Durable Polymer Everolimus-eluting Stent Research Articles

Everolimus-Eluting Biodegradable Polymer Versus Everolimus-Eluting Durable Polymer Stent for Coronary Revascularization in Routine Clinical Practice

ObjectivesThe aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population. BackgroundBP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk. MethodsAmong 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months. ResultsThe device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22). ConclusionsIn this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291)

Efficacy and Safety of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin, Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization of Patients With Diabetes Mellitus

Patients with diabetes mellitus are prone to increased adverse outcomes after percutaneous coronary intervention, even with contemporary drug-eluting stents. Randomized controlled trials have demonstrated comparable clinical outcomes between an ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES) and a thin-strut durable-polymer everolimus-eluting stent (DP-EES) that has specific labeling for patients with diabetes. We aimed to evaluate the safety and efficacy of the BP-SES in patients with diabetes mellitus. To determine the performance of the BP-SES in diabetic patients, patient-level data from the BIOFLOW II, IV, and V randomized controlled trials were pooled. The primary end point was target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, and definite or probable stent thrombosis, at 1 year. Among 1,553 BP-SES and 791 DP-EES patients, 757 diabetic patients were identified. Of the diabetic patients included in this analysis (494 BP-SES vs 263 DP-EES), the proportion of insulin- and noninsulin-treated patients was similar between groups. The 1-year TLF rate in the diabetic population was 6.3% in the BP-SES group and 8.7% in the DP-EES group (hazard ratio 0.82, 95% confidence interval 0.047 to 1.43, p = 0.493). There were no significant differences, based on stent type or diabetes treatment regimen, in TLF hazards. In a patient-level pooled analysis of the diabetic population from randomized trials, 1-year clinical safety and efficacy outcomes were similar in patients treated with ultrathin BP-SES and thin-strut DP-EES.

2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent

ObjectivesThe aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove–filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BackgroundThe long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. MethodsThe TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. ResultsAt 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). ConclusionsThe 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Comparative Effectiveness and Safety of Polymer-Free Biolimus-Eluting Stent and Durable Polymer Everolimus-Eluting Stent in All-Comer Patients Who Underwent Percutaneous Coronary Interventions

We aim to compare Polymer-Free Biolimus-Eluting Stent (PF-BES) with Durable Polymer Everolimus-Eluting stent (DP-EES) in unselected patients. PF-BES showed a favorable profile in high-bleeding risk patients who underwent percutaneous coronary intervention. Limited data are available on PF-BES compared with second-generation durable polymer-coated drug-eluting stents in patients eligible for standard dual antiplatelet therapy. A total of 848 consecutive patients were enrolled: 306 patients were treated with PF-BES and 542 with DP-EES. Stent performance was tested in a propensity score-matched population and in a Complex Higher-Risk and Indicated Patients (CHIP) subpopulation. A per-lesion analysis on 1,204 lesions (PF-BES = 424 vs DP-EES = 780) was also performed. At a medium follow-up of 18.5 ± 5.0 months, no differences in the matched population were found in terms of major adverse cardiac events (PF-BES 9.0% vs DP-EES 4.5%; p 0.091), myocardial infarction (PF-BES 6.2% vs DP-EES 2.3%; p 0.111), stent restenosis (PF-BES 2.3% vs DP-EES 0.0%; p 0.123), definite or probable stent thrombosis (PF-BES 2.8% vs DP-EES 1.1%; p 0.448). A significant inferior rate of restenosis was observed in the DP-EES arm in the whole (PF-BES 2.3% vs DP-EES 0.6%; p 0.041) and CHIP populations (PF-BES 4.3% vs DP-EES 0.5%; p 0.023), as well as in the per-lesion analysis (DP-EES 0.4% vs PF-BES 1.7%; p 0.039). In conclusion, in a real-world cohort PF-BES performed similarly to DP-EES in terms of restenosis and stent thrombosis in the matched population. Nonetheless, in the whole and CHIP populations, as well as in the per-lesion analysis, restenosis occurrence resulted higher in the PF-BES group.

TWO-YEAR RESULTS AFTER IMPLANTATION OF AN ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING CORONARY STENT COMPARED TO A THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENT: HEALTH ECONOMIC EVALUATION

The recent BIOFLOW V trial (ClinicalTrials.gov: [NCT02389946][1]) showed that the Orsiro ultrathin, bioresorbable polymer sirolimus-eluting stent (BP SES) (BIOTRONIK, Buelach, Switzerland) was in statistical favor to the Xience thin, durable polymer everolimus-eluting stent (DP EES) (Abbott Vascular

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention.

Background and ObjectivesThere are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI.MethodsPatients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up.ResultsOf 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246–1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244–2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157–8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139–1.095; p=0.074) did not differ between 2 stent groups after complex PCI.ConclusionsClinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.

Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial.

