SYNERGY Stent Research Articles

Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial

BackgroundPrevious studies have investigated a 1 to 6-month short dual antiplatelet therapy (S-DAPT) after percutaneous coronary intervention (PCI) with modern drug eluting-stents to reduce bleeding events. ObjectivesTo investigate cardiovascular outcomes in patients at high bleeding risk (HBR) according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria after PCI with the Synergy bioresorbable-polymer everolimus-eluting stents (EES). MethodsWe applied ARC-HBR criteria in the population of the prospective, single-arm, multicenter POEM (Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy Stent in Patients at HBR Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy) trial. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 12 months. ResultsThe original POEM cohort included 356 patients (80.4 %) fulfilling ARC-HBR criteria. Oral anticoagulant (OAC) usage and age ≥75 years were the most frequent major and minor ARC-HBR criteria, respectively. The ARC-HBR group was mainly represented by men (71.1 %), with 74.4 ± 9.3 years and a high burden of cardiovascular risk factors. DAPT was prescribed in 79.3 %, and single antiplatelet (SAPT) with OAC in 18.7 %. 12-month follow-up was completed in 96.2 %. The primary endpoint occurred in 5.2 % (95 % CI 3.29–8.10) of patients, whereas bleeding Academic Research Consortium type 3–5 occurred in 2.7 % (95 % CI, 1.39 %–5.05 %). ConclusionPrevious results of the POEM trial showed positive outcomes regarding ischemic and bleeding events with an S-DAPT regimen after Synergy EES. These results are also confirmed in sub-group analysis when ARC-HBR criteria are applied.

SYNERGY—Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent in patients with ST elevation myocardial infarction (STEMI). The only drug eluting stent approved for treatment of STEMI by the FDA is the Taxus stent which is no longer commercially available, so further data are needed. The CLEAR SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (N=7000), comparing colchicine vs. placebo and spironolactone vs. placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia driven target vessel revascularization (TVR) within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention (PPCI) for STEMI based on the TOTAL trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%.Overall, 733 patients were enrolled from 8 countries with a mean age 60.2 years, 19% diabetes, 41.3% anterior MI and median door to balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2-6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI or TVR were 2.7%, 1.9%, 1.0% respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4% and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared to the performance goal based on prior trials.Trial Registration: ClinicalTrials.gov Identifier: NCT03048825

Bleeding and Ischemic Risk Prediction in Patients With High Bleeding Risk (an EVOLVE Short DAPT Analysis)

The EVOLVE Short DAPT study demonstrated the safety of truncated dual antiplatelet therapy (DAPT) in patients with a high bleeding risk (HBR) treated with SYNERGY stent(s) (Boston Scientific Company, Marlborough, Massachusetts). In this population, bleeding and ischemic risk prediction may further inform DAPT decisions. This post hoc analysis of the EVOLVE Short DAPT study identified predictors of ischemic and bleeding events up to 15months using Cox proportional hazard models. The predicted probabilities of bleeding were calculated using the Breslow method. Of 2,009 enrolled patients, 96.9% of the patients met at least 1 HBR criteria. At 15months, the cumulative incidences of bleeding and ischemic events were 6.3% and 6.0%, respectively. The risk of bleeding was increased in patients who received oral anticoagulants (hazard ratio [HR] 2.24, 95% confidence interval [CI] 1.50 to 3.36, p <0.001) or had peripheral vascular disease (HR 1.61, 95% CI 1.01 to 2.56, p=0.045). The risk of ischemic events was increased in patients with diabetes (HR 1.86, 95% CI 1.24 to 2.78, p <0.01) or congestive heart failure (HR 2.06, 95% CI 1.39 to 3.04, p <0.001). Renal insufficiency/failure was associated with both endpoints. There was a strong positive correlation between the predicted probability of ischemic and bleeding events (R=0.77, p <0.001). In 617 patients with a predicted bleeding risk <4%, ischemic events predominated, and the ischemic and bleeding rates were higher in patients with a predicted bleeding risk ≥4%. Within an HBR cohort, specific characteristics identify patients at a higher risk for ischemic and separately, bleeding events. Increased bleeding risk is tied to increased ischemic risk. In conclusion, standardized risk models are needed to inform DAPT decisions in patients with a higher risk. Clinical Trial Registration: NCT02605447.

