Bioabsorbable Polymer Drug-eluting Stents Research Articles

Biodegradable polymer everolimus-eluting stents versus contemporary drug-eluting stents: a systematic review and meta‑analysis

In spite of similar efficacy and safety in pilot studies, compared with the contemporary durable polymer drug-eluting stent (DP-DES), the bioabsorbable polymer drug-eluting stent (BP-DES) may be more superior in promoting blood vessel healing. We sought to compare the safety and efficacy of everolimus-eluting BP-DES (BP-EES) with contemporary DP-DES through a meta-analysis. We performed this meta-analysis to provide further evidence of the safety and efficacy of BP-EES. Medline, Embase and the Cochrane library databases were searched for randomized controlled trials comparing clinical efficacy and safety of BP-EES versus contemporary DP-DES. Fifteen RCTs with a total of 15,572 patients were selected. The rate of MACE was 9.4% in patients receiving BP-EES and 7.3% receiving DP-EES (RR 1.13, 95% CI 0.99–1.29, p = 0.05; I2 = 46%). TLF and MI were also similar in both groups. Based on the available data, this review demonstrates that BP-EES displays a clinically comparable efficacy and safety profile to that of contemporary DP-DES at years of follow-up in patients undergoing PCI.

Comparison of neoatherosclerosis and a clinical outcomes between bioabsorbable versus durable polymer drug-eluting stent: Verification by optical coherence tomography analysis.

Neoatherosclerosis after drug-eluting stent (DES) implantation is known to be related with increased risk of late restenosis and stent thrombosis. Neoatherosclerosis and relevant clinical outcomes between bioabsorbable polymer DES (BP-DES) and second-generation durable polymer DES (DP-DES) were evaluated by optical coherence tomography (OCT) analysis. A total of 311 patients (319 lesions) undergoing OCT analysis after DES implantation were enrolled and divided into two groups according to stent type (BP-DES [150 patients, 153 lesions] and DP-DES [161 patients, 166 lesions]). Follow-up OCT analysis was performed at least 9 months after index stent implantation. Neoatherosclerosis was defined as presence of thin-cap fibroatheroma, calcified plaque, and lipid plaque. Primary endpoint was the incidence of neoatherosclerosis, and the secondary endpoints were the occurrence of major adverse cardiac events (MACE), defined as a composite of death, myocardial infarction, target lesion revascularization, or stent thrombosis and to find independent predictors of neoatherosclerosis. The incidence of neoatherosclerosis was lower in the BP-DES group than the DP-DES group (5.2% vs. 14.5%, p = 0.008), which was driven by lipid plaque. However, the incidence of MACE did not show statistical difference between the two groups in median 4-year follow-up (3.3% vs. 7.8%, hazard ratio 1.964, 95% confidence interval 0.688-5.611, p = 0.207). Less use of angiotensin converting enzyme inhibitors/angiotensin II receptor blockade and higher degree of neointimal hyperplasia remained independent predictors of neoatherosclerosis on Cox regression analysis. Patients undergoing BP-DES implantation had lower incidence of neoatherosclerosis than DP-DES, which did not reach statistically better clinical outcomes.

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

Bioabsorbable‐polymer drug‐eluting stents in acute myocardial infarction: Insights from the ULLISE registry

Limited information is available about the performance of bioabsorbable-polymer drug-eluting stents in the setting of acute myocardial infarction. Patients treated with these stents presenting with acute myocardial infarction are at higher risk of adverse events compared with stable patients. Further clinical trials are needed to fully understand the role of bioabsorbable-polymer drug-eluting stents in patients presenting with acute myocardial infarction.

Optical Coherence Tomography Tissue Coverage and Characterization with Grey-Scale Signal Intensity Analysis After Bifurcation Stenting with a New Generation Bioabsorbable Polymer Drug-Eluting Stent

