Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy: Insights from a multicenter, propensity score‐matched registry

Buszman, Piotr P.; Orlik, Bartłomiej; Trela, Blazej; Milewski, Krzysztof; Kozłowski, Michał; Pruski, Maciej; Drzewiecki, J; Peppas, Athanasios; Granada, Juan F.; Kałuża, Greg L.

doi:10.1002/ccd.24732

Cited by 6 publications

(5 citation statements)

References 18 publications

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“…These novel stents incorporated new thin-strut cobalt-chromium stent platforms, more biocompatible or biodegradable polymer matrices and new rapamycin analogues, like zotarolimus and everolimus, with controllable drug release kinetics. Several clinical studies have shown differences in adverse events among patients receiving different DES platforms [5][6][7] . Although some clinical trials 8 and early preclinical investigations 3,9 have hypothesised the role of paclitaxel in the overall outcome and biological effect, there are limited data studying the independent role of an eluted drug in the overall vascular healing response.…”

Section: Introductionmentioning

confidence: 99%

Differences in vessel healing following delivery of everolimus or paclitaxel: a comparative experimental study using identical stent and biodegradable polymer platforms

Buszman

Milewski²,

Pajak³

et al. 2014

EuroIntervention

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We aimed to compare the vascular effects exclusive to antiproliferative agents by using identical stent and biodegradable polymeric matrices eluting everolimus (BP-EES) (Carlo; Balton) and paclitaxel (BP-PES) (Luc-Chopin2; Balton) in the porcine model of coronary injury. A total of 37 stents were implanted with 110% overstretch in the coronary arteries of 14 domestic pigs: 13 BP-PES, 16 BP-EES and eight bare metal stents (BMS) (Chopin2; Balton). Coronary angiography was performed after 28 and 90 days, the animals were sacrificed and the stented segments harvested for histopathological evaluation. At 28 days, BP-PES most effectively limited angiographic late loss (LL PES: 0.15±0.1 vs. EES: 0.40±0.3 vs. BMS: 0.5±0.2 mm; p=0.04) and neointimal thickness (NT) in histology (PES: 0.12 [0.1-0.2] vs. EES: 0.38 [0.3-0.4] vs. BMS: 0.35 [0.3-0.4] mm; p<0.01). The BP-PES had lower endothelialisation (EES: 100% vs. PES: 40±4% vs. BMS: 97.5±5%; p<0.01) and slightly higher inflammation scores (EES: 1 vs. PES: 2.1±0.3 vs. BMS: 1; p<0.01). At three months, LL remained unchanged in the EES and BMS groups in contrast to an increase in the PES group (EES: 0.38±0.3 vs. PES: 0.52±0.4 vs. BMS: 0.51±0.3 mm; p=0.69). NT stabilised at 90 days in the EES group in comparison to a fourfold increase in the PES group and a 30% increase in the BMS group (EES: 0.35 [0.3-0.5] vs. PES: 0.53 [0.5-0.8] vs. BMS: 0.46 [0.4-0.5] mm: p=0.07). Stent endothelialisation and inflammation were comparable at 90 days in all groups. Temporal differences in vascular response were seen by the delivery of different antiproliferative agents. In contrast to everolimus, paclitaxel seems to induce a slightly higher degree of inflammation in the short term, potentially leading to further neointimal hyperplasia in the long term.

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Section: Introductionmentioning

confidence: 99%

Differences in vessel healing following delivery of everolimus or paclitaxel: a comparative experimental study using identical stent and biodegradable polymer platforms

Buszman

Milewski²,

Pajak³

et al. 2014

EuroIntervention

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“…BP‐DES have been proposed to allow a shorter duration of DAPT due to improved vascular healing response in the stented segment . In light of this theoretical advantage, BP‐DES might offer a valuable therapeutic option to patients at high risk of bleeding or deemed unsuitable for prolonged used of DAPT, with minimal penalty in terms of safety and efficacy outcomes .…”

Section: Discussionmentioning

confidence: 99%

Biodegradable polymer versus second‐generation durable polymer drug‐eluting stents in patients with coronary artery disease: A meta‐analysis

Way

Roy

et al. 2018

Health Science Reports

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AimsBiodegradable polymer drug‐eluting stents (BP‐DES) were developed in hopes of reducing the risk of stent thrombosis. The comparison of this new stent platform with second‐generation durable polymer drug‐eluting stents (DP‐DES) has not been well described. We, therefore, performed a meta‐analysis to evaluate the safety and efficacy profiles of BP‐DES versus second‐generation DP‐DES in patients with coronary artery disease.Methods and ResultsElectronic database searches were conducted, from their dates of inception to June 2018, to identify randomized controlled trials (RCTs) comparing patients with either BP‐DES or second‐generation DP‐DES. Risk estimates were expressed as risk ratios (RRs) with 95% confidence intervals (CIs). We also performed a landmark analysis beyond 1 year and sensitivity analyses based on different variables. A total of 24,406 patients from 19 RCTs were included in the present meta‐analysis. There were no significant differences between BP‐DES and second‐generation DP‐DES for the risks of definite or probable stent thrombosis (RR 0.88; 95% CI, 0.69–1.12; P = 0.29), myocardial infarction (RR 0.97; 95% CI, 0.86–1.09; P = 0.59), cardiac death (RR 1.08; 95% CI, 0.92–1.28; P = 0.34), all‐cause death (RR 1.02; 95% CI, 0.91–1.13; P = 0.77), target lesion revascularization (RR 1.05; 95% CI, 0.94–1.17; P = 0.38), and target vessel revascularization (RR 1.05; 95% CI, 0.95–1.16; P = 0.36). Similar outcomes were observed regardless of anti‐proliferative drug and duration of dual antiplatelet therapy (all P > 0.05).ConclusionOur findings demonstrate similar safety and efficacy profiles between BP‐DES and second‐generation BP‐DES, with comparable rates of stent thrombosis.

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“…Even though a total number of 12 randomized trials were included in this current analysis, our results were similar with that of the study published by Wang et al [ 21 ] Excluding data that were obtained from randomized trials, even an observational study comparing BP-DES with DP-PES showed comparable adverse outcomes (TVR, MACEs, ST) between these 2 types of stents during a 1-year follow-up period. [ 22 ] The LEADERS trial involving 1707 patients from 10 centers showed BP-DES to be noninferior to SES in terms of the primary endpoints at 5 years; however, BP-DES were associated with a significantly lower rate of very late (from 1 year to 5 years) ST than DP-SES. [ 23 ]…”

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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Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy: Insights from a multicenter, propensity score‐matched registry

Abstract: In this observational analysis, BP-PES were comparable to DP-PES, with regard to incidence of repeated revascularizations, stent thromboses and MACCE despite earlier DAPT discontinuation.

Cited by 6 publications

References 18 publications

Differences in vessel healing following delivery of everolimus or paclitaxel: a comparative experimental study using identical stent and biodegradable polymer platforms

Differences in vessel healing following delivery of everolimus or paclitaxel: a comparative experimental study using identical stent and biodegradable polymer platforms

Biodegradable polymer versus second‐generation durable polymer drug‐eluting stents in patients with coronary artery disease: A meta‐analysis

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

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