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Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic
Fabrizio Tomai1, Flavio Ribichini, Leonardo De Luca
1Department of Cardiovascular Sciences, European Hospital, Rome, Italy (F.T., L.D.L., A.P., A.S.G., L.W.); Division of Cardiology of the Department of Medicine, University of Verona, Verona, Italy (F.R., M.P., C.V.); Institute of Cardiology, University Magna Grecia, Catanzaro, Italy (C.S.); Department of Cardiology, Vannini Hospital, Rome, Italy (I.P.); Institute of Cardiology, Cattolica University, Rome, Italy (C.T.); and Division of Nuclear Medicine, Madonna della Fiducia Clinic, Rome, Italy (F.N.).
Insights
Drug-eluting stents (DES) significantly reduce target vessel revascularization compared to bare-metal stents (BMS) in chronic kidney disease patients. This study confirms DES superiority in preventing restenosis in this high-risk population.
Area of Science:
- Cardiology
- Nephrology
- Interventional Cardiology
Background:
- Percutaneous coronary interventions (PCI) in patients with chronic kidney disease (CKD) yield suboptimal outcomes.
- Drug-eluting stents (DES) may offer improved results over bare-metal stents (BMS) in CKD patients.
- Assessing neointimal growth post-PCI in CKD is complex due to multiple confounding variables.
Purpose of the Study:
- To directly compare the efficacy of everolimus-eluting stents (Xience V DES) versus BMS with identical designs in preventing clinical restenosis.
- To evaluate outcomes in patients with multivessel coronary artery disease and CKD (eGFR <60 mL/min).
Main Methods:
- Prospective, randomized, multicenter study (RENAL-DES trial).
- Comparison of Xience V DES and Multi-Link Vision BMS implanted in the same multivessel CKD patient.
- Primary endpoint: ischemia-driven target vessel revascularization at 12 months, assessed by myocardial scintigraphy.
Main Results:
- A total of 512 coronary vessels in 215 patients were treated.
- Ischemia-driven target vessel revascularization rates at 1 year were significantly lower for DES (2.7%) versus BMS (11.4%) (P<0.001).
- Independent predictors of revascularization included BMS implantation (OR, 4.95) and smaller vessel size (OR, 0.32).
Conclusions:
- This is the first randomized trial demonstrating reduced clinical restenosis with a new-generation DES compared to an identical BMS design in CKD patients.
- Everolimus-eluting stents represent a superior treatment option for multivessel coronary artery disease in patients with chronic kidney disease.
Background:
Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess.
Methods And Results:
Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006).
Conclusions:
This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease.
Clinical Trial Registration Url:
http://clinicaltrials.gov. Unique identifier: NCT00818792.
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