Trial of everolimus-eluting stents or bypass surgery of coronary disease

Mi Jin Kim, PharmD Candidate 2015, Mercer University College of Pharmacy

Coronary artery bypass graft (CABG) surgery is one of the most frequently performed surgical procedures in the United States1. According to clinical trials, CABG led to lower rates of most adverse clinical outcomes for patients with coronary artery disease (CAD) than percutaneous coronary intervention (PCI) did2. However, these trials were limited by the use of first-generation drug- eluting stents. Recent other studies supported that second-generation drug eluting stents have improved outcomes with PCI significantly3. A recently published study compared the safety of PCI using everolimus-eluting stents with one of CABG.

Title: Trial of everolimus-eluting stents or bypass surgery for coronary disease
Design Randomized, prospective, open-label, 1776 patients
Objective Compare the outcomes in patients with multivessel coronary artery disease who have undergone percutaneous coronary intervention (PCI) with the use of everolimus-eluting stents with the outcomes in those who have undergone coronary-artery bypass grafting(CABG)
Study Groups PCI groups vs. CABG group
Methods A total of 435 patients were randomly assigned to the PCI and 442 were assigned to the CABG group.
Duration Randomization occurred from July 2008 through September 2013 and participants were followed for a median of 4.6 years.
Primary Outcome Measure Composite of death, myocardial infarction (MI) or target-vessel revascularization at 2 years after randomization
Baseline Characteristics PCI group- age 64, male 69.4%, previous MI 25%, previous PCI 6.8%

CABG group- age 64.9, male 73.5%, previous MI 29%, previous PCI 8.6%

Results The primary composite end point had occurred in 11% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; p= 0.32 for noninferiority).
Adverse Events Common Adverse Events: not reported
Serious Adverse Events:

PCI group- death 6.6%, stroke 2.5%, MI 4.8%, major bleeding 6.8%

CABG group- death 5.0%, stroke 2.9%, MI 2.7%, major bleeding 29.9%

Percentage that Discontinued due to Adverse Events: not reported
Study Author Conclusions Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG.

This study suggests that PCI with the use of everolimus-eluting stents was not noninferior to CABG in terms of major adverse cardiovascular events at 2 years. The result of this study supports that CABG could lead to lower rates of most adverse clinical outcomes for patients with coronary artery disease (CAD) than percutaneous coronary intervention (PCI) did.  However, this trial focused on the Asian population, so this factor could affect the generalizability of the findings. Further investigation with other ethnic groups would help to create more accurate representation. Similar results from other samples would confirm this finding.

References:

  1. Wilson CT, Fisher ES, Welch HG, Siewers AE, Lucas FL. U.S. Trends In CABG Hospital Volume: The Effect Of Adding Cardiac Surgery Programs. Health Affairs. 2007; 26 (1); 162-168.
  2. Serruys PW, Morice MC, Kappetein AP, et al. Percutanous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360: 961-72.
  3. Gada H, Kirtane AJ, Newman W, et al. 5-year results of a randomized comparison of XIENCE 5 everolimu-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT 3 trial. JACC Cardiovasc Interv. 2013; 6:1263-6.
  4. Park SJ, Ahn JM, Kim YH, et al. Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease. N Engl J Med. 2015; 372(13).
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