Dataset Information

Efficacy and safety of bioresorbable scaffolds in patients with coronary bifurcation lesions: A systematic review and meta-analysis.

ABSTRACT:

Background

Bioresorbable scaffolds (BRS) were considered to be beneficial for coronary bifurcation lesions regarding the avoidance of lateral branch opening incarceration after complete absorption. However, data is limited in this setting. The aim of this meta-analysis was to evaluate the short (6-month) and medium-term (1-year) outcomes of BRS in patients with coronary bifurcation lesions.

Methods

PubMed, EMBASE, Web of Science, Cochrane library databases were searched to find the studies of BRS implantation in patients with coronary bifurcation lesions. The effective outcome was target lesion revascularization. The safety outcomes included major adverse cardiovascular events, target vessel revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death.

Results

A total of 1204 patients involved in 12 studies were included. The pooled estimate rate of target lesion revascularization as efficacy outcome was highly consistent between 6-month and 1-year follow-up, which was 4.74% (95% CI 2.36-9.54%, I² = 41.5%, p = 0.14) and 4.37% (95% CI 3.05-5.69%, I² = 4.6%, P = 0.39). The pooled estimated rate of major adverse cardiovascular events as safety outcome was 5.50% and 7.31% for both 6-month and 1-year follow-up. The pooled estimated rate of target vessel revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death at 1-year follow-up was 5.92%, 2.52%, 1.69%, and 0.42%.

Conclusions

The application of BRS for coronary bifurcation lesions is acceptable in efficacy outcome, but the high rate of scaffold thrombosis remains of concern (Registered by PROSPERO, CRD42019140341).

SUBMITTER: Liang XY

PROVIDER: S-EPMC9273238 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background and objectiveThe modified double-stent and provisional stenting strategies have been widely used in patients with coronary bifurcation lesions, but what is the optimization has not been clearly defined. This meta-analysis is to elucidate the benefits from modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions.MethodsElectronic databases were searched to identify studies comparing the modified double-stent and provisional stenting strategies in patients with coronary bifurcation lesions. The clinical outcomes were divided into early (≤6 months) and late (>6 months) events according to the follow-up duration. The early endpoints included cardiac death, myocardial infarction, target lesion revascularization or target vessel revascularization, and major adverse cardiac events (MACE), and the late endpoints also include stent thrombosis in addition to the early endpoints index. The angiographic endpoint was in-stent restenosis. Data were analyzed by the statistical software RevMan (version 5.3).ResultsA total of 6 studies involving 1683 patients with coronary bifurcation lesions were included in this meta-analysis, which found that the modified double-stent strategy was associated with a lower risk of cardiac death (odds ratio [OR] = 0.29, 95% confidence intervals [CI] 0.11-0.78, P = .01), myocardial infarction (OR = 0.41, 95% CI 0.21-0.82, P = .01), target lesion revascularization or target vessel revascularization (OR = 0.31, 95% CI 0.15-0.63, P = .001), and MACE (OR = 0.41, 95% CI 0.22-0.74, P = .003) compared with provisional stenting in the early follow-up endpoint events, while the risk of cardiac death and stent thrombosis were similar between both strategies (OR = 0.59, 95% CI 0.31-1.10, P = .09; and OR = 0.62, 95% CI 0.34-1.15, P = .13; respectively) in the late follow-up endpoint events. There were significant differences between both strategies in myocardial infarction (OR = 0.42, 95% CI 0.24-0.75, P = .003), MACE (OR = 0.44, 95% CI 0.31-0.62, P < .00001), and target lesion revascularization or target vessel revascularization (OR 0.35, 95% CI 0.25-0.49, P < .00001) between both strategies in the late follow-up endpoint events. The risk of in-stent restenosis favored the modified double-stent strategy (OR 0.29, 95% CI 0.20-0.43, P < .00001).ConclusionThe modified double-stent strategy is associated with excellent clinical and angiographic outcomes except for the occurrence of cardiac death and stent thrombosis late-term outcome compared with provisional stenting strategy in patients with coronary bifurcation lesions. These findings suggest that the modified double-stent strategy can be recommended as an optimization in patients with coronary bifurcation lesions.

Project description:UNLABELLED:Innovations in drug-eluting stents (DES) have substantially reduced rates of in-segment restenosis and early stent thrombosis, improving clinical outcomes following percutaneous coronary interventions (PCI). However a fixed metallic implant in a vessel wall with restored patency and residual disease remains a precipitating factor for sustained local inflammation, in-stent neo-atherosclerosis and impaired vasomotor function increasing the risk for late complications attributed to late or very late stent thrombosis and late target lesion revascularization (TLR) (late catch-up). The quest for optimal coronary stenting continues by further innovations in stent design and by using biocompatible materials other than cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding, local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics have been recently developed. These devices have been utilized in selected clinical applications so far providing preliminary evidence of safety showing comparable performance with current generation drug-eluting stents (DES). Herein we provide a comprehensive overview of the current status of these technologies, we elaborate on the potential benefits of transient coronary scaffolds over permanent stents in the context of vascular reparation therapy, and we further focus on the evolving challenges these devices have to overcome to compete with current generation DES. CONDENSED ABSTRACT:: The quest for optimizing percutaneous coronary interventions continues by iterative innovations in device materials beyond cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding; local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics were recently developed. These devices have been utilized in selected clinical applications providing preliminary evidence of safety showing comparable intermediate term clinical outcomes with current generation drug-eluting stents.

