An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition).

AIMS

We compared the mechanical and physical properties and the safety from strut fracture of side branch and post-dilatation strategies for the Absorb and DESolve bioresorbable scaffolds with the durable metallic drug-eluting XIENCE Xpedition stent using largely independent bench testing.

METHODS AND RESULTS

The strut thickness and crossing profile of the polymeric scaffolds was greater than those of the metallic drug-eluting stent. While all three devices recoiled after deployment, the DESolve enlarged between 10 mins and one hour returning to the immediate post-deployment diameter ("self-correction"). In 3.0 mm stents/scaffolds, the main branch post-dilatation safe threshold without fracture for Absorb was 3.8 mm at 20 atm, for DESolve was 5.0 mm at 20 atm whereas the ML8 did not fracture. For side branch dilatation with a 3.0 mm non-compliant balloon, the threshold before the Absorb fractured was 10 atm whereas the DESolve and ML8 did not fracture at 22 atm. The safe threshold for mini-kissing balloon post-dilatation in 3.0 mm scaffolds/stents with 3.0 mm non-compliant balloons was 5 atm for the Absorb whereas the DESolve and ML8 did not fracture up to 20 atm.

CONCLUSIONS

The metallic stent has thinner struts, lower profile, and greater radial strength than the polymeric scaffolds. Different safe pressure thresholds exist for different scaffolds/stents. Unlike the others, the DESolve showed "self-correction" or enlargement after initial recoil.