Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents.
The aim of a study was to compare the safety and efficacy of a biodegradable polymer-coated Biolimus-eluting stent with a thin-strut Everolimus-eluting stent coated with a durable biocompatible polymer.
This open-label, prospective, randomised, controlled, non-inferiority trial ( COMPARE II ) was undertaken at 12 sites across Europe.
Investigators have used limited exclusion criteria ( age greater than 18 years, life expectancy greater than 5 years, reference vessel diameter 2.0-4.0 mm ) to enrol patients eligible for percutaneous coronary intervention ( PCI ).
Patients were randomly allocated ( 2:1 ) to receive either a biodegradable polymer Biolimus-eluting stent ( Nobori ) or a durable fluoropolymer-based Everolimus-eluting stent ( Xience V or Prime, or Promus ).
The primary endpoint was a composite of safety ( cardiac death and non-fatal myocardial infarction ) and efficacy ( clinically indicated target vessel revascularisation ) at 12 months, analysed by intention to treat.
Patients received dual antiplatelet therapy for 12 months after discharge.
During the period 2009-2011, researchers enrolled 2707 patients ( 4025 lesions ), 1795 of whom were assigned to receive the Biolimus-eluting stent ( 2638 lesions ) and 912 to an Everolimus-eluting stent ( 1387 lesions ).
2688 ( 99.3% ) patients completed 12 months' follow-up.
Significantly more patients in the Biolimus-eluting stent group received a non-assigned stent than did those in the Everolimus-eluting stent group ( 105 [ 5.9% ] vs 19 [ 2.1% ]; p less than 0.0001 ).
The primary endpoint occurred in 93 ( 5.2% ) patients in the Biolimus-eluting stent group and 44 ( 4.8% ) patients in the Everolimus-eluting stent group at 12 months ( relative risk, RR=1.07; p non-inferiority less than 0.0001 ).
Analysis per protocol did not change the outcome of this trial ( p non-inferiority less than 0.0001 ).
In conclusion, biodegradable polymer Biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut Everolimus-eluting stent with a durable biocompatible polymer.
Researchers need to follow-up patients for longer to show whether the Biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the Everolimus-eluting stent. ( Xagena )
Smits PC et al, The Lancet 2013; 381: 651-660