The Pt-Cr everolimus-eluting stent with bioabsorbable polymer in the treatment of patients with acute coronary syndromes. Results from the SYNERGY ACS registry

Abstract

Objectives: We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS).

Background: A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm.

Methods: This is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months.

Results: A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01). Cardiac death was 1.3% (1.6%, p = 0.8 and 0.5%, P superiority =0.1 respectively). Myocardial infarction was 1.6% (4.6%, p < 0.01 and 1.8%, P superiority = 0.9 respectively). Target lesion revascularization was 1% (3.4%, p < 0.01 and 5.4%, P superiority <0.01 respectively). Definite or probable thrombosis was 0.9% (2.8%, p ≤ 0.01 and 1.1%, P superiority = 0.8 respectively).

Conclusions: The results of this registry show a very good safety and efficacy profile at 12 months for the SYNERGY stent in patients with ACS.

Summary: A recent trial (TIDES-ACS) in the context of acute coronary syndromes (ACS) reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY stent control arm. We investigated the safety of SYNERGY stent in a real-world study population with ACS applying the same inclusion/exclusion criteria as used in the TIDES-ACS trial. Primary endpoint was the composite of cardiac death, myocardial infarction and TLR at 12 months. A total of 1008 patients have been included. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority <0.01 and 6.3% in OPTIMAX TIDES-ACS arm, P superiority <0.01).

Keywords: Acute coronary syndrome; Bare metal stent; Drug-eluting stent.