Bioresorbable scaffolds (BRS) provide short-term coronary artery scaffolding and drug delivery. Although prior trials showed a higher rate of device failure compared with conventional drug-eluting stents (DES), only a single trial investigated patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). We aimed to compare outcomes with BRS vs. DES in patients undergoing PCI for MI. We did a prospective, randomized, multicentre, non-inferiority, clinical trial of everolimus-eluting BRS vs. durable polymer everolimus-eluting stents (EES) in patients with acute MI. Patients were eligible for enrolment if they presented with ST-elevation MI, or non-ST-elevation MI with thrombosis visual at angiography and were randomly allocated to treatment with BRS or EES in 2:1 proportion. Angiographic follow-up was scheduled at 6-8 months and clinical follow-up was done at 12 months. The primary endpoint was percentage diameter stenosis in-segment at follow-up. A total of 262 patients were enrolled and were allocated to BRS (n = 173) or EES (n = 89). Angiographic follow-up was available for 213 (81.3%) patients. Mean diameter stenosis was 24.6 ± 12.2% with BRS vs. 27.3 ± 11.7% with EES (mean difference -2.7%, upper limit of one-sided 97.5% confidence limit 0.7%, pre-specified margin of non-inferiority 5%, Pnon-inferiority <0.001). The rate of the device-oriented composite of cardiac death/target vessel MI/target lesion revascularization [BRS: 12 (7.0%) vs. EES: 6 (6.7%), hazard ratio (HR) 1.04, 95% confidence interval (CI) 0.39-2.78] and definite/probable stent thrombosis [3 (1.7%) vs. 2 (2.3%), HR 0.76, 95% CI 0.13-4.56] were comparable in both groups. In patients undergoing PCI for acute MI BRS were non-inferior to EES for percentage diameter stenosis at angiographic follow-up. Rates of clinical events were comparable between the treatment groups, although the study was not powered to detect differences in clinical outcomes. The trial was registered at www.clinicaltrials.gov (NCT01942070).

Health Economic Evaluation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent.

The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating. The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI). We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews. Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient. Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents

BackgroundCoronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. ObjectivesThe authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. MethodsBIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed. ResultsAmong 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (−4.33% treatment difference; 95% confidence interval: −8.16% to −0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045). ConclusionsIn a large randomized trial, significant differences in both TLF and target vessel–related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)

TCT-790 Efficacy and Safety of the Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents for Treatment of Patients With Diabetes Mellitus

Patients with diabetes mellitus (DM) are subjected to adverse outcome following PCI. Randomized, controlled trials have demonstrated comparable clinical outcomes of the bioresorbable polymer sirolimus-eluting stent (BP SES) with a thin strut durable polymer everolimus-eluting stent (DP-EES) that has

TCT-195 Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary Revascularization: Two-year Outcomes from the Randomized BIOFLOW V Trial

Coronary drug-eluting stent development has included new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been demonstrated in prior randomized trials. BIOFLOW V ([ClinicalTrials.gov][1] [NCT02389946][2

Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial

Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950). 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Clinical Trials Unit of the University of Bern and Biotronik.

P2638Comparison of in-stent responses in 8 month between durable polymer and bioabsorbable polymer everolimus-eluting stent: serial observation with angioscopy and optical coherence tomography

P2638Comparison of in-stent responses in 8 month between durable polymer and bioabsorbable polymer everolimus-eluting stent: serial observation with angioscopy and optical coherence tomography

P791Comparison between a novel bioabsorbable polymer everolimus-eluting stent and a durable polymer everolimus-eluting stent

P791Comparison between a novel bioabsorbable polymer everolimus-eluting stent and a durable polymer everolimus-eluting stent

BIOFLOW V: COMPARISON OF ULTRATHIN SIROLIMUS-ELUTING BIORESORBABLE POLYMER STENTS WITH THIN EVEROLIMUS-ELUTING DURABLE POLYMER STENTS - TARGET VESSEL MYOCARDIAL INFARCTION ANALYSIS

The BIOFLOW V trial demonstrated a lower rate of target lesion failure (TLF) at 12 months in patients treated with the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP SES) compared to a thin strut, durable polymer everolimus-eluting stent (DP EES). The difference in TLF was driven

Outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent in patients with chronic total occlusions: A multicenter registry

BackgroundWe aimed to evaluate the mid-term outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), as compared with durable-polymer everolimus-eluting stents (EES). MethodsWe compiled a multicenter registry of patients undergoing CTO recanalization followed by BP-SES or EES implantation. The primary endpoint was the incidence of target-lesion failure (TLF, a composite of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization) at one year. Propensity score matching (PSM) was used to adjust for case mix. ResultsOverall, 413 patients were included (BP-SES n = 242, EES n = 171). PSM resulted in 131 matched pairs, which represented the subject of the main analysis. Antegrade wire escalation was the most successful crossing technique (66% vs. 63%, p = 0.98) in both the BP-SES and EES groups, respectively. Procedural success rates were similar between groups (BP-SES 96% vs. EES 93%, p = 0.24). At one-year follow-up, there were no differences in the primary endpoint of TLF (5.7% vs. 8.3%, p = 0.44), and in cardiac death (0.9% vs. 2.8%, p = 0.32), target-vessel myocardial infarction (0.9% vs 1.9%, p = 0.57), target-lesion revascularization (3.7% vs 3.7%, p = 0.99), or stent thrombosis (0.9% vs. 1.9%, p = 0.57), in BP-SES vs. EES, respectively. ConclusionsPatients undergoing CTO PCI with BP-SES suffer a low rate of TLF at one-year follow-up, which is similar to that of subjects treated with durable-polymer EES.

