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

Costa, J. Ribamar; Abizaid, Alexandre; Whitbourn, Robert; Serruys, Patrick W.; Jepson, Nigel; Steinwender, Clemens; Stuteville, Marrianne; Ediebah, Divine E.; Sudhir, Krishnankutty; Bartorelli, Antonio L.; investigators, Absorb Extend

doi:10.1002/ccd.27715

Cited by 11 publications

(6 citation statements)

References 25 publications

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“…A total of 1,157 studies were screened for inclusion in our meta‐analysis, as shown in the flow‐chart for the selection process in Figure . Three studies were excluded since not designed as randomized clinical trials, one since not providing clinical outcome data, one study since not providing data on individual components of the primary composite endpoint, whereas one study was excluded since enrolling patients treated for PAD …”

Section: Resultsmentioning

confidence: 99%

“…Three studies were excluded since not designed as randomized clinical trials, 18,20,21 one since not providing clinical outcome data, 22 one study 19 since not providing data on individual components of the primary composite endpoint, whereas one study was excluded since enrolling patients treated for PAD. 23 After the exclusion of studies with duplicate data ad meta-analysis, 11 randomized clinical trials (RCTs) [14][15][16][24][25][26][27][28][29][30][31] were finally included in our analysis, with an overall population of 10,707 patients.…”

Section: Eligible Studiesmentioning

confidence: 99%

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Poly (l‐lactic acid) bioresorbable scaffolds versus metallic drug‐eluting stents for the treatment of coronary artery disease: A meta‐analysis of 11 randomized trials

Verdoia¹,

Kedhi

Suryapranata³

et al. 2019

Cathet Cardio Intervent

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Background: Bioresorbable vascular scaffolds (BVS) have been proposed for overcoming the long-term limitations of permanent metallic stents, while theoretically warranting similar advantages in plaque stabilization and anti-restenotic drug delivery in the early postrevascularization phase. However, increased rates of malapposition, restenosis, or thrombosis have emerged from initial trials with BVS, that were nevertheless underpowered for the evaluation of the real outcome benefits of these coronary devices. The recent completion of newer randomized clinical trials paves the way to the present meta-analysis, aiming at the comparison of Poly (L-Lactic acid) BVS (PLLA-BVS) versus metallic drug-eluting stents (DES) in the treatment of coronary stenoses. Methods: Literature and main scientific session abstracts were searched for randomized clinical trials (RCTs) comparing drug-eluting BVS versus metallic DES for the treatment of coronary artery disease (CAD). The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis and the composite of device-oriented target lesion failure (TLF). Results: We included 11 randomized trials, for a total population of 10,707 patients, 54.5% treated with BVS. The major indication for PCI was stable CAD, whereas acute coronary syndrome represented 30% of the patients. At a mean follow-up of 2.64 years (1-5 years), mortality occurred in 2.71% of the patients, with no difference according to the type of implanted stent (OR[95%CI] = 0.94 [0.74, 1.20], p = .62). No interaction was observed according to patients' risk profile or the rate of diabetes and ACS. However, a significant increase in myocardial infarction, stent thrombosis, TLR and TLF was observed with BVS as compared to DES. Conclusions: The present meta-analysis provides the most updated data on the use of PLLA-BVS for the treatment of CAD. We documented a poorer performance of these new coronary devices, as compared to new generation metallic DES, being associated with an increased rate of recurrent cardiovascular events. However, such ischemic complications did not impact on mortality, with a comparable survival independently from the type of stent.

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Section: Resultsmentioning

confidence: 99%

Section: Eligible Studiesmentioning

confidence: 99%

Poly (l‐lactic acid) bioresorbable scaffolds versus metallic drug‐eluting stents for the treatment of coronary artery disease: A meta‐analysis of 11 randomized trials

Verdoia¹,

Kedhi

Suryapranata³

et al. 2019

Cathet Cardio Intervent

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“…Furthermore, the angiographic surveillance at 5 years showed satisfactory results with an overall late luminal loss of 0.26 ± 0.42 mm 11 . Furthermore, a large‐scale study of 812 patients with predominately stable coronary artery disease and non‐complex lesions reports 3‐year rates for MACE, TLR, and ScT of 9.2%, 3.1%, and 2.2%, respectively 12 . Besides, randomized‐controlled trials with long‐term follow‐up comparing BRS and DES are available.…”

Section: Discussionmentioning

confidence: 92%

Five‐year follow‐up of patients who underwent everolimus‐eluting bioresorbable scaffold implantation

Wiebe

Hofmann

Dörr

et al. 2020

Cathet Cardio Intervent

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Objectives: The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation. Background: Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse. Methods: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including targetvessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed. Results: A total of 176 patients with a median age of 64 (55-72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years. Conclusions: Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.

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“…In particular another retrospective study showed favourable outcomes with EE-BRS at 2 years, comparable to modern DES in DM patients [29]. Similarly, other studies, have shown favourable results with EE-BRS at longer follow-up, however these studies were not exclusively focussed on DM patients [30, 31]. However, our data reveals similar clinical outcomes as the everolimus-eluting stent (EES) arm from a pooled database from the SPIRIT and COMPARE trials in DM patients [11].…”

Section: Discussionmentioning

confidence: 99%

Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study

Hommels

Hermanides

Rasoul

et al. 2019

Cardiovasc Diabetol

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Background Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. Methods The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). Results Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. Conclusion EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered

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

Cited by 11 publications

References 25 publications

Poly (l‐lactic acid) bioresorbable scaffolds versus metallic drug‐eluting stents for the treatment of coronary artery disease: A meta‐analysis of 11 randomized trials

Poly (l‐lactic acid) bioresorbable scaffolds versus metallic drug‐eluting stents for the treatment of coronary artery disease: A meta‐analysis of 11 randomized trials

Five‐year follow‐up of patients who underwent everolimus‐eluting bioresorbable scaffold implantation

Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study

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