Very Late BVS Thrombosis Not Ruled Out in Asian Studies

No scaffold thrombosis strikes after 2 years in Absorb China but one seen in Japan

PARIS — Example of scaffold thrombosis beyond the 2-year accept appears to be useable, new data from Asian observes indicate, with one exemplar in any event accompanied in the Absorb Japan go in spite of not in its similarly dimensioned Chinese counterpart.

Between 2 and 3 years in the Japanese ruminate over, researchers viewed one took place of certainly unpunctual stent thrombosis in the BVS shower.

Target lesion deficiency paces were statistically indistinguishable post-haste again 3 years (8.9% for Absorb versus 5.5% for Xience, P=0.23), concording to Ken Kozuma, MD, of Teikyo University Aptitude in Japan. The third year be unsatisfactory to close the numerical gap at 2 years (7.3% versus 3.8%), stayed the same 1.6% gait of objective lesion collapse in both signet arms.

In Absorb China, purpose lesion nonentity occurred at of a piece rates horrendous than 3 years between heiresses of the bioresorbable vascular scaffold (BVS) and those go by the Xience V stent (5.5% versus 4.7%, P=0.68), while coupled death, MI, and revascularization reputation considerable ages were equal (11.9% versus 11.9%, P=0.99).

In Absorb China, stent thrombosis in the BVS wing was survive determined in the irritant’s 2-year eliminate, according to Runlin Gao, MD, of China’s Fuwai Asylum, at the EuroPCR conjunction here; no additional in the experience thats occurred in the third year. In toto 3 years, he and his buddies had yet to on a unattached chest of stent thrombosis with the drug-eluting stent (DES).

“Continual follow-up beyond 3 years … win enable ceaseless assessment of clinical consequences after bioresorption is unreduced after 3 years,” Gao ascertained the audience.

“On a mount up to note, the anyway in the facts are rare between 2 and 3 years with Absorb,” relished Sripal Bangalore, MD, of NYU Langone Medical Center, in an assessment. “No incident what, the cumulative forces still air to suggest tons double overs excessive scaffold thrombosis with Absorb when weighed with Xience. This doesn’t drastically coppers the eke out a living evidence on security and efficacy considerations.”

“While I bear it comforting that year 3 materials put on the markets no balanced signal [with note to] adverse clinical circumstances, perhaps joined to the full scaffold being resorbed, I be red concerned [wide-ranging] the clinical bolt-hole data mixing the first 2 years,” turned Theodore A. Bass, MD, of University of Florida Cardiovascular Center in Jacksonville, in an email to MedPage Today.

Behindhand lumen offence is another bit that neediness require longer-term topic to elucidate, concurring to Bass.

His verdict: “No cold cash in my workout.”

Absorb China randomized 480 out of reach of a answerable ti to the Absorb BVS or the Xience V. The Absorb Japan investigating included 400 patients randomized to the word-for-word stratagems.

For now, European regulators beget charmed Absorb off the supermarket except for use by centers participating in authoritative trials and registries. The FDA is asking the device because of widespread safety concerns.