Everolimus-eluting Stent Research Articles

A novel polymer-free everolimus-eluting stent with a nitrogen-doped titanium dioxide film inhibits restenosis and thrombosis in a swine coronary model.

Short-term outcomes regarding the safety and efficacy of a polymer-free everolimus-eluting stent (EES) with a nitrogen-doped titanium dioxide (N-TiO₂) film in a swine coronary model have been reported. However, the long-term results of the use of this type of stent have not yet been evaluated or compared to those of other polymer-free coronary stents. Therefore, this study aimed to determine the mid- to long-term safety and efficacy of a polymer-free EES with an N-TiO₂ film in a swine coronary model. Polymer-free EES with N-TiO₂ films (n = 30) and polymer-free sirolimus-eluting stents (SES; n = 30) were implanted in 30 pigs. Quantitative coronary analysis and optical coherence tomography were conducted immediately and at 1 (quantitative coronary analysis only), 3, and 6 months after stenting. Histopathologic examinations were performed at 1, 3, and 6 months after stenting. The polymer-free EES group had a lower percentage of neointimal growth than the polymer-free SES group at 3 months (22.5% ± 11.4% vs. 32.1% ± 12.3%; p < 0.001). The polymer-free EES group had a lower fibrin score than the polymer-free SES group at 1 month (1.9 ± 0.45 vs. 2.5 ± 0.54; p = 0.001). The re-endothelialization rates were similar between groups. The polymer-free EES group had a lower percentage of the area of stenosis than the polymer-free SES group throughout the follow-up period. The novel polymer-free EES with an N-TiO₂ film has superior safety and efficacy than the polymer-free SES at the 6-month follow-up in a swine model.

Two Years Follow-Up Outcome of Synergy™ Coronary Stent: Comparison between Case Control Study-Oriented Definition/Criterion and Real-World Results

Objectives: To clarify the 2 years outcome of Bioabsorbable Polymer Everolimus-Eluting Stent (BP-EES) using several criteria/definitions. Previous reports have showed worse outcomes in Real-World (RW) setting than case-Controlled Clinical trials (CC). Methods and Materials: We studied consecutive patients who received BP-EES implantation from October 2017 through January 2018. We adopted the parameters used in previous BP-EES associated CC (SYNERGY, EVOLVE), compared the CC inclusion criteria (on-label) with others (offlabel) at 2 years follow-up. Results: There were 678 BP-EESs inserted in 437 patients (283 male, mean age 72.3±11.2 years). Data from 4 patients lacked, and therefore the follow-up rate was 99.1%. There were 381 patients (87.2%) satisfying the CC criteria. Male gender, ejection fraction &lt;40%, smoker, multiple stenting, total stent length, target vessel failure and all death was higher in the off-label group (P&lt;0.05). Regarding revascularization- related parameters (all target lesion/non-target lesion revascularization), there was no difference between the 2 groups (TLR 6.1% vs 3.6%, non-TL TVR 5.6% vs 10.9%; CC vs off-label, p=ns, respectively). On the other hand, comparison of TLR using the CC definition (ischemia-oriented TLR) and real-world definition (any TLR) showed approximately 2-3 times higher frequency in the real-world basis (1.6% vs 5.8% per patient basis and 2.1%vs 5.8% per stent basis). Conclusions: Different definitions for repeat angioplasty among the reports may be a key cause of the discrepancy in revascularization frequency in dug-eluting stent studies, and it is the different inclusion criteria among studies that are associated with patient vulnerability.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III.

