Author + information
- Patrick Serruys1,
- Taku Asano2,
- Salvatore Brugaletta3,
- Lorenz Raber4,
- Yoshinobu Onuma5,
- Stephan Windecker4 and
- Manel Sabate6
In the TROFI II randomized trial, stenting of culprit lesions with bioresorbable vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in an arterial healing pattern that was comparable with that of metallic Everolimus-eluting stent (EES) as assessed by optical frequency domain imaging at 6 months and associated with a low incidence of clinical adverse events . However, there is still limited data of the long-term outcome after implantation of Absorb with patients presenting with STEMI in the context of a randomized control trial. We sought to investigate the 3-year device-oriented composite endpoint (DOCE: a composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization) rate of the patients treated with Absorb scaffolds and EES in this challenging setting.
A total of 191 patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) in the TROFI II trial. The patients were clinically followed up yearly up to 3 years. The 3-year follow up data is being collected and will be analyzed according to the device type.
6-month optical frequency domain imaging healing score (HS) of Absorb, which was based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects, was 1.74 (±2.39) compared to HS of EES (2.80 ±4.44, difference [90% Cl] 21.06 [21.96, 20.16]; Pnon-inferioiity < 0.001). DOCE was comparably low between groups (3.2 % Absorb vs. 3.2% EES; p=ns) whereas device thrombosis rate was also comparable (2.1% Absorb vs 1.0% EES; p=ns) at 2-years follow-up.
In September 2017, 191 patients will have completed their 3-year clinical follow-up. The complete data of 3-year follow-up will be presented at the time of congress.
CORONARY: Acute Myocardial Infarction