Bifurcation stenting is thought to be associated with delayed healing and a subsequent risk of stent failure. The aim of this study was to further evaluate healing of thin-strut bioabsorbable polymer everolimus-eluting stents (EES) post bifurcation stenting by optical coherence tomography (OCT) including grey-scale signal intensity (GSI) analysis. Patients undergoing bifurcation stenting with a planned two-stent approach using EES with OCT follow-up at 3-6 months post-stenting were included in this study. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment. GSI analysis of neointimal regions of interest (ROI) overlying stent struts was performed for each of these cross-sections. Tissue coverage was classified as mature or immature. Data on a total of 31 lesions (17 cases) was available at a median of 168 days post stenting. Mean length of stented segments was 27.7 ± 16.6 mm. The mean minimum stent area was 6.50 ± 2.71 mm2 while the mean stent area was 8.69 ± 3.08 mm2. Amongst a total of 847 assessed frames, 9716 struts were visible. Overall strut coverage was 95.9%; 0.3% of struts were malapposed. The mean thickness of neointimal coverage was 100.95 ± 42.03 μm and the mean percentage area stenosis was 9.03 ± 7.80%. A total of 53.79% of ROIs were classified as mature. After implantation of EES in bifurcation lesions, rates of uncovered and malapposed struts were low. GSI analysis showed that more than half of neointimal areas analyzed were classified as mature in keeping with advanced vessel healing.

CRT-200.02 Endovascular Revascularization with Bioabsorbable-Polymer Drug-Eluting Stents in Patients with Severe Critical Limb Ischemia

The use of below-the-knee drug-eluting stents for endovascular revascularization in patients with critical limb ischemia (CLI) has been described. Data are lacking regarding use of bioabsorbable-polymer drug-eluting stents (BP-DES) in the infra-geniculate vessels in patients with CLI Rutherford

P2630Comparison of tissue characteristics in restenosis lesion between bioabsorbable polymer drug-eluting stent and durable polymer drug-eluting stent

P2630Comparison of tissue characteristics in restenosis lesion between bioabsorbable polymer drug-eluting stent and durable polymer drug-eluting stent

A Five-Year Follow-Up of Randomised Studies Comparing Outcomes Between Bioabsorbable-Polymer and Durable-Polymer Drug-Eluting Stents: Systematic Review and Meta-Analysis

Background: Bioabsorbable polymer drug-eluting stents (BP-DES) are non-inferior to current generation DES and bare metal stents (BMS) outcomes at 12 months [ 1 Natsuaki M. et al. JACC. 2013; 62: 181-190 Crossref Scopus (186) Google Scholar , 2 Smits P.C. et al. Lancet (London. England). 2013; 381: 651-660 Google Scholar , 3 Raber L. et al. JAMA. 2012; 308: 777-787 Crossref PubMed Scopus (252) Google Scholar ]. The assumed benefit of BP-DES is to remove the polymer-triggered inflammatory stimulation associated with durable-polymer DES (DP-DES). However, potential benefits of BP-DES may require a longer follow-up period, to overcome the time taken for polymer absorption. The purpose of this meta-analysis was to compare the safety and efficacy outcomes of BP-DES over a long-term follow-up.

A Meta-Analysis of Randomised Studies Comparing Two-Year Outcomes of Second-Generation Durable-Polymer and Everolimus and Sirolimus Bioabsorbable Polymer Drug-Eluting Stents

A Meta-Analysis of Randomised Studies Comparing Two-Year Outcomes of Second-Generation Durable-Polymer and Everolimus and Sirolimus Bioabsorbable Polymer Drug-Eluting Stents

Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database.

SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database requires nationwide mandatory notification for adverse events on devices approved for clinical use. This database was searched for adverse events reported between 1 October 2015 and 25 December 2016, encountered after the placement of either BP-DES or DP-DES. Only those adverse events were included where the exposure period to the stents was comparable after the index procedure. Of all the adverse events reported, the event of interest was ST. A total of 951 adverse events were reported. ST occurred in 48/951 of all events, 31/309 and 17/642 when BP-DES or DP-DES were used, respectively (P=0.00001). Of the 31 ST events with BP-DES, 68% (21/31) occurred within less than or equal to 24 h of the index procedure and 52% (16/31) occurred within less than or equal to 2 h. Our results raise the possibility of an increased risk of ST, particularly early ST (within 24 h), with the recently approved BP-DES. However, because of the inherent limitations of reporting within the MAUDE database, these data merely highlight a potential need for additional surveillance and randomized trials to assess further the safety of the bioabsorbable platform.

Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy.

Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety and effectiveness of the SYNERGY stent in patients with diabetes mellitus. SYNERGY is a thin-strut, platinum-chromium everolimus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TLR], target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes.

