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A drug-eluting stent made from bioresorbable material showed similar mid-term (12 month) safety and efficacy to a metal stent in patients undergoing PCI in the ABSORB Japan study and lays ‘a solid foundation’ for continued evaluation of long term outcomes for bioresorbable stents.
Study presenter Takeshi Kimura from Kyoto University Hospital said: ‘These results support the feasibility of bioresorbable vascular scaffolds to potentially improve longterm outcomes of patients.’
Theoretically, bioresorbable vascular scaffolds (BVS) may provide superior long-term results compared with permanent metallic DES, but whether they are as safe and effective as the metallic DES prior to complete bioresorption has been unknown.
In this ABSORB study, performed between April and December 2013, 400 patients with up to two de novo target lesions were randomised 2:1 to PCI using either BVS (n = 266) or metallic DES (n = 134). The study took place at 38 investigational sites in Japan.
The primary endpoint of target lesion failure (a composite of cardiac death, MI attributable to target vessel, or ischemiadriven target lesion revascularisation at one year) occurred in 4.2% of the BVS patients and 3.8% of the metallic DES patients (RR 1.10; 95% CI 0.39-3.11), demonstrating noninferiority for the bioresorbable stent (P<0.0001). Definite or probable stent scaffold thrombosis at 12 months occurred in 1.5% of patients with both devices. Procedure duration , however, was significantly longer for the bioresorbable stent.
‘These results support the feasibility of BVS use to potentially improve the long-term outcomes of patients undergoing percutaneous coronary intervention,’ write the authors. The study, they add, enrolled a highly selected patient population with mainly stable CAD and single de novo non complex target lesions. ‘As such, the study results should not be generalized to complex lesions, which are often encountered in clinical practice, such as bifurcations, heavily calcified lesions, diffuse disease, and thrombus.’
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