Stent Thrombosis with Biodegradable Polymer Drug-Eluting Stents versus Durable Polymer Sirolimus-Eluting Stents: An Update Meta-Analysis

Zhu, Lin; Lv, Yi; Wang, Li Yu

doi:10.1159/000368073

Cited by 6 publications

(4 citation statements)

References 24 publications

(67 reference statements)

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“…Presently, stent thrombosis in second or third generation stents is a rare clinical scenario [ 23 ]. Also, as confirmed in several meta-analyses BP-DES compared with DP-DES are associated with a lower rate of very late stent thrombosis and an equivalent risk of MACE [ 24 , 25 ]. This probably might be associated with the fact that over time, the drug-coated polymers of BP-DES can gradually degrade into completely harmless CO 2 and H 2 O molecules that are excreted from a patient’s body.…”

Section: Discussionmentioning

confidence: 90%

Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis

Bil

Gil

Witkowski³

et al. 2015

BMC Cardiovasc Disord

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BackgroundThe aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.MethodsWe prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.ResultsThere were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate – 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.ConclusionsSirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness. Trial registration numberClinicalTrials.gov NCT02545985.

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Section: Discussionmentioning

confidence: 90%

Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis

Bil

Gil

Witkowski³

et al. 2015

BMC Cardiovasc Disord

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“…At last, several meta-analysis have compared BP-DES with durable polymer DES [ 34 , 35 ], however, this is the first meta-analysis till date to compare the cardiovascular outcomes in DM versus non-DM participants who were treated with BP-DES.…”

Section: Discussionmentioning

confidence: 99%

Long-term cardiovascular outcomes of biodegradable polymer drug eluting stents in patients with diabetes versus non-diabetes mellitus: a meta-analysis

Wang,

Zu,

Tang

et al. 2023

Cardiovasc Diabetol

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Background Today, diabetes mellitus (DM) has become a worldwide concern. DM is a major risk factor for the development of cardiovascular diseases (CVD). Eligible patients with CVD are treated invasively by percutaneous coronary intervention (PCI) whereby a stent is implanted inside the coronary vessel with the particular lesion to allow sufficient blood flow. Newer scientific research have shown that even though associated with a lower rate of re-stenosis, first-generation drug eluting stents (DES) were associated with a higher rate of late stent thrombosis. Recently, newer stents, namely biodegradable polymer DES (BP-DES) have been developed to overcome the safety issues of earlier generation DES. In this analysis we aimed to systematically compare the long term (≥ 12 months) adverse cardiovascular outcomes observed in DM versus non-DM patients who were implanted with BP-DES. Methods Cochrane central, MEDLINE (Subset PubMed), EMBASE, Web of Science, http://www.ClinicalTrials.gov and Google scholar were searched for relevant publications involving BP-DES in patients with DM versus non-DM and their associated adverse cardiovascular outcomes. The mean follow-up time period ranged from 12 to 120 months. Data analysis was carried out with the latest version of the RevMan software (version 5.4). Based on the Mantel-Haenszel test, risk ratios (RR) with 95% confidence intervals (CI) were calculated and used to represent the results following analysis. Results Seven (7) studies with a total number of 10,246 participants were included in this analysis. Stents which were implanted during PCI were BP-DES. Participants were enrolled from the year 2006 to 2013. Our current results showed that in patients who were implanted with BP-DES, the risks of major adverse cardiac events (RR: 1.30, 95% CI: 1.18–1.43; P = 0.00001), myocardial infarction (RR: 1.48, 95% CI: 1.14–1.93; P = 0.003), all-cause mortality (RR: 1.70, 95% CI: 1.29–2.23; P = 0.0002), cardiac death (RR: 1.93, 95% CI: 1.28–2.93; P = 0.002), target vessel revascularization (RR: 1.35, 95% CI: 1.03–1.77; P = 0.03), target lesion revascularization (RR: 1.28, 95% CI: 1.07–1.54; P = 0.007) and target lesion failure (RR: 1.79, 95% CI: 1.52–2.12; P = 0.00001) were significantly higher in the DM group. Definite and probable stent thrombosis (RR: 1.80, 95% CI: 1.28–2.55; P = 0.0009) were also significantly higher in the DM group. Conclusions Diabetes mellitus was an independent risk factor associated with long term adverse cardiovascular outcomes following PCI with BP-DES.

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“…Another study showed BP-DES to be more effective in reducing MACEs and ST than DP-DES during the long term. [ 25 ] Even the study published by Zhu et al [ 26 ] showed BP-DES to be associated with a lower rate of very late ST. However, the authors suggested further studies to confirm their findings.…”

Section: Discussionmentioning

confidence: 99%

Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents

2017

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Background:Even if drug-eluting stents (DES) showed beneficial effects in patients with coronary artery diseases (CADs), limitations have been observed with the first-generation durable polymer DES (DP-DES). Recently, biodegradable polymer DES (BP-DES) have been approved to be used as an alternative to DP-DES, with potential benefits. We aimed to systematically compare BP-DES with the first-generation DP-DES using a large number of randomized patients.Methods:Electronic databases were searched for randomized controlled trials (RCTs) comparing BP-DES with first-generation DP-DES. The main endpoints were the long-term (≥2 years) adverse clinical outcomes that were reported with these 2 types of DES. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and the analysis was carried out by RevMan 5.3 software.Results:Twelve trials with a total number of 13,480 patients (7730 and 5750 patients were treated by BP-DES and first-generation DP-DES, respectively) were included. During a long-term follow-up period of ≥2 years, mortality, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACEs) were not significantly different between these 2 groups with OR: 0.84, 95% CI: 0.66–1.07; P = .16, I2 = 0%, OR: 1.01, 95% CI: 0.45–2.27; P = .98, I2 = 0%, OR: 0.91, 95% CI: 0.75–1.11; P = .37, I2 = 0% and OR: 0.86, 95% CI: 0.44–1.67; P = .65, I2 = 0%, respectively. Long-term total stent thrombosis (ST), definite ST, and probable ST were also not significantly different between BP-DES and the first-generation DP-DES with OR: 0.77, 95% CI: 0.50–1.18; P = .22, I2 = 0%, OR: 0.71, 95% CI: 0.43–1.18; P = .19, I2 = 0% and OR: 1.31, 95% CI: 0.56–3.08; P = .53, I2 = 6%, respectively.Conclusion:Long-term mortality, MI, TLR, MACEs, and ST were not significantly different between BP-DES and the first-generation DP-DES. However, the follow-up period was restricted to only 3 years in this analysis.

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Stent Thrombosis with Biodegradable Polymer Drug-Eluting Stents versus Durable Polymer Sirolimus-Eluting Stents: An Update Meta-Analysis

Cited by 6 publications

References 24 publications

Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis

Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis

Long-term cardiovascular outcomes of biodegradable polymer drug eluting stents in patients with diabetes versus non-diabetes mellitus: a meta-analysis

Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents

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