Biodegradable versus durable polymer drug eluting stents in coronary artery disease: Insights from a meta-analysis of 5834 patients

Lupi, Alessandro; Rognoni, Andrea; Secco, Gioel Gabrio; Lazzero, Maurizio; Nardi, Federico; Fattori, Rossella; Bongo, Angelo Sante; Agostoni, Pierfrancesco; Sheiban, Imad

doi:10.1177/2047487312467745

Cited by 28 publications

(26 citation statements)

References 57 publications

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“…Although a previous meta-analysis 5) did not report a signifi cantly decreased risk of late or very late ST in the biodegradable stent group, several recent trials have had mixed results. Taking into consideration recently accumulating evidence, the aim of the present study was to evaluate the longterm risk of ST by conducting a meta-analysis of studies of biodegradable versus durable polymer stent therapy for patients undergoing percutaneous coronary intervention.…”

Section: Discussionmentioning

confidence: 89%

“…A previous meta-analysis, 5) which included 10 studies (5,834 patients) with shorter follow-up (6-12 months), found that BP-DES and DP-DES showed similar rates of late ST (OR, 0.64; 95% CI, 0.36 to 1.16, P = 0.14). Similarly, in longer follow-up periods (12-60 months), we also found that there was no difference in defi nite early and late ST between the two groups.…”

Section: Discussionmentioning

confidence: 99%

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Stent Thrombosis in Patients With Coronary Artery Disease Treated With Biodegradable Polymer Drug-Eluting Stents

Zhang¹

2014

Int. Heart J.

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SummaryDelayed re-endothelialization may be the pathophysiological cause of stent thrombosis (ST). Biodegradable polymer drug-eluting stents (BP-DES) may reduce the risk of ST. The aim of this study was to evaluate the risk of ST in patients treated with BP-DES. Studies were retrieved from the PubMed, Cochrane Library, and EMBASE online databases. Twelve studies (15,155 patients) with long-term follow-up (≥ 12 months) were included. Compared with durable polymer drug-eluting stents (DP-DES), BP-DES did not signifi cantly decrease the risk of defi nite and probable ST (RR, 0.89; 95% CI, 0.68 to 1.18; P = 0.425) and defi nite ST (RR, 0.92; 95% CI, 0.66 to 1.30; P = 0.648). Furthermore, there was no difference in the risk of late ST (RR, 1.17; 95% CI, 0.39 to 3.53; P = 0.780). However, the rate of early ST was slightly higher in the BP-DES group (RR, 1.60; 95% CI, 0.94 to 2.73; P = 0.084) than in the DP-DES group. A signifi cant reduction in very late ST (> 12 months) was evident with the BP-DES group (RR, 0.27; 95% CI, 0.10 to 0.68; P = 0.006). Subgroup analysis showed that there was no difference in the rate of defi nite and probable ST between the BP-DES and fi rst-or second-generation DES groups.Biodegradable polymer stents were associated with a signifi cantly lower risk of very late ST. However, there was no difference in the risk of defi nite and probable ST between the two groups. (Int Heart J 2014; 55: 213-218) Key words: Infl ammation D rug-eluting stents (DES) reduce the risk of restenosis and the need for repeat revascularization compared with bare metal stents (BMS) at the expense of increased incidence of very late (> 1 year) stent thrombosis (ST) and extended duration of dual-antiplatelet therapy.1) Secondgeneration DES could signifi cantly lower the rate of defi nite ST.2) Despite these iterations, there is still the risk of very late ST, especially in the more complex patient and lesion subgroups.3) Durable polymers might trigger an infl ammatory response, 4) and cause incomplete endothelialization and positive vessel remodeling. Biodegradable polymer stents may overcome this problem by providing similar controlled drug release with subsequent degradation of the polymer.Although a previous meta-analysis 5) did not report a signifi cantly decreased risk of late or very late ST in the biodegradable stent group, several recent trials have had mixed results. Taking into consideration recently accumulating evidence, the aim of the present study was to evaluate the longterm risk of ST by conducting a meta-analysis of studies of biodegradable versus durable polymer stent therapy for patients undergoing percutaneous coronary intervention. , and the ClinicalTrials.gov Website (through June 2013) using the terms "biodegradable polymer", "bioabsorbable polymer", "drug-eluting stent", "coronary artery disease", and "stent thrombosis". Manual reference checking of the bibliographies of all relevant articles was performed. Abstracts from conference compilations of the American Heart Association, the European ...

