Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.

Kereiakes, Dean J; Meredith, Ian T; Windecker, Stephan; Lee Jobe, R; Mehta, Shamir R; Sarembock, Ian J; Feldman, Robert L; Stein, Bernardo; Dubois, Christophe; Grady, Timothy; Saito, Shigeru; Kimura, Takeshi; Christen, Thomas; Allocco, Dominic J; Dawkins, Keith D (2015). Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circulation: Cardiovascular interventions, 8(4) Lippincott Williams & Wilkins 10.1161/CIRCINTERVENTIONS.114.002372

[img]
Preview
Text
e002372.full.pdf - Published Version
Available under License Publisher holds Copyright.

Download (905kB) | Preview

BACKGROUND

Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent.

METHODS AND RESULTS

Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively.

CONCLUSIONS

In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1941-7632

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Judith Liniger

Date Deposited:

25 Feb 2016 11:25

Last Modified:

16 Jun 2016 10:20

Publisher DOI:

10.1161/CIRCINTERVENTIONS.114.002372

PubMed ID:

25855680

Uncontrolled Keywords:

drug-eluting stent; percutaneous coronary intervention

BORIS DOI:

10.7892/boris.75932

URI:

https://boris.unibe.ch/id/eprint/75932

Actions (login required)

Edit item Edit item
Provide Feedback