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TRUST = Tenax for the prevention of restenosis and acute thrombotic complications
– a useful stent trial
Purpose
A randomized trial of a silicon carbide coated stent versus uncoated reference stents
in patients with acute coronary syndromes (unstable angina) of either Braunwald IIB
or Braunwald IIIB Class.
Method
38 European and Canadian centers participated in the study, enrolling 485 patients in
1999 and 2000. Clinical follow-ups took place at 1, 3, 6 and 9 months. There were 314
patients in the Braunwald Class IIB group and 171 patients in the Braunwald Class IIIB
group. Angiographic follow-up took place at 6 months. The two patient groups were
comparable with regard to the major demographics and anamnestic data. Only 2.1 %
of the patients received GP IIb/IIIa receptor blocker agents. All were given Aspirin and
Ticlopidine or Clopidogrel.
Results
The 6-month follow-up shows that the MACE rate for the Braunwald IIB population
is comparable for both groups. A statistically significant difference is observed in the
Braunwald IIIB patient population with a MACE rate of 5.8 % for the PROBIO
®
coated stent
as opposed to 15.7 % in the reference stent group. This trend continued at 9 months.
Conclusion
Stents coated with silicon carbide in this study reduced Major Adverse Cardiac Events
during follow-up in the high-risk subgroup.
Clinical Effectiveness
6
Braunwald Class IIIB Patients
6-month
p = 0.021
9-month
p = 0.07
100 %
95 %
90 %
85 %
80 %
75 %
Time [Days] 30 60 90 120 150 180 210 240 270
PROBIO
®
Coated Stent
Uncoated Surface
MACE Free Survival