Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions

Abstract

Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System-The DESolve Nx Trial; NCT02086045).

Bioresorbable Vascular Scaffolds for Coronary Revascularization

“…43 The relationships of nominal BVS scaffold size to QCA maximum reference vessel diameter and to clinical outcomes were evaluated in a pooled patient-level analysis from 3 ABSORB studies. 44 Subjects with both proximal and distal maximum reference vessel diameters smaller than nominal scaffold size (scaffold oversize group) incurred higher rates of major cardiovascular events and TVMI than those in whom the proximal or distal maximum reference vessel diameter was larger than the scaffold (scaffold nonoversize group). Thus, careful attention to patient/lesion selection and optimal technique, including aggressive lesion preparation (1:1 balloon-artery ratio) with noncompliant balloons (or cutting/scoring balloons or atheroablation to improve lesion compliance), accurate vessel and device sizing (including avoiding very small vessels), routine noncompliant balloon high-pressure (≥16 atm.)…”

“…The first version of this device eluted the rapamycin analog myolimus, 52 whereas the current Conformité Europée-ne-marked version elutes novolimus (dose, 5 µm/mm scaffold length; 80% eluted within 1 month). 53,54 Novel features of DESolve include (1) a self-expanding (selfcorrection) property that allows the device to passively increase in diameter by ≈0.3 mm within 20 to 60 minutes of deployment that has been attributed to a proprietary blend of polymers and processing technique, plus storage at 0 to 8°C; (2) a 95% reduction in molecular weight by 1 year, with complete absorption by 2 years; (3) adequate radial strength and vessel support for 3 to 4 months; and (4) high elasticity and ductility, which provide expansion to 5 mm without strut fracture (although hoop strength is substantially reduced at these diameters).…”

“…DESolve has undergone several iterations through alterations in polymer processing, initially to 100-µm strut thickness, 54,55 although current studies are using a de- The denominator in each cell is eligible patients (1-year follow-up or earlier event). BVS indicates Bioresorbable Vascular Scaffold; CI, confidence interval; CoCr EES, cobalt-chromium everolimus-eluting stent; ID-TLR, ischemia-driven target lesion revascularization; ID-TVR, ischemia-driven target vessel revascularization; MI, myocardial infarction; NA, not applicable (cannot test for heterogeneity because no events were present in 1 cell in 3 of the 4 trials); SCAI, Society for Cardiac Angiography and Interventions; TLF, target lesion failure; and TVMI, target vessel-related myocardial infarction.…”

A review of bioresorbable scaffolds: hype or hope?

“…(16) Similar to the BVS, it is composed of a poly-Llactide scaffold and elutes either antiproliferative myolimus (firstgeneration) or novolimus (second-generation). In comparison to other BRSs, the DESolve Scaffold is believed to have a wider range of expansion, with reduced risk of strut fracture and selfcorrection of minor malapposition.…”

Bioresorbable vascular scaffolds—what does the future bring?

“…In this respect, promising results were reported with the DEsolve scaffold. Its biodegradation and bioresorption take place in one and two years, respectively (22).…”