In the Journals

SUPERB: Interwoven nitinol stent yields high primary patency rate at 3 years

The final 3-year outcomes of the SUPERB trial showed that use of an interwoven nitinol stent design achieved high primary patency and maintained clinical durability outcomes in patients with lower-limb arterial obstructive disease.

Peripheral artery disease is a growing worldwide epidemic,” Lawrence A. Garcia, MD, from the division of cardiology and vascular medicine at St. Elizabeth Medical Center, Tufts University School of Medicine in Boston, and colleagues wrote. “The unique design of the Supera stent (Abbott Vascular) allows for a uniquely strong radial force with the conformability that is currently unmatched in any currently available stent.”

Researchers enrolled 264 intention-to-treat and 64 roll-in patients in a single-arm study that compared the outcomes with an FDA-mandated objective performance goal.

Lawrence Garcia
Lawrence A. Garcia

There was a mean follow-up period of 887 ± 352 days.

In the trial, treated lesion lengths were 7.8 ± 4.3 cm and chronic total occlusions occurred in 65 (24.6%) patients.

Researchers reported 89% freedom from clinically driven target lesion revascularization at 12 months, 84% at 24 months and 82% at 36 months.

In interwoven nitinol stents deployed nominally in length, compressed or elongated (between −10% and +10% nominal length), the difference of clinically driven TLR at 36 months was affected, according to the researchers, as freedom at 2 and 3 years from clinically driven TLR was 86.7% in minimal compression and it 90% in moderate compression.

In stents deployed with minimal (10%-20%), moderate (20%-40%) or severe elongation (> 40%), there was a freedom from clinically driven TLR of 84.1%, 87.4% and 77%, respectively, at 12 months, according to the researchers.

Freedom from clinically driven TLR for moderate elongation was 81.8% at 2 years and 78.2% at 3 years. For severe elongation, it was 63.4% at 2 years and 42.3% at 3 years.

Researchers noted that fractures were uncommon with this stent, with a single facture event in the 36-month follow-up.

“The SUPERB study [demonstrates] excellent clinical outcomes in patients with symptomatic infrainguinal PAD,” Garcia and colleagues wrote. “It may be considered as a first-line therapy when stent revascularization is selected in this difficult anatomic location.” – by Dave Quaile

Disclosure: The study was funded by IDEV Technologies, now part of Abbott. Garcia reports consulting for Abbott Vascular, Boston Scientific, Medtronic and Spectranetics and has equity interests in CV Ingenuity, Essential Medical, Primacea, Scion Cardiovascular, Spirox, Syntervention and Tissue Gen. Please see the full study for a list of the other researchers’ relevant financial disclosures.

 

The final 3-year outcomes of the SUPERB trial showed that use of an interwoven nitinol stent design achieved high primary patency and maintained clinical durability outcomes in patients with lower-limb arterial obstructive disease.

Peripheral artery disease is a growing worldwide epidemic,” Lawrence A. Garcia, MD, from the division of cardiology and vascular medicine at St. Elizabeth Medical Center, Tufts University School of Medicine in Boston, and colleagues wrote. “The unique design of the Supera stent (Abbott Vascular) allows for a uniquely strong radial force with the conformability that is currently unmatched in any currently available stent.”

Researchers enrolled 264 intention-to-treat and 64 roll-in patients in a single-arm study that compared the outcomes with an FDA-mandated objective performance goal.

Lawrence Garcia
Lawrence A. Garcia

There was a mean follow-up period of 887 ± 352 days.

In the trial, treated lesion lengths were 7.8 ± 4.3 cm and chronic total occlusions occurred in 65 (24.6%) patients.

Researchers reported 89% freedom from clinically driven target lesion revascularization at 12 months, 84% at 24 months and 82% at 36 months.

In interwoven nitinol stents deployed nominally in length, compressed or elongated (between −10% and +10% nominal length), the difference of clinically driven TLR at 36 months was affected, according to the researchers, as freedom at 2 and 3 years from clinically driven TLR was 86.7% in minimal compression and it 90% in moderate compression.

In stents deployed with minimal (10%-20%), moderate (20%-40%) or severe elongation (> 40%), there was a freedom from clinically driven TLR of 84.1%, 87.4% and 77%, respectively, at 12 months, according to the researchers.

Freedom from clinically driven TLR for moderate elongation was 81.8% at 2 years and 78.2% at 3 years. For severe elongation, it was 63.4% at 2 years and 42.3% at 3 years.

Researchers noted that fractures were uncommon with this stent, with a single facture event in the 36-month follow-up.

“The SUPERB study [demonstrates] excellent clinical outcomes in patients with symptomatic infrainguinal PAD,” Garcia and colleagues wrote. “It may be considered as a first-line therapy when stent revascularization is selected in this difficult anatomic location.” – by Dave Quaile

Disclosure: The study was funded by IDEV Technologies, now part of Abbott. Garcia reports consulting for Abbott Vascular, Boston Scientific, Medtronic and Spectranetics and has equity interests in CV Ingenuity, Essential Medical, Primacea, Scion Cardiovascular, Spirox, Syntervention and Tissue Gen. Please see the full study for a list of the other researchers’ relevant financial disclosures.