Everolimus-eluting Stent Research Articles

Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus

BackgroundPatients with diabetes mellitus (DM) have worse outcomes following percutaneous coronary intervention than nondiabetic patients. The novel Supreme DES is a biodegradable polymer sirolimus-eluting stent designed to synchronize early drug delivery, limiting the potential for long-term inflammatory response. The purpose of this study was to evaluate the safety and efficacy of the Supreme DES in patients with DM. MethodsThis is a prespecified analysis of the diabetic subgroup from the PIONEER III randomized (2:1), controlled trial, comparing the Supreme DES with a durable polymer everolimus-eluting stent (DP-EES). The primary safety and efficacy composite endpoint was target lesion failure at 1 year, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. ResultsThe PIONEER III trial randomized 1629 patients, of which 494 (30.3%) had DM with 331 (398 lesions) randomly assigned to Supreme DES and 163 (208 lesions) to DP-EES. Among patients with DM, target lesion failure at 1 year was 6.1% (20/331) with Supreme DES vs 3.7% (6/163) with DP-EES (hazard ratio = 1.65; 95% confidence interval = 0.66-4.10, P = .28). The composite of cardiac death or target vessel myocardial infarction was 3.3% (11/331) with Supreme DES and 3.7% (6/163) with DP-EES (hazard ratio = 0.90; 95% confidence interval = 0.33-2.44, P = .83). There were no significant differences in other secondary endpoints. ConclusionsThis prespecified substudy of the PIONEER III trial demonstrated the relative safety and efficacy of the novel Supreme DES when compared with commercially available DP-EES in diabetics at 1 year. Longer term follow-up will be required to ensure continued safety and efficacy of the Supreme DES.

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

Case series of coronary artery aneurysms after Everolimus eluting stent implantation and comparison with Sirolimus eluting stents

BackgroundCoronary artery aneurysms after drug eluting stents are rare. We present a case series of type II coronary aneurysms after implantation of Everolimus eluting stents including patients developing giant aneurysms with a toxic course.Case presentationOver a span of 3.5 years at our center 2572 patients were implanted Everolimus eluting stents out of which 4 patients developed coronary type II aneurysms an incidence of 0.00156 whereas 5838 patients were implanted Sirolimus eluting 2nd generation stents out of which 2 patients developed similar aneurysms with an incidence of 0.00034. The slight increase in incidence in Everolimus stents does not reach statistical significance (p = 0.054) and is limited by single centre non randomized study. We also propose a hypothesis that the slight increase in the incidence maybe due to allergy to Methacrylate present in Everolimus eluting Xience stent’s primer which is absent in other Sirolimus eluting stents used at our center but that needs to be further investigated. We also found some patients who developed giant aneurysms including Left main aneurysms. In our series operative repair of these patients had better outcomes than covered stent deployment but larger trials maybe needed to confirm the same.ConclusionsCoronary artery aneurysms after stent implantation are rare but occasionally giant aneurysms are formed with a toxic course. The incidence and morphology of aneurysms after Everolimus and Sirolimus eluting stent deployment do not differ much.

Comparison of diagnostic accuracy of immediate angiography derived residual quantitative flow ratio after bioresorbable scaffold and drug eluting stent implantation.

Quantitative flow ratio (QFR) is a novel angiography derived fractional flow reserve (FFR) technique. However, its diagnostic accuracy has only be validated in native coronary lesions but not in vessels after bioresorbable scaffold (BRS) implantation. This study aims to evaluate the diagnostic accuracy of residual QFR in coronary vessels immediately post-BRS implantation. This is a retrospective, two center, validation cohort study. 73 stable angina patients who received at least one de novo lesion of an everolimus eluting stent (EES)/BRS implantation with subsequent residual FFR assessment were screened. Patients with aorta-ostial stenoses, bridge vessels at the distal segment of targeted vessels, acute coronary syndrome, previous coronary artery bypass grafting, age <18 years, lack of ≥2 final angiographic projections were excluded. Contrast QFR assessment was performed blinded to FFR assessment. A good correlation (r = 0.680, p < 0.001) was found between residual QFR and FFR. In the EES implantation cohort, a good correlation (r = 0.769, p < 0.001) was found between residual QFR and FFR, and a moderate correlation (r = 0.446, p = 0.038) in the BRS cohort. The area under the Receiver operator characteristic (ROC) curve for detecting FFR ≤0.86 was 0.883 for all patients. Residual QFR assessment after BRS implantation is feasible, and has a moderate correlation and agreement with residual FFR. QFR may be a promising tool similar to FFR to evaluate post-BRS effect.

