Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction - RACES-MI

Aug 25, 2014
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
San Giuseppe Moscati Hospital
Date Published:
01/01/2014
Date Updated:
08/25/2014
Original Posted Date:
08/25/2014
References

Description:

Patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) were randomized to receive either everolimus-eluting stents (EES) or sirolimus-eluting stents (SES).

Hypothesis:

EES would be superior to SES among STEMI patients undergoing PPCI.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • All STEMI patients eligible for PPCI 
    -  Chest pain for more than 30 minutes 
    - ST-segment elevation of ≥1 mm in ≥ contiguous electrocardiograph leads or with presumably new left bundle branch block


    Number of enrollees: 500
    Duration of follow-up: 3 years
    Mean patient age: 59 years
    Percentage female: 35%
    Ejection fraction: 47.5%

Exclusions:

  • Active internal bleeding or a history of bleeding diathesis within the previous 30 days
  • Contraindication to dual antiplatelet therapy for 12 months
  • Known allergy to sirolimus or everolimus
  • A history of stroke within 30 days or any history of hemorrhagic stroke
  • History, symptoms, or findings suggestive of aortic dissection
  • Pregnancy

Primary Endpoints:

  • MACE (cardiac death, TVR, reinfarction) at 3 years

Secondary Endpoints:

  • Cardiac death, reinfarction, TVR, and definite/probable stent thrombosis

Drug/Procedures Used:

Open-label randomization was performed in a 1:1 fashion to EES (Xience V, Abbott Vascular) or SES (Cypher, Johnson & Johnson).

Concomitant Medications:

All patients received 70 U/kg intravenous bolus of unfractionated heparin, aspirin intravenously (500 mg), and clopidogrel (600 mg loading dose). Post-interventional antiplatelet therapy for all patients consisted of aspirin (100 mg/day) indefinitely and clopidogrel (75 mg daily recommended for 12 months); intraprocedural glycoprotein IIb/IIIa inhibitors 48%.

Principal Findings:

A total of 500 patients were randomized at a single center, 250 to EES and 250 to SES. Baseline characteristics were fairly similar between the two arms. Approximately 26% had diabetes, 13% had prior MI, and 7% prior coronary artery bypass grafting. Anterior MI was observed in 43%, with the target infarct-related artery being the left anterior descending in 43%, right coronary artery in 33%, left circumflex in 18%, left main trunk in 3%, and saphenous vein graft in 1%. Preprocedure TIMI flow was 0 or 1 in two-thirds of the patients. Aspiration thrombectomy was performed in 22% of patients. Mean door-to-balloon time was 45 minutes, and ischemic time was 180 minutes.

Over 3 years of follow-up (mean 1,095 days), there was no difference in the primary major adverse cardiac events (MACE) endpoint between the EES and SES arms (16% vs. 20.8%, hazard ratio 0.75, 95% confidence interval 0.5-1.13, p = 0.17). Cardiac death (4.4% vs. 5.6%, p = 0.53), recurrent MI (6.4% vs. 10%, p = 0.13), and target vessel revascularization (TVR) (4.8% vs. 4.8%, p = 0.99) were similar, whereas stent thrombosis rates were lower in the EES arm (1.6% vs. 5.2%, p = 0.035). This included subacute (0.4% vs. 1.6%), late (0.8% vs. 2%), and very late (0.4% vs. 2%) stent thrombosis events.

Interpretation:

The results of this trial indicate that MACE, TVR, and recurrent MI rates are similar between Xience V EES and SES when used during PPCI for patients presenting with STEMI. Stent thrombosis rates were, however, significantly lower in patients receiving EES. Similar low rates with EES after PPCI were observed in the EXAMINATION and XAMI trials.

This trial establishes the safety of using EES in patients with STEMI undergoing PPCI. Practically though, several operators prefer bare-metal stents in this situation due to lack of adequate insight into patient compliance, bleeding risk, upcoming surgeries, etc.

References:

Di Lorenzo E, Sauro R, Varricchio A, et al. Randomized Comparison of Everolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With ST Elevation Myocardial Infarction: RACES-MI Trial. JACC Cardiovasc Interv 2014;7:849-56.

Keywords: Myocardial Infarction, Follow-Up Studies, Sirolimus, Percutaneous Coronary Intervention, Stents, Thrombectomy, Thrombosis, Saphenous Vein, Coronary Vessels, Confidence Intervals, Coronary Artery Bypass, Diabetes Mellitus, Patient Compliance


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