Xience or Vision for the Management of Angina in the Elderly - XIMA

Oct 26, 2012
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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:
Abbott Vascular
Date Presented:
01/01/2012
Date Updated:
10/26/2012
Original Posted Date:
10/26/2012
References

Description:

Most clinical trials in patients undergoing percutaneous coronary intervention (PCI) have had a poor representation of older patients. The current trial sought to compare outcomes after Xience (everolimus-eluting stent [EES]) versus Vision (bare-metal stent [BMS]) implantation in patients 80 years or older undergoing PCI.

Hypothesis:

Drug-eluting stent (DES) PCI with an EES stent would be superior to BMS PCI in patients 80 years or older undergoing PCI.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Age ≥80 years
  • Stable angina or acute coronary syndrome
  • Coronary artery disease requiring stenting:
    - Left main stem stenosis
    - Lesions length ≥15 mm long or ≤3 mm diameter
    - Lesion at high risk of restenosis (e.g., chronic total occlusion, bifurcation, severe calcification)

    Number of enrollees: 800
    Duration of follow-up: 1 year
    Mean patient age: 83.5 years
    Percentage female: 40%
    Left ventricular ejection fraction: <40% in 12%

Exclusions:

  • Acute STEMI
  • Cardiogenic shock
  • Platelet count <50 x 100/mm3
  • Patient life expectancy <1 year
  • Known allergies to clopidogrel, aspirin, heparin, intravenous contrast, or stent drug elutant
  • Recent major gastrointestinal hemorrhage (within 3 months)
  • Any previous cerebral bleeding episode
  • Participation in another investigational drug or device study
  • Patient unable to give consent
  • Clinical decision precluding the use of DES

Primary Endpoints:

  • MACE rate at 1 year

Secondary Endpoints:

  • Death at 1 year
  • MI at 1 year
  • TVR at 1 year
  • Stroke at 1 year
  • Major bleeding at 1 year

Drug/Procedures Used:

Patients were randomized in a 1:1 fashion to either PCI with Xience V (EES) or Vision (BMS) stents. Following the procedure, dual antiplatelet therapy was maintained for 12 months in the EES arm and 1 month in the BMS arm.

Concomitant Medications:

IIb/IIIa inhibitors (1.6%)

Principal Findings:

A total of 800 patients were randomized, 401 to BMS and 399 to EES. Baseline characteristics were fairly similar between the two arms. About 25% had diabetes, 5% were current smokers, 11% had undergone prior PCI, and 7% had chronic kidney disease. Stable angina accounted for 32% of the patients and non–ST-segment elevation myocardial infarction (NSTEMI) for 50%. Multivessel PCI was undertaken in 39% of the patients, including three-vessel PCI in 7%. Left main trunk PCI was undertaken in 8%, left anterior descending artery PCI in 62%, and graft PCI in 3%. Mean stented length was longer in the EES arm as compared with the BMS arm (26.6 mm vs. 24.0 mm). The mean number of stents deployed was 2.1.

The primary major adverse cardiac event (MACE) endpoint was similar between the BMS and EES arms (18.7% vs. 14.5%, p = 0.09). Of the individual components, target vessel revascularization (TVR) (7.0% vs. 2.0%, p = 0.0009) and MI (8.7% vs. 4.3%, p = 0.01) were significantly higher in the BMS arm. However, all-cause mortality (7.2% vs. 8.5%, p = 0.50) and major bleeding (1.7% vs. 2.3%, p = 0.61) were numerically lower in the BMS arm. Interestingly, noncardiovascular mortality was significantly higher in the EES arm (2.5% vs. 5.2%, p = 0.04).

Interpretation:

The results of the XIMA trial indicate that BMS and EES demonstrate equivalent safety and efficacy at 12 months for PCI in elderly patients ≥80 years of age. This is one of the only studies to focus on this patient population. The high noncardiac mortality in this population is sobering, and demonstrates the high comorbidity burden in elderly patients. Although the primary endpoint was negative, a reduction in TVR was noted in the EES arm, as has been noted for several trials comparing EES to BMS in a wide range of patients. In this context, it should be noted that the TVR rate in the BMS arm was only 7%, despite the specific inclusion of lesions with a high risk of restenosis such as long lesions, small vessels, chronic total occlusion, bifurcations, etc., in this trial.

Another noteworthy point regarding this trial is that it is not an all-comers trial in elderly patients; patients in whom DES use was thought to be prohibitive were not included. Thus, although bleeding rates were similar between the DES and BMS arms in the population studied, it may not be true for all elderly patients undergoing DES PCI.

References:

Presented by Dr. Adam de Belder at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2012), Miami, FL, October 26, 2012.

Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Follow-Up Studies, Angina, Stable, Drug-Eluting Stents, Comorbidity, Constriction, Pathologic, Cost of Illness, Diabetes Mellitus


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