CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

January 11th, 2011

Absorbable Stent Approved: Now You See It, Now You Don’t

Have questions about the new stent that just received CE Mark approval in Europe? Here’s a reality checklist.

1. What’s it called? The bioresorbable vascular scaffold (BVS) from Abbott Laboratories is named ABSORB (clever, huh?).

2. What are its advantages over a drug-eluting stent (DES)? Don’t know yet.  It may eliminate the need for long-term intensive antiplatelet therapy (speculative). Abbott says that the vessel treated with a BVS may “ultimately move, flex and pulsate similar to an untreated vessel” and calls this potential “vascular restoration therapy.” (In my opinion, this is a stretch…pun intended.)

3. What’s the composition? Everolimus is adhered to a bioabsorbable scaffold of polylactide, which is a biocompatible material commonly used in resorbable sutures.

4. How long does it take to absorb? The device dissolves within 2 years.

5. When will it be available in the U.S? Not in the near future. It’s not been studied in the U.S. Although available for clinical studies in Europe soon, it won’t be fully commercially available even there until late 2012.

6. Lots of data on its efficacy and safety? Surprisingly not. Thus far, the only safety and efficacy data come from a prospective, non-randomized (open label), 2-phase study that enrolled 131 patients from six European countries, Australia, and New Zealand.  In the study, major adverse cardiac events (MACE) and treated site thrombosis rates were evaluated at 30 days as well as at 6, 9, 12, and 24 months.

7. What do we know?

  • 5% incidence of MACE (composite cardiac death, MI, and ischemia-driven target lesion revascularization) at 9 months
  • No stent thrombosis
  • Minimal late loss (0.19 mm) at 9 months (comparable to DES)

8. What’s next? The ABSORB EXTEND trial is a single-arm study that will evaluate ~1000 patients with complex CAD in 100 centers in Europe, Asia Pacific, Canada, and Latin America. Later in 2011, a randomized, controlled trial in Europe will enroll ~500 patients at 40 centers to compare ABSORB to Abbott’s XIENCE PRIME everolimus-eluting metal DES.

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3 Responses to “Absorbable Stent Approved: Now You See It, Now You Don’t”

  1. Stephen Austin, MD says:
    January 13, 2011 at 1:14 pm

    Intriguing, but obviously too early to make any judgment–Need long term, randomized, statistically adequately powered studies, comparing the absorbable stent to standard drug eluting stents for efficacy and safety (particularly regarding the issues of stent thrombosis and potential toxicities)

    Competing interests pertaining specifically to this post, comment, or both:
    None–Just an interested reader of the posted blog

  2. ABOUBAKER EL-AGNAF, MD, MRCP,FRCP,DIM,FSCIA,MCS says:
    January 13, 2011 at 5:38 pm

    we need to know the restenosis rate? is it as effcient as DES in osteal and bifurcation lesion?

  3. Fahim H Jafary, MD, FACC, FSCAI says:
    February 22, 2011 at 9:19 am

    Intriguing concept and potentially very exciting. That said, we have no idea what will happen 5 years (or 10 years) down the line to that vessel once the stent vanishes. ?aneurysms ?ruptures ?nothing at all.

    On the other hand, bare metal stents have been implanted for 20 years and we know patients do very well with them. How about perfecting drug eluting stents such that after a short period of time (few months?) they become TRUE bare metal stents with no polymer? There are a few such stents out there (Biomatrix, Nobori) with bioabsorbable polymers but they require Plavix for a year.