The PIONEER III trial showed the 12-month safety and efficacy of the Supreme drug-eluting stent (DES) vs the durable polymer everolimus-eluting stent. We sought to assess whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location. This subgroup analysis of the PIONEER III trial compared the characteristics and outcomes of patients recruited from North America, Europe, and Japan and the relative differences in patient outcomes according to the site recruitment volume. From October 2017 to July 2019, 1629 patients were recruited in North America (816, 50.1%), Europe (650, 39.9%), and Japan (163, 10%). Procedural success was achieved in 1556 of 1611 procedures (96.6%), with no difference by the geographic location. Target lesion failure at 12 months for combined groups was observed in 84 of 1629 patients (5.2%), with no significant geographic differences (4.7%, 6.5%, and 2.5%, respectively; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.15). Compared with those from high-recruiting sites, results from low-recruiting sites were similar for target lesion failure, major adverse cardiac events, stent thrombosis, and mortality, with a nonsignificant trend for higher rates of myocardial infarction. Despite regional differences in patient characteristics, the clinical outcomes between Supreme DES and durable polymer everolimus-eluting stent in the PIONEER III trial were not different, supporting the generalizability and robustness of the findings from this multicenter controlled trial.

Efficiency of everolimus-eluting stents of different generations after functionally adequate myocardial revascularization in patients with diffuse and multivessel coronary artery disease

Efficiency of everolimus-eluting stents of different generations after functionally adequate myocardial revascularization in patients with diffuse and multivessel coronary artery disease

541 A CASE REPORT OF ACUTE CORONARY SYNDROME: VERY LATE STENT THROMBOSIS DUE TO MAJOR STENT MALAPPOSITION

Abstract Rational The occurrence of stent thrombosis (ST) is a rare event, but it remains one of the most catastrophic complications following percutaneous coronary intervention (PCI). Coronary angiography has limited value in differentiating the causative factors responsible for ST. Technical resolutions We report a case of a 78-year-old male, hypertensive and dyslipidemic who underwent PCI with stenting of the mid left anterior descending artery (LAD) due to chronic coronary syndrome (CCD) two years before. He was admitted to our emergency department for syncopal episode occurred at rest followed by chest pain radiating to the left arm and to the neck. At the time of admission, his electrocardiogram showed diffuse ST-segment elevation in V2-V6 and DI-aVL, therefore patient was urgently sent to the cath lab. Coronary angiography showed LAD occlusion at the proximal edge of the previously implanted stent with TIMI flow grade 0 and TIMI thrombus grade 5. Multiple thrombus aspiration passes were performed with distal flow restoration, followed by intracoronary abciximab administration. After additional thrombus aspiration passes, ST-segment resolution was observed and chest pain improved significantly. OCT imaging of mid-to-proximal LAD was then performed to better characterize the cause of thrombosis. OCT revealed in stent-thrombosis with mixed thrombus (6 mm length, arc &amp;gt;270°) associated with major stent malapposition (maximum malapposition distance: 1.3 mm) at the proximal edge of the previous implanted stent, without evidence of neoatherosclerosis and/or residual disease with unstable features at the stent edges. Additional thrombus aspiration was performed, further reducing the thrombotic burden. As te patient was hemodynamically stable and asymptomatic, with TIMI flow grade 3 at coronary angiography, we decided to start dual antiplatelet therapy (ASA+ticagrelor) plus continuous heparin i.v. infusion, and to defer PCI, planning a control coronary angiography after 72 hours. After 72 hours, OCT revealed almost complete thrombus resolution, and guided PCI with a 4.0/8 mm everolimus-eluting stent in overlap with the previously implanted stent, postdilated with a 4.5 semi-compliant balloon at 18 atm. Revascularization was completed with an OCT-guided PCI of the proximal left circumflex during the same procedure. Clinical implications Our case demonstrates the utility of OCT in determining thrombus burden and assessing the causes of late stent failure, guiding PCI. In this case, OCT was useful as diagnostic tool to identify the mechanism underlying the very-late ST, and as guidance for treatment. It enabled to exclude neoatherosclerosis and/or unstable plaques at stent edges, leaving us more confident to defer PCI after 72 h of antithrombotic therapy. Perspectives The occurrence of ST is rare, but it remains one of the most catastrophic complications following PCI. Coronary angiography has limited value in differentiating the causative factors responsible for ST, while OCT allows to detect and characterize the causes of stent thrombosis (i.e., evaluate thrombus burden, presence of neoatherosclerosis, stent malapposition/underxpansion, uncovred stent struts, significant disease and/or unstable plaques at the stent edges, etc.). A better understanding of the pathophysiological mechanism underlying ST is an important clinical need. The increasing availability of high-resolution intravascular imaging techniques such as OCT provides new opportunities for tailoring treatment strategy and guiding PCI.