Platinum chromium everolimus-eluting stent versus cobalt chromium zotarolimus-eluting stent in very late stent thrombosis: a meta-analysis of randomized controlled trials

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Very late stent thrombosis is a rare but potentially lethal outcome for drug-eluting stents used in percutaneous coronary intervention. There is limited research currently on the occurrence of very late stent thrombosis as a complication of two most used second-generation drug-eluting stents, i.e. platinum chromium everolimus-eluting stent (PtCR-EES) and cobalt chromium zotarolimus-eluting stent (CoCr-ZES). Purpose The study provides comparative information on the formation of very late stent thrombosis as a long-term outcome of PtCr-EES and CoCr-ZES. Results of this study may guide interventional cardiologists in decision-making regarding the choice of stent. Methods Randomized controlled trials (RCTs) which compared stent thrombosis end point of PtCr-EES and CoCr-ZES were identified through Pubmed. Results Data from three RCTs analyzed a total of 7,911 participants, with 4,574 in the PtCr-EES and 3,324 in the CoCr-ZES. Treatment with either stent showed no significant difference in the incidence of very late stent thrombosis. Conclusion Both stents showed comparable incidence of very late stent thrombosis. Additional RCTs are recommended to further establish the results for very late stent thrombosis. Longer follow-up is also suggested to discover more long-term outcomes.

Procedural and One-Year Clinical Outcomes of Long 48 mm Xience Xpedition Everolimus-Eluting Stent in Complex Long Diffuse Coronary Artery Lesions.

Long 48 mm drug-eluting stents (DES) used to treat long coronary lesions decreases the number of stents needed and avoids stent overlapping. Disadvantages include difficulty in delivery and size discrepancy between proximal and distal stent landing zones. The present study analyzed the rate of procedural, immediate angiographic, and 1-year clinical outcomes of long diffuse coronary artery lesions treated with 48 mm everolimus-eluting stents (EES) and compared the clinical outcomes with multiple overlapping DES. This retrospective analysis included 213 patients with 228 lesions treated with at least one 48 mm EES at 2 hospitals in Taiwan. About 40.4% of the lesions had moderate-severe calcification and 20.2% had acute angulation. The mean lesion length was 49.2 ± 18.1 mm. In 161 lesions requiring a single 48 mm EES, 67.1% had a discrepancy between proximal and distal reference diameter of ≥0.5 mm and 36% had a discrepancy of ≥1.0 mm. The procedural success rate was 98.6%. Target-vessel failure (TVF) rate at 1 year was 4.2%. Cardiac death occurred in 3 patients. The rates of target-vessel myocardial infarction (TV-MI), target-vessel revascularization (TVR) and definite/ probable stent thrombosis were 1.4%, 3.3%, and 0.9%, respectively. After adjusting patient variables by propensity score matching, no significant difference was found for cardiac death, TVF, TV-MI, and clinically driven TVR. Use of 48 mm EES to treat long coronary lesions in clinically and anatomically complex patients is safe and effective. In the propensity score-matched analysis, the 48 mm EES and multiple stents have comparable clinical outcomes.

ОТДАЛЁННЫЕ РЕЗУЛЬТАТЫ КОРРЕКЦИИ ПРОТЯЖЕННЫХ ПОРАЖЕНИЙ КОРОНАРНЫХ АРТЕРИЙ С ПРИМЕНЕНИЕМ БИОДЕГРАДИРУЕМЫХ СОСУДИСТЫХ СКАФФОЛДОВ

Materials and methods. Over the period of 2013 to 2018, endovascular correction of long (more than 25 mm) coronary artery lesions was performed on 80 patients in RSPC “Cardiology”, Minsk. Randomly the patients were divided into 2 groups: experimental group (EG) (n = 40) – endovascular correction with bioresorbable everolimus-eluting vascular scaffold Absorb BVS, and control group (CG) (n = 40) – endovascular correction with everolimus-eluting metallic stent Xience V/ Xience Pro. During further observations we estimated the development of death outcomes (from any reasons and from heart diseases), cases of acute myocardial infarction, incidence of revascularization due to target lesion patency failure, as well as a combined endpoint (all death cases + cases of acute myocardial infarction+ revascularization due to target lesion patency failure). The information about the presence or absence of negative outcomes was collected during the observation via a telephone contact with the patient or their relatives. Results. In the mean long-term observational period of 86.5 months (interquartile range from 77.0 to 93.0 months) after percutaneous intervention (PCI) total death cases were registered in 7.5% cases for the experimental group and in 5% cases for the control group (CG) (p = 1.00). The combined endpoint (death + myocardial infarction + target lesion revascularization) was registered in 17.5% cases for EG and in 15% cases for CG (p = 1.00). Kaplan-Meier analysis did not reveal statistical signif icance between the study groups (p = 0.78). Conclusion. Long lesion correction with biodegradable vascular scaffolds shows similar long-term clinical results in comparison with everolimus-eluting stents. The combined endpoint risk (all death cases + myocardial infarction + revascularization due to target lesion failure) statistically did not differ in long-term period between both groups.

Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test.

To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy.

The Supreme healing-targeted drug-eluting stent (DES) is designed to promote endothelial healing to reduce stent-related adverse events. This may be particularly relevant among complex lesions that have a higher rate of adverse events. We sought to compare 1-year outcomes of percutaneous coronary intervention in complex lesions between the Supreme DES and contemporary durable-polymer, everolimus-eluting stents (DP-EES). PIONEER III was a multicenter, prospective, single-blind clinical trial, randomizing 1629 patients with either an acute or chronic coronary syndrome in a 2:1 ratio to the Supreme DES or DP-EES. Complex lesions (American College of Cardiology/American Heart Association type B2/C) were found in 1137 patients. Outcomes were also compared for specific parameters of lesion complexity: severe calcification, long length (>20​mm), and severe tortuosity. The primary end point was target lesion failure at 1​year. At 1​year, there was no difference in target lesion failure between the Supreme DES and DP-EES: (5.7% vs 5.6%; hazard ratio 1.00, 95% confidence interval 0.59-1.68, P = .99). Similarly, there were no differences in the secondary end points of lesion success (99.7% vs 99.4%, P = .41), device success (97.0% vs 98.5%, P = .14), target vessel failure (6.5% vs 7.4%, P = .50), major adverse cardiac events (7.8% vs 8.5%, P = .64), or stent thrombosis (0.7% vs 1.1%, P = .48). A trend was observed toward a higher rate of target lesion revascularization with the Supreme DES (2.5% vs 0.9%, P = .06). This study suggests that the Supreme DES is as effective and safe at 1​year compared with the standard DP-EES across a broad spectrum of lesion complexity.

A Warm Welcome to The First Issue of JSCAI

A Warm Welcome to The First Issue of JSCAI

β-Blockers Reduced the Target Lesion Revascularization After Percutaneous Coronary Intervention Using an Everolimus-eluting Stent

The effect of β-adrenergic blockers on everolimus-eluting stent (EES) implantation is unknown. We aimed to investigate how β-blockers affect the outcomes of EES by using the Tokyo-MD PCI registry data and analyse real-world data in this drug-eluting stent era in Japan.We selected 1,899 patients who underwent EES implantation. We compared patients with β-blocker administration versus those without, at follow-up regarding the incidence rate of ischemia-driven target lesion revascularization (ID-TLR), all-cause death, cardiac death, acute myocardial infarction (AMI), and stent thrombosis (ST).Patients in the β-blocker group had higher coronary risks than those in the non-β-blocker group. Although no significant difference was observed in the five-year incidence of all-cause death, cardiac death, AMI, and ST between the two groups, the incidence of ID-TLR was significantly lower in the β-blocker group (4.5% vs. 6.6%; p=0.04). β-Blocker administration (hazard ratio=0.61; p=0.016) was negatively associated with ID-TLR via multivariate analysis.β-Blocker administration reduced ID-TLR after percutaneous coronary intervention using an EES despite the greater comorbid risks and more severe disease lesions.

