Comparison of the Biodegradable Polymer Biolimus-Eluting Stents（BP-BES） and Durable Polymer Everolimus-Eluting Stent (DP-EES) in Patients with Coronary Artery Disease at five years follow up：A Systemic Review and Meta-analysis
Biodegradable polymer biolimus-eluting stents (BP-BES) coated with biodegradable polymer were expected to reduce the risk of late stent thrombosis, very late stent thrombosis, and to improve the outcomes of patient undergone percutaneous coronary intervention (PCI). we undertook to pool the data from clinical trials and observational studies to assess the safety and efficacy of BP-BES versus DP-EES at five-year follow-up in patients refer for PCI.
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Retrieve strategy and selection criteria. We identified all applicable studies presented outcome at 5-year clinical follow-up comparing the biodegradable polymer biolimus-eluting stent (BP-BES) with durable polymer everolimus-eluting stent (DP-EES) by comprehensive retrieving on Pubmed, the Cochrane database, clinicaltrial, Embase, using the keywords ‘biodegradable polymer biolimus-eluting stents’, ‘BP-BE’, 'Nobori', in accordance with PRISMA guideline (18). No language restriction was applied. The data on research identification, design, baseline characteristics, intervening measure, and results were independently extracted, screened, recorded, evaluated by two authors. Any divergences were resolved by discussion among the authors. Inclusion criteria Studies reported the number of events for the outcome comparing the BP-BES versus DP-EES in patients with coronary artery disease underwent PCI The follow-up of these studies are 5 years Exclusion criteria Duplicate study. Non-clinical studies. Clinical outcomes and definition The primary efficacy outcome measure was target lesion revascularisation (TLR). The primary safety outcome measure was definite or probable stent thrombosis (ST) at cumulative 5-year follow-up. Secondary outcome includes all-cause mortality, cardiac death, myocardial infarction (MI) and major adverse cardiac events (MACE). TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Stent thrombosis was classified as late (30 days to 1 year), and very late (>1 year). In current research, all outcome definitions were based upon the ARC consensus 2007(19). We assessed all outcomes according to the definitions described in the original study protocols with the intention-to-treat principle. Statistical Analysis The odds ratios (ORs) and their 95% confidence interval（CI） were used to present as the outcomes measure. Combination of ORs were assessed using either a fixed-effects model (I2 < 50%) or random-effects model (I2 > 50%). The I2 and χ2 statistic was used as measure to estimate the heterogeneity. P < 0.10 showed a statistically significant heterogeneity. The I2 values within the range of <25%, 25–50%, 50–75% and >75% were designated as no, small, moderate and significant heterogeneity, respectively. The weights of the study, which were calculated from the inverse of the variance of each study’s effect estimate, complied with the methodology explored by Der Simonian and Laird (20). We employed funnel plots with the Begg’s test to evaluate the publication bias for the primary outcome (21). We carried out all the statistical analyses using STATA（STATA 15.1）. We used Endnote (Endnote X9) software to manage references, find duplicated literatures and removed it. We set statistical significance as P < 0.05 except in the estimation of heterogeneity. All P values in the study were two-sided.