Clinical Research
Absorb Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Metallic Stent in ST-Segment Elevation Myocardial Infarction: 1-Year Results of a Propensity Score Matching Comparison: The BVS-EXAMINATION Study (Bioresorbable Vascular Scaffold-A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction)

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Abstract

Objectives

The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients.

Background

The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients.

Methods

This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated.

Results

The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS.

Conclusions

At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.

Key Words

ABSORB
everolimus-eluting stent
STEMI

Abbreviations and Acronyms

BVS
bioresorbable vascular scaffold(s)
CI
confidence interval
DOCE
device-oriented endpoint
EES
everolimus-eluting stent(s)
GP
glycoprotein
HR
hazard ratio
MI
myocardial infarction
PCI
percutaneous coronary intervention
RR
relative risk
STEMI
ST-segment elevation myocardial infarction
TIMI
Thrombolysis in Myocardial Infarction

Cited by (0)

This work was funded in part by the “Ministerio de Economia y Competitividad, Instituto de Salud Carlos III” (RIC RD12/0042/0006). Dr. Brugaletta has received speakers fees from Abbott and AstraZeneca. Dr. Gori has received speakers honoraria from Abbott Vascular. Dr. Kocka has received speaker honorarium from Abbott Vascular; has been a transcatheter aortic valve implantation proctor for and received an institutional grant from Medtronic; and has received grant support from Zentiva. Dr. Widimsky has received speakers honoraria from Abbott. Dr. Sabaté has served as a consultant for Abbott and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.