Objective: We sought to assess vascular remodelling and neointima formation after implantation of bioabsorbable magnesium alloy stents (AMS).
Design: Randomized experimental study Interventions AMS (n=11), sirolimus-eluting stents (CypherÒ; n=11) and bare-metal stents (BMS; n=9) were randomly implanted in 31 porcine coronary arteries (n=11 pigs).
Main outcome measures: Neointima formation was measured by histomorphometry at 90 days. Vascular remodelling defined as change in external elastic membrane area from index intervention to follow-up was assessed by serial intravascular ultrasound (IVUS).
Results: By histomorphometry, lumen [median (quartiles); AMS: 1.75 mm2 (1.07-3.26), Cypher 2.52 mm2 (2.22-5.01), BMS 4.55 mm2 (3.2-7.44); p=0.013] and external elastic membrane area [AMS: 5.56 mm2 (4.09-6.95), Cypher 7.95 mm2 (6.45-10.92), BMS 9.08 mm2 (7.85-11.63); p=0.014] were smallest after AMS implantation. By IVUS, external elastic membrane area at follow-up was smallest [AMS: 7.5±2.8 mm2, Cypher 9.1±2.7 mm2, BMS 9.9±3.1 mm2; p=0.33] and change in external elastic membrane area from index intervention to follow-up [remodelling; AMS: -1.0±3.1 mm2, Cypher 1.0±0.8 mm2, BMS 0.9±1.2 mm2; p=0.30] was greatest in the AMS group. In a dichotomized IVUS assessment of vascular remodelling, 6 AMS stents were remodelled (negative remodelling: n=5; positive remodelling: n=1) at 90 days follow-up (AMS versus Cypher+BMS: p=0.001). Neointima formation was smallest in the AMS group (p<0.05 for both histomorphometry and IVUS).
Conclusion: Coronary implantation of absorbable magnesium stents, as compared to two non-absorbable stents, was associated with the smallest lumen area at 3-month follow-up due to negative vascular remodelling.
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