Abstract 2889: OPTION CRT/ATX: An Original CRT-Defibrillator Study Design
Hypothesis: The effectiveness of the Tupos LV/ATx Cardiac Resynchronization Therapy defibrillator (CRT-D) for treatment of CHF is equivalent to that of marketed CRT-Ds.
Background: The BIOTRONIK OPTION CRT/ATx study is an IDE clinical investigation to evaluate the safety and effectiveness of the Tupos LV/ATx in a multi center, randomized trial. The Tupos LV/ATx is a dual-chamber ICD that provides both atrial and ventricular tiered antitachycardia pacing and conversion therapy and CRT. Patients (pts) were randomly assigned (2:1 ratio) to the study group with the Tupos LV/ATx or the active control group with marketed CRT-Ds. The control group received Medtronic (31.9%), Guidant (53.6%), and St. Jude (14.5%) CRT-Ds.
Methods: The primary study endpoint compared the functional benefits of CRT between the 2 randomized groups using a composite of the improvement in six minute walk test (6 min WT) and Quality of Life (QOL) measurement from baseline to the 6-month follow up. The 6 min WT and QOL were equally weighted at 50%. Each metric was also evaluated independently.
Results: 200 pts were enrolled, with the following clinical demographics: - 133 study pts: 69.9% male, 69.5 ± 0.9 yrs, 66.9% Class IIa ICD indication, 91% NYHA Class III, LVEF 22.1 ± 0.6%, and QRS 161.9 ± 2.0 ms - 67 control pts: 76.1% male, 69.1 ± 1.2, 74.6% Class IIa ICD indication, 89.6% NYHA Class III, LVEF 23.3 ± 0.8, and QRS 156.1 ± 2.3 - Pts had either a documented history of AT (39.1% study vs. 41.8% control) or significant risk of AT (60.9% study vs. 58.2% control) - There were no statistically significant differences in CHF medications.
Conclusion: The composite rate of improvement over 6 months in 6 min WT and QOL score demonstrates that the study group is non-inferior to the control group and that the primary effectiveness study endpoint is met. Additionally, no significant differences were found in the 6 min WT and QOL improvement between the two groups. The results confirm the clinical utility of this unique study design.