Efficacy of Percutaneous Coronary Intervention With Synergy Stents in Patients Aged ≥75 Years: 1-Year Clinical Outcomes from the Synergy Elderly Registry

Data regarding the clinical outcomes of older patients after Synergy everolimus-eluting stent (S-EES) implantation are limited. This study investigated the 12-month clinical outcomes of older patients who underwent percutaneous coronary intervention with new-generation drug-eluting stents according to ischemic risks. This prospective multicenter study targeted patients aged ≥75years who underwent S-EES implantation. The primary and secondary end points included 12-month device-oriented composite end point (DOCE) (cardiovascular death, target vessel myocardial infarction, or target lesion revascularization) and major adverse cardiac and cerebrovascular events (MACCEs; all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis, or stroke), respectively. A stratified analysis was conducted according to high-ischemic risk (HIR), defined as complex coronary intervention (number of stents implanted ≥3, total stented length >60mm, chronic total occlusion, left main, or bifurcation), diabetes, or chronic kidney disease. In total, 650 enrolled patients aged ≥75years were categorized into HIR (n=425) and non-HIR groups (n=225). In the total population, the 1-year incidence of DOCEs was 2.5%. The rates of DOCEs were not significantly different between the HIR and the non-HIR groups, whereas the MACCE rate was higher in the HIR (9.4%) than the non-HIR group (4.9%, p=0.035), and the DOCE and MACCE components did not differ significantly in the occurrence between the groups. The independent predictors for the DOCEs or MACCEs included age, anemia, or left ventricular ejection fraction <40%. In conclusion, in older patients, S-EES implantation demonstrated favorable device-related outcomes, regardless of procedural complexity or co-morbidities. However, it requires careful attention because older patients with HIR are associated with worse clinical outcomes.

Reduced-dose prasugrel monotherapy without aspirin after PCI with the SYNERGY stent in East Asian patients presenting with chronic coronary syndromes or non-ST-elevation acute coronary syndromes: rationale and design of the ASET Japan pilot study

The Acetyl Salicylic Elimination Trial (ASET) Japan pilot study is a multicentre, single-arm, open-label, proof-of-concept study with a stopping rule based on the occurrence of definite stent thrombosis. This study aims to demonstrate the feasibility and safety of low-dose prasugrel monotherapy following percutaneous coronary intervention (PCI) in Japanese patients presenting with chronic coronary syndromes (CCS) or non-ST-elevation acute coronary syndromes (NSTE-ACS). Four hundred patients with a SYNTAX score <23 requiring PCI due to CCS or NSTE-ACS will be screened and considered eligible for the study. The enrolment is planned in two phases: 1) 200 patients presenting with CCS, followed by 2) 200 patients presenting with NSTE-ACS. After optimal PCI with implantation of a SYNERGY (Boston Scientific) stent, patients will be enrolled and loaded with prasugrel 20 mg, followed by a maintenance dose of prasugrel 3.75 mg once daily without aspirin continued for 3 months in Phase 1 (CCS patients), and for 12 months in Phase 2 (NSTE-ACS patients). After these follow-up periods, prasugrel will be replaced by standard antiplatelet therapy according to local practice. The primary endpoint is a composite of cardiac death, target vessel myocardial infarction, or definite stent thrombosis after the index procedure. The primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 or 5 bleeding occurring within 3 months of the index PCI for CCS patients, or 12 months for NSTE-ACS patients. The ASET Japan study is designed to demonstrate the feasibility and safety of reduced-dose prasugrel monotherapy after PCI in East Asian patients with acute and chronic coronary syndromes.