76 INSIDE VEIN GRAFT FAILURE: A WORK FOR OCT

Abstract An 84-years-old woman with prior history of triple coronary artery bypass graft and subsequent percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) for right coronary artery (RCA) was admitted for non-ST-elevation myocardial infarction and newly diagnosed atrial fibrillation. Coronary angiography showed chronic occlusion of native vessels and good flow in all grafts, in absence of critical stenoses. However, SVG for RCA presented a small filling defect of non-univocal interpretation (atherothrombosis, thromboembolus, venous valve). Optical coherence tomography (OCT) was performed for better assessment of the lesion, which was found to be a red thrombus, overlying a ruptured thin-cap fibroatheroma. To reduce the risk of distal embolization, a well-known complication of SVG PCI, direct stenting with conservative stent sizing was performed: everolimus-eluting stent diameter (3,5 mm) was chosen according to mean reference lumen diameter, while length (18 mm) was determined to obtain complete plaque coverage. Repeated OCT showed proximal stent malapposition and underexpansion at the mid portion. The stent was post-dilated with 4,0×12 mm non-compliant balloon and final OCT showed correction of both malapposition and underexpansion. The presented case offers an example of the advantages of intravascular imaging in diagnosis and treatment of SVG lesions. Venous grafts have high failure rate: up to 12% of graft are occluded before hospital discharge and up to 60% after 10 years. While in the first year graft occlusion is mainly caused by neointimal hyperplasia, after this period neoatherosclerosis is the leading cause of failure, as exemplified in the case. Intravascular imaging, and particularly OCT, may help to elucidate graft failure mechanism, with important implications for treatment strategy. Moreover, SVG interventions have higher incidence procedural complications, particularly no-reflow and periprocedural myocardial infarction, due to high plaque burden and friable atheromatous material. Proposed strategies to mitigate procedural risk include use of embolic protection devices, direct stenting and use of undersized stents. In this complex setting, intravascular imaging can guide stent sizing and optimization, thus reducing procedural complications and long-term lesion failure.

29 PROGNOSTIC IMPACT OF TARGET VESSEL FAILURE AS FIRST EVENT AFTER ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: INSIGHT FORM 10-YEAR FOLLOW-UP OF THE EXAMINATION EXTEND TRIAL

Abstract Background Outcome after primary PCI for ST-segment elevation myocardial infarction may be very different. Either it may be free of events during years or it may be characterized by many recurrent events. It is unknown whether to have a target vessel failure (TVF) as first event may impact subsequent outcomes during follow-up. We aim to evaluate very long-term outcomes of STEMI patients according to the occurrence of TVF as the first event during follow-up. Methods EXAMINATION-EXTEND trial randomized STEMI patients to everolimus-eluting stent or bare-metal stent with 10-year follow-up. All the patients were stratified according to their first event (TVF-First vs. NonTVF-First). TVF was defined as the composite of TV cardiac death, TV myocardial infarction, or TV revascularization. The primary endpoint of this study was 10-year POCE, defined as the composite of all-cause death, any myocardial infarction, or any revascularization. Results Out of the 1498 enrolled patients, 161 (10.7%) had a TVF as first clinical event during follow-up. TVF-First patients had higher rates of previous MI or PCI, with less use of manual thrombectomy, and received more BMS with a longer total stent length. On multivariate analysis, manual thrombectomy and bare-metal stent implantation were independent predictors of TVF as first event. Ten-year adjusted POCE was statistically higher in TVF-First patients compared to the NonTVF-First group (31.1% vs 27.5%, adjHR: 1.82; 95%CI: 1.34 - 2.48; p &amp;lt; 0.001). Conclusions In our STEMI population TVF occurred in 10.7% as the first event during follow-up. At 10-year follow-up, patients who experienced a TVF as first event exhibited a high risk for subsequent POCE events as compared to patients who did not.