698 Acute coronary syndrome in neoatherosclerosis with major stent malapposition and OCT-guided PCI

AimsDue to its bidimensional nature, angiography is not always sufficient to accurately define coronary lesions, in particular when they are ambiguous or indeterminate. Intracoronary imaging, such as intravascular ultrasound or optical coherence tomography (OCT), is often useful in these cases to better characterize the ambiguous angiographic images, to identify the culprit lesion during acute coronary syndrome (ACS) and to guide percutaneous coronary intervention (PCI).Methods and resultsWe report a case of a 61-year-old male with multiple cardiovascular risk factors and a previous ST-segment elevation myocardial infarction treated by PCI of the right coronary artery (RCA) about 7 years before, wo was admitted to our emergency department after acute onset chest pain. At the time of admission, his ECG was normal and cardiac troponin was below the upper reference limit of normality with positive molecular SARS-CoV-2 diagnostic test. Echocardiogram disclosed a mild left ventricular dysfunction with inferior wall hypokinesia. Coronary angiography showed a moderate in-stent restenosis at mid RCA and a hazy, undetermined image at the proximal edge of the previously implanted stent. Left coronary artery angiography showed only diffuse atherosclerotic disease without significant stenoses and a myocardial bridge at the mid tract of left anterior descending artery. OCT pullback of RCA to better characterize the undetermined lesions shown by angiography. OCT revealed significant neointima hyperplasia and a focal area of neoatherosclerosis with unstable features (fissure/microthrombi) at mid RCA. Severe stent strut malapposition embedded neointimal hyperplasia was observed at the proximal stent edge, resulting in ‘dual’ lumen appearance. The two lesions were treated with a single 3.5/48 mm everolimus-eluting stent (stent-in-stent), which was post-dilated with a 3.5/20 mm non-compliant balloon (18 atm) in the mid-to-distal segments, and 4.5/15 mm (16 atm) and 5.0/8 mm (14 atm) semi-compliant balloons in the proximal stent segment. Post-PCI OCT imaging confirmed good stent expansion and apposition. Our case demonstrates the utility of OCT in clarifying the aetiology of ambiguous angiographic lesions and as a guide for PCI. Indeed, the ‘hazy’ appearance on the angiograms corresponded to the major stent malapposition covered by neointima disclosed by OCT as a ‘dual-lumen’. Of note, OCT allowed to confirm the correct guidewire position in the ‘true’ lumen preventing a crush of the previously implanted stent. OCT was also useful as a diagnostic modality for the identification and characterization of the mechanism underlying the ACS (neoatherosclerosis instability).ConclusionsDue to its unprecedented spatial resolution, OCT enables an ‘optical biopsy’ of the coronary artery wall and intrastent tissue. Therefore, OCT imaging should be considered when lesions are ambiguous or indetermined by coronary angiography to guide the diagnosis and treatments of ACS patients. OCT imaging is also useful to guide stenting and to optimize PCI result, and its impact on clinical outcome is under investigation in large randomized clinical trials.

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p<0.0001) and ST (aHR 0.08, 95% CI: 0.03-0.19; p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95% CI: 0.70-1.55; p=0.84) or ST (aHR 0.86, 95% CI: 0.42-1.75; p=0.67). DAPT did not have major effects upon bleeding or death in either period. DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.

Comparison between biodegradable- and durable-polymer everolimus-eluting stents in hemodialysis patients with coronary artery disease.

To investigate the clinical outcomes after biodegradable-polymer (BP) and durable-polymer (DP) everolimus-eluting stent (EES) implantation in hemodialysis (HD) patients with coronary artery disease. We enrolled 221 consecutive HD patients successfully treated with EES implantation for coronary lesions. Over the following 2years, we assessed the incidence of target lesion revascularization (TLR) and major adverse cardiac event (MACE), defined as the composite endpoint of TLR, all-cause mortality, or myocardial infarction. We performed a propensity-score matching analysis and collected follow-up coronary angiography data. There were 91 patients in the BP-EES group and 130 in the DP-EES group. Male sex and diabetes rates were significantly lower in the BP-EES group than in the DP-EES group. A debulking device was less frequently used in the BP-EES group than in the DP-EES group (7.6% vs. 21.5%, p = 0.006). TLR occurred in 38 patients, while stent thrombosis was observed in 3 patients; 19 patients died. TLR and MACE rates at 2years were comparable between the two groups (19.2% in the BP-EES group vs. 20.4% in the DP-EES group, p = 0.73 and 26.9% vs. 34.2%, p = 0.93, respectively). In the propensity-score-matched cohort, TLR and MACE rates were similar between the two groups (19.2% in the BP-EES group vs. 18.1% in the DP-EES group, p = 0.69, and 26.9% vs. 30.2%, p = 0.66, respectively). Restenosis rates at follow-up angiography were similar between the two groups (p = 0.79). In hemodialysis patients, BP-EES and DP-EES showed similar 2-year clinical outcomes.

