Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials

Collet, Carlos; Asano, Taku; Miyazaki, Yosuke; Tenekecioğlu, Erhan; Katagiri, Yuki; Sotomi, Yohei; Cavalcante, Rafael; Winter, Robbert J. de; Kimura, Takeshi; Gao, Runlin; Puricel, Serban; Cook, Stéphane; Capodanno, Davide; Onuma, Yoshinobu; Serruys, Patrick W.

doi:10.1093/eurheartj/ehx155

Cited by 44 publications

(38 citation statements)

References 38 publications

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“…However, although in randomized trials BVS met criteria for noninferiority compared with contemporary metallic DES within the first year after implantation, 6 an ongoing risk of adverse events between 1 and 2 years was identified, 7 resulting in increased patient-oriented and device-oriented adverse event rates with BVS compared with DES at cumulative 2-year follow-up. 8,9 Comprehensive analysis of BVS outcomes through 3-year follow-up has not been performed, in part because the 3-year results from the ABSORB III trial, the largest BVS randomized trial to date, have not been reported. In this regard, characterizing the safety and efficacy profile of BVS at 3 years, when its bioresorption is complete, 10 is essential to understanding the limitations of this first-generation device that must be overcome if the potential later advantages of BVS are to be realized.…”

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confidence: 99%

Three-Year Outcomes With the Absorb Bioresorbable Scaffold

et al. 2018

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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.

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Three-Year Outcomes With the Absorb Bioresorbable Scaffold

et al. 2018

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“…Recently, Collet et al published a metanalysis with the late clinical outcomes (> 2 years) of 1,730 patients treated either with either ABSORB BVS or metallic EES from five randomized clinical trials . Patients treated with the scaffold had a higher risk of definite/probable thrombosis compared with patients treated with metallic DES (OR 2.93, 95% CI 1.37–6.26, P = .01).…”

Section: Discussionmentioning

confidence: 99%

“…Despite the attractive concept of “vessel uncaging and vascular restoration” that prompted the development of bioresorbable vascular scaffolds (BVS), recent randomized trials and “real‐world” registries have raised concern about the safety of the 1st generation of this novel technology, especially due to increased risk of thrombosis within the first weeks of the scaffold implantation and also lately, after the 1st year of follow‐up, when mechanical properties of the BVS were expected to have disappeared or markedly attenuated …”

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confidence: 99%

Three‐year clinical outcomes of patients treated with everolimus‐eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial

Costa

Abizaid

Whitbourn

et al. 2018

Cathet Cardio Intervent

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Background There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year‐performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. Methods ABSORB EXTEND is a prospective, single‐arm, open‐label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0–3.8 mm (as assessed by on‐line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. Results Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia‐driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for “bail out” stent. Conclusion At three‐year follow‐up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on https://clinicaltrials.gov (unique identifier NCT01023789).

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“…Moreover, both OCT and CT angiography confirmed the acceptable results of Absorb implantation in SCAD patients at 1 and 3 years of follow‐up, respectively. However, due to significantly higher rates of scaffold thrombosis with Absorb implantation compared to metallic Everolimus‐eluting stents in patients with coronary artery disease, Absorb was recently withdrawn from the market.…”

Section: Discussionmentioning

confidence: 99%