Generation Drug-eluting Stents Research Articles

Thrombogenicity of biodegradable metals

Biodegradable metals offer a promising means to ameliorate many of the long-term risks associated with vascular devices made of conventional biostable stent metals. While numerous biodegradable metal alloys have been developed and characterized in animal models, knowledge of their blood reactivity and thrombogenicity remains unknown. Metal hemocompatibility is particularly valuable because current generation drug-eluting stents pose a significant long-term thrombosis risk. In this study, four pure metals, widely used as degradable base materials (Fe, Zn, Mg, and Mo), and three alloys commonly used in cardiovascular devices [NiTi, CoCr, and stainless steel (SS)] were evaluated. This work examined how each of these metals activate platelets, coagulation factors, and inflammation using in vitro hemocompatibility assays and a clinically relevant ex vivo non-human primate arteriovenous shunt model. Testing found that while all metals promoted a downstream activation of platelets and coagulation in flowing whole blood, platelet and fibrin attachment to Mg was markedly reduced. Additionally, Fe and Mo trended toward higher platelet attachment and contact pathway activation. Overall, the results suggest that Mg may delay clot initiation, but not eliminate clot formation, indicating the importance of understanding thrombosis in Mg alloys that are currently being developed for clinical use as biodegradable stents.

Outpatient PCI - early discharge PCI, single center experience

Abstract Funding Acknowledgements None. Background Percutaneous coronary intervention (PCI) has undergone rapid evolution over the last years and is currently a widely generalized therapeutic option. In the past, it was associated with a significant rate of complications, yet, with the improvement of new generation drug eluting stents, and the radial access (RA) development, PCI has become safer and simpler, with a minimum rate of complications. This allows patient’s faster discharge. Besides the pressure from the limited number of beds in wards, the improvement of PCI has given the confidence to urge outpatient PCI programs. However, there are still centers where there is no ambulatory PCI. Purpose This study aims to describe our center experience of ambulatory PCI program, in terms of safety and efficacy. Methods We analyzed our center’s retrospective cohort of 723 PCI, in 2022. Ambulatory PCI was defined as PCI with same day hospital discharge. Our inclusion criteria were patients submitted to PCI. We excluded patients with acute coronary syndromes and patients needing hospital admission for other non-coronary reasons. Results 467 (65%), of the 723 PCI were performed in ambulatory setting. Patients mean age was 67,8±11 years and 23% (n=107) were female. In 12% (n=55) of the cases, the coronary anatomy was previously known, from a differed procedure. 63% (n=298) had a normal left ventricle ejection fraction (LVEF), 6% (n=26) had a moderate depression of LVEF and 3% (n=13) had LVEF severe depression. RA was possible in 82% of the cases (n=384), and 18% (n=83) of PCI was done by femoral access (FA). The access size was 6 Fr in 77% (n=359) of the cases, 7Fr in 22% (n=105) and 8Fr in 1% (n=2). The RA hemostasis was by compression (either manually or by external device) and FA hemostasis was first intended by closing device, however in 17% of the transfemoral PCI (n=14) had to be compressed, due to device hemostasis failure. PCI was successful in 97% of the cases (n=449), with revascularization of the goal lesion. The unsuccessful PCI (3% n=18) were because uncrossable lesion in 2% (n=14), and no reflow after PCI in 1% (n=4). 6 patients had to be admitted, after planned outpatient PCI, 5 due to peripheral access complication with hemorrhage of FA (after closing device and manual compression failure) and 1 due to PCI complication, with small coronary perforation. There was a higher probability of admission in patients submitted to transfemoral PCI (p<0,05), and there was no statistically significant relation between unplanned admission and patient’s LVEF. There were no episodes of death, MACE, non-planned hospital readmission and stent failure in the ambulatory PCI population. PCI has become a predictable and reliable technique, capable to treat outpatients. Patients undergoing successful non-complex PCI, without events, can safely be discharged on the same day. Outpatient PCI helps with the functioning of inpatient care, allowing beds to be freed up for other situations.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock.

