Overlapping meta-analyses of bioresorbable vascular scaffolds versus everolimus-eluting stents: bringing clarity or confusion?
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SUBMITTER: Capodanno D
PROVIDER: S-EPMC4958870 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimsTo compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES).MethodsThe EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years.ResultsFive-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup.ConclusionFive-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.
| S-EPMC9544452 | biostudies-literature
Project description:The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes.
| S-EPMC6617525 | biostudies-literature
Project description:BackgroundBioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug-eluting stents (DES) by dissolving once they have restored lasting patency.ObjectivesCompare the safety and efficacy of BVS versus DES in patients receiving percutaneous coronary intervention for coronary artery disease across a complete range of randomised controlled trial (RCT) follow-up intervals.MethodsA systematic review and meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. MEDLINE, EMBASE and Web of Science were searched from inception through 5 January 2022 for RCTs comparing the clinical outcomes of BVS versus DES. The primary safety outcome was stent/scaffold thrombosis (ST), and the primary efficacy outcome was target lesion failure (TLF: composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR)). Secondary outcomes were patient-oriented composite endpoint (combining all-death, all-MI and all-revascularisation), its individual components and those of TLF. Studies were appraised using Cochrane's Risk of Bias tool and meta-analysis was performed using RevMan V.5.4.Results11 919 patients were randomised to receive either BVS (n=6438) or DES (n=5481) across 17 trials (differing follow-up intervals from 3 months to 5 years). BVS demonstrated increased risk of ST across all timepoints (peaking at 2 years with risk ratio (RR): 3.47; 95% CI 1.80 to 6.70; p=0.0002). Similarly, they showed increased risk of TLF (peaking at 3 years, RR: 1.35; 95% CI 1.07 to 1.70; p=0.01) resulting from high rates of TVMI and ID-TLR. Though improvements were observed after device dissolution (5-year follow-up), these were non-significant. All other outcomes were statistically equivalent. Applicability to all BVS is limited by 91% of the BVS group receiving Abbott's Absorb.ConclusionThis meta-analysis demonstrates that current BVS are inferior to contemporary DES throughout the first 5 years at minimum.
| S-EPMC9615997 | biostudies-literature
Project description:BackgroundSecond-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.Methods/designThe EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.DiscussionEVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.Trial registrationThe trial listed in clinicaltrials.gov as NCT01711931.
| S-EPMC3926690 | biostudies-literature
Project description:BackgroundBioresorbable vascular scaffolds (BVS) completely resorb within 3 years after placement into the coronary artery. The safety and effectiveness of bioabsorbable scaffolds are of critical importance during this 3-year period.ObjectiveWe performed a meta-analysis to compare the safety and efficacy of BVS and second-generation drug-eluting stents (DES) at 3 years after implantation.MethodsPublished randomized trials comparing BVS to second-generation DES for the treatment of coronary artery disease were identified within PubMed, EMBASE, Cochrane Library, Web of Science, and relevant Web sites with publication dates through June 2019. The primary efficacy endpoint was target lesion failure. The primary safety endpoint was definite/probable stent/scaffold thrombosis. Secondary outcomes were cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and a patient-oriented composite end point.ResultsSix randomized controlled trials, with a total of 5,412 patients (BVS n = 3,177; DES n = 2,235), were included. At 3 years, BVS was associated with higher rates of target lesion failure (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/scaffold thrombosis (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel myocardial infarction (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven target lesion revascularization (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the patient-oriented composite end point(OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups.ConclusionsAt the 3-year follow-up, BVS was inferior to second-generation DES in both safety and efficacy.
| S-EPMC7402797 | biostudies-literature
Project description:Preclinical evaluation of the vascular response of drug-eluting stents is limited especially in the setting of diabetes mellitus preventing the evaluation of changes in drug-eluting stent design and eluted drugs after clinical use.Cultured human aortic endothelial cells were used to assess the differences between sirolimus and its analog, everolimus, in the setting of hyperglycemia on various cellular functions necessary for endothelial recovery. A diabetic rabbit model of iliac artery stenting was used to compare histological and morphometric characteristics of the vascular response to everolimus-eluting, sirolimus-eluting, and bare metal stent placement. Under hyperglycemic conditions, sirolimus impaired human aortic endothelial cell barrier function, migration, and proliferation to a greater degree compared with everolimus. In our in vivo model of diabetes mellitus, endothelialization at 28 days was significantly lower and endothelial integrity was impaired in sirolimus-eluting stent compared with both everolimus-eluting and bare metal stents. Neointimal area, uncovered struts, and fibrin deposition were significantly higher in sirolimus-eluting compared with everolimus-eluting and bare metal stents.Use of everolimus-eluting stent results in improved vascular response in our preclinical models of diabetes mellitus.
| S-EPMC4140961 | biostudies-literature
Project description:Background It is unknown whether contemporary drug-eluting stents have a similar safety profile in high bleeding risk patients treated with 1-month dual antiplatelet therapy following percutaneous coronary interventions. Methods and Results We performed an interventional, prospective, multicenter, single-arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable-polymer everolimus-eluting stent followed by 1-month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1-year primary outcome occurred in 4.82% (95% CI, 3.17%-7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% (Pnoninferiority<0.001) notwithstanding the lower-than-expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%-2.50%), 3.42% (95% CI, 2.08%-5.62%), and 0.94% (95% CI, 0.35%-2.49%), respectively. Conclusions Among high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable-polymer everolimus-eluting stent, a 1-month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03112707.
