P2801Hard events after orsiro sirolimus-eluting stent (HEROES) in STEMI: a multicenter registry

Abstract

Abstract Background Primary percutaneous coronary intervention (pPCI) using drug-eluting stents (DES) is the treatment of choice for the ST segment elevation Myocardial infarction (STEMI). Specific DES platforms, as well the strategies used to control drug release, may influence mid-to-long term pPCI success rate. Orsiro, a third generation hybrid sirolimus eluting stent with a biodegradable polymer, may potentially cause less stent malapposition, stent-induced inflammation and mechanical damage, ultimately reducing the thrombogenicity of the stent. Purpose The aim of the HEROES Registry is: 1) to evaluate the safety and efficacy of the Orsiro stent in STEMI patients undergoing pPCI; 2) to capture data that reflect the “real-world” use of Orsiro stents in pPCI and provide insights into patient characteristics, comorbid conditions, patterns of care, quality of care and performance measurements. Methods From January 2012 to March 2018 we prospectively enrolled all patients diagnosed with STEMI who have received one or more Orsiro stents in the target vessel of pPCI at 9 Italian centres. The primary end-point of the study was a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction (MI) clearly attributable to the intervention culprit vessel (TVMI) and ischemic-driven target lesion revascularization (ID-TLR) at 1-year follow up. Secondary end-points were: 1) DOCE at 6-month and 3-year follow-ups; 2) any definite/probable stent thrombosis; 3) any TIMI major bleeding (in-hospital, within 7 days after pPCI and at follow-up). Results Study cohort comprised 338 patients with a mean age of 64.9±12.0 years; 255 (75.4%) were men, 69 (20.4%) had diabetes and 59 (17.5%) chronic kidney disease. Median follow-up was 10.5 (range 0–67) months. Culprit vessel was the left anterior descending (LAD) in 167 (49.4%), right coronary (RCA) in 97 (28.7%), left circumflex artery (LCX) in 42 (12.4%) and other vessels in 32 (9.5%). Multivessel disease was present in 178 (52.7%); 106 (31.4%) had bifurcation lesion as a culprit. In 155 (45.9%) the culprit lesion was proximal, in 154 (45.6%) mid-vessel. Stent per lesion ratio was 1.3±0.6. Thrombus grade was 0–2 in 236 (69.8%) and 3–5 in 102 (30.2%). At 1-year follow-up we observed a 4.4% cumulative incidence of DOCE, consisting of 13 (3.8%) cardiac deaths, 1 (0.3%) TVMI and 1 (0.3%) ID-TLR. Definite stent thrombosis occurred in only 1 (0.3%) patient during hospital stay. There were only 4 major bleedings (1.2%), all during follow-up. Kaplan-Meier analysis showed a DOCE-free survival at 6 months of 95.9%, and at 1 and 3 years of 95.6 and 95%, respectively. DOCE-free survival curve Conclusions Orsiro stent seems to be effective and safe in contemporary pPCI. The optimal features of Orsiro contribute to the few adverse events observed during follow-up and to an event-free survival that compares favorably with similar registries of modern DES.