The benefits of intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) in the clinical context of cardiogenic shock (CS) complicating acute myocardial infarction are lacking. We aimed to investigate the impact of IVUS-guided PCI in patients with AMI and CS. From the pooled data based on a series of Korean AMI registries during 2011-2020, we identified 1418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. In total, 294 (20.7%) and 1124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. The 1-year TLF was not significantly different between groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65-1.34, p = 0.70). Additionally, the adjusted landmark analysis for TLF at 30days and between 30days and 1year after PCI demonstrated no significant difference between the groups. In conclusion, in patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve the 1-year TLF compared with angiography-guided PCI.Registration: URL: http://cris.nih.go.kr . KCT0000863 and KCT0008355.

Same-day discharge after percutaneous coronary procedures-Consensus statement of the working group of interventional cardiology (AGIK) of the Austrian Society of Cardiology.

Percutaneous coronary intervention is awell-established revascularization strategy for patients with coronary artery disease. Recent technical advances such as radial access, third generation drug-eluting stents and highly effective antiplatelet therapy have substantially improved the safety profile of coronary procedures. Despite several practice guidelines and aclear patient preference of early hospital discharge, the percentage of coronary procedures performed in an outpatient setting in Austria remains low, mostly due to safety concerns. The aim of this consensus statement is to provide apractical framework for the safe and effective implementation of coronary outpatient clinics in Austria. Based on astructured literature review and an in-depth analysis of available practice guidelines aconsensus statement was developed and peer-reviewed within the working group of interventional cardiology (AGIK) of the Austrian Society of Cardiology. Based on the available literature same-day discharge coronary procedures show afavorable safety profile with no increase in the risk of major adverse events compared to an overnight stay. This document provides adetailed consensus in various clinical settings. The most important prerequisite for same-day discharge is, however, adequate selection of suitable patients and astructured peri-interventional and postinterventional management plan. Based on the data analysis this consensus document provides detailed practice guidelines for the safe operation of daycare cathlab programs in Austria.

P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent

P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, -0.93 [1-sided 95% CI, -2.64 to 0.77] percentage points; P < .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, -0.49 [95% CI, -2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, -0.60 [95% CI, -1.33 to 0.12] percentage points; P = .10). In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. ClinicalTrials.gov Identifier: NCT03447379.

Circulating intermediate monocytes CD14++CD16+ are increased after elective percutaneous coronary intervention

Aim Inflammation plays a central role in the pathogenesis of atherosclerosis and in the sequelae of percutaneous coronary intervention (PCI). Previous work demonstrated that intermediate monocytes (CD14++CD16+) are associated with adverse cardiovascular events, yet monocyte subset response following elective PCI has not been described. This article explores the changes in monocyte subset and humoral response after elective PCI. Methods This prospective study included 30 patients without inflammatory diseases being referred for elective PCI. We included patients treated with drug coated balloons or 2nd generation drug eluting stents. Patients underwent blood tests at baseline (prior to PCI), four hours, two weeks and two months later. Analyses were performed in terms of monocyte subsets (classical CD14++CD16-, intermediate CD14++CD16+ and non-classical CD14+CD16++), gene expression of CD14+ leucocytes and humoral biomarkers. Results Intermediate monocytes decreased significantly four hours after PCI, were recovered at two weeks, and increased significantly at two months post elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group. Gene expression analysis of CD14+ leucocytes showed IL18 had decreased expression at two weeks, CXCR4 and IL1β decreased at two months, while pentraxin 3 increased at two weeks and two months. In terms of humoral biomarkers, hsTnI remains elevated up to two weeks post PCI while IL6 and TNFα remain elevated till two months post PCI. Conclusion Intermediate monocytes increase significantly two months following elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group suggesting that the PCI strategy could be one of the ways to modulate the inflammatory response post PCI.

Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis

BackgroundDrug-coated balloons (DCBs) are an established strategy for coronary artery disease. However, the new generation drug-eluting stent (DES) is recommended for patients with Acute myocardial infarction (AMI) for coronary artery revascularization. Our aim is to provide a comprehensive appraisal of the efficacy of DCBs in patients with AMI undergoing PCI.MethodsWe searched the WOS, PubMed, Scopus, and Cochrane CENTRAL till March 2023, for studies that compared DCBs versus DES in patients with AMI undergoing PCI. We used a random-effects model to compare major adverse cardiac events (MACE), cardiac death, all-cause death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, Late lumen Loss (LLL), and minimum lumen diameter (MLD) between the two groups.ResultsThirteen studies comprising 2644 patients were included. The pooled OR showed non-inferiority of DCB over DES in terms of MACE (OR = 0.89, 95% CI [0.57 to 1.40], p = 0.63). When we defined MACE as a composite of cardiac death, MI, and TLR; the pooled OR favored DCB over DES (OR = 0.50, 95% CI [0.28 to 0.9], p = 0.02). Moreover, DCB was not inferior to DES in terms of all-cause mortality (OR = 0.88, 95% CI: 0.43 to 1.8, p = 0.73), cardiac mortality, (OR = 0.59, 95% CI: 0.22 to 1.56, p = 0.29), MI (OR = 0.88, 95% CI: 0.34 to 2.29, p = 0.79), stent thrombosis (OR = 1.21, 95% CI: 0.35 to 4.23, p = 0.76), TLR (OR = 0.9, 95% CI: 0.43 to 1.93, p = 0.8), LLL (MD = -0.6, 95% CI: -0.3 to 0.19, p = 0.64), or MLD (MD = -0.4, 95% CI: -0.33 to 0.25, p = 0.76).ConclusionOur meta-analysis indicated that DCB intervention was not inferior to DES in the PCI setting in patients with AMI, and can be recommended as a feasible strategy in AMI.PROSPERO registrationCRD42023412757.

Mechanisms of Very Late Stent Thrombosis in Japanese Patients as Assessed by Optical Coherence Tomography

BackgroundAlthough very late stent thrombosis (VLST) remains an important concern, the underlying etiology and clinical characteristics are not fully elucidated in Japanese patients who undergo intravascular imaging-guided percutaneous coronary intervention (PCI) regularly. MethodsWe identified 50 VLST lesions (bare-metal stent [BMS] [n = 16], first-generation drug-eluting stent [DES] [n = 14] and newer-generation DES [n = 20]) in patients managed in our institutes. The underlying mechanism of VLST was assessed by optical coherence tomography (OCT), and the major etiology of each lesion was determined. The aim of this study was to explore the mechanisms of VLST of BMSs and DESs in Japanese patients. ResultsThe median duration since stent implantation was 10 years (range: 1-20). The most frequent etiology of VLST was neoatherosclerotic rupture (44%), followed by neointimal erosion (24%). Edge disease (10%) and evagination (10%) were similarly observed. Malapposition (8%) was deemed to be acquired late by looking at intravascular imaging from the index procedure. Uncovered struts (2%) and in-stent calcified nodule (2%) were the least frequent etiologies. Regardless of etiology, signs of neoatherosclerosis were present in most lesions (82%). Most patients received single (68%) or dual (8%) antiplatelet therapy or oral anticoagulation alone (4%), whereas a considerable proportion of patients discontinued medication (20%). Regarding the treatment strategy, drug-coated balloon was the most frequent strategy (56%), followed by implantation of newer DESs (34%). ConclusionsVarious mechanisms have been identified in Japanese patients with VLST. In these patients, biological responses seemed to be more relevant than the index procedure-related factors.

Comparison of clinical outcomes with short-term and long-term DAPT after PCI using second-generation drug-eluting stents in high bleeding risk patient : a systematic review and meta-analysis

Abstract Background Now that second-generation drug-eluting stents (DES) are available in almost every hospital in the world, it is unknown whether reducing the duration of double antiplatelet therapy (DAPT) following percutaneous coronary intervention in high-bleeding-risk (HBR) populations is beneficial and safe. Purpose This systematic review and meta-analysis aims to determine the safety, efficacy, and advantages of shortening the duration of DAPT (&amp;lt;6 months) in HBR patients with second-generation DES implantation. Methods We searched Ebsco, PubMed, Web of Science, Scopus, and Google scholar databases from inception to December 2022 for papers comparing short-term DAPT (6 months) followed by aspirin or P2Y 12 inhibitor monotherapy with long-term DAPT (6 months) in HBR patients after PCI with second generation DES. The primary objectives are major bleeding, definite or probable stent thrombosis (ST), and myocardial infarction (MI), while the secondary endpoint is mortality from any cause. Random-effect models were used to assess the relative risk and 95% confidence interval. Results This study included 9,789 HBR patients from three observational studies and one randomized controlled trial (Figure 1). Short DAPT for HBR patients undergoing PCI with second generation DES had a tendency of lower incidence of major bleeding in comparison with standard (6 months) DAPT, even though statistically non-significant (2.33% vs. 3.36%, RR 0.66 [95% CI 0.39 – 1.10], p = 0.11). Short-term DAPT was also found to be comparable and non-inferior to standard DAPT with in term of stent thrombosis (0.251% vs. 0.252%, RR 1.00 [95% CI 0.46-2.17], p = 0.99), Myocardial Infarction (2.08% vs. 1.85%, RR 1.09 [95% CI 0.82-1.44], p = 0.57), and All cause of death (3.01% vs. 2.56%, RR 1.17 [95% CI 0.93-1.49], p = 0.18) (Figure 2). Conclusions Among HBR patients implanted with second-generation DES, short DAPT was associated with slightly lower but comparable risk of major bleeding and non-inferior to reduce stent thrombosis, myocardial infarction, and all cause of death compared to standard DAPT.

