ASSENT-4 PCI: should facilitated percutaneous coronary intervention be used in clinical practice?

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Abstract

BACKGROUND

In clinical practice, the goal of 90 min or less between patient presentation and percutaneous coronary intervention (PCI) is frequently not realized. Pretreatment with fibrinolytics, glycoprotein IIb/IIIa inhibitors, or both before PCI could counteract the delay in reperfusion and, therefore, benefit patients.

OBJECTIVE

To compare tenecteplase-facilitated PCI with primary PCI in terms of patient outcomes.

DESIGN

The international Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) trial enrolled patients between 10 November 2003 and 22 April 2005. Patients had to present with ST-segment elevation myocardial infarction (ST-segment elevation of ≥0.6 mV across multiple leads; ST-segment elevation of ≥0.1 mV with new-onset left-bundle-branch block; or for patients with inferior infarction, ST-segment deviations of ≥0.6 mV if ST-segment elevations of ≥0.4 mV were seen in leads II and III, and ventricular fibrillation), within 6 h of symptom onset. Patients were excluded if they were not expected to arrive at the catheterization laboratory within 1-3 h after symptom onset.

INTERVENTION

Patients were randomly assigned a weight-adjusted tenecteplase bolus before PCI or standard primary PCI. All patients in the facilitated-PCI group received a 60 U/kg bolus of heparin (maximum 4,000 U/kg; activated clotting time 350-400 s) and patients in the primary PCI group received 70 U/kg (no maximum dose; activated clotting time 300-350 s). All patients were given 150-325 mg aspirin; however, only patients in the primary PCI group could receive glycoprotein IIb/IIIa inhibition. Patients' Thrombolysis in Myocardial Infarction (TIMI) flow grade was assessed before and after intervention. All analyses were done on the basis of intention to treat.

OUTCOME MEASURE

The primary endpoint was shock, congestive heart failure and death in the 90 days after intervention.

RESULTS

Of the patients who completed follow-up 823 received facilitated PCI and 831 received primary PCI. After 1,667 of the 4,000 planned patients had been enrolled, trial enrollment was stopped because of safety concerns; significantly more patients in the facilitated PCI group developed congestive heart failure or shock, or died within 90 days than patients who received primary PCI (151 [18.6%] versus 110 [13.4%]; relative risk 1.39, 95% CI 1.11-1.74; P=0.0045). Furthermore, there were more deaths with facilitated than standard PCI within 90 days follow-up (55 [6.7%] versus 41 [4.9%], respectively; relative risk 1.35, 95% CI 0.91-2.01; P=0.1187). There was no significant difference in the incidence of major noncerebral bleeding events and blood transfusions between the two treatment groups; however, there were significantly more strokes (15 versus 0, P<0.0001) and ischemic cardiac complications with facilitated PCI.

CONCLUSIONS

The authors advise that facilitated PCI with full-dose fibrinolytic therapy should not be used in routine practice.

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