Early and long-term outcomes of bioresorbable vascular scaffolds in the treatment of patients with coronary artery disease in real-world clinical practice – insights from the ZABRZE-BVS registry (original) (raw)
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Indian Heart Journal, 2017
Background and objective: Studies conducted across the world have reported that the rates of major adverse cardiac events (MACE) following the use of bioresorbable vascular scaffolds (BVS) are comparable to that noted with traditional drug eluting stents (DES). However, there is limited data on the immediate and medium-term clinical outcomes following the use of the Absorb BVS (Abbott Vascular, Santa Clara, SA) in the Indian context. This study was conducted to determine real-world evidence on the immediate and medium-term clinical outcomes in all patients undergoing percutaneous coronary intervention (PCI) with the Absorb BVS. Methods: Data of all patients who were treated with Absorb BVS at our center were evaluated. Between December 2012 and October 2016, 142 patients underwent PCI with BVS. The MACE rates during hospitalization, at 30 days, 3 months, 6 months after PCI, and every 6 months thereafter were the primary endpoints evaluated with median follow up of 13 months. Results: Mean age of the study participants was 53.7 AE 11.8 years. Intravascular ultrasound imaging was performed in 15.34% of patients. Predilatation and postdilatation were performed in 81.8% and 84.6% of scaffolds, respectively. There were no episodes of MACE during hospitalization. However, 1 BVS-related MACE was observed at the 1-month (0.7%) as well as at the !12 month (0.8%) follow up visits. At the 6and 12-month follow up visits, 2 (1.5%) and 3 (2.5%) non-BVS-related MACEs, respectively, were recorded. Conclusion: The use of Absorb BVS in this real-world experience was associated with very good immediate and medium-term clinical outcomes.
EuroIntervention
Aims: The safety of bioresorbable scaffolds (BRS) has recently been challenged. However, it is unclear whether outcomes depend on the complexity of the lesion or on the technique used to implant the device. The aim of this study was to report on the outcomes after BRS implantation in complex lesions. Methods and results: This investigator-initiated, single-centre, single-arm observational study recruited 657 consecutive patients (79% male, 66.7% acute coronary syndrome, age 63±12 years). Three hundred and twenty-two lesions (42.3%) in 297 (45.2%) patients with type B2 or C lesions were classified as the "complex lesions group". Post-procedural residual stenosis was slightly but significantly greater in the complex lesions group (15.7±11.3% vs. 13.5±10.2%, p=0.0109). The median follow-up was 1,076 (762-1,206) days without difference between groups. The Kaplan-Meier rates of early scaffold thrombosis (3.5% vs. 1.1%, p=0.0478, HR 3.03 [1.06-8.70]) and scaffold restenosis (9.9% vs. 9.1%, p=0.0262, HR 2.34 [1.11-4.94]) were higher in patients with complex lesions than in those with simple lesions. Late/very late thrombosis, death, repeat myocardial infarction, or repeat coronary interventions were not different. In patients in whom strict guidelines for implantation were applied, the incidence of thrombosis was reduced by 76% in complex lesions and by 92% in simple ones, such that there were no differences between groups (2.3% vs. 0.5%, p=0.3899). In contrast, the incidence of scaffold restenosis was reduced by 59% and 89%, and a difference between groups persisted (7.0% vs. 1.6%, p=0.0235). Conclusions: BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.
Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up
JAMA Cardiology, 2019
IMPORTANCE Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. OBJECTIVE To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. DATA SOURCES We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. STUDY SELECTION Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. DATA EXTRACTION AND SYNTHESIS Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. MAIN OUTCOMES AND MEASURES The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. RESULTS Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. CONCLUSIONS AND RELEVANCE The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease.
Journal of Clinical Medicine, 2020
Introduction: We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. Methods: Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641–2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan–Meier and Cox regression analysis. Results: 512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second–third year, and 0.6% in the fourth–fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. P...
Journal of the American College of Cardiology, 2017
Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes. This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters). TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and ...
Journal of International Medical Research, 2018
Objectives To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population. Methods This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization. Results A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26–41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with...
The Egyptian Heart Journal, 2014
Objective: To evaluate the feasibility, efficacy, and safety of the ABSORB BVS (Bioresorbable Vascular Scaffold) for the treatment of de novo native coronary artery stenosis. Methods: Thirty patients with ischemic heart disease were selected between September 2012 and December 2012 and received ABSORB BVS for the treatment of de novo native significant ccoronary artery stenosis. Patients were followed up for six months after the procedure. In each patient, the treated segment and the periscaffold segments (5 mm proximal and distal to the scaffold edge) were analyzed by Quantitative coronary angiography (QCA) and phased-array intravascular ultrasound (IVUS) catheters in paired matched angiographic views after the procedure and at follow-up. The major clinical end point was ischemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization. Results: Overall the scaffold area remained unchanged. The angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in the mean lumen area. After 2 weeks, 1 patient presented with STEMI, control coronary angiography revealed a patent stent with thrombus distal to it that was treated with a metallic drug-eluting stent (Xience V). There were no cardiac deaths or ischemiadriven target lesion revascularizations. At six months the hierarchical ID-MACE was 3.3%. Conclusions: ABSORB BVS seems an attractive option for the treatment of significant de novo native coronary artery stenosis with low risk of serious adverse events.
Acta Cardiologica Sinica, 2017
Available data on the use of the Bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) in real-world patients is limited, particularly in Asian populations. The aim of this study was to assess clinical outcomes of patients treated with a BVS in real-world practice in Taiwan. This study focused on 156 patients with coronary artery disease and a total of 249 lesions who received BVS implantation from October 2012 to October 2015. The study's primary endpoint was major adverse cardiac event (MACE), such as a myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite or possible scaffold thrombosis, cardiovascular death, and all-cause mortality during the thirty-day follow-up period. The secondary endpoint was MACE during the one-year follow-up period. Additionally, the composite clinical secondary endpoint was target lesion failure (TLF), which was called device-oriented composite endpoint. The average age o...
2016
Bioresorbable vascular scaffolds (BVS) represent a promising novel approach for the treatment of coronary artery disease. BVS promise to address some of the well-known limitations of current drug-eluting stents, while providing a transient scaffolding of the vessel to prevent acute vessel closure/recoil. Drug elution by BVS prevents neointimal proliferation in a similar fashion to drug-eluting stents, and complete bioresorption is associated with late vessel lumen enlargement, plaque regression, and restoration of vasomotion. Based on the pathophysiological reasons and on the results derived from clinical studies, BVS are increasingly being used in clinical practice. The aim of this review is to provide an overview of the current evidence supporting the use of BVS in clinical practice. In particular, we will discuss the randomized controlled trials and registries evaluating the clinical outcome of these devices, with a special focus on their application in patients with acute corona...
Journal of Interventional Cardiology, 2017
With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. Background: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. Methods: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. Results: A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. Conclusions: In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.