Key result
Biodegradable-polymer DES cuts 3-year repeat interventions ~67% vs BMS, with similar death or MI.
Why the study?
The long-term clinical performance of drug-eluting stents coated with biodegradable polymers is poorly known.
Do biodegradable-polymer coated drug-eluting stents (paclitaxel or sirolimus) reduce adverse clinical outcomes compared to bare metal stents in coronary patients?
RCT (n=274)
2:2:1 ratio
Do biodegradable-polymer coated drug-eluting stents (paclitaxel or sirolimus) reduce adverse clinical outcomes compared to bare metal stents in coronary patients?
Absolute Event Rate: 9% vs 7.1%
p-value: p=0.6
Biodegradable-polymer coated drug-eluting stents releasing either paclitaxel or sirolimus effectively reduce the 3-year rate of re-interventions compared to bare metal stents.
Similar 3-year cardiac event rates suggest comparable safety; leaves open durability versus BMS in larger trials.
AIMS: The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. METHODS AND RESULTS: A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents. CONCLUSIONS: The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.
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Lemos et al. (2012) conducted an RCT in Coronary patients (n=274). Biodegradable-polymer coated drug-eluting stents (paclitaxel or sirolimus) vs. Bare metal stents was evaluated on Cardiac death or myocardial infarction (p=0.6). Biodegradable-polymer coated drug-eluting stents reduced 3-year repeat interventions (10.0% vs 29.9%; p<0.01) compared to bare metal stents, with similar rates of cardiac death or MI (9.0% vs 7.1%).
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