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention

BackgroundDiabetes was reported to be associated with an impaired response to clopidogrel. ObjectivesThe aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI). MethodsA subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year. ResultsThere were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; Pinteraction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; Pinteraction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; Pinteraction = 0.19). ConclusionsClopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)

Frequency of In-Stent Restenosis among Different 2nd/3rd Drug Eluting Stents in Patients Presenting with ACS/Angina at Trtiary Cradiac Care Centre

Objective: Primary objective was to determine the frequency of in-stent restenosis (ISR) among second/third generation drug eluting stents (DES), diagnosed angiographically in cardiac catheterization laboratory either in emergency settings or elective stage procedure and to determine the risk factors precipitating ISR.&#x0D; Study Design: Analytical Cross-sectional study.&#x0D; Place and Duration of the study: Tertiary Cardiac Care Center of Rawalpindi Pakistan, from Nov 2021 to Apr 2022.&#x0D; Methodology: After hospital ethical committee approval, medical data of consecutive patients were analyzed. Clinical and bio data were obtained followed by admission. Risk factors for atherosclerosis obtained along with baseline investigations and echocardiogram obtained to calculate ejection fraction. Classified interventional cardiologists analyzed angiographic images and confirmed the presence of ISR. Details of previous angioplasty and type of stent were documented.&#x0D; Results: Out of total 137 patients, 98(72%) were males and 39(28%) females. 94(68%) patients were diabetic, 102(72%) were hypertensive, 72(52%) had dyslipidemia, 56(40%) were smokers, and 32(23.35%) strong family history of CHD. After coronary angiography we found that frequency of ISR was 32(23%) in patients who had Xlimus sirolimus stent, 34(24.8%) patients had Xience (everolimus eluting stent), 33(24%) had Ultimaster (sirolimus eluting stent), 38(27%) had Biomatrix stent with p-value=0.25.&#x0D; Conclusion: The clinical presentation of ISR is usually with angina in all new generation DES. There was no statistically significant difference in terms of ISR among second/3rd generation DES. DES ISR not only depends upon the type of DES used but also depends upon multiple patient ...

Biochemical and electrochemical characterization of biofilms formed on everolimus-eluting coronary stents

Drug-eluting stents (DES) are mostly used in percutaneous coronary intervention, which is the main treatment for coronary artery occlusion. This procedure aims to restore the natural lumen, while minimizing the risk of restenosis. However, stent insertion increases the risk for infections, due to contamination of the device or insertion hub with normal skin flora. While coronary stent infection is a rare complication, it can be fatal. Currently, there is little information on biofilm formation on everolimus-eluting stents. Although everolimus is not designed as an antimicrobial agent, its antimicrobial activity should be investigated. In this study, biofilm formation on everolimus-eluting and bare metal stents (BMS) is characterized through biochemical and electrochemical methods. DES and BMS are inoculated with Pseudomonas aeruginosa and Staphylococcus epidermidis, both independently and in co-culture. Biofilms formed on DES were 49.6 %, 12.9 % and 47.5 % higher than on BMS for P. aeruginosa, S. epidermidis and their co-culture, respectively. Further, the charge output for DES was 18.9 % and 59.7 % higher than BMS for P. aeruginosa and its co-culture with S. epidermidis, respectively. This observation is most likely due to higher surface roughness of DES, which favors biofilm formation. This work shows that bioelectrochemical methods can be used for rapid detection of biofilms on drug-eluting and bare metal stents, which may find application in quality assessment of stents and in characterization of stents removed after polymicrobial infections.

