Paclitaxel-Eluting Bioabsorbable Stent Shows Advantage over Bare-Metal Version

SAN FRANCISO, CA—In 6-month results, a new paclitaxel-eluting bioabsorbable stent shows a strong safety profile and improved efficacy compared with an absorbable bare-metal predecessor, according to a report presented November 9, 2011, at the annual Transcatheter Cardiovascular Therapeutics scientific symposium.

For the prospective, first-in-man BIOSOLVE-I study, Raimund A. Erbel, MD, of the West German Heart Center (Essen, Germany), and colleagues followed 46 patients who underwent PCI of single de novo lesions with the drug-eluting absorbable metal scaffold (DREAMS; Biotronik AG, Zurich, Switzerland). For cohort 1 (n = 22), the primary endpoint was target lesion failure (TLF; composite of cardiac death, target-vessel MI, or clinically driven TLR) at 6 months; while for cohort 2 (n = 24), the primary endpoint will be TLF at 12 months.   

For DREAMS, alterations to the earlier absorbable bare-metal scaffold include changes in strut geometry, refinement of the magnesium alloy, and addition of a paclitaxel-eluting polymer matrix to provide scaffolding and drug release for up to 3 months. All components of DREAMS are expected to be fully absorbed into the body within 6 to 12 months.   

Marked Decrease in Late Lumen Loss   

Implantation was successful in all patients. In the combined cohorts at 6 months, there were no instances of cardiac death, MI, or scaffold thrombosis and only 2 cases each of TLF and clinically driven TLR. IVUS imaging showed a 41% reduction in late lumen loss and an approximate fivefold reduction in the rate of binary restenosis with DREAMS compared with the first-generation absorbable stent (figure 1).   

In addition, optical coherence tomography revealed a low incidence (4.7%) of malapposition and complete coverage of strut remnants at 6 months. Moreover, after DREAMS biodegraded, vasomotion was restored. 

Asked why DREAMS incorporated paclitaxel rather than one of the limus drugs, Dr. Erbel said it was a matter of what was available at the time of the study. He added that he would like to see absorbable SES investigated. 

“Overall, this study shows a considerable step forward in the use of absorbable scaffolds,” Dr. Erbel concluded, although he admitted that there is room for improvement. 

Panelist Jorge A. Belardi, MD, of the Instituto Cardiovascular de Buenos Aires (Buenos Aires, Argentina), commented, “It’s nice to see there’s not only one player in the absorbable stent field.” 

Study Details

The mean reference vessel diameter was 2.73 ± 0.48 mm, while the mean scaffold length was 16 mm. 

 

Source:

Erbel R. BIOSOLVE-I: A prospective study of a paclitaxel-eluting bioabsorbable magnesium scaffold in patients with coronary artery disease. Presented at: Transcatheter Cardiovascular Therapeutics 2011; November 9, 2011; San Francisco, CA. 

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Paclitaxel-Eluting Bioabsorbable Stent Shows Advantage over Bare-Metal Version

SAN FRANCISO, CA—In 6 month results, a new paclitaxel eluting bioabsorbable stent shows a strong safety profile and improved efficacy compared with an absorbable bare metal predecessor, according to a report presented November 9, 2011, at the annual Transcatheter Cardiovascular
Disclosures
  • Dr. Erbel reports receiving grant or research support from Biotronik. 
  • Dr. Belardi reports receiving consulting fees/honoraria from Biotronik. 

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