SPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease

Nikolsky, Eugenia; Lansky, Alexandra J.; Sudhir, Krishnankutty; Doostzadeh, Julie; Cutlip, Donald E.; Piana, Robert N.; Su, Xiaolu; White, Roseann; Simonton, Charles A.; Stone, Gregg W.

doi:10.1016/j.ahj.2009.07.025

Cited by 41 publications

(41 citation statements)

References 37 publications

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“…A detailed description of the Xience V USA Study (IDE G050050) has been previously described [10]. Briefly, the Xience V USA Study was a large, prospective, multicenter, real-world single-arm postmarket surveillance trial.…”

Section: Methodsmentioning

confidence: 99%

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Clinical outcomes in real‐world patients with bifurcation lesions receiving Xience V everolimus‐eluting stents: Four‐year results from the Xience V USA study

Hermiller

Applegate

Baird

et al. 2015

Cathet Cardio Intervent

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Section: Methodsmentioning

confidence: 99%

“…The primary endpoint of the Xience V USA study was the incidence of ARC-defined definite and probable stent thrombosis rate at 1 year [10]. The coprimary endpoint was the composite rate of cardiac death and any ARC-defined MI at 1 year.…”

Section: Study Endpoints and Data Managementmentioning

confidence: 99%

Clinical outcomes in real‐world patients with bifurcation lesions receiving Xience V everolimus‐eluting stents: Four‐year results from the Xience V USA study

Hermiller

Applegate

Baird

et al. 2015

Cathet Cardio Intervent

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“…The safety and efficacy of the everolimus-eluting stent have been studied in randomized trials such as the SPIRIT study program [9,20,21,22,23] where the SPIRIT II [20,22], III [9,23] and IV [24] studies compared the everolimus-eluting Xience V stent with the paclitaxel-eluting Taxus stent. The SORT OUT IV trial has been undertaken to compare directly the efficacy and safety of the first generation sirolimus-eluting Cypher Select+ stent and the second generation everolimus-eluting Xience V/Promus stent.…”

Section: Introductionmentioning

confidence: 99%

Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

Jensen

Thayssen²,

Tilsted³

et al. 2010

Cardiology

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Background: The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent. Method: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled. Conclusion: The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations.

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“…Comparison of the antiplatelet effect of the 2 forms of clopidogrel was performed on the per-protocol population, defined as all patients who were randomized to receive treatment and who finished the study schedule without protocol violation. 25,26 Baseline data were compared using 1-way analysis of variance (continuous variables) or the 2 test (discrete variables) by the independent biostatistician. SPSS version 17.0 (SPSS Inc., Chicago, Illinois) was used for all statistical analyses, and P Ͻ 0.05 was considered significant.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Antiplatelet Effect and Tolerability of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD-Equivalent Risks: A Phase IV, Prospective, Double-Dummy, Parallel-Group, 4-Week Noninferiority Trial

Suh

Seung

Gwak

et al. 2011

Clinical Therapeutics

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SPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease

Cited by 41 publications

References 37 publications

Clinical outcomes in real‐world patients with bifurcation lesions receiving Xience V everolimus‐eluting stents: Four‐year results from the Xience V USA study

Clinical outcomes in real‐world patients with bifurcation lesions receiving Xience V everolimus‐eluting stents: Four‐year results from the Xience V USA study

Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

Comparison of Antiplatelet Effect and Tolerability of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD-Equivalent Risks: A Phase IV, Prospective, Double-Dummy, Parallel-Group, 4-Week Noninferiority Trial

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