Healthcare company Abbott has started the ABSORB IV clinical trial to test the cost-effectiveness of its medical device Absorb bioresorbable vascular scaffold (BVS), which is used in the heart to function such as a stent.
The ABSORB IV trial will compare the device with a permanent metallic drug eluting stent in people with coronary artery disease.
Absorb is the world's first drug eluting BVS that works similar to a metallic stent by opening up blocked blood vessels in the heart and restoring blood flow. Once it completes its function, the polylactide-made Absorb dissolves completely over time.
The trial is also the first randomised heart stent trail to measure angina as a primary endpoint at one year. Angina is a kind of chest pain that occurs due to reduced supply of blood to the heart.
According to studies, about 25% people treated for angina with percutaneous coronary intervention (PCI) with metallic stents still experienced the pain over the course of a year.
The aim of the current trial is to confirm these findings so that it can lead to angina patients having a better quality of life.
The ABSORB IV trial also assesses long-term clinical safety and performance based on the change in target lesion failure (TLF) which is a traditional endpoint in heart stent trials and measures the level of safety and effectiveness of a device.
Principal investigator of the Absorb IV trial Dr Gregg Stone said: "The ABSORB IV trial will rigorously and prospectively examine whether there are differences in angina rates between a permanent stent and a dissolvable device after a percutaneous coronary intervention.
"People care about their quality of life following a procedure, and this trial will allow us to measure that important outcome, in addition to traditional clinical endpoints."
The data collected from this trial will be combined with ABSORB III trails, which collectively would have studied a group of close to 5,000 people from the US. This data will help the company to evaluate the performance of the product and compare it with the effectiveness of similar products in the market.
The randomised data of ABSORB II trials conducted in Europe showed that people treated with the device experienced less angina in comparison to people using metallic stents.