Randomized comparison of XiEnce-V and Multi-link VisioN Coronary Stents in the sAme MuLtivessel Patient with Chronic kiDnEy diSease - RENAL-DES

Description:

The goal of the trial was to evaluate treatment with the everolimus-eluting stent (Xience V) compared with the bare-metal stent (Multi-Link Vision) within the same patient with multivessel coronary artery disease (CAD) and chronic kidney disease (CKD).

Hypothesis:

The everolimus-eluting stent will prevent ischemia-driven target vessel revascularization.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with CKD undergoing multivessel PCI

    Number of enrollees: 215 patients
    Duration of follow-up: mean 11.8 months
    Mean patient age: 73 years
    Percentage female: 27%
    Ejection fraction: 53%

Exclusions:

  • Age <18 or >85 years
  • Left main artery stenosis
  • In-stent restenosis
  • Saphenous vein graft disease
  • ST-elevation myocardial infarction
  • Vessel diameter <2.5 mm or >4 mm
  • Contraindication to long-term dual antiplatelet therapy
  • Complete functional revascularization not achievable by PCI
  • Severe valvular heart disease
  • Childbearing potential

Primary Endpoints:

  • Ischemia-driven target vessel revascularization at 12 months

Secondary Endpoints:

  • Cardiac death
  • Percutaneous coronary intervention (PCI)-related myocardial infarction or stent thrombosis

Drug/Procedures Used:

Each vessel within eligible patients with multivessel CAD and CKD was randomized to an everolimus-eluting stent (n = 257) versus a bare-metal stent (n = 255). All patients underwent a stress test between 9 and 12 months unless they had undergone coronary angiography for ischemic symptoms.

Principal Findings:

Overall, 512 vessels within 215 patients were randomized. The mean age was 73 years, 27% were women, mean systolic blood pressure was 142 mm Hg, 44% had diabetes mellitus, and mean ejection fraction was 53%. The location of the treated vessel was the left anterior descending artery in 36.9%, left circumflex artery in 32.5%, and right coronary artery in 30.6%. The mean stent diameter was 2.89 mm in the everolimus-eluting stent group versus 3.02 mm in the bare-metal stent group (p = 0.002), while the mean total stent length was 24.7 mm in the everolimus-eluting stent group versus 19.6 mm in the bare-metal stent group (p = 0.001).

The primary outcome of ischemia-driven target vessel revascularization at 12 months occurred in 2.7% of the everolimus-eluting stent group and 11.4% mm in the bare-metal stent group (p < 0.001). This difference was especially noted among patients with the most severe renal dysfunction.

Multivariate independent predictors of ischemia-driven target vessel revascularization were implantation of a bare-metal stent (odds ratio [OR] 4.95, p < 0.001) and vessel size (OR 0.32, p = 0.006).

Interpretation:

Among patients with multivessel CAD and CKD, the use of an everolimus-eluting stent reduced ischemia-driven target vessel revascularization compared with a bare-metal stent within the same patient. Clinical outcomes such as stent thrombosis (n = 1) or myocardial infarction (n = 3) were too infrequent to comment upon. This unique study design was able to control for baseline patient comorbidities; however, the size and length of stents was slightly different between groups. These differences (smaller stent diameter and longer total stent length in the everolimus-eluting stent group) would have tended to attenuate the difference between study groups.

References:

Tomai F, Ribichini F, De Luca L, et al. Randomized comparison of XiEnce-V and Multi-link VisioN Coronary Stents in the sAme MuLti-vessel Patient with Chronic kiDnEy disease (RENAL-DES) Study. Circulation 2013;Dec 19:[Epub ahead of print].

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Odds Ratio, Myocardial Infarction, Coronary Artery Disease, Comorbidity, Blood Pressure, Sirolimus, Stents, Coronary Angiography, Thrombosis, Kidney, Diabetes Mellitus, Renal Insufficiency, Chronic, Exercise Test


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