3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds

Kereiakes, Dean J.; Ellis, Stephen G.; Metzger, Christopher; Caputo, Ronald P.; Rizik, David G.; Teirstein, Paul S.; Litt, Mortimer; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O.; Popma, Jeffrey J.; McGreevy, Robert; Zhang, Zhen; Simonton, Charles A.; Stone, Gregg W.; Investigators, Absorb Iii

doi:10.1016/j.jacc.2017.10.010

Cited by 227 publications

(153 citation statements)

References 27 publications

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“…Figure details the search process including reasons for study exclusion. We included five trials (Kereiakes et al., ; Kozuma, Tanabe, & Kimura, ; Sabate & Asano, ; Serruys, Chevalier, et al., ; Xu et al., ) that comprised n = 3,575 patients randomized to either the everolimus‐eluting Absorb™ BVS ( n = 2,256) or an EES ( n = 1,319). We have supplied the patient characteristics for these trials in Table .…”

Section: Resultsmentioning

confidence: 99%

“…Prolonging DAPT for patients with the BVS implanted to 3 years (when bioresorption is complete) has also been suggested in order to avoid stent thrombosis (Buccheri, Caramanno, Geraci, & Cortese, ). However, it should be noted that most of the ST events in ABSORB III occurred in patients maintained on DAPT (Kereiakes et al., ). Prospective, randomized data comparing DAPT duration in patients implanted with the BVS is necessary to reach a conclusive recommendation.…”

Section: Discussionmentioning

confidence: 99%

“…Thirdly, the biases of the included studies apply to the current review. Fourthly, the patients in the ABSORB trials (Kereiakes et al., ; Kozuma et al., ; Serruys, Chevalier, et al., ; Xu et al., ) make up the majority included in our analysis. The inclusion and exclusion criteria in these trials were highly selective, and thereby, the performance of the BVS in “high‐risk” patients and complex lesions was not assessed.…”

Section: Discussionmentioning

confidence: 99%

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Everolimus‐eluting bioabsorbable vascular scaffolds (BVS) versus everolimus‐eluting metallic stents (EES) at 3 years: Systematic review and meta‐analysis

Medveczky

O'Loughlin

2018

Med Devices & Sens

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Background This systematic review and meta‐analysis aimed to assess the efficacy and safety of the Absorb bioabsorbable vascular scaffold (BVS) versus everolimus‐eluting metallic stents (EES) at 3 years. Methods We searched MEDLINE, EMBASE, CENTRAL and relevant websites for articles published between 30 November 2006 and 18 December 2017. The primary efficacy outcome was target lesion revascularization (TLR), and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes included target lesion failure, myocardial infarction (MI), death, all revascularization and a patient‐oriented composite end‐point. We derived odds ratios (ORs) for the outcomes according to a fixed‐effects model. His study was registered with PROSPERO (CRD42017084290). Results We included five trials comprising data for 3,575 patients randomized to receive BVS (n = 2,256) or EES (n = 1,319). Patients treated with the BVS had a non‐statistically significant increased risk of TLR (OR 1.30 [95% CI 0.95–1.78]; p = 0.10). Patients treated with the BVS had a higher risk of definite or probable stent thrombosis (OR 2.68 [95% CI 1.57–4.58]; p < 0.001), target lesion failure (1.41 [1.12–1.78]; p = 0.004), MI (1.49 [1.13–1.98]; p = 0.005) and a patient‐oriented composite end‐point (1.21 [1.01–1.44]; p = 0.038) than those treated with an EES. Patients treated with the BVS had no statistically significant difference in death (0.80 [0.51–1.25]; p = 0.325) and all revascularization (1.12 [0.91–1.40]; p = 0.052) compared to those treated with an EES. Conclusion Everolimus‐eluting bioabsorbable vascular scaffolds are inferior to everolimus‐eluting metallic stents at 3 years.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Everolimus‐eluting bioabsorbable vascular scaffolds (BVS) versus everolimus‐eluting metallic stents (EES) at 3 years: Systematic review and meta‐analysis

