Abbott is a step closer to crossing the Atlantic with its Absorb dissolving scaffold following broadly positive interim results from the Absorb II trial, in which the device performed just as well as Abbott’s billion-dollar selling metal Xience V drug-eluting stent.
Although the study was conducted in Europe Absorb II is important because it represents the template for the pivotal trial the group is using for FDA approval. If Abbott can replicate or beat these results when Absorb III reads out next year the device could get the US green light in early 2016.
In the 501-patient Absorb II trial 7.3% of those treated with Absorb suffered death or heart attack, or had to have a repeat procedure, after one year, compared with 9.1% of Xience patients. However, the target lesion failure rate – a composite of cardiac death, heart attack caused by a re-blockage of the vessel and need for a repeat procedure – was 4.8% for Absorb and 3.0% for Xience.
Although this was not significant, the difference in heart attack rate might be a cause for worry for some doctors, and as such the larger 2,200-patient Absorb III trial results will be watched with interest.
One benefit the trial threw up was that patients treated with Absorb were less likely to report angina symptoms – 16.4% versus 25.6% for Xience patients. Although the trial's small size made it hard to draw definite conclusions Abbott will be keen to highlight this difference as angina patients typically cost healthcare providers more because of repeated hospital and doctor visits.
And Abbott has indeed wasted little time in trying to curry favour with payers, initiating Absorb IV, a continuation of Absorb III designed specifically to evaluate quality of life and cost savings.
Absorb has been on the market in Europe since 2011, but sales have been sluggish as doctors have failed to embrace the technology. This could be partly thanks to its innovative nature; while Absorb props open arteries in same way as a traditional stent it eventually dissolves, allowing the treated vessel to regain motion, expanding and contracting in response to stress to the heart from normal activities such as exercise (Interview – Biotronik backs absorbable stent polymer over absorbable scaffolds, September 8, 2014).
Still, if analysts from Credit Suisse are to be believed, US approval could act as the spur for a huge rise in sales. Forecasts for the product stand at $825m in 2020, up from just $89m in 2013.
Even without US approval the scaffold might see some uplift in sales on the back of the Absorb II results, as it is the first randomised trial of the device, which gained European approval on single-arm studies.
There is also growing interest in bioresorbable scaffolds, as shown by last year’s European CE mark approval of Elixir Medical’s DESolve. But for this interest to be translated into big sales, as the technology trailblazer Abbott needs to show either stellar results from Absorb III or make a strong case for the benefits of angina reduction.
If it does not accomplish this it is unlikely that Absorb will unseat Abbott’s own market leader, Xience.
|Absorb III (US pivotal trial)||NCT01751906|