Durable Polymer Drug-eluting Stents Research Articles

“Silent” Diabetes and Clinical Outcome After Treatment With Contemporary Drug-Eluting Stents: The BIO-RESORT Silent Diabetes Study

ObjectivesThis study sought to assess the prevalence and clinical impact of silent diabetes and pre-diabetes in “nondiabetic” percutaneous coronary intervention (PCI) all-comers. BackgroundPatients with undetected and thus untreated (silent) diabetes may have higher event risks after PCI with contemporary drug-eluting stents (DES). MethodsThe BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized multicenter BIO-RESORT (BIOdegradable Polymer and DuRable Polymer Drug-eluting Stents in an All COmeRs PopulaTion) trial (NCT01674803). Patients underwent oral glucose tolerance testing (OGTT), and assessment of glycosylated hemoglobin with fasting plasma glucose. Primary endpoint was a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization at 1 year. ResultsOf the 988 participants, OGTT detected silent diabetes in 68 (6.9%), pre-diabetes in 133 (13.3%), and normal glucose metabolism in 788 (79.8%). Patients with silent diabetes had higher primary endpoint rates (13.2% vs. 7.6% vs. 4.8%; p < 0.001; silent diabetes vs. normal: hazard ratio: 4.2; 95% confidence interval: 1.9 to 9.2). Differences were driven by myocardial infarction (p < 0.001) which occurred mostly <48 h. Based on glycosylated hemoglobin and fasting plasma glucose, silent diabetes was found in 33 (3.3%) patients, pre-diabetes in 217 (22.0%) patients, and normal glucose metabolism in 738 (74.7%) patients; primary endpoint rates were similar to OGTT-based analyses (12.1% vs. 5.5% vs. 3.1%; p = 0.01). Multivariate analyses demonstrated that abnormal glucose metabolism by either diagnostic approach, present in 330 (33.4%) patients, independently predicted adverse event risk (hazard ratio: 2.2; 95% confidence interval: 1.2 to 4.2). ConclusionsAbnormal glucose metabolism was detected in 1 of 3 “nondiabetic” PCI patients and was independently associated with up to 4-fold higher event risks. Future intervention trials should determine whether meaningful benefits accrue from routine glycemia testing in such patients.

Vascular response to percutaneous coronary intervention with biodegradable-polymer vs. new-generation durable-polymer drug-eluting stents: a meta-analysis of optical coherence tomography imaging trials.

Whether biodegradable-polymer drug-eluting stents (BP-DES) induce a vascular response at follow-up more favourable than that of new-generation durable-polymer drug-eluting stents (DP-DES) remains controversial. We sought to evaluate the vascular response to percutaneous coronary intervention (PCI) with BP-DES vs. new-generation DP-DES as assessed by optical coherence tomography (OCT) imaging at follow-up. We undertook a meta-analysis of aggregate data by searching electronic scientific databases for investigations of PCI-patients receiving BP-DES vs. new-generation DP-DES and OCT imaging at follow-up. The primary outcome was neointima hyperplasia (NIH) thickness. The co-primary outcome was the incidence of lesions with uncovered struts. The main secondary outcome was the incidence of lesions with malapposed struts. Among 10 trials, a total of 544 PCI-patients were assigned to BP-DES (n = 282) or new-generation DP-DES (n = 262). Of these, 447 participants with 480 treated lesions had analysable OCT imaging at a weighted median follow-up of 7 months. Lesions treated with BP-DES vs. new-generation DP-DES showed comparable NIH thickness [weighted mean difference 95% confidence intervals (CI) = -11.37 (-29.25, 6.52); P = 0.21]. However, thick-struts (>100 μm) BP-DES showed less NIH thickness as compared to new-generation DP-DES [-20.39 (-33.83, -6.95); P = 0.003]. BP-DES vs. new-generation DP-DES showed a higher risk for uncovered struts [odds ratio 95% CI = 3.50 (1.69-7.26); P = 0.0008] and a trend towards higher risk for malapposed struts [2.01 (0.98-4.12); P = 0.06]. In PCI-patients with available OCT imaging at follow-up, BP-DES with thicker backbones delay vascular response as compared with new-generation DP-DES.

