Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial)

Chevalier, Bernard; Cequier, Ángel; Dudek, Dariusz; Haude, Michael; Carrié, Didier; Sabaté, Manel; Windecker, Stephan; Reith, Sebastian; Almeida, Manuel; Campo, Gianluca; Íñiguez, Andrés; Onuma, Yoshi; Serruys, Patrick W.

doi:10.4244/eij-d-17-00873

Cited by 45 publications

(33 citation statements)

References 9 publications

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“…In contrast to current CE‐marked drug‐eluting polymeric scaffolds with a resorption time up to 3 years, the magnesium scaffold backbone is nearly fully absorbed within one year and at 6 months struts are not discernable by optical coherence tomography (OCT) anymore . Therefore the conclusion of overall safety related to scaffold thrombosis is already justified for DREAMS 2G/Magmaris in this early phase as 12‐month outcomes somewhat reflect 3‐year outcomes of ABSORB (Abbott Vascular, Santa Clara, California) for which so far, no scaffold thrombosis beyond the resorption period of 3 years was observed in the ABSORB and ABSORB‐II studies . Likewise, the recommended dual antiplatelet therapy for Magmaris is shorter than for polymeric scaffolds as recent state of the art papers discuss a prolonged dual antiplatet therapy covering the complete biodegradation time of the BRS .…”

Section: Resultsmentioning

confidence: 99%

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

Haude

İnce

Kische

et al. 2018

Cathet Cardio Intervent

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Section: Resultsmentioning

confidence: 99%

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

Haude

İnce

Kische

et al. 2018

Cathet Cardio Intervent

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“…In the ABSORB II trial, a downturn of events has been reported between the 3rd and 4th year of follow-up, thereby positively impacting the difference between the target-lesion failure rates of Absorb BVS and Xience EES at 4-year follow-up [17]. Moreover, within the ABSORB III trial, in contrast to the pattern observed before 3 years, the event rates were similar between the Absorb BVS and Xience EES groups after 3 years [18].…”

Section: Discussionmentioning

confidence: 96%

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry

et al. 2020

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Background Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry. Methods and results In the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre-Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median followup of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term followup, the composite endpoint of TVF had occurred in 27 patients. The 4-year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days

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“…16 Patient Enrollment Patients were randomized into either the Absorb BVS arm or the XIENCE arm (2:1 ratio) and stratified by diabetic status and number of lesions to be and were likely related to scaffold sizing and suboptimal implantation technique. 15 Currently, there is a lack of adequate evidence from RCTs to support the safety and performance of BVS vs. metallic stent beyond 3 years, and post-resorption of scaffold.…”

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confidence: 99%

Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent　― A Randomized Comparison Through 5 Years in Japan ―

Kozuma

Tanabe

Yuji³

et al. 2020

Circ J

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year have demonstrated noninferiority of Absorb BVS compared with XIENCE cobalt-chromium everolimuseluting stent (CoCr-EES), with comparable rates of patientoriented (all-cause death, all myocardial infarction [MI], or all revascularization) and device-oriented (target lesion failure [TLF]) composite endpoints. 9 However, mid-term results showed increased rates of composite device-oriented adverse events and device thrombosis at 2 years, 10,11 and 3 years 12,13 of follow-up compared with EES. Scaffold undersizing was determined to be an independent predictor of very late scaffold thrombosis with BVS. 14 Long-term follow-up to 4 years did not show improvement in TLF or device thrombosis rates for BVS between 3 and 4 years, B ioresorbable vascular scaffolds (BVS) were developed with the aim of preventing the adverse events associated with the use of metallic drug-eluting stents (DES), such as very late stent thrombosis (ST), late restenosis, and neoatherosclerosis. 1,2 Progressive resorption of the scaffold may help the vessel wall recover its normal physiological pulsatile strength, thereby reducing the long-term risk of adverse events. 3,4 The Absorb BVS resorbs completely within 3 years of implantation, 5,6 and at 5 years, there is evidence of restored vasomotion, endotheliummediated vasodilation, vessel remodeling, plaque regression, and the formation of stable neointima. 7,8 Short-term randomized controlled trials (RCTs) up to 1

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Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial)

Cited by 45 publications

References 9 publications

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry

Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent　― A Randomized Comparison Through 5 Years in Japan ―

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Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial)

Cited by 45 publications

References 9 publications

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry

Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent ― A Randomized Comparison Through 5 Years in Japan ―

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Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent　― A Randomized Comparison Through 5 Years in Japan ―