Patient-level outcomes of patients undergoing resorbable magnesium scaffold (RMS) implantation stratified according to different subgroups: a post-hoc analysis of SHERPA MAGIC study

Abstract Background The SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing resorbable magnesium scaffold (RMS) implantation in 18 Italian centers. The results from the first 543 patients supported the safety and long-term performance of RMS in a real-world population. Purpose The present post-hoc analysis aimed to assess differences in adverse events at patient-level (patient-oriented composite endpoints, POCE, defined as the composite of all-cause death, myocardial infarction -MI- and ischemia-driven coronary revascularization) at the longest follow-up between different subgroups of the final study population (n=543). Methods We identified the subgroups according to different variables: age, sex, cardiovascular risk factors, clinical presentation, left ventricle ejection fraction, multivessel disease, multivessel PCI, and antiplatelet therapy. If the analysis highlighted a subgroup of patients at higher risk of adverse events, to understand if this finding is related to RMS implantation or to the characteristic itself, a propensity score matched analysis was conducted comparing patients of the SHERPA-MAGIC study with a matched cohort of patients receiving second generation drug eluting stent. The endpoint for the comparison between the two matched cohorts was POCE. Results The mean age of the final study population was 56±9 years. 433 (78%) patients were men, and the most common clinical presentation was MI (n=402, 74%). At the median follow-up of 3.5 [2.6-4.3] years, the cumulative occurrence of the primary endpoint (vessel-oriented composite endpoints, VOCE, including cardiac death, target vessel MI, and ischemia-driven target vessel revascularization) was 37 (5.8%, 95%CI 4.1%-7.9%) and 54 (9.9%, 95% CI 7.5%-12.7%) patients met criteria for POCE. There was no significant difference among POCE in the subgroup analysis (Figure 1), with the exception of patients with MI as clinical presentation. As compared to patients admitted for chronic coronary syndrome, MI patients showed a significantly higher POCE rate (11.4 vs 5.6%, CI 8.5-14.9, p=0.04). Therefore, a propensity score matched analysis was conducted comparing MI patients of the SHERPA-MAGIC study with a matched cohort of MI patients from the Acute coRonary sYndrOmes proSpective regisTry Of Ferrara (ARYOSTO) study (NCT02438085) treated with second-generation DES. We did not find significant differences in the cumulative occurrence of POCE between SHERPA MAGIC and ARYOSTO (11.4% vs. 12.5% respectively, p=0.71) (Figure 2). Conclusions The present analysis confirmed the safety and effectiveness of RMS across several subgroups of patients stratified by clinical and procedural characteristics. We found that MI patients had an higher occurrence of POCE, but this was not related to RMS implantation. Indeed, a similar MI population treated with second generation DES showed the same long-term outcome.Fig 1POCE difference between subgroupsFig 2Propensity matched MI populations

Mechanisms of very late stent thrombosis assessed by optical coherence tomographyin japanese patients

