Xience Everolimus-eluting Stent Research Articles

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial.

Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial.

In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months. This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent. The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years. The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES. At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population. gov: NCT02870140.

Long-term (beyond 5 years) clinical impact of Xience everolimus-eluting stent implantation.

ObjectsWe aim at examining the long‐term clinical outcome after Xience everolimus‐eluting stent (X‐EES) implantation.BackgroundLong‐term clinical outcomes beyond 5 years after X‐EES implantation remain unclear.MethodsThis retrospective study has collected data from 1184 consecutive patients, corresponding to 1463 lesions, who were treated with X‐EES alone in the Nagoya Heart Center between January 2010 and December 2013. The primary endpoint was the 10‐year cumulative incidence of target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Definite/probable stent thrombosis (ST) was evaluated as a secondary outcome.ResultsAt 10 years, the cumulative incidence of TLF was recorded to be 12.4%, whereas that of cardiac death, target vessel MI, and clinically indicated TLR was at 4.4%, 4.1%, and 7.8%, respectively. The cumulative rate of definite/probable ST was observed to remain low (0.3% at 30 days; 0.3% at 1 year; 0.6% at 5 years; and 1.1% at 10 years). In the multivariate analysis, the risk factors of TLF were insulin‐treated diabetes (hazard ratio (HR), 1.93; 95% confidence interval (CI), 1.13‐3.29; P = .02), left ventricular dysfunction (HR, 2.28; 95% CI, 1.43‐3.62; P < .01), hemodialysis (HR, 2.22; 95% CI, 1.39‐3.56; P < .01), prior percutaneous coronary intervention (HR, 1.68; 95% CI, 1.18‐2.41; P < .01), peripheral vascular disease (HR, 1.70; 95% CI, 1.07‐2.69; P < .01), severe calcification (HR, 2.08; 95% CI, 1.36‐3.09; P < .01), and in‐stent restenosis (HR, 2.93; 95% CI, 1.64‐4.89; P < .01).ConclusionsThe incidence rates of the long‐term adverse effects after X‐EES implantation, such as late TLR and ST, were determined to be low in this study; however, they increased over time until 10 years after stent implantation.

Four-year results of the AIDA trial: comparison of Absorb bioresorbable scaffold with Xience everolimus-eluting metallic stent in daily clinical practice

Abstract Aims Absorb bioresorbable scaffold (BRS) related events were noticed between 1 and 3 years – the approximate time of active scaffold bioresorption. This resulted in the recommendation for 3 year DAPT after Absorb BRS implantation. We aimed to evaluate the safety and efficacy of the Absorb BRS in comparison with Xience everolimus-eluting stent (EES) at 4 years follow-up in large unselected population. In addition, we aimed to assess the value of prolonged DAPT against scaffold thrombosis. Methods AIDA was an investigator-initiated, non-inferiority, multicenter, randomized, all-comers trial. Target vessel failure (a composite of cardiac death, target-vessel myocardial infarction and target-vessel revascularization) and device thrombosis at 4-year follow-up are the primary focus of this analysis. During the trial recommendation for DAPT was changed to up to 3-years post Absorb BVS implantation. Whether this adaption influenced the results after Absorb BVS will be assessed. Results Between August 2013 and December 2015, 1,845 patients were enrolled, of whom 924 were randomized to treatment with Absorb BRS and 921 to Xience EES. The baseline characteristics in the two study arms were well balanced. Of all patients, 18% had diabetes mellitus, more than 50% presented with ACS and the median SYNTAX score was 11. In the Absorb BRS arm, 97% of lesions were predilated and in 74% post-dilatation was performed. Four-year clinical outcomes are currently being adjudicated by an independent clinical event committee. The results will be available at EuroPCR 2020. Conclusions Absorb BRS is associated with higher rates of scaffold thrombosis throughout 3-year of follow-up. The performance of Absorb BRS beyond 3-years, in comparison with the Xience EES, in a large unselected population will be presented. (ClinicalTrials.gov Identifier: NCT01858077) Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Two-year clinical performance of Absorb BVS compared to Xience EES in ST-segment elevation myocardial infarction: a pooled analysis of AIDA and COMPARE-ABSORB trials

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to Xience everolimus-eluting stent in routine PCI in patients with diabetes mellitus-AIDA sub-study.

