BIOSOLVE-II Trial: Novel Absorbable Scaffold Performs Well in De Novo Coronary Lesions at 6 Months

SAN FRANCISCO – New 6-month data suggest that a second-generation drug-eluting absorbable metal scaffold is feasible, safe, and associated with favorable outcomes in de novo coronary artery lesions.

Michael Haude, MD, of  Lukaskrankenhaus Neuss in Germany, presented the results of the prospective, multicenter, nonrandomized, first-in-man BIOSOLVE-II trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

At a press conference, Haude explained that the sirolimus-eluting absorbable metal scaffold (Dreams 2G; Biotronik, AG, Buelach, Switzerland) is made out of a magnesium alloy with an absorption time of 12 months and behaves very similarly to a permanent metal stent.

“You can nicely implant it as you are used to implanting your permanent device,” Haude said. “It has better trackability because it does not have sharp edges; it has rounded edges. Although the strut thickness is the same (150 mcm) compared to the first-generation bioresorbable scaffolds made out of [poly-L-lactide].”

Haude and colleagues enrolled 123 patients with de novo coronary artery stenosis from 13 percutaneous coronary intervention centers between October 8, 2013 and May 22, 2015.

Six months after implantation with the absorbable metal scaffold, the primary endpoint of in-segment late lumen losswas 0.27 mm.

Among patients who received 6 months of vasomotion testing (n=25), 80% had angiographically discernable vasomotion.

Intravascular ultrasound revealed a preservation of the scaffold area of 6.24 mm² post-procedure compared with 6.21 mm² at 6 months with a low mean neointimal area of 0.08 mm². Furthermore, optical coherence tomography did not identify any intraluminal mass.

In clinical outcomes data, 4 patients (3%) experienced target lesion failure. One patient died from cardiac death; 1 had periprocedural myocardial infarction; and 2 underwent clinically-driven target lesion revascularization.

Dr. Haude noted that the target lesion failure and target lesion revascularization rates were comparable to those observed with permanent drug-eluting stents and other scaffolds.

There were no reported cases of definite or probably scaffold thrombosis.

Going forward, as the absorbable technology continues to evolve, Haude suggested that future research should focus on reducing strut thickness and, most importantly, modifying the shape of the strut. 

“This rectangular shape … for the polymers is almost unavoidable,” Haude said. “To make it more round is excessively difficult without breaking the structure of the polymer. With these metal [stents], you can have nicely rounded shapes. If you look at fluid dynamic experiments, we do note that [it is] much more beneficial if you have round shapes when you compare it to rectangular.”

Disclosures: This study was funded by Biotronik AG (Buelach, Switzerland). Michael Haude, MD received research/grant support from Biotronik AG (Buelach, Switzerland).

References

1. Haude M et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2015;doi:10.1016/s0140-6736(15)00447-x.

2. Haude M et al. Late-Breaking Trials and First Report Investigations I. Presented at: 27^th Annual Transcatheter Cardiovascular Therapeutics scientific symposium; October 10-15, 2015; San Francisco.