Durable polymer versus bioabsorbable polymer drug eluting stents in right coronary artery chronic total occlusions: Eighteen months (median) results of a single-center experience

Objective: There are a few data regarding the long-term clinical outcomes of durable polymer (DP) drug-eluting stents (DES) versus bio absorbable polymer (BP) drug-eluting stents treatment in patients with right coronary artery (RCA) chronic total occlusion (CTO). The aim of this study was to compare the clinical outcomes of these stents according to their polymer-based difference. Methods: Between June 2013 and August 2016, 66 RCA CTO patients enrolled in the study. Fortyseven patients with successful CTO recanalization of RCA via ante grade or retrograde approach using either DP (n=25) and BP (n=22) were scheduled for 6, 12, and 18 months clinical follow-up. Primary clinical outcomes were cardiac death and major adverse cardiac events (MACE). Results: RCA CTO success rate was 71%. There was no difference in Japanese-CTO (JCTO) scores between two groups. Total stent length was longer in BP group, and it was statistically significant (p=0.015). The incidence of cardiac death was not significant between the two groups. After propensity score matching, TVR rates were 12.0% for DP group and 9.1% for BP group at the end of the 18th month (hazard ratio [HR]=0.815; 95% confidence interval [CI]=0.123–5.418; p=0.832) and composite MACE rates were 16.0% for DP group and 15.0% for BP group (hazard ratio [HR]=0.926; 95% confidence interval [CI]=0.182–4.718; p=0.927). Conclusion: This study shows that the efficacy of BP-DES is comparable to that second-generation DP-DES treatment for RCA CTO over 18-month follow-up.

The "crushing'' aortic prosthesis: a fatal acute myocardial infarction

We report a 67 years old woman with prior mitral and aortic metallic prosthesis 14 days before, who came to the Emergency Room (ER) due to chest pain and hemodynamic instability, with dyspnoea in NYHA III and with an echocardiography showing hypocinesia of the anterior wall of the heart with low Left Ventricular Ejection Fraction (LVEF) of 35% and both prosthesis with normal function. The electrocardiogram showed sinus tachycardia and diffuse ST depression, diagnosing of Non ST-Elevation Myocardial Infarction (NSTEMI). We decided to perform an emergent coronary angiography. She had previously carried out a coronary angiography, five months earlier, with no evidence of Coronary Artery Disease (CAD). At the moment of the present NSTEMI, we observed high prosthesis implantation, with slow hemi-disc movement and evidence of thrombus in the Left Main (LM) with TIMI flow I, as well as in the left coronary sinus. An Intra-aortic Balloon pump was implanted and a thrombus aspiration catheter was used to improve the coronary flow. Then the TIMI flow improved, and we decided to fix the lesion with a 4.0×15 mm drug eluting stent of everolimus (SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System from Boston Scientific) in the ostia of LM. The stent was implanted without complications, but few minutes later the patient went into refractory cardiogenic shock. The hemi disc of the prosthesis was literally crushing the stent and the TIMI flow was progressively worsen with associated thrombus. Finally the patient was exitus because of cardiac arrest with no response to the advance cardiopulmonary resuscitation. We present the report case and a brief review of the literature.

CRT-200.59 The Fribourg Synergy Experience: One-year Outcomes With the Bioabsorbable Polymer-coated Thin Strut Everolimus-eluting Synergy Stent for Coronary Revascularization in All-comers

New-generation thin strut bioabsorbable polymer drug-eluting stents (DES) have shown promising mid-term results in clinical trials and real-world registries. We sought to assess 1-year efficacy and safety outcomes in all-comer patients treated with the SYNERGY stent at our institution. All

TCT-587 Bioabsorbable polymer-coated thin strut everolimus-eluting synergy stent for coronary revascularization in daily clinical practice: One-year results of the SWEET registry

Bioabsorbable polymer drug-eluting stents (DES) represent an indisputable improvement over first-generation DES with promising results on long-term adverse events. We sought to determine the 1-year clinical follow-up in patients treated with the bioabsorbable polymer-coated everolimus-eluting

Evaluating the vascular response of bioabsorbable polymer drug-eluting stents in atherosclerosis

Evaluating the vascular response of bioabsorbable polymer drug-eluting stents in atherosclerosis