BackgroundIn this prespecified AIDA‐trial sub‐study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus‐eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3‐year follow‐up.Methods and resultsAll 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin‐treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively).ConclusionsIn routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3‐year follow‐up.

PATHOLOGY OF NEOATHEROSCLEROSIS IN THREE CURRENT STANDARD DRUG-ELUTING STENTS IN HUMANS

Recent clinical studies have revealed that neoatherosclerosis is one of the major causes of very late stent thrombosis in currently available drug-eluting stents (DES). We have previously shown that the prevalence of neoatherosclerosis is similar in Xience everolimus-eluting stents and first-

TCT-291 Comparison of Thromboresistance Between Everolimus-Eluting Fluoropolymer Stent and Currently Available Drug-Eluting Stent in an Ex Vivo Swine Shunt Model Under Only Single Antiplatelet Therapy

Recent clinical studies suggest that 1-month dual antiplatelet therapy is feasible for patients receiving Xience everolimus-eluting stents, but whether this applies to other current drug-eluting stents (DES) remains uncertain. Under low-dose heparin treatment, ex vivo porcine arteriovenous shunt

A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial

BackgroundFemales are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. MethodsThe AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. ResultsOf the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). ConclusionsIn this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial.

The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

Twelve-month comparative analysis of clinical outcomes using biodegradable polymer–coated everolimus-eluting stents versus durable polymer–coated everolimus-eluting stents in all-comer patients

AimThe purpose of the present study was to examine whether clinical differences exist between the biodegradable polymer (BDP)–coated Tetrilimus everolimus-eluting stent (EES) and the durable polymer (DP)–coated Xience EES by comparing the major adverse cardiac event (MACE) rate at 12 months in all-comer patients. MethodsThis study was designed as a multicentre, observational, retrospective, investigator-initiated study between January 2016 and October 2016. Two hundred thirteen patients who underwent percutaneous coronary intervention (PCI) with the BDP-EES were compared with 204 patients who underwent PCI with the DP-EES, irrespective of lesion complexity, comorbidities and acute presentation. The primary end point was MACE defined as a composite of cardiac death, myocardial infarction and target lesion revascularization. ResultsBaseline clinical and lesion characteristics of both the groups were similar, although the BDP-EES group had a significantly higher number of patients with diabetes mellitus (39.9% vs. 30.4%; p = 0.042) and type C lesion (67.4% vs. 48.1%; p < 0.001) than the DP-EES group. The 12-month MACE rate was 4.2% for the BDP-EES group versus 4.9% for the DP-EES group (p = 0.740). Mortality was lower in the BDP-EES group than in the DP-EES group (0.9% vs. 2.0%; p = 0.441). ConclusionThe present comparative analysis shows that the BDP-coated Tetrilimus EES was as safe and effective as the DP-coated Xience EES during the 12-month follow-up period despite complex lesion characteristics.

Comparison of Resolute zotarolimus-eluting and Xience everolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES VI trial.

Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Fracture in drug-eluting stents increases focal intimal hyperplasia in the atherosclerosed rabbit iliac artery.

