Percutaneous coronary intervention in the Occluded Artery Trial: procedural success, hazard, and outcomes over 5 years

Abstract

Background: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI failure, procedural hazard, and crossover on trial results has not been reported.

Methods: Study angiograms were analyzed and adjudicated centrally. Factors associated with PCI failure were examined. Time-to-event analysis using the OAT primary outcome was performed by PCI success status. Landmark analysis (up to and beyond 30 days) partitioned early hazard versus late outcome according to treatment received.

Results: Percutaneous coronary intervention was adjudicated successful in >87%. Percutaneous coronary intervention failure rates were similar in US and non-US sites, and did not significantly influence outcome at 60 months (hazard ratio for success vs fail 0.79, 99% CI 0.45-1.40, P = .29). Partitioning of early procedural hazard revealed no late benefit for PCI (hazard ratio for PCI success vs medical therapy alone 1.06, 99% CI 0.75-1.50, P = .66).

Conclusions: Percutaneous coronary intervention failure and complication rates in the OAT were low. Neither PCI failure nor early procedural hazard substantively influenced the primary trial results.

Figures

Figure 1

Primary OAT outcome according to PCI success or failure (fail) in PCI-assigned patients, and for reference, in MED-assigned patients treated without crossover to PCI or coronary artery bypass graft within 30 days of enrollment (MED); no significant difference in outcomes over 5 years was detected (HR succ vs fail 0.79, 99% CI 0.45–1.40, P = .29; HR succ vs MED 1.11 99% CI 0.81–1.51, P = .40).

Figure 2

Landmark analysis of the OAT primary outcome by intention-to-treat (A) from enrollment through 30 days and (B) after 30 days to 5 years.