Comparison of the Absorb bioresorbable vascular scaffold to the Xience durable polymer everolimus-eluting metallic stent in routine clinical practice: a propensity score-matched analysis from a multicenter registry.

IntroductionMost clinical trials related to bioresorbable vascular scaffold (BVS) technology are limited to a highly selected patient population.AimTo evaluate early and long-term clinical outcomes of the Absorb everolimus-eluting BVS compared to the everolimus-eluting metallic XIENCE V stent in routine clinical practice.Material and methodsThis is a multicenter, retrospective propensity score-matched comparative study, comprising 76 patients treated with a bare metal stents (BMS) and 501 with a XIENCE stent. Patients included in the study had stable and unstable angina and both types of myocardial infarction (STEMI and NSTEMI) as an indication for intervention and at least one significant de novo lesion in native coronary arteries. The primary endpoint was major adverse cardiovascular event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR).ResultsMedian follow-up was 400 days in both groups. After propensity score matching for patient baseline characteristics, only higher rate of predilatation, predominantly treated left anterior descending artery (LAD) and lower number of used stents in the BVS group remained statistically significant. After adjustment there was no difference in type of treated lesions. The MACE rate did not differ between BVS and drug-eluting stents (DES) groups (7.2% vs. 11.15%, respectively; p = 0.17). The TVR was 2.9% in both groups. Except in the periprocedural period, there were no deaths or MI in the BVS group. There was no stent thrombosis in either studied group.ConclusionsIn routine clinical practice throughout long-term follow-up, clinical outcomes of patients who successfully received the Absorb BVS did not differ from those of patients who received the Xience stent. Longer follow-up data are required to determine whether these findings will persist beyond one year.

Optical coherence tomography for evaluating Synergy everolimus-eluting stents with biodegradable polymer and Xience durable polymer everolimus-eluting stents following percutaneous coronary intervention in patients with left main coronary artery stenosis

Aim. The development of on a new generation of stents with abluminal biodegradable polymer is aimed at accelerating the neointimal growth and reducing the inflammatory response of the vascular wall. This article presents an analysis of healing characteristics, as assessed by optical coherence tomography (OCT), of ultrathin Synergy everolimus-eluting stent with biodegradable polymer and Xience everolimus-eluting stent with durable polymer three months after implantation.Methods. In this prospective, single-center study fifty patients with significant stenosis of the left main coronary artery were randomized in 2 groups for implantation of everolimus-eluting stents with durable polymer (Xience) or abluminal biodegradable polymer (Synergy). After three months all patients underwent control coronarography supported by optical coherence tomography. A Neointimal Healing Score (NIH Score) obtained at three months after stent implantation by means of optical coherence tomography was the primary endpoint. Such OCT data as percentage of uncovered or malapposed struts only and presence of both malapposed and uncovered struts were planned as the secondary endpoints. To study the freedom from adverse events, one composite endpoint including myocardial infarction, repeat left coronary artery revascularization and death within 12 months after the procedure was determined. Results. There were no significant differences in the NIH score (primary endpoint) in two groups (25.6±12.3 in Xience vs 32.5±20.3 in Synergy, respectively; p = 0.12). The struts of both types of stents showed statistically similar coverage and apposition at 3-month OCT follow-up: percentage of uncovered struts only was 6.3±3.9 and 9.9±7.8 in Xience and Synergy groups, respectively (p = 0.098) and malapposed struts only 0.25±0.5 vs 0.37±0.5; p = 0.628. The presence of both malapposed and uncovered struts was 4.9±3.8 and 5.1±4.5 in two groups and didn’t differ statistically (p = 0.92). During 12-month follow-up, two cases of stent thrombosis were recorded (one in each group), which required repeat revascularization. In addition, one case of myocardial infarction related to the right coronary artery occurred in the Synergy group.Conclusion. The Synergy everolimus-eluting stent with abluminal biodegradable polymer has a healing profile comparable to that of Xience everolimus-eluting stent with durable polymer with a low rate of uncovered and malapposed struts at 3-month follow-up. A low incidence of adverse events in both groups during 12-month follow-up indicates the safety of the stents under study.Received 18 September 2017. Revised 13 December 2017. Accepted 15 December 2017.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.Author contributionsAll authors contributed equally to the work.

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.

TCT-228 Early neointimal coverage of new biodegradable polymer drug-eluting stent compared with durable polymer everolimus-eluting stent: optical frequency domain imaging analysis

TCT-228 Early neointimal coverage of new biodegradable polymer drug-eluting stent compared with durable polymer everolimus-eluting stent: optical frequency domain imaging analysis