Clinical Outcomes and OCT Analysis After Culotte Stenting With 2nd- and 3rd-Generation Everolimus-Eluting Stents: Two-Year Follow-Up of the CELTIC Bifurcation Study

PurposeThe aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. MethodsA total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. ResultsAfter 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years.OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. ConclusionsThe first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.

Mobilization of progenitor cells and vessel healing after implantation of SYNERGY in acute coronary syndrome

This study was aimed to compare the vascular healing process of a SYNERGY stent with that of a PROMUS PREMIER stent in patients with acute coronary syndrome (ACS). In 71 patients with ACS, undergoing coronary stent implantation using the SYNERGY stent (n = 52) or PROMUS PREMIER stent (n = 19), we measured circulating CD34+/CD133+/CD45null cells and CD34+/KDR+ cells and observed vascular healing at the stented sites using optical coherence tomography (OCT) and coronary angioscopy. On the day 7, circulating CD34+/CD133+/CD45null cells increased in SYNERGY group (P < 0.0001), while it did not change in PROMUS group. The CD34+/KDR+ cells also increased in SYNERGY group (P < 0.0001) but less significantly in the PROMUS group (P < 0.05). The OCT-based neointimal thickness (P < 0.0005) and neointimal coverage rate (P < 0.05) at 12 months were greater in SYNERGY group, compared with PROMUS group. The coronary angioscopy-based neointimal coverage grade at 12 months was also greater in SYNERGY group (P < 0.001). In overall patients, the change in CD34+/KDR+ cells on the day 7 correlated with the OCT-based neointimal thickness at 12 months (R = 0.288, P < 0.05). SYNERGY stent seems to have potential advantages over PROMUS PREMIER stent for ACS patients in terms of vascular healing process at the stented sites.

Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study.

ObjectivesThe EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions.BackgroundClinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long‐term data in a broad population of patients undergoing PCI.MethodsPatients with lesion length >34‐ ≤44 mm and reference vessel diameter (RVD) ≥2.5‐ ≤ 4.0 mm were enrolled in this prospective, multicenter, single‐arm study. The primary endpoint was 12‐month target lesion failure (TLF; composite of target lesion revascularization [TLR], target‐vessel myocardial infarction [TV‐MI], or cardiac death) compared to a prespecified performance goal (PG).ResultsA total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre‐TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One‐year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV‐MI in two patients treated with SYNERGY 48 mm stent. Between the 1‐2‐year timeframe, TV‐MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years.ConclusionsPCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Effects of Simulated COVID-19 Cytokine Storm on Stent Thrombogenicity

BackgroundCytokine storm-related hypercoagulation may be important in the pathogenesis of stent thrombosis in patients with SARS-CoV-2. Whether stent polymers behave differently under such conditions has never been explored. MethodsFluorinated polymer-nanocoated and uncoated COBRA stents (CeloNova), BioLinx-polymer-coated Resolute Onyx stents (Medtronic), and Synergy stents (Boston Scientific), which are abluminally coated with a bioabsorbable polymer, were exposed to human blood from healthy donors which was supplemented with 400 pg/mL IL-6 and 100 pg/mL TNF-α, similar to what is seen in cytokine storm caused by SARS-CoV-2. Platelet adhesion and neutrophil activation, assessed by immunofluorescence, were compared under cytokine storm and control conditions (untreated blood) (n = 4 experimental runs). ResultsPlatelet adhesion values, defined as %platelet-covered area x staining intensity, were significantly lower in coated and uncoated COBRA and in Resolute Onyx than in Synergy under control conditions (1.28 × 107 ± 0.43 × 107 vs. 2.92 × 107 ± 0.49 × 107 vs. 3.57 × 107 ± 0.73 × 107 vs. 9.94 × 107 ± 0.99 × 107; p ≤0.0001). In cytokine storm, platelet adhesion values remained low in coated COBRA-PzF (1.78 × 107 ± 0.38 × 107) compared to all other devices (uncoated COBRA: 5.92 × 107 ± 0.96 × 107; Resolute Onyx: 7.27 × 107 ± 1.82 × 107; Synergy: 11.28 × 107 ± 1.08 × 107; p ≤ 0.0001). Although cytokine storm conditions significantly increased neutrophil activation in all stents, it was significantly less in coated and uncoated COBRA, and in Resolute Onyx than in Synergy. ConclusionsBlood-biomaterials interactions may determine the thrombogenic potential of stents. Under simulated cytokine storm conditions, fluoropolymer-coated stents showed the most favorable anti-thrombogenic and anti-inflammatory properties.