Drug-eluting stent (DES) strut fracture (SF) is associated with higher incidence of In-stent restenosis (ISR)-return of blockage in a diseased artery post stenting-than seen with bare metal stents (BMS). We hypothesize that concomitance of drug and SF leads to greater neointimal response. Controlled release of therapeutic agents, such as sirolimus and its analogs, or paclitaxel from has reduced tissue based DES failure modes compared to BMS. ISR is dramatically reduced and yet the implications of mechanical device failure is magnified. Bilateral Xience Everolimus-eluting stents (EES) were implanted in 20 New Zealand White rabbits on normal (n = 7) or high fat (HF)/high cholesterol (HC) (n = 13) diets. Implanted stents were intact or mechanically fractured. Everolimus concentration was as packaged or pre-eluted. After 21 days, stented vessels were explanted, resin embedded, MicroCT scanned, and analyzed histomorphometrically. Fractured EES were associated with significant (P < 0.05) increases in arterial stenosis and neointimal formation and lower lumen-to-artery area ratios compared to intact EES. Hyperlipidemic animals receiving pre-eluted EES revealed no significant difference between intact and fracture groups. SF increases intimal hyperplasia, post EES implant, and worse with more advanced disease. Pre-eluted groups, reflective of BMS, did not show significant differences, suggesting a synergistic effect of everolimus and mechanical injury, potentially explaining the lack of SF reports for BMS. Here, we report that ISR has a higher incidence with SF in EES, the clinical implication is that patients with SF after DES implantation merit careful follow-up.

TCT-539 Clinical outcomes in high bleeding risk patients undergoing complex PCI with the Xience everolimus eluting stent: a patient-level pooled analysis from four Xience post-approval trials

High bleeding risk (HBR) patients experience not only high risk for bleeding but also high risk for ischemic events. Similarly, complex vs. non-complex PCI is generally associated with increased ischemic risk. We aimed to evaluate whether complex vs. non-complex PCI further increases the ischemic

TCT-734 Comparison of Thromboresistance between Everolimus-eluting Fluoropolymer Stent and ELuNIR Ridaforolimus Eluting Coronary StentRidaforolimus-Eluting Stent in an Ex Vivo Swine Shunt Model

Several meta-analyses have demonstrated that stent thrombosis is significantly lower in Xience everolimus-eluting stents (Xience-EES) as compared to bare metal stents (BMS) and biodegradable polymer stent drug-eluting stents. Likewise, ex-vivo porcine arteriovenous shunt studies also support

A Study Comparing the Outcomes Between the Orsiro Sirolimus Eluting Stent and Xience Everolimus Eluting Stent in the ST-Elevation Myocardial Infarction Population

Background: At present, the Xience everolimus eluting stent (X-EES) is considered the gold standard drug-eluting stent (DES). The Orsiro sirolimus eluting stent (O-SES) with a biodegradable polymer coating has been shown in subanalyses of the BIOSCIENCE trial to have possible improved outcomes compared to Xience in the STEMI population; however, research in this subset remains limited.

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.

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial

ObjectivesThe authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR). BackgroundThe treatment of ISR remains challenging in contemporary clinical practice. MethodsIn a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months. ResultsA total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65). ConclusionsIn patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.

Evaluation of chemical stability of polymers of XIENCE everolimus-eluting coronary stents in vivo by pyrolysis-gas chromatography/mass spectrometry.

The polymers poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) and poly(n-butyl methacrylate) (PBMA) are employed in manufacturing the XIENCE family of coronary stents. PBMA serves as a primer and adheres to both the stent and the drug coating. PVDF-HFP is employed in the drug matrix layer to hold the drug everolimus on the stent and control its release. Chemical stability of the polymers of XIENCE stents in the in-vivo environment was evaluated by pyrolysis-gas chromatography with mass spectrometry (Py-GC/MS) detection. For this evaluation, XIENCE stents explanted from porcine coronary arteries and from human coronary artery specimens at autopsy after 2-4 and 5-7 years of implantation, respectively, were compared to freshly manufactured XIENCE stents (controls). The comparison of pyrograms of explanted stent samples and controls showed identical fragmentation fingerprints of polymers, indicating that PVDF-HFP and PBMA maintained their chemical integrity after multiple years of XIENCE coronary stent implantation. The findings of the present study demonstrate the chemical stability of PVDF-HFP and PBMA polymers of the XIENCE family of coronary stents in the in-vivo environment, and constitute a further proof of the suitability of PVDF-HFP as a drug carrier for the drug eluting stent applications. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1721-1729, 2018.