Is early angioplasty following fibrinolysis more effective than delayed or rescue angioplasty in patients with ST-segment elevation myocardial infarction?

In patients with ST-segment elevation myocardial infarction (STEMI) who are treated with fibrinolysis, early routine transfer for angiography -- within 6 hours in this study -- to centers with capability for percutaneous coronary intervention (PCI) reduced the risk of the combination of death, reinfarction, recurrent ischemia, new or worsening heart failure, or cardiogenic shock at 30 days without increasing the major bleeding risk. (LOE = 1b)

Cantor WJ, Fitchett D, Borgundvaag B, et al, for the TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Eng J Med 2009;360(26):2705-2718.  [PMID:19553646]

Randomized controlled trial (nonblinded)

Industry + govt

Concealed

Inpatient (any location)

Current guidelines for patients with STEMI recommend PCI within 90 minutes of presentation. However, many hospitals do not provide PCI services. In this nonblinded study, investigators randomized, using concealed allocation, 1059 patients with STEMI who were treated with fibrinolysis at centers that did not have the capability to perform PCI. All patients received aspirin, tenecteplase, and heparin or enoxaparin, and the majority received clopidogrel. The early PCI group was promptly transferred to a PCI center with the goal of performing angiography within 6 hours after fibrinolysis. The standard therapy group remained at the presenting hospital for at least 24 hours and was referred for elective angiography and PCI within 2 weeks, or more urgently if there was evidence of reinfarction. The 2 groups were balanced, except for a higher prevalence of previous stroke or transient ischemic attack in the study group and a higher prevalence of previous congestive heart failure in the control group. The analysis was by intention-to-treat with more than 99% completed follow-up at 30 days in both groups. PCI was performed in 67.4% of the standard therapy group at a median of 21.9 hours and in 84.9% of the early PCI group at a median of 3.2 hours. Although patients and clinicians were not masked, all nonfatal outcomes were assessed by a committee masked to the treatment received. Early routine PCI following fibrinolysis reduced the primary outcome of the combination of death, reinfarction, recurrent ischemia, new or worsening heart failure, or cardiogenic shock at 30 days (relative risk (RR) = 0.64; 95% CI, 0.47-0.87; number needed to treat [NNT] = 16; 11-45). Individual end points showed a benefit of routine early PCI in the case of recurrent ischemia (RR = 0.09; 0.01-0.68) and new or worsening heart failure (RR = 0.54; 0.30-0.98). One patient in the standard therapy group who was being transferred for rescue PCI died during the transfer process. There were no other deaths during transfer. There were no significant differences between the 2 groups in the rates of major bleeding, or in death or reinfarction at 6 months.