Safety and performance of a new drug-eluting metal scaffold

This study looked at the safety and performance of a new drug-eluting metal scaffold in patients with narrowed blood vessels to the heart. The new scaffold was shown to be safe for use up to 12 months.  

In patients with narrowed arteries, a scaffold can be inserted into the blood vessel to improve blood flow to the heart. Some scaffolds also slowly release medications (drug-eluting), such as sirolimus (Rapamycin), to decrease blood clotting, which can reblock the vessel. A new drug-eluting metal scaffold that can be reabsorbed into the body called DREAMS 2G had been developed. The safety and effectiveness of this new scaffold must be determined.  

123 patients received the new scaffold and followed for an average 12 months. At the start of the study, 71.5% patients had stable angina (chest pain on exertion), 13.8% had unstable angina (chest pain at rest), and 14.6% had reduced blood supply to the heart with no symptoms.

After 12 months, 86.2% patients were symptom-free, 12.1% had stable angina, and 0.9% had reduced blood supply to the heart with no symptoms.

While some narrowing of the vessel was to be expected over time (due to tissue growth), there was no significant changes in average vessel size at 6 or 12 months following the insertion of the scaffold. 

At 12 months, 1 patient had died of an unknown cause, 1 patient had a heart attack and 2 patients had to have a repeat procedure. No patient experienced a blood clot at the site of the scaffold over 12 months.

The authors concluded that this new absorbable metal scaffold is safe and gives relatively stable blood vessels size up to 12 months. 

There was a small sample size of patients studied, and longer term studies are needed.