Key result
Absorb BVS shows a ~4% target vessel failure rate at six months.
Why the study?
The efficacy and safety of everolimus-eluting bioresorbable vascular scaffold Absorb implantation in real-world patients with coronary artery disease were not well established in Russia.
Does everolimus-eluting bioresorbable vascular scaffold implantation provide safe and effective outcomes in real-world patients with coronary artery disease?
Observational (n=500)
No
Does everolimus-eluting bioresorbable vascular scaffold implantation provide safe and effective outcomes in real-world patients with coronary artery disease?
In a real-world Russian registry, BVS Absorb implantation showed high procedural success and low 6-month adverse events, though a concerning tendency toward high scaffold thrombosis was noted.
Acceptable short-term outcomes support Absorb BVS feasibility in real-world CAD; leaves open thrombosis risk for randomized confirmation.
Aim. The paper demonstrates the interim analysis of efficacy and safety after everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb implantation in “real-world patients” with coronary artery disease.Methods. A cohort of 500 consecutive patients who underwent percutaneous coronary intervention for stable chest pain or acute coronary syndrome with implantation of at least one BVS (Absorb, Abbott Vascular) and followed up by telephone interview and review of medical charts were included in a singlecenter, prospective, all-comers, first in Russia registry. The primary endpoint, target vessel failure, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization and secondary endpoints, MACCE (composite of cardiovascular death, myocardial infarction, coronary artery bypass surgery, target vessel revascularization, stroke) and stent thrombosis, were assessed during 6-month follow-up.Results. A total of 500 patients with coronary artery disease (CAD) (stable CAD 54.4%, acute coronary syndrome 45.6%) and different amount of affected vessels (1 vessel CAD 40.8%, n = 204; 2-vessel CAD 32.8%, n = 164; 3-vessel CAD 26.4%, n = 132) received 664 scaffolds and 55 stents in 603 stenoses. Procedure success, defined as a residual stenosis less than 30% and TIMI 3 flow in target vessel at the end of procedure, was observed in 98.51% (n = 594). At the moment of 6-month follow-up 4.2% (n = 24) of patients were lost to contact. After 6 months, incidence of target vessel failure and MACCE was 4.2% (n = 21) and 5% (n = 25). The cumulative rate of definite/probable scaffold thrombosis was 1.6% (n = 8).Conclusion. The interim analysis of Gabi-R: Russia registry, the largest trial of BVS Absorb implantation in routine clinical practice, showed high procedural success and low incidence of adverse events during follow-up. However, a tendency to high incidence of scaffold thrombosis compared to drug-eluting stents can be observed. Considering the long-term results of randomized trials retrospective registries, safety in terms of BVS routine use is of big concern. Longterm 24-month data regarding safety endpoints are required to test the afore-mentioned suggestion. Received 5 January 2019. Revised 28 March 2019. Accepted 29 March 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.
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Prokhorikhin et al. (2019) conducted an observational in Coronary artery disease (n=500). Everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb was evaluated on Target vessel failure (combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization). Implantation of the Absorb bioresorbable vascular scaffold in patients with coronary artery disease resulted in a 6-month target vessel failure rate of 4.2%.
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