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

Gogas, Bill D; Bourantas, Christos V; Garcia Garcia, Hector Manuel; Onuma, Yoshinobu; Muramatsu, Takashi; Farooq, Vasim; Diletti, Roberto; van Geuns, Robert-Jan M; De Bruyne, Bernard; Chevalier, Bernard; Thuesen, Leif; Smits, Pieter C; Dudek, Dariusz; Koolen, Jacques; Windecker, Stephan; Whitbourn, Robert; McClean, Dougal; Dorange, Cecile; Miquel-Hebert, Karine; Veldhof, Susan; ... (2013). 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. EuroIntervention, 9(6), pp. 709-720. Europa Digital & Publishing 10.4244/EIJV9I6A115

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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.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Garcia Garcia, Hector Manuel, Windecker, Stephan
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1774-024X
Publisher:	Europa Digital & Publishing
Language:	English
Submitter:	Judith Liniger
Date Deposited:	24 Mar 2014 09:47
Last Modified:	05 Dec 2022 14:28
Publisher DOI:	10.4244/EIJV9I6A115
PubMed ID:	23628499
URI:	https://boris.unibe.ch/id/eprint/41675