Abstract Background Although very late stent thrombosis (VLST) remains an important concern, the underlying etiology and clinical characteristics are not fully elucidated in Japanese patients who daily undergo intravascular imaging-guided percutaneous coronary intervention (PCI). Objectives The aim of this study was to explore the mechanisms of VLST in bare metal stents (BMSs) and drug eluting stents (DESs) in Japanese patients. Methods We identified 50 VLST lesions (BMS [n=16], 1ST generation DES [n=14], newer generation DES [n=20]) in patients managed in our institutes. The underlying mechanism of VLST was assessed by optical coherence tomography (OCT) and the major etiology of each lesion was determined. Results The median duration following stent implantation was 10 (range 1–20) years. The most frequent etiology of VLST was neoatherosclerotic rupture (44%) followed by neointimal erosion (24%). Edge disease (10%) and evagination (10%) were similarly observed. Malapposition (8%) was mostly acquired late by going back to the index procedure. Uncovered strut (2%) and in-stent calcified nodule (2%) were the least frequent etiologies. Regardless of etiology, signs of neoatherosclerosis were present in most (82%) lesions. Most patients received single (68%) or dual (8%) antiplatelet therapy or oral anticoagulation alone (4%), whereas considerable proportion of patients stopped any medication (20%). Regarding the treatment strategy, drug-coated balloon was the most frequent strategy (56%), followed by newer DES implantation (34%). Conclusion The mechanisms underlying VLST in Japanese patients were unique, with neoathersclerotic rupture and neointimal erosion accounting for two-thirds of cases of VLST. In these patients, biological responses seemed to be more relevant rather than index procedure-related factors.

Meta-analysis of 3-month vs 12-month dual anti-platelet therapy after percutaneous coronary intervention

Abstract Background The optimal duration of dual antiplatelet therapy (DAPT) in the era of second generation drug-eluting stents is a matter of debate as increasing evidence suggests that shorter periods of DAPT are feasible and reduce bleeding events. However, the non-inferiority design of the published trials regarding ischemic events still raises doubt on its effectiveness. Methods We performed a meta-analysis to evaluate short-term (≤ 3 months) vs long-term (≥ 12 months) DAPT after percutaneous coronary intervention (PCI). PubMed, Embase and Cochrane Central were searched from inception to February 2023 to identify randomized controlled trials that compared outcomes of patients between these two regimens. Primary outcome of interest included a composite of ischemic events (cardiovascular death, myocardial infarction, re-revascularization and stroke) and secondary outcome was major bleeding as assessed by Bleeding Academic Research Consortium (BARC) classification ≥ 3 after 1 year of follow up. Event rates were extracted and Mantel-Haenszel fixed-effects model was used to perform the meta-analysis. Results We identified a total of 5 trials with 18.682 randomized patients. The use of short-term DAPT was not associated with increased risk of ischemic events (0.90 [0.75-1.08], p=0.250; Figure 1) and was associated with reduced risk of major bleeding (0.74 [0.65-0.84], p&amp;lt;0.001; Figure 2). Conclusion The present meta-analysis provides an updated data on the use of DAPT duration. Short-term DAPT appears to be equivalent to long-term DAPT regarding ischemic risk and a superior strategy in optimizing bleeding risk reduction.Forest plot of ischemic outcomesForest plot of bleeding outcomes

STANLEy score: a new predictive model of 3-year major adverse cardiac events following "Full Metal Jacket" using new-generation drug-eluting stents

Abstract Introduction Percutaneous Coronary Intervention (PCI) using a "Full Metal Jacket" (FMJ) procedure (≥60 mm of continuous stent length) is often required to treat very long lesions, but its clinical efficacy and safety using contemporary drug-eluting stents (DES) remains to be determined. Objectives To identify predictors of major adverse cardiac events (MACE) associated with FMJ using new-generation DES. We sought to develop a simple model capable of accurately predict 3-year MACE following FMJ PCI. Methods A retrospective single-centre analysis of consecutive FMJ PCI performed between January 2015 and December 2018. Exclusion criteria were use of non-third generation DES, unsuccessful procedure and loss to follow-up. The primary endpoint was a composite of all-cause death, myocardial infarction, and target vessel revascularization. Demographic, clinical, angiographic, and procedural variables were evaluated. Logistic regression analysis was performed to determine independent predictors of outcome. Based on the results, a weighted scoring system was developed. Results The derivation cohort included 162 patients, mean age 65.9 ± 11.1 years, 83% male. The mean stent length was 73.8 ± 12.3 mm (range 60 to 116 mm), and the average number of stents was 2.74 ± 0.74 (range 2 to 5). 30-day, 1-year and 3-year MACE were 5.5%, 12.9% and 29.0%, respectively. Multivariate analysis identified diabEtes mellitus (hazard ratio (HR) 5.92; 95% confidence interval (CI) 1.57-11.54; p=0.011), Smoking habits (HR 8.37; 95%CI 3.05-15.55; p=0.001), Acute coronary syndrome (HR 3.51; 95%CI 1.030-8.98; p=0.045), Non-right coronary artery (HR 4.38; 95%CI 1.09-7.68; p=0.038), osTial lesion (HR 10.01; 95%CI 2.91-19.14; p=0.006) and severe caLcification (HR 8.59; 95%CI 2.65-15.72; p=0.001) as independent predictors of 3-year MACE. A composite score based on these 6 variables (STANLEy score) was created, ranging from 0 to 10 (Fig.1). High acuity was verified by ROC curve analysis (AUC 0.941, p &amp;lt;0.001). A score ≤ 3 was associated with a reduced probability (&amp;lt;15%) and a score ≥ 7 with high probability (&amp;gt;90%) of 3-year MACE. Conclusion The STANLEy score is a good predictive model which relies on 6 simple clinical and angiographic characteristics. This score may assist physicians in selecting high-risk patients for closer monitoring or aggressive antithrombotic strategy.Figure 1

