The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: Insights from the first-in-man ABSORB Cohort B and SPIRIT II trials

Bill D. Gogas, Christos V. Bourantas, Hector M. Garcia-Garcia, Yoshinobu Onuma, Takashi Muramatsu, Vasim Farooq, Roberto Diletti, Robert Jan M. Van Geuns, Bernard De Bruyne, Bernard Chevalier, Leif Thuesen, Pieter C. Smits, Dariusz Dudek, Jacques Koolen, Stefan Windecker, Robert Whitbourn, Dougal McClean, Cecile Dorange, Karine Miquel-Hebert, Susan VeldhofRichard Rapoza, John A. Ormiston, Patrick W. Serruys

Research output: Contribution to journalArticlepeer-review

14 Citations (Scopus)

Abstract

Aims: To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES). Methods and results: Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive remodelling and distal edge changes in plaque composition with increase of the percent fibro-fatty (FF) tissue component. The 5 mm proximal and distal segments adjacent to the implanted devices were investigated serially with intravascular ultrasound (IVUS), post procedure, at six months and at two years, from the ABSORB Cohort B1 (n=45) and the SPIRIT II (n=113) trials. Twenty-two proximal and twenty-four distal edge segments were available for analysis in the ABSORB Cohort B1 trial. In the SPIRIT II trial, thirty-three proximal and forty-six distal edge segments were analysed. At the 5-mm proximal edge, the vessels treated with an Absorb BVS from post procedure to two years demonstrated a lumen loss (LL) of 6.68% (-17.33; 2.08) (p=0.027) with a trend toward plaque area increase of 7.55% (- 4.68; 27.11) (p=0.06). At the 5-mm distal edge no major changes were evident at either time point. At the 5-mm proximal edge the vessels treated with a XIENCE V EES from post procedure to two years did not show any signs of LL, only plaque area decrease of 6.90% (-17.86; 4.23) (p=0.035). At the distal edge no major changes were evident with regard to either lumen area or vessel remodelling at the same time point. Conclusions: The IVUS-based serial evaluation of the EVR up to two years following implantation of a bioresorbable everolimus-eluting scaffold shows a statistically significant proximal edge LL; however, this finding did not seem to have any clinical implications in the serial assessment. The upcoming imaging follow-up of the Absorb BVS at three years is anticipated to provide further information regarding the vessel wall behaviour at the edges.

Original languageEnglish
Pages (from-to)709-720
Number of pages12
JournalEuroIntervention
Volume9
Issue number6
DOIs
Publication statusPublished - 10-2013
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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