Abstract 15084: One- versus Three-Month DAPT in Diabetic Patients With High Bleeding Risk Undergoing PCI: Results From the Xience Short DAPT Global Program

Introduction: In patients at high bleeding risk (HBR), a short dual antiplatelet therapy (DAPT) duration after coronary stenting has been associated with fewer bleeding events and preserved ischemic protection. Whether these effects are maintained in diabetic patients is unclear. Purpose: To assess the safety and efficacy of 1- versus 3-month DAPT after percutaneous coronary intervention (PCI) with stent implantation among HBR patients with or without diabetes. Methods: We included patients from three prospective, international, single-arm studies (XIENCE Short DAPT Program), which enrolled HBR patients successfully treated with a fluoropolymer-based cobalt-chromium everolimus-eluting stent (XIENCE, Abbott). Subjects were eligible for DAPT discontinuation at 1 month (XIENCE 28 USA and Global) or at 3 months (XIENCE 90), if free from ischemic events and adherent to DAPT. The primary endpoint was the composite of all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding. Outcomes were assessed between 1 and 12 months after index PCI using propensity score adjustment. Results: Out of 3,352 patients, 1,299 (38.8%) had diabetes. The rate of death or MI at 12 months was higher in diabetic than in non-diabetic patients (10.1% vs 6.6%) while the rate of BARC 2-5 bleeding was similar (9.5% vs 9.2%). A one v. three months of DAPT duration resulted in a borderline reduction in death or MI (adj. HR 0.70, 95% CI 0.47-1.05) in diabetic but not in non-diabetic patients (adj. HR 1.24, 95% CI 0.86-1.79; p-interaction=0.016) and fewer BARC 2-5 bleeding in both groups (adj. HR 0.67, 95% CI 0.45-1.01 and adj. HR 0.77, 95% CI 0.56-1.06, respectively; p-interaction=0.950). Conclusions: Among HBR patients undergoing everolimus-eluting stent implantation, diabetic patients derive important benefit in reducing death and MI and bleeding events from a one month compared with three-month DAPT duration.

Design and Rationale of Targeted Therapy With a Sirolimus-Eluting, Biodegradable Polymer Coronary Stent in Chronic Total Occlusions (TARGET CTO): A Multicenter, Open-Label, Randomized Noninferiority Trial.

Treatment of chronic total occlusions (CTOs) is referred to as the last frontier of percutaneous coronary interventions and is currently performed in 10% to 20% of procedures. Improved outcomes with newer generation drug-eluting stents require further research. The TARGET CTO trial (NCT03040934) is a prospective, multicenter, randomized, noninferiority trial that plans to randomize 196 subjects (1:1) to either a newer-generation sirolimus target-eluting stent or an everolimus-eluting stent. Patients are candidates if they present with at least 1 CTO lesion in a native coronary artery with a diameter of ≥2.50 mm to ≤4.00 mm and a length of <100 mm. In addition, 44 subjects will participate in an optical coherence tomography (OCT) substudy. Clinical follow-up is planned up to 5 years after stent implantation. Angiographic follow-up is planned at 12 months, whereas OCT will be obtained after the procedure, at 3 and 12 months. The primary end point is in-stent late lumen loss by quantitative coronary angiography at 12 months. The key secondary end point is neointimal thickness by OCT at 3 months. Imaging end points are assessed by an independent core lab. Clinical end points are adjudicated by an independent clinical events committee. The TARGET CTO trial compares a sirolimus target-eluting stent with an everolimus-eluting stent for management of CTOs according to contemporary interventional practices. The primary angiographic end points will be reported at 12 months and clinical follow-up will continue for up to 5 years.

