4-Year Clinical Outcomes and Predictors of Repeat Revascularization in Patients Treated With New-Generation Drug-Eluting Stents: A Report From the RESOLUTE All-Comers Trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention)

• Published in: Journal of the American College of Cardiology Vol. 63; no. 16; pp. 1617 - 1625
• Main Authors: TANIWAKI, Masanori, STEFANINI, Giulio G, SILBER, Sigmund, RICHARDT, Gert, VRANCKX, Pascal, SERRUYS, Patrick W, BUSZMAN, Pawel E, KELBAEK, Henning, WINDECKER, Stephan
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 29.04.2014
• Subjects: Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antineoplastic Agents; Biological and medical sciences; Cardiology. Vascular system; Coronary heart disease; Diseases of the cardiovascular system; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Heart; Humans; Immunosuppressive Agents - pharmacology; Male; Medical sciences; Middle Aged; Myocardial Infarction - diagnosis; Myocardial Infarction - surgery; Percutaneous Coronary Intervention - methods; Pharmacology. Drug treatments; Prognosis; Prosthesis Design; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Reoperation; Sirolimus - analogs & derivatives; Sirolimus - pharmacology; Time Factors; Prognosis; Angioplasty; Predictor; Cardiovascular disease; Percutaneous route; Randomization; Clinical trial; Evolution; Protein synthesis inhibitor; Cardiology; Everolimus; Drug eluting stent; Revascularization; Human; Drug; Atherectomy; Coronary artery; Prediction; Instrumentation therapy; Lactone; Patient; Zotarolimus; Macrolide; Coronary heart disease; Generation; Circulatory system; Immunosuppressive agent; Antibacterial agent; Predictive factor; Comparative study; everolimus-eluting stent(s); all-comers population; long-term outcomes; Resolute zotarolimus-eluting stent(s); drug-eluting stent(s)
• ISSN: 0735-1097; 1558-3597; 1558-3597
• DOI: 10.1016/j.jacc.2013.12.036

The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Minneapolis, Minnesota) and XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial. Data on long-term outcomes of new-generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown. Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis. At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis. R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE-AC]; NCT00617084).