Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine PCI: three-year clinical outcomes from the AIDA trial

Kerkmeijer, Laura S.M.; Tijssen, R.; Hofma, Sjoerd H.; Schaaf, René J. van der; Arkenbout, Karin; Kraak, Robin P.; Weevers, Auke; Piek, Jan J.; Winter, Robbert J. de; Tijssen, Jan G.P.; Henriques, José P.S.; Wykrzykowska, Joanna J.; Ijsselmuiden, Alexander; Kauer, Floris; Beijk, Marcel A.M.; Vis, Marije M.; Koch, Karel T.

doi:10.4244/eij-d-19-00325

Cited by 12 publications

(9 citation statements)

References 6 publications

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“…Absorb BVS was initially expected to be fully resorbed at 2 years after device implantation. Several studies have, however, reported that (very) late ScT also frequently occurs between the 2nd and 3rd year after device implantation, and even beyond 3 years, with the latest case of ScT reported as late as 44 months after Absorb BVS implantation [5,6,8,9]. In these studies, the leading mechanisms of very late ScT were associated with (disintegrated) strut material that protruded into the coronary lumen, most likely as a consequence of intraluminal scaffold dismantling or late (acquired) malapposition [10].…”

Section: Discussionmentioning

confidence: 99%

“…The 2-year results of the AMC Absorb Registry showed that the use of Absorb BVS in a patient registry reflecting daily clinical practice was associated with good procedural safety and acceptable clinical outcomes at mid-term (2-year) followup [4]. Higher rates of device thrombosis, however, have been reported up to 3 years after Absorb BVS implantation [5,6]. Long-term follow-up after Absorb BVS implantation is therefore necessary in order to examine whether the annual event rates will decline after scaffold dismantling and resorption has been completed.…”

Section: What's New?mentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: What's New?mentioning

confidence: 99%

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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“…In the AIDA trial, Absorb BVS was associated with higher rates of target vessel myocardial infarction (TV‐MI) and device thrombosis at 3 years compared to Xience EES 11 . In this sub‐study, we found that (1) DM is associated with higher rates of all‐cause death, revascularization and TLR, (2) TVF and its individual components were not different between absorb BVS and Xience EES in both DM and non‐DM, (3) Absorb BVS implantation lead to higher rates of device thrombosis in patients both with and without DM, and (4) rates of TVF were highest in iTDM patients, both for absorb BVS versus Xience EES (25.2 vs. 20.5%, respectively).…”

Section: Discussionmentioning

confidence: 99%

“…The AIDA trial was a multicenter, investigator‐initiated, randomized controlled trial. The study design, 12 the preliminary safety report, 13 2‐year 10 and 3‐year 11 results have been published previously. Briefly, between August 2013 and December 1, 2015, 845 consecutive patients were randomized to either Absorb BVS (924) or Xience EES (921).…”

Section: Methodsmentioning

confidence: 99%

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Three‐year clinical outcomes of the absorb bioresorbable vascular scaffold compared to Xience everolimus‐eluting stent in routine PCI in patients with diabetes mellitus— AIDA sub‐study

Kerkmeijer

Tijssen

Hofma

et al. 2020

Catheter Cardiovasc Interv

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Background In this prespecified AIDA‐trial sub‐study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus‐eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3‐year follow‐up. Methods and results All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin‐treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively). Conclusions In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3‐year follow‐up.

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ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry

Rapetto

Leoncini

Cerrato

et al. 2021

Cardiovascular Revascularization Medicine

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Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine PCI: three-year clinical outcomes from the AIDA trial

Cited by 12 publications

References 6 publications

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

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

Three‐year clinical outcomes of the absorb bioresorbable vascular scaffold compared to Xience everolimus‐eluting stent in routine PCI in patients with diabetes mellitus— AIDA sub‐study

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry

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