Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents.

Kereiakes, Dean J; Windecker, Stephan; Jobe, R Lee; Mehta, Shamir R; Sarembock, Ian J; Feldman, Robert L; Stein, Bernardo; Dubois, Christophe; Grady, Timothy; Saito, Shigeru; Kimura, Takeshi; Underwood, Paul; Allocco, Dominic J; Meredith, Ian T (2019). Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circulation. Cardiovascular interventions, 12(9), e008152. American Heart Association 10.1161/CIRCINTERVENTIONS.119.008152

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BACKGROUND

The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY.

METHODS

Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203).

RESULTS

The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%.

CONCLUSIONS

SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients.

CLINICAL TRIAL REGISTRATION

URL: https://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:

American Heart Association

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

10 Feb 2020 14:49

Last Modified:

10 Feb 2020 14:49

Publisher DOI:

10.1161/CIRCINTERVENTIONS.119.008152

PubMed ID:

31451014

Uncontrolled Keywords:

biodegradable polymer diabetes mellitus everolimus-eluting stent percutaneous coronary intervention polymers stent thrombosis

BORIS DOI:

10.7892/boris.139089

URI:

https://boris.unibe.ch/id/eprint/139089

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