Abstract 12825: Immediate versus Staged Complete Revascularization in Acute ST-segment Elevation Myocardial Infarction Patients With Multi-Vessel Disease Undergoing Primary Percutaneous Coronary Intervention: Prospective, Randomized, Multicenter Trial of Complete versus Culprit Lesion Revascularization in Acute ST-segment Elevation Myocardial Infarction Patients With Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention With Everolimus Eluting Stent (cocua Trial)

Background: In the present study, we aimed to compare the 12-month clinical outcomes of immediate versus staged complete revascularization in acute ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease undergoing primary percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Method: A total of 248 patients were enrolled in a prospective, randomized, open-label, multicenter registry. Immediate complete revascularization was defined as simultaneous PCI of the culprit and non-culprit lesions during the index procedure (Immediate group). Staged complete revascularization was defined as PCI of non-culprit lesion as a separate staged procedure after the culprit lesion PCI (mean 4.4 days, interquartile range; 1 to 11.4, Staged group). The study end points were major adverse cardiovascular events (MACE; the composite of total death, recurrent myocardial infarction, and revascularization), and individual hard endpoints including cardiac death, stent thrombosis and stroke at 12 months clinical follow up. Results: Although the incidence of MACE was not significantly different between the two groups (11.6% vs. 7.5%, p = 0.313), the incidence of total death was higher in the immediate group than the staged group (9.7% vs. 2.8%, P=0.040). Despite the incidence of target lesion and vessel revascularization were similar, there was a trend toward higher incidence of TLR- MACE in the immediate group than the staged group (9.7% vs. 3.7%, p =0.086). There was no significant difference in the risk of in-hospital complications including transfusion, bleeding, acute renal failure or acute heart failure between the groups. Conclusion: For STEMI patients with multi-vessel disease undergoing primary PCI with drug-eluting stents, routine immediate complete revascularization should not be justified possibly due to higher event risks.

Investigation of the drug release time from the biodegrading coating of an everolimus eluting stent.

This case-study examines the release time of the everolimus drug from an experimental biodegrading coating of a Rontis corp. drug eluting stent (DES). The controlled drug release is achieved by the degradation of the coating, which consists of a mixture of polylactic co-glycolic acid (PLGA) and everolimus (55:45). In our analysis, we used the outcome of another study, which contains the geometry of an in-silico deployed Rontis corp. stent in a 3D reconstructed coney arterial segment. Using this geometry as input, the everolimus release was simulated using a computational model that includes: i) modeling of the blood flow dynamics, ii) modeling of PLGA degradation, and iii) modeling of the everolimus advection and diffusion towards both the lumen and the arterial wall. The results show the rapid release of everolimus. This is justified due to the high porosity of the coating, which is caused by the initial high concentration of everolimus in the coating.Clinical Relevance - The methodology presented in this work is an additional step towards predicting accurately drug release from DES. Also, the results of our work prove that high drug concentration in the coating causes its rapid release, which could be used as input in the design of new DES.

Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. ObjectivesThe purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation. MethodsThe XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. ResultsA total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference −0.2%; 95% CI: −2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference −2.5%; 95% CI: −4.6% to −0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference −1.1%; 95% CI: −2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). ConclusionsAmong HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742)

Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film-Coated Coronary Stent Loaded With Mycophenolic Acid.

Background: Titanium is commonly used in blood-exposed medical devices because it has superior blood compatibility. Mycophenolic acid inhibits the proliferation of vascular smooth muscle cells. This study examined the effect of a non-polymer TiO2 thin film–coated stent with mycophenolic acid in a porcine coronary overstretch restenosis model. Methods: Thirty coronary arteries in 15 pigs were randomized into three groups in which the coronary arteries were treated with a TiO2 film–coated stent with mycophenolic acid (NTM, n = 10), everolimus-eluting stent with biodegradable polymer (EES, n = 10), or TiO2 film–coated stent (NT, n = 10). A histopathologic analysis was performed 28 days after the stenting. Results: There were no significant intergroup differences in injury score, internal elastic lamina area, or inflammation score. Percent area stenosis was significantly smaller in the NTM and EES groups than in the NT group (36.1 ± 13.63% vs. 31.6 ± 7.74% vs. 45.5 ± 18.96%, respectively, p = 0.0003). Fibrin score was greater in the EES group than in the NTM and NT groups [2.0 (range, 2.0–2.0) vs. 1.0 (range, 1.0–1.75) vs. 1.0 (range, 1.0–1.0), respectively, p < 0.0001]. The in-stent occlusion rate measured by micro-computed tomography demonstrated similar percent area stenosis rates on histology analysis (36.1 ± 15.10% in NTM vs. 31.6 ± 8.89% in EES vs. 45.5 ± 17.26% in NT, p < 0.05). Conclusion: The NTM more effectively reduced neointima proliferation than the NT. Moreover, the inhibitory effect of NTM on smooth muscle cell proliferation was not inferior to that of the polymer-based EES with lower fibrin deposition in this porcine coronary restenosis model.