Project description:Background Bifurcation lesions account for 20% of all percutaneous coronary interventions and represent a complex subset which are associated with lower procedural success and higher rates of restenosis. The ideal bifurcation technique, however, remains elusive. Methods and Results Extensive search of the literature was performed to pull data from randomized clinical trials that met predetermined inclusion criteria. Conventional meta-analysis produced pooled relative risk (RR) and 95% CI of 2-stent technique versus provisional stent on prespecified outcomes. Both frequentist and Bayesian network meta-analyses were performed to compare bifurcation techniques. A total of 8318 patients were included from 29 randomized clinical trials. Conventional meta-analysis showed no significant differences in all-cause mortality, cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization between 2-stent techniques and provisional stenting. Frequentist network meta-analysis revealed that double kissing crush was associated with lower cardiac death (RR, 0.57; 95% CI, 0.38-0.84), major adverse cardiac events (RR, 0.50; 95% CI, 0.39-0.64), myocardial infarction (RR, 0.60; 95% CI, 0.39-0.90), stent thrombosis (RR, 0.50; 95% CI, 0.28-0.88), target lesion revascularization, and target vessel revascularization when compared with provisional stenting. Double kissing crush was also superior to other 2-stent techniques, including T-stent or T and protrusion, dedicated bifurcation stent, and culotte. Conclusions Double kissing crush was associated with lower risk of cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization compared with provisional stenting and was superior to other 2-stent techniques. Superiority of 2-stent strategy over provisional stenting was observed in subgroup meta-analysis stratified to side branch lesion length ≥10 mm.

Project description:Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear. Objective: To examine the effect of DCB in side branch protection for de novo CBL. Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed. Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P < 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P > 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P > 0.05). Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].

Project description:BackgroundIn patients with complex true coronary bifurcation lesions (CBLs), Crush or Culotte stenting has been the commonest approaches of percutaneous coronary intervention (PCI). However, the optimal one remains in debate.MethodsA systematic review and meta-analysis of cohort studies searched from PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese National Knowledge Infrastructure (CNKI), VIP information database, and WangFang Data Information Site, to compare the long-term safety and efficacy of PCI with Crush versus Culotte in patients with CBLs. The primary end point was target lesion revascularization (TLR) and secondary end points were a composite of major adverse cardiac events (MACE) including cardiac death (CD), myocardial infarction (MI), stent thrombosis (ST), and target vessel revascularization (TVR) by PCI or bypass surgery, and each individual component at long-term follow-up. Furthermore, omitting each study in turn was used to sensitivity analysis for high heterogeneity of studies.ResultsA total of 7 studies were included to perform a meta-analysis, 3 randomized trials and 4 observational studies with 2211 patients, 1281 treated with Crush and 930 with Culotte. There was no significant difference in TLR and MACE between Crush and Culotte [RR 0.76, 95% CI (0.48-1.23), I = 57%; RR 0.78, 95% CI (0.47-1.29), I = 83%, respectively]. ST tended to be lower in patients treated with Crush [RR 0.61, 95% CI (0.37-1.01), I = 23%]. CD and MI were comparable between the 2 groups [RR 0.80, 95% CI (0.43-1.49), I = 0%; RR 0.74, 95% CI (0.49-1.13), I = 32%, respectively]. TVR was also associated with the similar risk [RR 0.76, 95% CI (0.49-1.16), I = 60%]. However, high heterogeneity was detected for TLR, MACE, and TVR, and the source of heterogeneity was DKCRUSH-III study by Chen, SL.ConclusionsIn the treatment of coronary bifurcation lesions, TLR and MACE were not significant difference between the Crush and Culotte groups, but TLR and MACE were also regarded as high heterogeneity mainly due to better outcomes achieved by DK Crush and there was a trend toward lower ST in the Crush group. Crush, particularly DK Crush, may be superior to conventional Culotte for treatment of CBLs.Prospero registration numberCRD42018111868.

Project description:BackgroundEverolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes.MethodsWe searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ? 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.ResultsFive studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n?=?917; DES n?=?841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P?=?.02) and stent/scaffold thrombosis (ST/ScT) (OR?=?2.35, 95% CI: 1.13-4.89, P?=?.02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P?=?.22). The risk for all-cause death (OR?=?1.32 95% CI: 0.61-2.88, P?=?.48), cardiac death (OR?=?1.29, 95% CI: 0.58-2.86 P?=?.52), target vessel myocardial infarction (OR?=?1.50, 95% CI: 0.86-2.61, P?=?.15), and target lesion failure (OR?=?1.34, 95% CI: 0.76-2.35, P?=?.31) did not differ between BVS and DES groups.ConclusionAt mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.