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Delayed PCI Versus Fibrinolysis Stratified by Time From Symptoms

Question Type:
Intervention
Full Question:
Among patients with STEMI stratified by time from symptom onset to presentation when fibrinolysis is readily available  (P), does does delayed PCI  (I), compared with compared with fibrinolysis  (C), change medium term mortality (30 day), reinfarction, long term mortality (6-60 months), major bleeding, Intracranial Hemorrhage (O)?
Consensus on Science:
In STEMI Patients Presenting Less Than 2 Hours After Symptom Onset in Whom Immediate PPCI Will Delay Treatment 60 to 160 Minutes Compared With Fibrinolysis For the critical outcome of 30-day mortality, we have identified low-quality evidence (downgraded for indirectness and imprecision) from a combined analysis of 2 RCTs(Westerhout 2011, 283-290) enrolling 646 patients showing greater harm with delayed PPCI compared with fibrinolysis (OR, 2.6; 95% CI, 1.2–5.64). For the critical outcome of 5-year mortality, we have identified low-quality evidence (downgraded for indirectness and imprecision) from 1 RCT(Bonnefoy 2009, 1598-1606) enrolling 449 patients showing greater harm with delayed PPCI compared with fibrinolysis (OR, 2.03; 95% CI, 1.1–4.08). For the important outcome of reinfarction, we have identified low-quality evidence (downgraded for indirectness and imprecision) from a combined analysis of 2 RCTs(Westerhout 2011, 283-290) enrolling 657 patients showing no difference between delayed PPCI compared with fibrinolysis (OR, 0.43; 95% CI, 0.17–1.1). For the important outcome of severe bleeding we have identified low-quality evidence (downgraded for indirectness and imprecision) from 1 RCT(Steg 2003, 2851-2856) enrolling 455 patients showing no difference in delayed PPCI compared with fibrinolysis (OR, 0.33; 95% CI, 0.01–8.15). In STEMI Patients Presenting 2 to 6 Hours After Symptom Onset in Whom PPCI Will Delay Treatment 60 to 160 Minutes Compared With Fibrinolysis For the critical outcome of 30-day mortality, we have identified low-quality evidence (downgraded for indirectness and imprecision) from a combined analysis of 2 RCTs(Westerhout 2011, 283-290) enrolling 508 patients showing no benefit of delayed PPCI over fibrinolysis (1-year mortality OR, 0.85; 95% CI, 0.42–1.74). For the critical outcome of 5-year mortality, we have found low-quality evidence (downgraded for indirectness and imprecision) from 1 RCT(Bonnefoy 2009, 1598-1606) enrolling 367 patients showing no benefit of fibrinolysis over delayed PPCI (OR, 0.99; 95% CI, 0.55–1.77). For the important outcome of reinfarction, we have identified low-quality evidence (downgraded for indirectness and imprecision) from a combined analysis of 2 RCTs(Westerhout 2011, 283-290) enrolling 511 patients showing no difference (OR, 0.4; 95% CI, 0.13–1.22). For the important outcome of severe bleeding, we have identified low-quality evidence (downgraded for indirectness and imprecision) from 1 RCT(Steg 2003, 2851-2856) enrolling 375 patients showing greater harm from delayed PPCI compared with fibrinolysis (OR, 8.18; 95% CI, 1.01–66.04). In STEMI Patients Presenting 3 to 12 Hours After Symptom Onset in Whom PPCI Will Delay Treatment 60 to 140 Minutes Compared With Fibrinolysis For the critical outcome of 30-day mortality, we have identified very-low-quality evidence (downgraded for bias, indirectness, and imprecision) from 1 RCT(Widimsky 2003, 94-104) enrolling 295 patients showing benefit of delayed PPCI (mean fibrinolysis-to-balloon delay of 85 ± 28 minutes) over immediate fibrinolysis (OR, 0.35; 95% CI, 0.16–0.79). Other Analyses A reanalysis of the raw data from 16 RCTs comparing 30-day mortality between fibrin-specific fibrinolysis and PPCI(Tarantini 2010, 676-683) has suggested that the acceptable fibrinolysis to PPCI delay varies depending on the patient’s baseline risk and presentation delay (low-quality evidence, downgraded for inconsistency and indirectness). Patients with higher risk including Killip class >1, may benefit from PPCI even when there are treatment delays up to 120 minutes. The acceptable delay may range from 35 minutes when the risk is low (4%) through to greater than 5 hours for high risk (18%). A pragmatic simplification of the formula derived in the analysis has been suggested in the associated editorial: Patients over 65 years of age, and all patients in Killip class greater than 1, should be treated with PPCI.(Widimsky 2010, 634-636) Patients less than 65 years of age in Killip class 1 should have PPCI unless delay is greater than 35 minutes. Two observational studies(Pinto 2006, 2019-2025; Pinto 2011, 2512-2521) used propensity-matched analysis of the National Registry of Myocardial Infarction registry, so they were not included in the original search strategy of RCTs only. The findings suggest an upper time limit for delay of 120 minutes overall.
Treatment Recommendation:
In patients with STEMI presenting less than 2 hours after symptom onset, when PPCI will result in a delay of greater than 60 minutes, we suggest fibrinolysis in comparison with PPCI (weak recommendation, low-quality evidence). In patients with STEMI presenting 2 to 3 hours after symptom onset, when PPCI will result in a delay of 60 to 120 minutes, we suggest either fibrinolysis or PPCI (weak recommendation, low-quality evidence). In patients with STEMI presenting 3 to 12 hours after symptom onset, when PPCI will result in a delay of up to 120 minutes, we suggest PPCI in comparison with fibrinolysis (weak recommendation, very-low-quality evidence). The evidence does not differentiate the late presenters with long delays to PCI. It is acknowledged that fibrinolysis becomes significantly less effective more than 6 hours after symptom onset and, thus, a PPCI may be the ideal option in patients more than 6 hours after symptom onset, even if this can only be accomplished with a long delay to PPCI (eg, more than 120 minutes). When long delays to PPCI are anticipated (more than 120 minutes), a strategy of immediate fibrinolysis followed by routine early (within 3–24 hours) angiography and PCI, if indicated, is reasonable (ACS 334). Values, Preferences, and Task Force Insights In making this recommendation, we place a high priority on the evidence of mortality benefit; however, we acknowledge that geographic and resource factors may limit the availability of PPCI.
CoSTR Attachments:
337 AMSTAR delayed PPCI.pdf    
337 Bias delayed PPCI_n.xlsx    
337 Bias Tarantini RCTs.xlsx    
337 Data Col Delayed PPCI.xls    
337 SOF greater 2hr.Dallas.docx    
337 SOF greater 3hr.docx    
337 SOF less 2hr Dallas.docx    
337 SOF less 3hr.docx    
AMSTAR Tarantini 2010 676.pdf    

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