SES vs Brachytherapy for Bare Metal In-stent Restenosis
SES vs Brachytherapy for Bare Metal In-stent Restenosis
The trial design and primary end point of the SISR trial have been previously reported. In summary, this is a multicenter, prospective, 2-arm randomized study designed to evaluate the safety and effectiveness of the SES as compared with VBT for the treatment of in-stent restenosis of BMS. The primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), or target vessel revascularization at 9 months postprocedure. The following secondary end points were assessed: composite of major adverse cardiac events (MACE) defined as death, MI (Q wave and non–Q wave), emergent bypass surgery or repeat target lesion revascularization, and stent thrombosis at year 1 and then yearly thereafter, for a total of 5 years postprocedure. Vascular brachytherapy was performed with either γ or β sources using standard techniques.
Baseline and clinical data were collected by clinical investigators at the clinical sites. The data-coordinating center was the Harvard Clinical Research Institute, Harvard Medical School, Boston, MA. The data presented herein represent all angiographic and clinical follow-up data available as of October 2, 2009.
The effectiveness analysis and safety evaluation were performed on the intention-to-treat study population. This study was designed to demonstrate the noninferiority or superiority of the Cypher stent (Cordis) compared with intracoronary VBT (either γ or β) for the primary end point of TVF. The trial was designed and powered for the 9-month primary end point: although no specific hypothesis was prespecified for a longer-term evaluation, follow-up was prespecified for the first year after treatment and then yearly thereafter, for a total of 5 years. Thus, the statistics for these later time points are descriptive.
The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Funding for this study was provided by the Cordis Corporation (Warren, NJ), a Johnson & Johnson Company.
Methods
The trial design and primary end point of the SISR trial have been previously reported. In summary, this is a multicenter, prospective, 2-arm randomized study designed to evaluate the safety and effectiveness of the SES as compared with VBT for the treatment of in-stent restenosis of BMS. The primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), or target vessel revascularization at 9 months postprocedure. The following secondary end points were assessed: composite of major adverse cardiac events (MACE) defined as death, MI (Q wave and non–Q wave), emergent bypass surgery or repeat target lesion revascularization, and stent thrombosis at year 1 and then yearly thereafter, for a total of 5 years postprocedure. Vascular brachytherapy was performed with either γ or β sources using standard techniques.
Data Collection and Core Laboratory Analysis
Baseline and clinical data were collected by clinical investigators at the clinical sites. The data-coordinating center was the Harvard Clinical Research Institute, Harvard Medical School, Boston, MA. The data presented herein represent all angiographic and clinical follow-up data available as of October 2, 2009.
Statistical Analysis
The effectiveness analysis and safety evaluation were performed on the intention-to-treat study population. This study was designed to demonstrate the noninferiority or superiority of the Cypher stent (Cordis) compared with intracoronary VBT (either γ or β) for the primary end point of TVF. The trial was designed and powered for the 9-month primary end point: although no specific hypothesis was prespecified for a longer-term evaluation, follow-up was prespecified for the first year after treatment and then yearly thereafter, for a total of 5 years. Thus, the statistics for these later time points are descriptive.
The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Funding for this study was provided by the Cordis Corporation (Warren, NJ), a Johnson & Johnson Company.
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