Usefulness of a Perfusion Balloon for Intraprocedural Stent Thrombosis in a Patient With ST-Segment Elevated Myocardial Infarction Complicated With Cardiogenic Shock

Intraprocedural stent thrombosis is a rare but serious complication of reperfusion therapy for acute coronary syndrome. There is currently no consensus on the intraprocedural management of intraprocedural stent thrombosis. It is difficult to attain thrombolysis in myocardial infarction flow grade 3, particularly in cases of cardiogenic shock. A 49-year-old man who presented with anterior ST-segment elevated acute myocardial infarction with cardiogenic shock underwent emergency percutaneous coronary intervention to diffuse proximal lesions in the left anterior descending artery under the support of intra-aortic balloon pumping. Intraprocedural stent thrombosis occurred following the postdilations with a 3.5- × 38-mm everolimus-eluting stent. Despite administration of argatroban and nitroprusside, and after frequent balloon inflations using 3.5-mm noncompliant balloons and thrombectomy, the no-reflow phenomenon was repetitively established. However, after brief and prolonged balloon inflations using 3.5- and 3-mm Ryusei perfusion balloon catheters (Kaneka Medix), the diffusely protruded thrombus inside the stent regressed, and thrombolysis in myocardial infarction flow grade 3 was obtained. The final intravascular ultrasound image showed a well-suppressed, in-stent thrombus and 24% gain of stent area (from 7.5 to 9.3 mm2). A Ryusei perfusion balloon enabled frequent, long inflation times without deteriorating hemodynamics during reperfusion in ST-segment elevated acute myocardial infarction complicated with cardiogenic shock. Thus, extended balloon inflation using a perfusion balloon is deemed a viable option not only for intraprocedural stent thrombosis but also for cases with a high burden of thrombi during the primary stenting procedure for patients with acute coronary syndrome.

Short dual antiplatelet therapy duration in high bleeding risk patients undergoing PCI for non-ST-elevation acute coronary syndrome

Abstract Background Patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain at increased risk of recurrent ischemic events. An abbreviated dual antiplatelet therapy (DAPT) duration as short as 1 month has been suggested for those at high bleeding risk (HBR). Whether the benefits of 1-month DAPT are preserved in HBR patients presenting with non-ST-elevation ACS (NSTE-ACS) is subject of debate. Purpose To assess the impact of NSTE-ACS presentation on the ischemic and bleeding outcomes of HBR patients undergoing PCI with a cobalt-chromium everolimus-eluting stent followed by a 1-month versus 3-month DAPT. Methods The XIENCE Short DAPT Program encompasses three prospective, international, single-arm studies evaluating the safety and efficacy of a 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT duration. The program enrolled HBR patients who had undergone successful XIENCE stent implantation for acute or chronic coronary syndrome (excluding ST-elevation ACS). Event-free subjects discontinued DAPT at 1 or 3 months post-PCI. The primary endpoint was the composite of all-cause death or myocardial infarction (MI), while the key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2–5 bleeding between 1 and 12 months post-PCI. Ischemic and bleeding events associated with 1-month versus 3-month DAPT were assessed according to clinical presentation using propensity-score (PS) adjustment. Results Out of 3,364 HBR patients (n=1,392 on 1-month DAPT and n=1,972 on 3-month DAPT), 1164 (34.6%) underwent PCI for NSTE-ACS. At 12 months, the risk of death or MI was similar between 1- and 3-month DAPT in patients with (adjHR 1.12, 95% CI 0.73–1.70) and without NSTE-ACS (adjHR 0.92, 95% CI 0.65–1.29; p-interaction = 0.33). Landmark analysis between 1 and 3 months post-PCI showed significant treatment effect modification according to clinical presentation (p-interaction = 0.03) with greater benefit of 1-month DAPT in stable patients. BARC 2–5 bleeding was consistently reduced in both NSTE-ACS (adjHR 0.58, 95% CI 0.38–0.90) and stable patients (adjHR 0.86, 95% CI 0.63–1.18; p-interaction = 0.15). Conclusions Among HBR patients undergoing PCI with an everolimus-eluting stent, 1-month compared with 3-month DAPT was associated with similar 1-year risk of ischemic events and reduced bleeding, irrespective of clinical presentation. Between 1 and 3 months post-PCI, however, stable patients seemed to derive greater net benefit from 1-month DAPT compared to those with NSTE-ACS. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Abbott

