Three-Year Outcomes With the Absorb Bioresorbable Scaffold

Abstract

Background: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. Methods: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. Results: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10–1.73; P =0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; P =0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P =0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P =0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P =0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P =0.02) and device thrombosis rates (1.1% versus 0.0%; P <0.0001) were higher with BVS than cobalt-chromium everolimus-eluting stents. Conclusions: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Tuning structural relaxations, mechanical properties, and degradation timescale of PLLA during hydrolytic degradation by blending with PLCL-PEG

“…In particular it has gained prevalence in the field of bioresorbable cardiac stents, being used as the main stent structural material for commercial devices including the ABSORB (Abbott Vascular) and DESolve (Elixir Medical) stents [1]. These devices have shown promising initial results, demonstrating noninferiority to metallic stents, and low rates of complications [2,3], however more recent results have indicated increased rates of device-associated adverse events compared with metallic stents [4,5]. The ABSORB stent was voluntarily withdrawn from sale by the manufacturer in 2017 after the declaration of safety concerns, and to date the successful use of bioresorbable stents has been limited, in large part, by their mechanical and degradation properties [1,6,7].…”

Current perspectives on the role of bioresorbable scaffolds in the management of coronary artery disease

“…Interestingly, a landmark analysis between one and two years confirmed higher rates of TVF (3.3% vs. 1.9%; p = 0.0376) and device thrombosis (0.5% vs. 0.0%; p < 0.001) in patients treated with the Absorb [29]. These findings were strengthened by a recent individual-patient-data pooled meta-analysis of 3389 patients from four ABSORB trials [30]. In this meta-analysis, implantation of the Absorb was associated with higher three-year rates of TVF (11.7% vs. 8.1%; p = 0.006), target-vessel MI (7.8% vs. 4.2%; p = 0.0006), and ischaemia-driven TLR (6.6% vs. 4.4%; p = 0.02), with comparable cardiac mortality (1.1% vs. 1.1%; p = 0.85; Fig.…”

“…The risk of device thrombosis at three years was higher for BRS (2.4% vs. 0.6%; p = 0.001). In addition, between one and three years, TVF (6.1% vs. 3.9%; p = 0.02) and device thrombosis (1.1% vs. 0.0%; p < 0.001) were higher for the Absorb [30]. A recent network meta-analysis by Kang et al [31] provides some data on the indirect comparison of the long-term clinical performance of the Absorb in comparison to other metallic BMSs and DESs.…”

Advances and Challenges of Biodegradable Implant Materials with a Focus on Magnesium-Alloys and Bacterial Infections

“…One of the first commercially available fully absorbable polylactic acid stent (Absorb, Abbot) that was FDA approved in 2016 dissolved in two to three years, but despite promising short-term results long-term side effects were negative and sales were terminated by 2017 [42,43]. In clinical trials these polymer stents were more difficult to insert due to the increased efforts required for imaging, and over a two-year period induced higher rates of in-stent thrombosis than drug eluting metal stents [44]. In summary, the presently investigated resorbable polymer stents were deemed inferior to established metal stents.…”