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AIDA: BVS noninferior to EES in TVF, but confers higher device thrombosis

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A bioresorbable vascular scaffold was noninferior to an everolimus-eluting stent for target vessel failure but conferred higher rates of device thrombosis and target vessel MI, according to the complete 2-year results of the all-comers AIDA trial presented at EuroPCR.

The findings were consistent with preliminary 2-year results published in March 2017 and previously reported by Cardiology Today’s Intervention.

In the all-comers trial of the BVS (Absorb, Abbott Vascular) vs. the EES (Xience, Abbott Vascular), researchers randomly assigned 1,845 patients undergoing PCI representative of those seen in real-world clinical practice (mean age, 64 years; 74% men) to one or the other.

The primary outcome was TVF, defined as cardiac death, target vessel MI or target vessel revascularization. For the complete 2-year follow-up, which was simultaneously published in EuroIntervention, 96.9% of patients had adequate data available.

Joanna J. Wykrzykowska, MD, PhD, from Heartcenter, Academic Medical Center, University of Amsterdam, and colleagues reported that the estimated Kaplan-Meier 2-year event rates of TVF were 11% in the BVS group and 9.9% in the EES group (P for noninferiority = .003; HR = 1.12; 95% CI, 0.94-1.49).

The researchers also reported that the estimated Kaplan-Meier 2-year event rates of definite or probable stent thrombosis were 3.3% in the BVS group and 0.9% in the EES group (HR = 3.76; 95% CI, 1.73-8.21). The difference was driven by definite stent thrombosis (2.9% vs. 0.5%; HR = 5.2; 95% CI, 2-13.59) and occurred in the subacute, late and very late stages, Wykrzykowska and colleagues found.

Target vessel MI occurred in 5.1% of the BVS group and 3.1% of the EES group (HR = 1.65; 95% CI, 1.03-2.64).

“Efforts are ongoing to develop a second generation of safer bioresorbable coronary scaffolds,” the researchers wrote in EuroIntervention. “The hope is that, after absorption and integration processes are complete, event rates will be lower than those of DES. An analytic Markov model of the most recent updated corresponding meta-analyses of randomized clinical trials with Absorb BVS versus metallic stents, performed under the assumption of no scaffold thrombosis or [target lesion revascularization] between 3 and 25 years, suggested that the observed 3-year increased rate of [scaffold thrombosis] would be offset 19 years after PCI. This means that the allowable excess risk of [scaffold thrombosis] during the first 3 years after scaffold implantation must decline significantly in order to justify the value of treatment with a bioresorbable scaffold.” – by Erik Swain

References:

Wykrzykowska JJ, et al. BRS technology: Clinical outcomes continued. Presented at: EuroPCR; May 22-25, 2018; Paris.

Tijssen RYG, et al. EuroIntervention. 2018;doi:10.4244/EIJ-D-18-00335.

Disclosure: Wykrzykowska reports she receives consultant fees and research grants from Abbott Vascular.