המידע שלהלן מוצג מטעמה של חברת בוסטון סיינטפיק:
Quality of the study and the data:
- Large trail with 536 patients
- IVUS used at time of implantation for accurate baseline characteristics and follow up analysis
- Angiographic F/U in 98% of SR (slow release) and 95% of MR (moderate release) patients; IVUS F/U in 90% and SR and 87% of MR. Unprecedented in a clinical trial of this importance. Provides indisputable evidence and extensive sub set analysis opportunities.
- Sets the standard by which all clinical trials on DES should be measured.
- Builds upon the science of the pre-clinical work
Safety
- 30 day: 2% MACE in SR and MR arms and 4% in control arm
- 6 month MACE: SR: 8.5% Vs Control 19%; MR: 7.8 Vs Control of 20%
- Only 1 SAT (SR release cohort, none in MR). This mirrors what we have seen in Taxus I and III
- 6 Month late loss in stented segment: SR = .31mm Vs .79mm in Control; MR = .3mm Vs .77mm in Control arm. Indicative of healing!
- Also note that the initial burst of PTx delivered to the vessel from the MR is 8-10 times that of the SR, giving further evidence of a wide safety margin. No Deaths
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