Reinfarction after percutaneous coronary intervention or medical management using the universal definition in patients with total occlusion after myocardial infarction: Results from long-term follow-up of the Occluded Artery Trial (OAT) cohort

doi:10.1016/j.ahj.2012.01.016

American Heart Journal

Volume 163, Issue 4, April 2012, Pages 563-571

https://doi.org/10.1016/j.ahj.2012.01.016 Get rights and content

Background

The OAT study randomized 2,201 patients with a totally occluded infarct-related artery on days 3 to 28 (>24 hours) after myocardial infarction (MI) to percutaneous coronary intervention (PCI) or medical treatment (MED). There was no difference in the primary end point of death, reinfarction, or heart failure at 2.9 or 6-year mean follow-up. However, in patients randomized to PCI, there was a trend toward a higher rate of reinfarction.

Methods

We analyzed the characteristics and types of reinfarction according to the universal definition. Independent predictors of reinfarction were determined using Cox proportional hazard models with follow-up up to 9 years.

Results

There were 169 reinfarctions: 9.4% PCI vs 8.0% MED, hazard ratio 1.31, 95% CI 0.97-1.77, P = .08. Spontaneous reinfarction (type 1) occurred with similar frequency in the groups: 4.9% PCI vs 6.7% MED, hazard ratio 0.78, 95% CI 0.53-1.15, P = .21. Rates of type 2 (secondary) and 3 (sudden death) MI were similar in both groups. There was an increase in type 4a reinfarctions (related to protocol or other PCI) (0.8% PCI vs 0.1% MED, P = .01) and type 4b reinfarctions (stent thrombosis) (2.7% PCI vs 0.6% MED, P < .001).

Multivariate predictors of reinfarction were history of PCI before study entry (P = .001), diabetes (P = .005), and absence of new Q waves with the index infarction (P = .01).

Conclusions

There was a trend for reinfarctions to be more frequent with PCI. Opening an occluded infarct-related artery in stable patients with late post-MI may expose them to a risk of subsequent reinfarction related to reocclusion and stent thrombosis.

Section snippets

Patient population

The design of the OAT study has been described in detail.3, 5 In summary, between February 2000 and June 2006, 2,201 patients were enrolled. Eligible patients had a totally occluded IRA on angiography on calendar days 3 to 28 (>24 hours) after MI, met an additional high-risk criterion (ejection fraction <50% or proximal occlusion), and were clinically stable. Exclusion criteria included NYHA class III or IV heart failure, shock, serum creatinine >2.5 mg/dL (221 μmol/L), significant left main or

Results

Review of all suspected reinfarctions submitted by sites resulted in an additional 29 events according to the universal definition that were not confirmed by the Mortality and Morbidity Classification Committee (MMCC) because they did not meet the OAT criteria defined in the original protocol (Figure 1; Table I). Of these 29 events, 9 were classified as spontaneous MI, 4 as secondary, 10 as sudden death, 4 as PCI related, 1 as stent related, and 1 as CABG related.

There were 169 reinfarctions

Discussion

In this trial of 2,201 stable patients with occluded IRAs treated medically or with PCI in the subacute-phase post-MI, we found a low rate of reinfarction that continued to accrue over 9 years of follow-up. The low rates of reinfarction illustrate the stable ischemic substrate of these patients when treated with the current medical therapy. There was a trend for more reinfarctions in patients randomized to PCI (P = .08). The reinfarctions in the PCI group were similar to those in the MED group

Conclusions

In the OAT trial, there was an ongoing low rate of reinfarction at 9 years of follow-up. Reinfarction tended to occur at a higher rate in patients randomized to PCI. Most reinfarctions were spontaneous (type 1), which occurred at a similar frequency in both randomized treatment groups. However, in the PCI group, there were more type 4a (both protocol PCI-related and other PCI-related reinfarctions) and type 4b (stent thrombosis) reinfarctions. The reinfarctions were clinically significant, with

