Efficacy and safety of bioresorbable scaffolds in patients with coronary bifurcation lesions: A systematic review and meta-analysis.
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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
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Project description:BackgroundBifurcation lesions represent 15-20% of all patients undergoing a percutaneous coronary intervention (PCI) for coronary artery disease. The provisional 1-stent stenting strategy is the preferred strategy to treat bifurcation lesions. Other strategies used to treat bifurcation lesions include 2-stent complex stenting strategies and the Tryton Side Branch Stent® (TSB)-a dedicated side-branch stent for bifurcation lesions, which gained FDA approval in March 2017.ObjectivesTo conduct a systematic literature review of the safety and effectiveness of three stenting strategies (provisional, complex, and Tryton Side Branch Stent®) for bifurcation lesions with a side-branch diameter ≥2.25 mm, undergoing PCI.MethodsLiterature searches in Medline, Cochrane Library, Web of Science and Embase were conducted to identify prospective clinical trials from January 2007-July 2017.Results602 articles were identified. Nine articles (6275 patients) met all inclusion criteria. Seven studies (5282 patients) compared provisional to complex stenting strategies. Two studies (993 patients) compared provisional to the TSB. Outcomes of interest reported were target vessel failure in 2 studies, major adverse cardiac event (MACE) (cardiac death, all myocardial infarction, ischemic driven target legion revascularization TLR) in 5 studies. For target vessel failure, the provisional strategy ranged from 5.6% to 15.6 %; complex at 7.2% (one study); and TSB from 11.3% to 17.4%. For MACE, provisional strategy ranged from 8%-13.2%; complex from 11.9%-15.2%; and TSB from 8.2%-18.6%.ConclusionsTo our knowledge, this is the first review comparing three bifurcation lesion stenting strategies. Significant heterogeneity in the study design of the nine studies reviewed prevented a meta-analysis. A clinical trial comparing the TSB to both the provisional and complex strategies would provide better inference on the safety and effectiveness when comparing strategies.
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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.
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Project description:BackgroundBRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited.MethodsWe systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322).ResultsThirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04).ConclusionsImplantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.
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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].
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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.
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