| S-EPMC9075308 | biostudies-literature
Project description:BACKGROUND:Drug-eluting stents are widely used in coronary artery intervention. However, vessel caging and very late thrombotic events are of persistent and substantial concern. Bioresorbable vascular scaffolds (BVS) were developed to deliver vascular reparative therapy, by eliminating permanent mechanical restraint. However, data regarding its clinical performance is lacking. METHODS:After the BVS implantation procedure received national approval in May 2014, patients receiving BVS implantation until November 2014 in National Taiwan University Hospital (NTUH) were enrolled. Clinical variables, angiographic data, procedural details, and follow-up information were collected and compared with those receiving BVS at NTUH as part of the global ABSORB EXTEND trial. RESULTS:A total of 35 patients (38 target vessels) with 48 BVS implanted after approval were enrolled, as the "real-world practice" group. Data of the 34 patients (34 target vessels) with 37 BVS implanted in the ABSORB EXTEND trial were also obtained. Differences in lesion complexity (0% type B2/C lesion in ABSORB EXTEND, versus 23.7% in real-world, p = 0.007) and lesion length (20.9 ± 6.1 mm in ABSORB EXTEND, versus 29.5 ± 15.9 mm in real-world, p = 0.008) were noted. The ischemia-driven target vessel revascularization after an average of 732 days follow-up was 11.8% in the ABSORB EXTEND trial. However, there was no ischemia-driven target lesion revascularization (TLR), no scaffold thrombosis, no myocardial infarction (MI), and no patients passed during the follow-up period. In real-world patients, there is 5.3% of MI, 2.6% ischemia-driven TLR, and 2.6% of non-fatal probable scaffold thrombosis. CONCLUSIONS:The use of BVS in real-world practice is feasible, with clinical outcomes comparable to those in the ABSORB EXTEND trial.
| S-EPMC5445242 | biostudies-literature
Project description:BackgroundSeveral studies compared everolimus-eluting bioresorbable scaffolds (EE-BRS) with everolimus-eluting stents (EES), but only few assessed these devices in patients with diabetes mellitus.AimTo evaluate the safety and efficacy outcomes of all-comer patients with diabetes mellitus up to 2 years after treatment with EE-BRS or EES.MethodsWe performed a post hoc pooled analysis of patient-level data in diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials: The ABSORB DM Benelux Study (NTR5447), TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707). Primary endpoint of the analysis was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization. Secondary endpoints included major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction or clinically driven target vessel revascularization, as well as definite or probable device thrombosis (ST).ResultsA total of 499 diabetic patients were assessed, of whom 150 received EE-BRS and 249 received EES. Total available follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group. The adverse events rates were similar in both treatment groups for TLF (7.2 vs. 5.2 events per 100 PY, p = 0.39; adjusted hazard ratio (HR) = 1.48 (95% confidence interval (CI): 0.77-2.87), p = 0.24), MACE (9.1 vs. 8.3 per 100 PY, p = 0.83; adjusted HR = 1.23 (95% CI: 0.70-2.17), p = 0.47), and ST (0.9 vs. 0.6 per 100 PY, p > 0.99).ConclusionIn this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.
| S-EPMC7532086 | biostudies-literature
Project description:PurposeData regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial.MethodsIn ISAR-Absorb MI, AMI patients were randomized to BRS or EES implantation, with 6-8 month angiographic follow-up. This analysis includes patients who underwent OCT during surveillance angiography. Tissue characterization was done using grey-scale signal intensity analysis. The association between OCT findings and target lesion failure (TLF) at 2 years was investigated.ResultsOCT was analyzed in 103 patients (2237 frames, 19,827 struts) at a median of 216 days post-implantation. Of these, 70 were treated with BRS versus 32 with EES. Pre-(92.8 vs. 68.7%, p = 0.002) and post-dilation (51.4 vs. 12.5%, p < 0.001) were more common in BRS as compared to EES. Strut coverage was higher in BRS vs. EES (97.5% vs. 90.9%, p < 0.001). Mean neointimal thickness was comparable in both groups [85.5 (61.9, 124.1) vs. 69.5 (32.7, 127.5) µm, respectively, p = 0.20]. Mature neointimal regions were numerically more common in BRS (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in ST-elevation myocardial infarction patients (40.9% vs. 21.1%, p = 0.03). At two-years, 8 (7.8%) patients experienced TLF. Mean neointimal area [0.61 (0.21, 1.33) vs. 0.41 (0.11, 0.75) mm2, p = 0.03] and mean neointimal coverage [106.1 (65.2, 214.8) vs. 80.5 (53.5, 122.1) µm, p < 0.01] were higher, with comparable tissue maturity, in lesions with versus without TLF.ConclusionsIn selected patients who underwent OCT surveillance 6-8 months after coronary intervention for AMI with differing implantation characteristics depending on the device type used, vessel healing was more advanced in BRS compared with EES, particularly in the STEMI subgroup.
| S-EPMC8494721 | biostudies-literature