Study Summary

The COMPLETE trial investigated whether revascularization of nonculprit lesions in patients with STEMI provides additional benefit beyond PCI for culprit lesions. Patients with STEMI and multivessel CAD who had undergone successful culprit lesion PCI were randomly assigned to complete revascularization of appropriate nonculprit lesions (>70% stenosis or fractional flow reserve <0.80; n = 2,016) or to guideline-directed medical therapy (n = 2,025). PCI of chronic total occlusions (CTO) was recommended only when likelihood of success was high and only by experienced operators. The median follow-up period was 3 years. Complete revascularization reduced the incidence of the composite endpoint (cardiovascular death and MI) compared with medical therapy (7.8% versus 10.5%; P = 0.004). The risk of a composite of cardiovascular death, MI, and ischemia-driven revascularization was also reduced among patients who underwent complete revascularization (8.9% versus 16.7%; P <0.001). There was no significant difference between the groups in the incidence of stroke, major bleeding, or contrast-associated kidney injury.


Study Strengths: The strengths of the COMPLETE trial include its large size, diverse recruitment, hard outcomes, pragmatic treatment arms (the complete revascularization strategy allowed clinical judgment about the timing of staged PCI and the use of CTO PCI), minimal crossover (4.3%), intention-to-treat analysis, and long-term follow-up.

Study Limitations: COMPLETE was not a trial of immediate multivessel PCI. No patients with cardiogenic shock were enrolled, prohibiting the application of findings to this group. Disease complexity was low (average residual SYNTAX score after primary PCI = 7), and >75% of patients had only one residual diseased vessel. The trial was unblinded, and the observed benefits may be confounded by differences in subsequent medical management.

Next Steps/Clinical Perspectives: The findings provide strong evidence that routine staged PCI for nonculprit lesions after successful primary PCI reduces subsequent risk of MACE (particularly nonfatal MI and ischemia-driven revascularization). More work is required to determine optimal management of patients with complex disease or hemodynamic instability.

Trial Reference

Mehta  SR, Wood  DA, Storey  RF, et al. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N. Engl. J. Med. doi: 10.1056/NEJMoa1907775.