Disclosures

Conflict of interest statement: Drs White, Reynolds, Carvalho, Liu, Martin, Pearte, Knatterud, Kruk, Cantor, Menon, and Hochman report having no conflict of interest. Dr Dzavik received consulting fees from Cordis (a Johnson & Johnson company) and Boston Scientific, speaking fees, and grant support from Cordis and Abbott Vascular. Dr Steg received consulting and speaking fees from Merck and honoraria from Schering-Plough. Dr Lamas received speaking fees from Medtronic and Guidant and consulting

Acknowledgements

We would like to thank the patients in the OAT trial, the investigators, and coordinators who enrolled and followed up the patients, Charlene Nell for secretarial assistance, and Sharon Fick for coordinating the review committee.

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29 events were identified by the universal definition but not by the OAT study definition. The 7-year reinfarction event rate by the OAT definition was 7.4% (PCI vs. MED HR = 1.20, 95% CI 0.86–1.67, p = 0.27) and by the universal definition was 8.7% (PCI vs. MED HR = 1.31, 95% CI 0.97–1.77, p = 0.08) [3,5]. Details of baseline and angiographic characteristics of patients with and without reinfarction are presented in Table 1a for patients who died and in Table 1b for patients who survived the follow-up period, respectively.
The Occluded Artery Trial (OAT) randomized stable patients (n = 2201) > 24 h (calendar days 3–28) after myocardial infarction (MI) with totally occluded infarct-related arteries (IRA), to percutaneous coronary intervention (PCI) with optimal medical therapy, or optimal medical therapy alone (MED). PCI had no impact on the composite of death, reinfarction, or class IV heart failure over extended follow-up of up to 9 years. We evaluated the impact of early and late reinfarction and definition of MI on subsequent mortality.
Reinfarction was adjudicated according to an adaptation of the 2007 universal definition of MI and the OAT definition (≥ 2 of the following — symptoms, EKG and biomarkers). Cox regression models were used to analyze the effect of post-randomization reinfarction and baseline variables on time to death.
After adjustment for baseline characteristics the 169 (PCI: n = 95; MED: n = 74) patients who developed reinfarction by the universal definition had a 4.15-fold (95% CI 3.03–5.69, p < 0.001) increased risk of death compared to patients without reinfarction. This risk was similar for both treatment groups (interaction p = 0.26) and when MI was defined by the stricter OAT criteria. Reinfarctions occurring within 6 months of randomization had similar impact on mortality as reinfarctions occurring later, and the impact of reinfarction due to the same IRA and a different epicardial vessel was similar.
For stable post-MI patients with totally occluded infarct arteries, reinfarction significantly independently increased the risk of death regardless of the initial management strategy (PCI vs. MED), reinfarction definition, location and early or late occurrence.

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Clinical InvestigationAcute Ischemic Heart DiseaseReinfarction after percutaneous coronary intervention or medical management using the universal definition in patients with total occlusion after myocardial infarction: Results from long-term follow-up of the Occluded Artery Trial (OAT) cohort

Background

Methods

Results

Conclusions

Section snippets

Patient population

Results

Discussion

Conclusions

Disclosures

Acknowledgements

Am Heart J

Am Heart J

Coronary intervention for persistent occlusion after myocardial infarction

N Engl J Med

Long-term effects of percutaneous coronary intervention of the totally occluded infarct-related artery in the subacute phase after myocardial infarction

Circulation

Universal definition of myocardial infarction

Circulation

Persistent lack of benefit of late revascularization of the occluded coronary artery post-MI—the Occluded Artery Trial (OAT) long term results

Circulation

Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation

N Engl J Med

Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial

JAMA

Clinical end points in coronary stent trials: a case for standardized definitions

Circulation

Nonparametric estimation from incomplete observation

J Am Stat Assoc

Clinical Investigation
Acute Ischemic Heart Disease
Reinfarction after percutaneous coronary intervention or medical management using the universal definition in patients with total occlusion after myocardial infarction: Results from long-term follow-up of the Occluded Artery Trial (OAT) cohort