Dual antiplatelet therapy for 1 versus 3 months in high bleeding risk patients with or without oral anticoagulant therapy after coronary stenting

Abstract Background A short DAPT duration after coronary stenting has been associated with similar ischemic outcomes and fewer bleeding complications in patients at high bleeding risk (HBR). Whether these effects are preserved irrespective of concomitant oral anticoagulant (OAC) therapy remains unclear. Purpose To evaluate the safety and efficacy of 1-month versus 3-month DAPT among HBR patients with or without indication to OAC therapy who undergo cobalt-chromium everolimus-eluting stent implantation. Methods The XIENCE Short DAPT Program comprises three prospective, international, single-arm studies evaluating 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT in HBR patients who had undergone successful everolimus-eluting XIENCE stent implantation. OAC therapy at discharge was a study inclusion criterion. Subjects were eligible to discontinue DAPT at 1 or 3 months if free from ischemic events and adherent to DAPT. The primary endpoint was the composite of all-cause death or any myocardial infarction (MI). The major secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2–5 bleeding. In this exploratory analysis, HBR patients on 1-month DAPT were compared with those on 3-month DAPT according to the presence of background OAC therapy. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI using propensity-score (PS) adjustment. Results A total of 3,364 patients, 1,392 on 1-month DAPT and 1,972 on 3-month DAPT, were eligible for the analyses. Patients on OAC therapy (n=1424, 42.3%) were younger, more often male and of white race, and with a lower prevalence of other HBR criteria such as chronic kidney disease and anemia. The incidence of death or MI at 12 months was similar between the two groups (8.0% vs 7.9%) while BARC 2–5 bleeding was higher in OAC patients (12.2% vs 7.2%). After PS adjustment, 1-month DAPT, compared with 3-month DAPT, did not increase the 1-year risk of death or MI in both OAC (adjHR 0.71, 95% CI 0.47–1.08) and non-OAC patients (adjHR 1.24, 95% CI 0.88–1.75; p-interaction = 0.11). The risk of BARC 2–5 bleeding was consistently reduced in both OAC (adjHR 0.71, 95% CI 0.51–1.00) and non-OAC patients (adjHR 0.77, 95% CI 0.53–1.11; p-interaction = 0.69). Conclusions Among HBR patients undergoing everolimus-eluting stent implantation, 1-month DAPT compared with 3-month DAPT was associated with similar ischemic outcomes and reduced bleeding, regardless of concomitant OAC therapy. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Abbott

Angiographic derived physiological assessment after intervention for predicting 2-year vessel-oriented composite endpoints in Multivessel TALENT trial

Abstract Aims The purpose of the study is to assess the treatment results in the first 200 patients in the ongoing Multivessel TALENT trial and to predict the vessel-oriented endpoint by assessing the quantitative flow ratio (QFR) post PCI in a central independent core laboratory. Methods In this prospective, randomized, 1:1 balanced, multi-centre, open-label trial, de novo multivessel coronary artery disease patients without left main disease are assigned to the sirolimus-eluting stent or everolimus-eluting stent arm. The percutaneous coronary intervention (PCI) is planned based on functional lesion evaluation by QFR provided by the Core laboratory and the PCI has to be optimized by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. Results Mean age of the population was 66.6±14.7 years, and 78.1% of them were male. This population consists of 17.4% unstable angina and of 31.8% diabetic patients. Anatomical SYNTAX score was 18.8±9.1. Total 458 lesions were treated from September 2020 to December 2021. Left anterior descending artery accounts for 40.3%, bifurcation lesion was present in 40.8%, total occlusion in 4.2%. The average stent diameter and total stent length were 3.0±0.4mm and 38.7±22.4mm, respectively. Intravascular imaging was used in 92.8% of treated vessels (intravascular ultrasound 56.5%, optical coherent tomography 36.3%). Pre-PCI QFR was analysable in 435 vessels (0.59±0.21), and 5.5% of them were treated even though the pre-PCI QFR values were more than 0.8. Post-PCI QFR has been so far analysed in 303 vessels (0.93±0.11) and 79.5% of them achieved a post-PCI QFR equal or superior to 0.91. Based on the previous study [1], Two-year vessel-oriented composite endpoint (VOCE) was estimated to become 5.4% in the present study population (3.7% in the patient group that achieved post PCI QFR equal or superior to 0.91, while 12% in the patients who could not reach the threshold), which was almost equal to what is expected in the power calculation. Conclusions In the Multivessel TALENT trial, the large majority of the vessels treated (94.5%) complied with the hemodynamic criteria of recommended PCI as provided by the QFRs of the Core laboratory. Favourable post-PCI QFR (≥0.91) obtained in 80% of the patients let expected a favourable VOCE outcome of 5.4%. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The National University of Ireland Galway

