The DESolve novolimus-eluting bioresorbable scaffold (BRS) offers safe and early enlargement in vessel, lumen, and scaffold dimensions for patients with simple lesions, according to midterm results.
The novel stent — with a poly-L-lactic-acid (PLLA) scaffold designed to provide structural support for at least 3 months and then bioresorb within 2 years, demonstrated an in-scaffold late lumen loss of 0.20 mm at 6 months, Alexandre Abizaid, MD, of Instituto Dante Pazzanese of Cardiology in Brazil, and colleagues reported in JACC: Cardiovascular Interventions.
Major adverse cardiac events — a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization — occurred in 3.3% of patients at 6 months, 5.7% at 1 year, and 7.4% at 2 years.
With a device success rate of 97% and and procedural success at 100%, the only case of scaffold thrombosis emerged within 30 days of the procedure (0.8%).
“The DESolve scaffold appears efficacious and safe in noncomplex lesions, with an added benefit of earlier lumen enlargement than that previously reported for other PLLA-based scaffolds,” the researchers concluded.
Compared with the everolimus-eluting Absorb BRS that got a strong recommendation for approval by an FDA advisory panel last week, DESolve “has a faster degradation and resorption profile leading to earlier lumen remodeling,” Abizaid’s group noted.
In addition, DESolve boasts of a novel self-correction property: “any tendency for initial recoiling is offset within the first few hours after deployment as the unconstrained device expands toward its nominal diameter,” according to Gregg W. Stone, MD, of Columbia University Medical Center/New York-Presbyterian Hospital in New York City.
“This ‘pre-programmed memory’ function as the crimped device hydrates would be expected to increase scaffold dimensions and minimize malapposition, attributes that may be especially useful after device under-deployment or in ST-segment elevation myocardial infarction (STEMI), in which infarct-related vessel dimensions tend to increase over time after PCI [percutaneous coronary intervention],” Stone wrote in an accompanying editorial.
Thus, he concluded, “the vast array of BRS devices that have been developed for human investigation are in many ways more different than alike, and the concept of a class effect must be rejected. Trials comparing different BRS will be useful in identifying which of their unique properties are most beneficial to patients (e.g., defining the optimal rate of structural support and bioresorption).”
Abizaid’s study included 126 patients enrolled in the DESolve NX registry between 2011 and 2012.
By 2 years, target lesion failure was recorded in 7.4%, cardiac death in 2.5%, and myocardial infarction in 0.8%.
Recipients of the DESolve had a 99% rate of full strut coverage at 6 months, but “whether this represents healthy endothelium and protects against device thrombosis is unknown,” according to the editorialist.
The investigators also warned that “the results cannot be extrapolated to more complex lesions and higher-risk patients.”
And with no head-to-head comparison to Absorb, “long-term comparative data will be needed to determine any true differences,” the authors wrote, nonetheless noting that “the late lumen loss observed at 6 months positions DESolve in the range of contemporary metallic drug-eluting stents [DES].”
“Coronary artery healing is the ultimate goal after intervention; however, the optimal timeline and overall process remain controversial,” they added.
Stone brought up another potential issue with the device that will demand attention in upcoming investigations.
“Intra-luminal scaffold dismantling has been associated with several cases of very late (>1 year) scaffold thrombosis with Absorb, and its frequency may be increased and time course shortened with devices that absorb more rapidly,” Stone wrote with a nod at DESolve. “At least 1 case of intra-luminal scaffold dismantling with a DESolve resulting in scaffold collapse at 5 months with subtotal occlusion has been reported.”
“Ultimately, whether all BRS are as safe and effective as best-in-class metallic DES within the first year of implantation and thereafter provide superior long-term clinical outcomes can only be answered by large-scale randomized trials,” Stone concluded.
Abizaid reported research funding from Abbott Vascular, Reva Medical, Biotronic, and Elixir Medical; as well as consulting fees from Elixir Medical.
Stone disclosed serving as chairman of ABSORB III and IV (sponsored by Abbott Vascular) and consulting for Reva.
JACC: Cardiovascular Interventions
Abizaid A, et al “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” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2015.12.004.
JACC: Cardiovascular Interventions
Stone GW “Bioresorbable vascular scaffolds: more different than alike?” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.01.012