Final 5-Year Results in Randomized Japanese Patients Implanted With a Thin-Strut, Bioabsorbable, Polymer-Coated, Everolimus-Eluting SYNERGY Stent (From the EVOLVE II Study).

Background: SYNERGY is a thin-strut, platinum-chromium metal alloy stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer. EVOLVE II was a global randomized controlled trial that enrolled 1,684 patients treated with either a SYNERGY or durable polymer PROMUS Element Plus (PE+) everolimus-eluting stent, including 155 patients from Japanese sites. This substudy analyzed 5-year clinical outcomes in the Japanese and non-Japanese cohorts.Methods and Results: Patients aged ≥18 years with ≤3 native coronary artery lesions (reference vessel diameter ≥2.25–≤4.00 mm; length ≤34 mm) in ≤2 major vessels were randomized 1 : 1 to receive either SYNERGY (n=74 patients in Japan) or PE+ (n=81 patients in Japan). Five-year target lesion failure (TLF) was observed in 8.3% SYNERGY- and 11.2% PE+-treated patients (P=0.54). There were no cardiac deaths, and rates of target lesion revascularization and myocardial infarction were comparable between treatment arms. One patient in the SYNERGY arm experienced a very late definite stent thrombosis (ST); no ST occurred in the PE+ arm (P=0.30). Despite differences in baseline clinical and lesion characteristics, the 5-year TLF rates were not significantly different in SYNERGY-treated patients either in (8.3%) or outside (14.8%) Japan (P=0.14).Conclusions: In Japanese patients with coronary artery disease, SYNERGY showed comparable efficacy to PE+, with low rates of adverse events over 5 years. Similarly, 5-year clinical outcomes were favorable in Japanese vs. non-Japanese patients implanted with SYNERGY.

A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and design of the Multivessel TALENT trial.

The purpose of the Multivessel TALENT trial is to compare clinical outcomes of the novel Supraflex Cruz stent with those of the SYNERGY stent in patients with three-vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI). In this prospective, randomised, 1:1 balanced, multicentre, open-label trial, 1,550 patients with de novo 3VD without left main disease will be assigned to the Supraflex Cruz or SYNERGY arm. The following treatment principles of "best practice" PCI will be applied: Heart Team consensus based on SYNTAX score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimisation by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularisation, at 12 months post procedure. The powered secondary endpoint is a superiority comparison of the vessel-oriented composite endpoint (VOCE), defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically indicated target vessel revascularisation, at 24 months. The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin Supraflex Cruz stents, compared with SYNERGY stents. Clinical Trial Registration URL: https://www.clinicaltrials.gov/ct2/show/NCT04390672. Unique Identifier: NCT04390672

Synergy stent for treating unprotected left main stenosis with the large reference vessel diameter.

Synergy stent for treating unprotected left main stenosis with the large reference vessel diameter.

SAFETY OF ABBREVIATED DAPT IN HIGH BLEEDING RISK PATIENTS ON ANTICOAGULANTS OR AGE ≥75 YEARS AFTER PCI WITH THE SYNERGY STENT: A SUBGROUP ANALYSIS OF THE EVOLVE SHORT DAPT STUDY

SYNERGY stent was designed to improve arterial healing and reduce the risk of stent thrombosis (ST) with thin struts and abluminal everolimus-eluting bioabsorbable polymer. Safety and efficacy of SYNERGY has been established in normal bleeding risk patients treated with standard duration DAPT.

