Last week, Abbott Laboratories issued a statement on its website announcing it would halt the sales of its Absorb Bioresorbable Vascular Scaffold and Absorb GT1 Bioresorbable Vascular Scaffold system as of Sep. 14. The devices treat coronary artery disease.
The quiet statement without a press release made it clear that the Illinois device maker was pulling the plug on the expensive stents because of low commercial sales, globally. But an analysis of the product’s history from the presentation of the Absorb III clinical trial results back in October 2015 at a major cardiology conference, to the FDA safety alert in March proves that physicians are weighing cost versus clinical value propositions more closely than ever before.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
And that is a notable departure from the past.
Historically, the medical device industry made new products, tacked on a premium and expected physicians — with whom the company reps maintained close relationships — to flock toward the new device. And flock they did. That dynamic has largely disappeared even in the context of seemingly new innovations like Absorb, which was billed as the world’s first fully resorbable cardiac stent that leaves no permanent implant behind.
Let’s rewind to October 2015, when Abbott unveiled results of the Absorb stent to the medical community at Transcatheter Cardiovascular Therapeutics’ annual meeting in San Francisco (which I attended as a reporter for my previous employer that published Medical Devices + Diagnostic Industry). Back then, Abbott was presenting results from Absorb III, which compared the fully resorbable stent to its own best-in-class Xience V stent.
Both Absorb and Xience V deliver the everolimus drug to keep previously narrowed arteries open after the stent is placed. However, Absorb is designed to disappear from the body completely two to three years after placement. The metallic Xience V stent remains in the body permanently.
All Abbott was able to prove in the pivotal study was that Absorb is not inferior to Xience. It had met its clinical endpoint of target lesion failure at one year. There was also no statistical differences between the two devices in other clinical outcomes.
Numerically, however, the study told a different story. Absorb’s results were worse off than Xience on a number of different outcomes, including device thrombosis, where a thrombus or blood clot suddenly forms in a stented coronary artery impeding blood flow and is a life-threatening complication.
Within one year, “device thrombosis had occurred in 1.5 percent of patients in the Absorb group and in 0.7 percent of those in the Xience group” according to results published in the New England Journal of Medicine. The Absorb III trial implanted 1,322 patients with the Absorb device and 686 with the Xience stent.
Given the just-presented results, a panel of clinical experts at TCT questioned the utility and price — in Germany, the device apparently cost eight times the cost of the standard drug-eluting stent — for Absorb. The consensus was this may have a benefit in the future and in general not having a permanent implant is great, but it sure costs a lot.
Nearly a year and a half later in March 2017, FDA sounded alarm bells about this new innovation from Abbott. Here’s what the FDA alert said on March 18.
The FDA’s initial review of two-year data from the BVS pivotal clinical study (the ABSORB III trial) shows an 11 percent rate of major adverse cardiac events (e.g., cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel) in patients treated with the BVS at two years, compared with 7.9 percent in patients treated with the already-approved Abbott Vascular’s metallic XIENCE drug-eluting stent (p = 0.03). This study also shows a 1.9 percent rate of developing blood clots (thrombosis) within the BVS versus 0.8 percent within the XIENCE stent at 2 years. These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels.
Following the alert, the money quote came from Dr. Deepak Bhatt, senior associate editor of ACC.org and Dr. Kim Eagle, editor-in-chief of ACC.org (American College of Cardiology).
“While the notion of a bioresorbable scaffold resonates with clinicians and patients alike until we have large trials demonstrating their clear superiority over existing platforms using drug-eluting stents, we should temper our enthusiasm for using them,” he said in an article posted on the site.
Both advocated for a “wait for more data” approach to weighing fully resorbable stents against the standard drug-eluting permanent metallic stents.
While Abbott is suspending sales of Absorb, it said it would continue to follow patients in existing clinical studies per protocols and work on a next-generation product. Physicians can also use up whatever is left in their inventory.
An Abbott spokeswoman, Kristina Becker, provided the following statement from the company:
Analysis of the recent US pivotal study (ABSORB III) and other randomized clinical trials of Absorb suggest similar outcomes to the gold-standard drug-eluting stent when contemporary implantation guidance is applied. If earlier implantation guidance was used, the studies also showed that most patients implanted with Absorb will have positive outcomes even though more major adverse coronary events rates were observed compared to XIENCE. There was no difference in death rate between Absorb and XIENCE across studies.
The question is how much the alert or how much the low sales or both —Absorb reportedly accounted for less than 1 percent of Abbott’s overall stent sales — figured in the decision to pull the plug and focus instead on the second-generation device. The device’s price certainly was an issue right from the get-go.
Back in October 2015, Abbott’s principal investigator for the Absorb III pivotal trial had struck a defiant tone when reporters questioned him on whether the price of the device —and the fact that it wasn’t better than Xience V — would hinder market adoption if the device was approved. [FDA approved the Absorb scaffold in July 2016. ]
“You know what my standard answer is on that?” declared Dr. Dean Kereiakes, medical director of The Christ Hospital Heart and Vascular Center in Ohio. “It’s not my job. My job is to do the trial and get the device approved….”
Let’s hope that Absorb 2.0, if and when it arrives, will arm company executives and associates with better answers from both a clinical-outcomes and pricing standpoints.
Until then, all that glitters is not gold, and physicians are looking for clear clinical superiority to pay top dollar.
Photo: AlisLuch, Getty Images
The story has been updated with a comment from Abbott.
