A double-blind randomised study to evaluate the efficacy and safety of bindarit in preventing coronary stent restenosis.

Colombo, Antonio; Basavarajaiah, Sandeep; Limbruno, Ugo; Picchi, Andrea; Lettieri, Corrado; Valgimigli, Marco; Sciahbasi, Alessandro; Prati, Francesco; Calabresi, Marco; Pierucci, Daniela; Guglielmotti, Angelo (2015). A double-blind randomised study to evaluate the efficacy and safety of bindarit in preventing coronary stent restenosis. EuroIntervention, 11(8), e1385-e1394. Europa Digital & Publishing 10.4244/EIJY15M12_03

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AIMS

Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention.

METHODS AND RESULTS

A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively.

CONCLUSIONS

This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Valgimigli, Marco
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1774-024X
Publisher:	Europa Digital & Publishing
Language:	English
Submitter:	Daria Vogelsang
Date Deposited:	05 Apr 2016 15:21
Last Modified:	05 Dec 2022 14:53
Publisher DOI:	10.4244/EIJY15M12_03
PubMed ID:	26690313
URI:	https://boris.unibe.ch/id/eprint/78783