EFFECT OF THE DRUG COATING CHARACTERISTICS ON VASCULAR REMODELING: COMPARING THE LATEST GENERATIONS OF STENTS

The basic method of myocardial revascularization in acute coronary syndrome is coronary stenting. Due to the high risk of later coronary events such as restenosis and late coronary thrombosis, studies on the different types of stents are currently underway.The objective was to evaluate the degree of neointimal coverage of stents with a permanent and biodegradable polymer in one patient.The patient with unstable angina was implanted 2 everolimus-containing stents with a constant polymer (Promus Premier) and a biodegradable polymer (Synergy). After 9 months, optical coherence tomography (OCT) was performed with the calculation of indicators.774 struts of the Synergy and 701 struts of the Promus Premier were analyzed. When evaluating the thickness of the formed neointima, no significant differences was obtained (p=0.47). At the same time, a greater number of uncovered struts were detected in the Promus Premier stent compared with Synergy stent (1.14 vs. 0 %, p = 0.002). The number of malposed uncovered struts was not statistically different (0.14 versus 0.13, p = 1.00), the difference in the number of malposed struts covered approaches statistically significant (1.14 versus 0.26, p = 0.0545).According to the results of optical coherence tomography, no significant differences between the studied platforms was obtained when assessing the late lumen loss. A greater number of uncovered struts in the stent with permanent polymer was detected, which could be considered as a risk factor for the development of late coronary thrombosis.

Prasugrel monotherapy after PCI with the SYNERGY stent in patients with chronic stable angina or stabilised acute coronary syndromes: rationale and design of the ASET pilot study.

Prasugrel monotherapy after PCI with the SYNERGY stent in patients with chronic stable angina or stabilised acute coronary syndromes: rationale and design of the ASET pilot study.

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study

Background/aimsDrug eluting stent (DES) decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. Bioresorbable vascular scaffold (BVS) may overcome the risk of stent/scaffold thrombosis when completely resorbed. The purpose of this randomised trial was to compare the arterial healing response in the short term, as a surrogate for safety and efficacy, between the metallic everolimus-eluting stent (Synergy; Boston Scientific, Marlborough, MA, USA) and the everolimus BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) in the particular setting of acute myocardial infarction (AMI). This pilot study sought to compare the neointimal response of metallic everolimus DES (Synergy) with polymeric everolimus BVS (Absorb) by optical coherence tomography (OCT) 3 months after an AMI.MethodsCOVER-AMI was a single-centre, single-blind, non-inferiority, randomised controlled trial. Patients with ST segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention were randomly allocated (1:1) to treatment with the Synergy DES or Absorb BVS. The primary endpoint was the 3-month neointimal response assessed as the percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. The main secondary endpoint included the device-oriented composite endpoint according to the Academic Research Consortium definition.ResultsTwenty patients without clinical and/or angiographic complications (Synergy (n = 10) or BVS (n = 10); mean age 59.0 years; 20% female) were enrolled in our centre. The stent diameter was higher in the Synergy group (3.7 ± 0.4 mm vs 3.4 ± 0.4 mm in the BVS group, p = 0.01). At 3 months, no significant differences in angiographic lumen loss were observed between the everolimus DES and everolimus BVS (0.04 mm (IQR 0.00–0.07) vs 0.11 mm (IQR 0.04–0.31), p = 0.165). OCT analysis of 420 cross-sections showed that the total neointimal area and in-stent obstruction were lower in the Synergy group, while OCT analysis at the strut level (n = 3942 struts) showed that the rate of uncovered struts was lower in the BVS group.ConclusionsStenting of culprit lesions in the setting of STEMI resulted in a nearly complete arterial healing for both the Synergy and the BVS devices. Lower neointimal thickness and in-stent obstruction but a higher rate of uncovered struts were observed in the Synergy group. These findings provide the basis for further exploration in clinically oriented outcome trials.

