Recommendations

82
Table 30. Published Randomized Trials and Selected Registry Experiences of Drug-Eluting Stents Compared With Bare Metal Stents
Deaths MI, Restenosis, TLR,
Active/Control, Active/Control, Active/Control, Active/Control,
% % % %
Eluting n, Eluting Drug
Drug Trial (Ref.) Year Active/Control Stent Dosage
NA NA 0% at 1 year Minimal neointimal proliferation
at 1 year
Sirolimus FIM (628) 2001 30 in Sao Paulo; BxVelocity 140 mcg/cm 2
15 in Rotterdam
NA NA 0% at 2 years Minimal neointimal proliferation
at 2 years
FIM (879) 2002 15 from Rotterdam BxVelocity 140 mcg/cm 2
1.7/1.7 3.3/4.2 0/26.6 at 6 months 0/22.9 at 1 year
(P less than 0.001) (P equals 0.001)
RAVEL (624) 2002 120/118 BxVelocity 140 mcg/cm 2
0.9/0.6 2.8/3.2 8.9/36.3 at 8 months 4.9/20 at 1 year
(P less than 0.001) (P less than 0.001)
SIRIUS (698) 2004 533/525 BxVelocity 140 mcg/cm 2
0/0 2.0/4.0 2.3/51.1 4.0/18.0 at 9 months
(P less than 0.001)
C-SIRIUS (880) 2004 50/50 BxVelocity 140 mcg/cm 2
1.1/0.6 4.6/2.3 5.9/42.3 4.0/20.9 at 9 months
(P less than 0.001)
E-SIRIUS (881) 2003 175/177 BxVelocity 140 mcg/cm 2
1.6/2.0 0.8/1.6 at 30 days NA 1.0/1.8 at 30 days
at 30 days
RESEARCH 2004 508/450 BxVelocity 140 mcg/cm 2
Registry
Overall (236)
3.0/3.0 3.0/1.0 at 30 days NA 1.0/2.7 at 30 days
at 30 days
RESEARCH 2003 198/301 BxVelocity 140 mcg/cm 2
Registry
ACS (882)
8.3/8.2 0.5/2.2 at 300 days NA 1.1/8.2 at 300 days
at 300 days (P less than 0.01)
RESEARCH 2004 186/183 BxVelocity 140 mcg/cm 2
Registry
STEMI (441)
0/0 NA NA 12-month MACE:
in hospital 5.6/17.2
(P less than 0.05)
RESEARCH 2004 56/28 BxVelocity 140 mcg/cm 2
Registry
Chronic
Totals (883)
ACC - www.acc.org
AHA - www.americanheart.org
SCAI - www.scai.org
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