番茄社区

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Further data from the ABSORB clinical series have again shown the everolimus-eluting bioresorbable scaffold noninferior to a standard everolimus-eluting metal stent.

But the "disappearing" stent consistently came out numerically not quite as good as what is considered a best-in-class drug-eluting stent (Xience), although without reaching statistical significance.

In ABSORB II, for example, at 2 years, the device-oriented composite endpoint (cardiac death, target-vessel myocardial infarction, and clinically-driven target-lesion revascularization) was 7.0% versus 3.0% for the conventional Xience stent (P=0.07).

In the pivotal ABSORB III trial that will be used to support FDA approval, target lesion failure at 1 year was 7.8% with the novel stent versus 6.1% for Xience, albeit well within the prespecified 4.5% noninferiority margin (P=0.007 for noninferiority versus P=0.16 for superiority).

In ABSORB China, 1-year angiographic data showed late lumen loss of 0.19 mm for the bioresorbable stent versus 0.13 mm for the cobalt-chromium scaffold control, which met the prespecified limit for noninferiority and closely mirrored results from ABSORB Japan reported last month at the European Society of Cardiology meeting.

All three were reported as late-breakers at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco. ABSORB III was simultaneously published in The while ABSORB China was published in the Journal of the American College of Cardiology.

At a press conference at TCT, , from the Linder Research Center in Cincinnati, dismissed price considerations when asked if the less than stellar numbers could be problematic for either approval or for eventual uptake.

Kereiakes, who presented the ABSORB III results there, said that the concept of stenting without permanently implanting metal in an artery was so appealing that it would gain acceptance on that basis even without demonstrating superiority.

However, press conference discussant of University Hospitals in Cleveland, suggested that price would be a big issue for a stent expected to be substantially more expensive without evidence of superiority.

"We do 13,000 procedure in six angio hospitals each year and we are going to face the same questions ... why are you paying more?" he said regarding his hospital system.

In Germany where Absorb is available, it costs about $1,340 in Germany versus only about $170 for a Xience stent, which is why cost is becoming more of an issue from Lukaskrankenhaus Neuss in Germany, noted as a member of the panel at the press conference.

Absorb scaffolds are used in about 10% to 15% of cases there, with outcome data collected in registry that so far in the accumulated 3 to 5 years of data is showing no difference, Haude said.

It will be "8 to 10 years before Absorb will be able to demonstrate superiority and superiority is what will be needed to convince the insurers to pay for it," he told 番茄社区 at the briefing.

The real test of superiority might not be apparent yet because it takes at least 3 to 4 years for the scaffold to be fully absorbed and the vessel to be "uncaged."

Simon agreed that now is too soon to look for observable clinical advantage, and "there is going to need to be some patient-centered outcome benefit."

Still, Simon agreed with Kereiakes that patient demand would also be a motivation for hospital systems to offer bioresorbable technology, saying, "We will pay a little more for a device that patients are asking for because they are concerned about rigid cages."

ABSORB III randomized 2,008 patients with stable or unstable angina in a 2:1 ratio to receive Absorb or Xience. ABSORB China assigned 480 eligible patients with one or two de novo native coronary artery lesions to Absorb or Xience.

ABSORB II randomized 335 patients to single blind treatment with Absorb or Xience. At 2 years, the all-cause mortality rate was 1.2% for Absorb versus 0.6 with Xience; MI rate was 5.8% versus 2.4%; and definite or probable stent thrombosis rate was 1.54% versus 0.0%.