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Stent Thrombosis in Patients With Coronary Artery Disease Treated With Biodegradable Polymer Drug-Eluting Stents

Zhang¹

2014

Int. Heart J.

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“…Among different DES platforms, several authors have been able to demonstrate an association of (late) stent thrombosis with the polymer and ISR due to a delayed healing and endothelialization process [33,34]. More recently, bioabsorbable polymers that leave, in effect, a BMS after drug delivery have been developed with promising results [35]. Even polymer-free DES, with less reliable drug-release-kinetics, have been proposed to overcome the burden of depleted permanent polymers [36].…”

Section: Discussionmentioning

confidence: 99%

Drug eluting balloons for de novocoronary lesions – a systematic review and meta-analysis

Fröhlich

Lansky

et al. 2013

BMC Med

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BackgroundThe role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.MethodsThis is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/− bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.ResultsEight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (− 0.26 mm (−0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).ConclusionOverall, drug-eluting balloons (+/− bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.

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“…[13][14][15][16][17] Trials have revealed the lower rates of MACE in short-and long-term follow-up after the DP-EES implantation in comparison to the earlier generation and have introduced the DP-EES as the standard of DES, versus other design improvements. 18 Investigators have also confirmed the superiority of the BP-BES over the first-generation DES.…”

Section: Discussionmentioning

confidence: 99%

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study

Parsa¹,

Saroukhani²,

Majlessi³

et al. 2016

Texas Heart Institute Journal

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We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents.At C oronary artery stenting is widely accepted as the treatment of choice for most cases of coronary artery disease (CAD). Implantation of the drug-eluting stents (DESs), in comparison with the bare-metal stents (BMS), has conferred better outcomes for coronary artery stenting. [1][2][3][4] Although the administration of the first-generation DES showed a higher rate of success than that of the BMS, doubts were raised over its safety because of the reported cases of late stent thrombosis and very late restenosis. 5 The link between late stent thrombosis and incomplete endothelial coverage of the stent struts caused changes in the design and materials of the platforms and polymers of the stents. 6 Randomized controlled trials and studies have revealed promising results after the implantation of the zotarolimus-and the everolimus-eluting stents, in comparison with the first-generation DES and the BMS.7-9 On the other hand, concerns about late stent failure caused by untoward reactions to the stent polymer led to the introduction of a new-generation DES in which polymers degrade after the termination of drug release. 10 In these stents, drug release lasts about 28 days and an abluminal biodegradable polymer is absorbed after 6 to 9 months, thus turning the DES into a BMS and, theoretically, averting late stent failure as a result of reaction to polymers. Trials have shown the noninferiority of the biodegradable-polymer biolimus-eluting stent (BP-BES) to the previous generations of DESs; however, only a few investigators have compared the biodegradable-polymer with the durable-polymer DES in real-world registries. 11,12 Further analysis of large and

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Biodegradable versus durable polymer drug eluting stents in coronary artery disease: Insights from a meta-analysis of 5834 patients

Abstract: Our present meta-analysis showed that BP-DES when compared with DP-DES significantly reduced LLL and TVR but without clear benefits on mortality, MI and LST rates. (Clinicaltrials.gov identifier: NCT01466634).

Cited by 28 publications

References 57 publications

Stent Thrombosis in Patients With Coronary Artery Disease Treated With Biodegradable Polymer Drug-Eluting Stents

Stent Thrombosis in Patients With Coronary Artery Disease Treated With Biodegradable Polymer Drug-Eluting Stents

Drug eluting balloons for de novocoronary lesions – a systematic review and meta-analysis

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study

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