Medveczky

O'Loughlin

2018

Med Devices & Sens

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“…The ABSORB III trial randomized 2008 patients with unstable or stable angina in 2:1 ratio to receive everolimus‐eluting BVS or a cobalt‐chromium EES (Xience) stent . Although no significant difference in the primary endpoint of TLF at 1 year was noted, at 3 year follow up, BVS was associated with higher target vessel myocardial infarction (TVMI) (8.6% vs 5.9%, P = 0.03) and device thrombosis (2.3% vs 0.7%, P = 0.01) in the setting of similar DAPT use between groups . Additionally, although adverse outcomes were associated with reference vessel diameter (RVD) <2.25 mm before 1 year, 90% of scaffold thrombosis occurred in appropriately sized vessels between 1 and 3 years.…”

Section: Bioresorbable Scaffoldmentioning

confidence: 99%

Percutaneous coronary intervention: 2017 in review

Rao

Sheth

Grines

2018

J Interven Cardiology

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In an effort to keep the interventional community up-to-date with the abundant amount of new data, we have selected what we believe to be the most important publications in percutaneous coronary intervention from January 1, 2017 to 2 The overall rate of complete revascularization (CR) was 61.7%.In those patients with CR, there was no difference between CABG or PCI regarding death from any cause as well as composite of death, MI, and stroke at 5 year follow up, even at higher SYNTAX scores.However, compared to CABG with CR, PCI with incomplete revascularization put patients at a significant higher risk for similar endpoints. These studies suggest that the ability to achieve CR should be strongly considered when deciding between CABG and PCI in MVD.As we have learned from contemporary data on revascularization, certain subsets of patients have fared better with one revascularization strategy over another. An observational cohort study of multiple Swedish registries found that in patients with Type 1 diabetes and MVD, first multi-vessel revascularization with PCI was associated with higher risk of cardiac death, MI, and repeat revascularization although with similar all-cause mortality when compared to CABG. 3 This study indicates that CABG may be the preferred strategy in patients with Type 1 diabetes in need of multi-vessel revascularization, and is in agreement with earlier trials showing most of the benefit in patients treated with insulin, but not oral agents.In patients with low or intermediate SYNTAX score, PCI of unprotected left main with everolimus-eluting stents (EES) was shown to be noninferior to CABG with respect to a composite endpoint of death, stroke, and MI at 3 years in the EXCEL trial. 4 Of the 1905 patients randomized during the trial, 1788 patients were also followed for quality of life assessment to fully understand patient's perspective.

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“…Current data of the Absorb everolimus‐eluting poly‐L‐lactid acid‐based bioresorbable vascular scaffold (BVS, Abbott Vascular, Santa Clara, California, US) confirmed a distinctly poorer angiographic and clinical performance at long‐term follow‐up compared to modern drug‐eluting stents (DES) . BVS implantation in small vessels, suboptimal implantation technique and BVS‐resorption related phenomena such as intraluminal scaffold dismantling and discontinuity have been identified as important factors determining outcomes after BVS implantation …”

Section: Introductionmentioning

confidence: 99%

Hybrid‐stenting with metallic and bioresorbable drug‐eluting stents 2‐year clinical outcomes in KUM ABSORB registry

Baquet

Grundmann

Schmidt

et al. 2018

Cathet Cardio Intervent

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3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds

Cited by 227 publications

References 27 publications

Everolimus‐eluting bioabsorbable vascular scaffolds (BVS) versus everolimus‐eluting metallic stents (EES) at 3 years: Systematic review and meta‐analysis

Everolimus‐eluting bioabsorbable vascular scaffolds (BVS) versus everolimus‐eluting metallic stents (EES) at 3 years: Systematic review and meta‐analysis

Percutaneous coronary intervention: 2017 in review

Hybrid‐stenting with metallic and bioresorbable drug‐eluting stents 2‐year clinical outcomes in KUM ABSORB registry

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