OCT analysis of early endothelialization of the Synergy stent in young non-ST segment elevation acute coronary syndrome. The OCT EROS study

Early healing of the struts is a major challenge to reduce the risk of late stent thrombosis (LST), and for decreasing the duration of dual antiplatelet therapy (1 or 3 months), in patients high risk of bleeding. The bioresorbable polymer everolimus eluting stent (EES) SYNERGY, new generation of stent, has biocompatibility and mechanical properties, allowing complete strut coverage throughout the entire length of the stent at 3 months, in humans, resulting in a low rate of LST. Optical Coherence tomography analysis (OCT), which provide the best spatial resolution, is the method of choice to evaluate early healing of the strut. To estimate the early healing of the strut at 1 month after implantation of the EES, using OCT analysis, in patients admitted for acute coronary syndrome without ST segment elevation. This was a prospective and mono-centric study performed at the university hospital the North of Marseille. The patients eligible had to benefit from complementary angioplasty at 1 month after implantation of the EES for the culprit lesion of the acute coronary syndrome. An OCT of EES implanted was performed. OCT analysis and proofreading of coronary angiography were achieved by 2 physicians practicing these tests on daily basis. The primary study endpoint was the percentage of uncovered struts in OCT imaging, at 1 month ( Fig. 1 ). Twenty-four patients were included between December 2016 and February 2018. The percentage of uncovered struts was 21,48 ± 10% of 3849 struts analyzed. The neointimal thickness facing covered struts was 0,0508 ± 0,016mm. At follow-up, no ischemic event was reported, however, one death by hemorrhagic stroke was identified. The percentage of uncovered struts of the SYNERGY stent was 21,48% at 1 month post angioplasty in the context of ACS. This result provides a logical rationale for decreasing the duration of dual antiplatelet therapy at 1 month in patients at high risk of bleeding.

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)

ObjectivesThe aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). BackgroundCurrently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. MethodsThis randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. ResultsA total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). ConclusionsAt 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

FINAL 5-YEAR OUTCOMES OF THE EVOLVE II TRIAL: A PROSPECTIVE RANDOMIZED INVESTIGATION OF A NOVEL BIOABSORBABLE POLYMER-COATED, EVEROLIMUS-ELUTING SYNERGY STENT

Durable polymers may contribute to increased risk of late thrombotic events and the need for prolonged DAPT as they have been associated with delayed arterial healing, incomplete endothelialization and hypersensitivity. The SYNERGY stent (Boston Scientific Corporation, Marlborough, MA) designed to

Assessment of strut coverage of everolimus-eluting platinum chromium stent 2 weeks after implantation by optical coherence tomography.

The SYNERGY coronary stent is new-generation drug-eluting stents, which has a thin-strut platinum-chromium platform with everolimus in a biodegradable polymer applied to the abluminal surface. It would be speculated that favorable arterial healing with early strut coverage could be achieved. The present study investigated the degree of strut coverage using optical coherence tomography (OCT) 2weeks after SYNERGY implantation and clinical factors contributing to strut coverage. A total of 29 patients who underwent staged percutaneous coronary intervention (PCI) to residual lesions 2weeks after the index PCI with SYNERGY stent implantation were enrolled. At the time of staged PCI, OCT examinations of the SYNERGY stent were performed for conventional OCT analysis on both cross-sectional and strut level. SYNERGY stent showed a high level of strut coverage and apposition, and the percentage was 82.4 ± 12.4% and 96.2 ± 5.0%, respectively. The lesion complexity was significantly related to greater strut coverage on univariate analysis; however, it was found to be insignificant in multivariate analysis. Our findings suggest early arterial healing after SYNERGY stent implantation.