Safety and Efficacy of Polymer-Free Versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

Purpose: Polymer-free-drug-eluting stents (PF-DES) were developed to reduce the risk of stent thrombosis in patients receiving percutaneous coronary intervention. However, the performance of this new stent technology compared with durable polymer DES (DP-DES) has not been well described. This study aimed to perform a meta-analysis of randomised, controlled trials (RCTs) comparing patients with PF-DES versus DP-DES.

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.

Meta-Analysis of Biodegradable Polymer Versus Second-Generation Durable Polymer Drug-Eluting Stents in Patients Receiving Percutaneous Coronary Intervention

Meta-Analysis of Biodegradable Polymer Versus Second-Generation Durable Polymer Drug-Eluting Stents in Patients Receiving Percutaneous Coronary Intervention

Polymer-Free Versus Durable Polymer Drug-Eluting Stents for the Treatment of Coronary Artery Disease: An Updated Meta-Analysis of Randomised Trials

Polymer-Free Versus Durable Polymer Drug-Eluting Stents for the Treatment of Coronary Artery Disease: An Updated Meta-Analysis of Randomised Trials

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], pnon-inferiority=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis

Biodegradable polymer biolimus-eluting stents (BP-BES) are third-generation drug-eluting stents (DES) composed of biodegradable polymers that may improve prognosis after percutaneous coronary intervention (PCI). After five years of follow-up, BP-BES showed conflicting results compared to durable polymer drug-eluting stents (DP-DES). We performed a meta-analysis of the outcomes of studies on BP-BES and DP-DES after percutaneous coronary intervention (PCI) at five years of follow-up. Eligible studies were retrieved from PubMed, Embase and the Cochrane Library and reported the results of all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST) at five years of follow-up. Five studies of a total of 4687 patients were included in the meta-analysis. At five years of follow-up, BP-BES was associated with lower rates of major adverse cardiac events (MACE) (OR = 0.83, 95%CI = [0.71, 0.97]), TLR (OR = 0.77, 95%CI = [0.62, 0.96]) and ST (OR = 0.60, 95%CI = [0.43 to 0.84]), whereas no significant differences in mortality, MI, or TVR rates were detected. Our results demonstrated that at five years of follow-up, BP-BES can significantly reduce the risk of MACE, TLR and ST, which indicate that safety and efficacy were increased after PCI.

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.

Endothelial Barrier Protein Expression in Biodegradable Polymer Sirolimus-Eluting Versus Durable Polymer Everolimus-Eluting Metallic Stents

ObjectivesThis study sought to investigate endothelial coverage and barrier protein expression following stent implantation. BackgroundBiodegradable polymer drug-eluting stents (BP-DES) have been purported to have biological advantages in vessel healing versus durable polymer DES (DP-DES), although clinical trial data suggest equipoise. MethodsBiodegradable polymer-sirolimus-eluting stents (BP-SES), durable polymer-everolimus-eluting stents (DP-EES), and bare-metal stents (BMS) were compared. In the rabbit model (28, 45, and 120 days), stented arteries underwent light microscopic analysis and immunostaining for the presence of vascular endothelium (VE)-cadherin, an endothelial barrier protein, and were subjected to confocal microscopy and scanning electron microscopy. A cell culture study in stented silicone tubes was performed to assess cell proliferation. ResultsLight microscopic assessments were similar between BP-SES and DP-EES. BMS showed nearly complete expression of VE-cadherin at 28 days, whereas both DES showed significantly less with results favoring BP-SES versus DP-EES (39% coverage in BP-SES, 22% in DP-EES, 95% in BMS). Endothelial cell morphologic patterns differed according to stent type with BMS showing a spindle-like shape, DP-EES a cobblestone pattern, and BP-SES a shape in between. VE-cadherin-negative areas showed greater surface monocytes regardless of type of stent. Cell proliferation was suppressed in both DES with numerically less suppression in BP-SES versus DP-EES. ConclusionsThis is the first study to examine VE-cadherin expression after DES. All DES demonstrated deficient barrier expression relative to BMS with results favoring BP-SES versus DP-EES. These findings may have important implications for the development of neoatherosclerosis in different stent types.