Outcomes at 1 Year of Non-Left Main Trunk Bifurcation Lesions Treated With a 2-Stent Strategy Using Newer-Generation Everolimus-Eluting Stents.

Percutaneous coronary intervention (PCI) for coronary bifurcation lesions using the 2-stent strategy remains a challenging procedure for interventionalists because of the higher incidence of in-stent restenosis (ISR) and adverse events. ISR predictors in patients treated with newer-generation everolimus-eluting stents (EES) and the 2-stent strategy remain unknown. Hence, we aimed to evaluate the 1-year clinical and angiographic outcomes of non-left main trunk (LMT) bifurcation lesions treated with the 2-stent strategy using newer-generation EES.Methods and Results:The study sample consisted of 262 non-LMT bifurcation lesions treated using culotte or T-stenting with EES between 2010 and 2018. One-year post-procedural angiographic and clinical examinations were conducted in 208 (79.4%) and 260 (99.2%) lesions, respectively. The primary outcome measure was the 1-year post-procedural ISR rate, which was found to be 15.9%. Independent predictors of 1-year post-procedural ISR were long side branch lesions (adjusted odds ratio [aOR] 2.31; 95% confidence interval [CI] 1.02-5.23; P=0.04) and 3-link EES implantation (aOR 2.45; 95% CI 1.07-5.61; P=0.03). The 1-year cumulative incidence of target lesion revascularization was 3.5%. The 1-year clinical outcomes of non-LMT bifurcation lesions treated with the 2-stent strategy using EES were acceptable. Long side branch lesions and lesions treated with 3-link EES were independent predictors of 1-year post-procedural ISR.

Comparison between a novel sirolimus-eluting bioresorbable scaffold with everolimus-eluting metallic stent in patients with coronary artery disease: three-year follow-up from the neovas rct study

Abstract Background Previous trials and meta-analyses have demonstrated that risk of adverse clinical events, especially thrombosis and target vessel myocardial infarction is increasing between 1 and 3 years after Bioresorbable Scaffolds (BRS) implantation. Purpose We sought to evaluate the long-term clinical outcomes of a novel NeoVas BRS in comparison with cobalt chromium everolimus-eluting stent (EES) following implantation in patients with coronary artery disease by 3-year follow-up results from the NeoVas RCT. Methods Overall, 560 patients with a single de novo native coronary artery lesion with reference vessel diameter 2.5–3.75 mm and lesion length ≤20 mm were randomized 1:1 to NeoVas BRS vs. cobalt-chromium everolimus-eluting stents (CoCr-EES). Optical coherence tomography (OCT) and fractional flow reserve (FFR) were both performed in a pre-specified subgroup at 3-year follow-up. Clinical outcomes from NeoVas RCT were analyzed by randomized device (intention to treat) cumulative to 3 years. Results Over 3 years, the overall target lesion failure (TLF) rate was 6.9% in the NeoVas group and 6.1% in the CoCr-EES group (HR 1.13, 95% CI 0.59 to 2.18; p=0.71). There was no statistically significant difference of the definite or probable stent thrombosis between the NeoVas group and the CoCr-EES group (1.1% vs. 0.7%, HR 1.51, 95% CI 0.26 to 8.73, p=0.64). In a landmark analysis of TLF, we found no difference in rate of late events from 2 to 3 years between two groups. FFR was not significantly different between the two group at 3 years (NeoVas vs. CoCr-EES, 0.89±0.07 vs. 0.90±0.05). NeoVas was largely absorbed (72.26% ± 13.21%) examined by OCT follow-up. Of 55 patients who finished 3-year absorption analysis, NeoVas was totally absorbed in 4 patients. Conclusions At the 3-year follow-up in the Neovas RCT trial, overall TLF rates were comparable between Neovas BRS and CoCr-EES, and adverse event rates relating to device safety were not increased with Neovas BRS compared with CoCr-EES up to 3 years after implantation. Funding Acknowledgement Type of funding sources: None.