Three-year outcomes following sirolimus- versus paclitaxel-eluting stent implantation in an unselected population with coronary artery disease (from the REWARDS Registry).
The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) study includes unselected patients with coronary artery disease treated with sirolimus-eluting stents (SESs; n = 2,392) or paclitaxel-eluting stents (PES; n = 1,119). This study aimed to examine the long-term safety profile of the 2 stents in a "real-world" population, especially in relation to stent thrombosis, and to compare differences in the diabetic cohort. Patients were followed for 3 years with regard to major adverse cardiac events (MACEs), including death, Q-wave myocardial infarction, and target lesion revascularization. Rates of stent thrombosis were also studied. Baseline characteristics were similar between stents. Although MACE rates at 3 years were similar (SES 28.1% vs PES 28.9%, p = 0.62), there was a significant difference in unadjusted rates of target lesion revascularization (SES 15.6% vs PES 12.6%, p = 0.03), death (SES 15.7% vs PES 19.0%, p = 0.02), and Q-wave myocardial infarction (SES 0.8% vs PES 2.1%, p = 0.003). After multivariable Cox regression to adjust for confounders, there was no significant difference in overall MACEs. Incidence of stent thrombosis was higher in the SES group (SES 2.2% vs PES 1.6%, p = 0.22), but this was not statistically significant (hazard ratio 1.6, 95% confidence interval 0.8 to 2.9, p = 0.17). Overall, diabetics had a higher MACE rate, but there was no difference between insulin- and noninsulin-dependent diabetics. In conclusion, at 3 years, PES and SES achieved similar results in MACEs and stent thrombosis. This should foster confidence that SES or PES can be compared to second-generation drug-eluting stents without concerns for safety or efficacy.
Hanna
Nicholas N
NN
Division of Cardiology, Washington Hospital Center, Washington, DC, USA.
Gaglia
Michael A
MA
Torguson
Rebecca
R
Ben-Dor
Itsik
I
Gonzalez
Manuel A
MA
Collins
Sara D
SD
Syed
Asmir I
AI
Maluenda
Gabriel
G
Kaneshige
Kimberly
K
Xue
Zhenyi
Z
Satler
Lowell F
LF
Kent
Kenneth M
KM
Suddath
William O
WO
Pichard
Augusto D
AD
Waksman
Ron
R
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000209:etiology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology*; D048909:Diabetes Complications; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus