Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial

Abstract

AimsPatients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.Methods and resultsABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) −1.06 (−1.96, −0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).ConclusionStenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

Bioresorbable vascular scaffolds in patients with acute myocardial infarction: a new step forward to optimized reperfusion?

“…Importantly, a device-oriented composite end-point (cardiac death, target vessel MI and clinically-driven target lesion revascularization) (1.1% vs. 0%) and stent thrombosis rates (1.1% vs. 0%) were similar in the BVS and EES arms, respectively. This study demonstrated that BVS implantation in STEMI patients is associated with a nearly complete arterial healing at followup, with morphological findings comparable with those seen with EES (23). This is of potential clinical relevance considering previous studies suggesting superior healing characteristics of EES compared with first-generation DES.…”

“…In addition, the combined clinical outcome measure was similar in the 3 arms. The ABSORB-STEMI-TROFI II was a multicenter randomized clinical trial that allocated (1:1) STEMI patients to BVS (95 patients) or EES (96 patients) (23). Randomization was performed after achievement of TIMI 2 flow following thrombus aspiration.…”

“…Optical coherence tomography was used to compare arterial healing responses (non-inferiority design) with both devices as a surrogate for safety and efficacy. The primary endpoint was the comparison of the healing score (presence of uncovered struts, malapposed struts and intraluminal material) at 6 months assessed by optical coherence tomography (23). The healing score was lower (1.74 vs. 2.80, P for non-inferiority <0.001, P for superiority 0.053) in the BVS arm.…”

Bioresorbable vascular scaffolds—time to vanish?

“…The ABSORB-stemi TROFI II trial Sabaté et al made another important contribution by publishing the primary outcome of the multicentric, randomised, single-blinded TROFI II trial (31). They reported BVS to be non-inferior to EES in STEMI patients at six months for arterial healing based on a multimodal imaging score.…”

Bioresorbable drug eluting scaffolds—are bioresorbable stents ready for today’s clinical practice?

“…These findings were recently confirmed in the Absorb III trial which showed a non-inferiority of BRS compared with metallic DES in regards of target lesion failure at one year follow up (7). Furthermore, fully biodegradable scaffolds were recently investigated in the setting of acute ST-elevation myocardial infarction and compared against 2 nd generation DES with regards to their performance on a multicomponent ordinal healing score (8).…”