Extracting information from free-text electronic patient records to identify practice-based evidence of the performance of coronary stents.

Background and objectivePercutaneous coronary intervention (PCI) using drug-eluting stents (DES) is an indispensable treatment for coronary artery disease. However, to evaluate the performance of various types of stents for PCI, numerous resources are required. We extracted clinical information from free-text records and, using practice-based evidence, compared the efficacy of various DES.Materials and methodsWe developed a text mining tool based on regular expression and applied it to PCI reports stored in the electronic health records (EHRs) of Ajou University Hospital from 2010–2014. The PCI data were extracted from EHRs with a sensitivity of 0.996, a specificity of 1.000, and an F-measure of 0.995 when compared with a sample of 200 reports. Using these data, we compared the performance of stents by Kaplan-Meier analysis and the Cox hazard proportional regression.ResultsIn the self-validation analysis comparing the first-generation to the second-generation DES, the second-generation DES was superior to the first-generation DES (hazard ratio [HR]: 0.423, 95% confidence interval [CI]: 0.284–0.630) in terms of target vessel revascularization (TVR), showing similar findings to the established results of previous studies. Among the second-generation DES, the biodegradable-polymer DES tended to be superior, with a risk of TVR (HR: 0.568, 95% CI: 0.281–1.147) falling below than that for the durable-polymer DES approximately 1 year after the index procedure. The Endeavor stent had the highest TVR risk among the newer generation DES (HR: 2.576, 95% CI: 1.273–5.210).ConclusionsIn this study, we demonstrated how to construct a PCI data warehouse of PCI-related parameters obtained from free-text electronic records with high accuracy for use in the post surveillance of coronary stents in a time- and cost effective manner. Post surveillance of the practice based evidence in the PCI data warehouse indicated that the biodegradable-polymer DES might have a lower risk of TVR than the durable-polymer DES.

Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials.

Background:Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents (DP-DES). We aimed to compare the adverse cardiovascular events associated with BP-DES and durable polymer everolimus-eluting stents (DP-EES) using a large number of patients obtained from randomized controlled trials (RCTs).Methods:Electronic databases were searched for randomized trials comparing BP-DES with DP-EES. Adverse cardiovascular outcomes observed between 6 months and 3 years were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. All authors had full access to the data, and they have read and agreed to the manuscript as written.Results:Ten trials involving a total number of 13,218 patients (7451 patients treated by BP-DES and 5767 patients treated by DP-EES) were included. No significant difference was observed when analyzing mortality and myocardial infarction between BP-DES and DP-EES with OR 1.08, 95% CI 0.87–1.34, P = .47 and OR 1.04, 95% CI 0.84–1.28, P = .72 respectively. Target vessel revascularization, target lesion revascularization, major adverse cardiac events, and stroke were also not significantly different with OR 1.11, 95% CI 0.92–1.33, P = .28; OR 1.11, 95% CI 0.94–1.33, P = .22; OR 1.12, 95% CI 0.99–1.27; P = .07; and OR 1.13, 95% CI 0.69–1.84; P = .62 respectively. In addition, total stent thrombosis (ST) was similarly reported between BP-DES and DP-EES with OR 0.85, 95% CI 0.59–1.21; P = .37. However, even if BP-DES were associated with a higher rate of definite ST with OR 1.69, 95% CI 0.92–3.08, P = .09 and DP-EES were associated with a higher rate of probable ST with OR 0.67, 95% CI 0.38–1.17, P = .16, these results were not statistically significant.Conclusions:Between 6 months and 3 years, BP-DES were similar in terms of cardiovascular outcomes compared to DP-EES. However, further long-term follow-up research is recommended.

Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial

Objective: Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). Methods: We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). Results: At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00). Conclusions: The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

Contemporary Drug-Eluting Stents and Vascular Response

Cardiovascular disease is a leading cause of death and disability worldwide. Current treatment strategies aimed at treating the consequences of coronary artery disease have embraced both optimal medical therapy and catheter based percutaneous coronary intervention with drug-eluting stents (DES). Current-generation DES elute predominantly mammalian target of rapamycin (mTOR) inhibitors, which act primarily as a cytostatic agent that retards vascular smooth muscle cell proliferation and migration; this occurs in response to injury and thus prevents restenosis. While DES have reduced restenosis, the use of first-generation DES was associated with an increased risk of late stent thrombosis and accelerated neointimal atherosclerosis (i.e. neoatherosclerosis), both major contributors to late stent failure. The underlying substrate of late DES failure is likely related to vascular endothelial dysfunction, which occurs after DES implantation. Initial concerns with first-generation DES have led to improvements in stent design, polymer load and biocompatibility, and pharmacologic agents, all of which have helped to improve healing responses, lessen late stent failure, and result in an overall improved safety profile. The armamentarium of DES has expanded from the current-generation durable polymer DES to bioresorbable polymer DES, polymer-free DES, and lastly totally bioresorbable vascular scaffolds with a goal of improving vascular responses and endothelial function while preserving anti-restenotic efficacy. We will review these contemporary DES in relation to their short and long-term effects on vascular biocompatibility and healing responses.

Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents

ObjectivesThe authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). BackgroundPrior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. MethodsThe authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. ResultsThe authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (<6 months vs. >6 months), the strut thickness of the BP-DES (thin <100 μm vs. thick >100 μm), or the DAPT duration (≥6 months vs. ≥12 months). ConclusionsBP-DES have similar safety and efficacy profiles to second-generation DP-DES.

COMPARISON OF BIODEGRADABLE DRUG ELUTING POLYMER STENTS AND DURABLE POLYMER DRUG ELUTING STENT FOR THE TREATMENT OF CAD: A META-ANALYSIS OF RCT'S

Introduction: Durable polymer drug eluting stent (DEP) has endothelial anti-proliferative properties that can decrease stent restenosis rates. We sought to compare the safety and efficacy of BEP to DEP for treatment of ACS. Methods: Pub Med and Chochrane database were searched using all RCT's that

ENDOTHELIAL MATURATION AND FUNCTION FOLLOWING IMPLANTATION OF ABLUMINAL COATING BIODEGRADABLE POLYMER BASED SIROLIMUS-ELUTING METALLIC STENT VERSUS CONFORMAL COATING DURABLE POLYMER BASED EVEROLIMUS ELUTING STENT

Background: Endothelial barrier function is important. Current drug eluting stents (DESs) using biodegradable polymer technologies are now available. However, little is known about endotheliual barrier function after biodegradable versus durable polymer DES. Methods: Ultimaster® (UM, biodegradable

Bioresorbable Polymers and Stent Devices.

Percutaneous coronary interventions will never become obsolete, as evolution is inherent to interventional cardiology. Current drug-eluting platforms have appreciably improved their safety and efficacy profiles in different clinical settings compared to first-generation devices such that it is difficult to consider other alternatives. However, there is definite biological plausibility to consider devices with bioabsorbable polymers and/or scaffolds. It is also an undeniable fact that many patients, based on variety of belief systems, would prefer not to have a permanently implanted device. BP DES with or without bioresorbable scaffolds offer advantages over durable polymer DES in restoring normal coronary physiology and vascular adaptive responses, resulting in late lumen gain and plaque regression. They will likely allow flexibility in treating complex CAD. However, so far, we have been able to prove non-inferiority in a selected population of patients without long-term data. Is "as good as" good enough? Are we ready to reach for the BRS or a BP DES in our catheterization laboratory based on preclinical and mechanistic data (endothelialization, OCT imaging, vasomotion) with limited human experience? I am not. While I will maximize my efforts to recruit patients in related randomized controlled trials, the technology is not ready for prime time. Randomized controlled trials are needed to determine whether any or all of these devices improve long-term outcome compared to best in class DP DES. Most definitive evidence is likely about a decade away. Until then, we can learn to be disciplined implanters not only in selecting the appropriate patient but also in perfecting implantation techniques.

Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial

ObjectivesThe authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BackgroundBiodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. MethodsThe study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months. ResultsFrom March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33). ConclusionsAt 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.

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.