important outcome of target vessel revascularization, we have identified low-quality evidence (downgraded for inconsistency and imprecision) from 4 RCTs(Kurihara 2004, E14; Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators 2006, 569-578; Ellis 2008, 2205-2217; Itoh 2010, 1625-1634) enrolling 3360 patients showing no benefit when fibrinolytic administration is combined with immediate PCI versus immediate PCI alone (OR, 1.16; 95% CI, 0.91–1.47).
For the important outcome of major bleeding, we have identified high-quality evidence from 5 RCTs(Kurihara 2004, E14; Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators 2006, 569-578; Thiele 2006, 1132-1139; Ellis 2008, 2205-2217; Itoh 2010, 1625-1634) enrolling 3543 patients showing harm when fibrinolytic administration is combined with immediate PCI versus immediate PCI alone (OR, 1.52; 95% CI, 1.05–2.20).
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We recommend against the routine use of fibrinolytic administration combined with immediate* PCI, compared with immediate PCI alone in patients with STEMI (strong recommendation, moderate-quality evidence).
*In these studies, the time frame from fibrinolysis to PCI ranged from 1 to 4 hours.
Values, Preferences, and Task Force Insights
In making this recommendation, we place a higher value on avoiding harm (intracranial hemorrhage and major bleeding), given that the evidence suggests no mortality benefit for fibrinolytic administration combined with immediate PCI.
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