"Percutaneous Coronary Intervention in Stable Patients with Occluded Infarct-Related Artery". The New England Journal of Medicine. 2006.

Clinical Question

In stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified days after myocardial infarction, does percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduce the risk of subsequent events?

Bottom Line

In stable patients with occluded infarct-related artery days after myocardial infarction, PCI did not reduce the occurrence of death, reinfarction, or heart failure compared to optimal medical therapy alone.

Major Points

Guidelines

Current guidelines do not recommend routine PCI for stable patients with occluded infarct-related artery beyond the period of expected myocardial salvage.

Design

Randomized, controlled trial with 2166 stable patients enrolled between February 2000 and December 2005. Participants were divided into two groups: 1082 assigned to routine PCI plus optimal medical therapy and 1084 to optimal medical therapy alone.

Population

Inclusion Criteria:
- Total occlusion of infarct-related artery identified 3 to 28 days after myocardial infarction
- Ejection fraction <50% or proximal occlusion

Exclusion Criteria:
- NYHA class III or IV heart failure, shock, serum creatinine >2.5 mg/dL, significant left main or three-vessel coronary artery disease, rest angina, severe ischemia on stress testing

Interventions

Participants received either PCI with stenting and optimal medical therapy or optimal medical therapy alone.

Outcomes

Primary Outcomes:
- Composite of death, myocardial reinfarction, or NYHA class IV heart failure
- 4-year cumulative primary event rate was 17.2% (PCI group) and 15.6% (medical therapy group), not statistically significant

Secondary Outcomes:
- Similar rates of nonfatal reinfarction and NYHA class IV heart failure in both groups
- No interaction observed between treatment effect and any subgroup variable

Criticisms

- Trend towards excess nonfatal reinfarctions in the PCI group raised concerns
- Studies reflecting current PCI practice and use of drug-eluting stents were not performed
- Limitations in the data on thienopyridine use and long-term impact on left ventricular remodeling

Funding

Grants from the National Heart, Lung, and Blood Institute (NHLBI) and various in-kind and monetary support from the pharmaceutical and medical device industry.

Further Reading

ClinicalTrials.gov number NCT00004562. Additional results can be read in the full text of the study available at www.nejm.org.