Sex Differences in 10-Year Outcomes Following STEMI

Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95%CI: 0.91-1.42; P=0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95%CI: 0.99-1.71; P=0.063), with no difference in cardiac death or other endpoints. At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimedatboth cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up oftheEXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Immediate stent fracture after everolimus-eluting stent implantation: a case report

A 60-year-old man presented with exertional chest pain and was hospitalized on a diagnosis of unstable angina. Coronary angiography revealed left main true bifurcation lesions and percutaneous coronary intervention (PCI) was conducted using the culotte-stenting technique. Post-dilatational angiography revealed an irregular protrusion of the stent strut in mid left anterior descending (LAD) coronary artery. Intravascular ultrasound (IVUS) showed a discontinuation of the middle stent strut with calcified nodules. An additional everolimus-eluting stent (EES) was placed across the discontinued lesions. Post-procedural IVUS revealed good expansion of the stents and final angiography showed optimal angiographic results with thromboly sis in myocardial infarction (TIMI) 3 flow. The patient was discharged the next day after the operation and maintained asymptomatic for chest pain at the 6-month follow-up point.

Comparison of 6-Month and Prolonged Dual Antiplatelet Therapy after Percutaneous Coronary Intervention with Biodegradable Polymer Everolimus-Eluting Stent.

Background The optimal duration of dual antiplatelet therapy (DAPT) after biodegradable-polymer (BP) everolimus-eluting stent (EES) implantation remains uncertain. Methods This study analyzed 793 patients who underwent percutaneous coronary intervention (PCI) with BP-EES in 10 cardiovascular centers in Korea between July 2016 and January 2018. Using the prescription data at 6 months post-PCI, we divided these patients into two groups, namely, short-DAPT and prolonged-DAPT groups, which underwent DAPT for 6 and > 6 months of PCI, respectively. The primary endpoint, which included mortality, myocardial infarction, or target-vessel revascularization at 2 years, was compared by propensity score (PS) matching between the two groups. Results Out of the 793 patients, 283 matched pairs were identified by PS matching. Out of this matched population, 405 (71.6%) patients had an acute coronary syndrome. The primary endpoint did not differ in 2 years between the short-DAPT and prolonged-DAPT groups (7.5% vs. 8.3%; hazard ratio, 0.87; 95% confidential interval, 0.47–1.60; P = 0.648). Likewise, no difference was found regarding mortality, cardiac mortality, myocardial infarction, target-lesion failure, target-vessel failure, and bleeding events defined by the Bleeding Academic Research Consortium and Thrombolysis In the Myocardial Infarction classification. Meanwhile, one patient in the short-DAPT group had definite stent thrombosis at 364 days post-PCI. Subgroup analysis showed that several anatomical and procedural factors were not significantly related to DAPT duration. Most patients (77.4%) in both groups were prescribed clopidogrel at discharge. Conclusions In real-world patients undergoing PCI with BP-EES, the ischemic and bleeding endpoints demonstrated no difference between 6-month and prolonged (>6 months) DAPT.