Computational modeling of in-stent restenosis: Pharmacokinetic and pharmacodynamic evaluation

Persistence of the pathology of in-stent restenosis even with the advent of drug-eluting stents warrants the development of highly resolved in silico models. These computational models assist in gaining insights into the transient biochemical and cellular mechanisms involved and thereby optimize the stent implantation parameters. Within this work, an already established fully-coupled Lagrangian finite element framework for modeling the restenotic growth is enhanced with the incorporation of endothelium-mediated effects and pharmacological influences of rapamycin-based drugs embedded in the polymeric layers of the current generation drug-eluting stents. The continuum mechanical description of growth is further justified in the context of thermodynamic consistency. Qualitative inferences are drawn from the model developed herein regarding the efficacy of the level of drug embedment within the struts as well as the release profiles adopted. The framework is then intended to serve as a tool for clinicians to tune the interventional procedures patient-specifically.

Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial

Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P&lt;0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.

Clinical and procedural outcomes of percutaneous coronary intervention for de novo lesions involving the ostial left circumflex coronary artery.

Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results. The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy. Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization. A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450-1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25-1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25-0.75, p = 0.002). Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates.

Randomized clinical trial of abluminus DES+ sirolimus-eluting stent versus everolimus-eluting DES for percutaneous coronary intervention in patients with diabetes mellitus: An optical coherence tomography study.

Diabetic patients are at higher risk of recurrent adverse events following percutaneous coronary intervention (PCI) than the nondiabetics. Despite the introduction of new generation drug-eluting stents, their efficacy in the diabetics is still limited. To evaluate the efficacy of the Abluminus DES+ biodegradable polymer sirolimus-eluting stent in reducing neointimal hyperplasia in diabetic patients, compared to a durable polymer everolimus-eluting stent (DP-EES). A total of 131 patients with diabetes and coronary artery disease were enrolled in six Italian centers and randomized in a 2:1 fashion to PCI with Abluminus DES+ or DP-EES: 85 were assigned to Abluminus DES+ and 46 to DP-EES. The primary endpoint was optimal coherence tomography (OCT)-derived neointimal volume at 9-12 months. Secondary endpoints included OCT-derived neointimal area, neointimal volume obstruction and adverse clinical events. The primary endpoint, neointimal volume, did not differ between Abluminus DES+ and DP-EES (29.11 ± 18.90 mm3 vs. 25.48 ± 17.04 mm3 , p = 0.40) at 9-12-month follow-up. This finding remained consistent after weighing for the sum of stents lengths (1.14 ± 0.68 mm3 vs. 0.99 ± 0.74 mm3 for Abluminus DES+ and DP-EES, respectively, p = 0.38). Similarly, other OCT-derived and clinical secondary endpoints did not significantly differ between the two groups. Rate of target lesion failure was high in both groups (21.2% for Abluminus DES+ and 19.6% for DP-EES). This preliminary study failed to demonstrate the superiority of the Abluminus DES+ over the DP-EES in diabetic patients in terms of neointimal proliferation.

CORONARY IN-STENT RESTENOSIS: A LITERATURE REVIEW

Intrastent restenosis is a narrowing of the lumen of a coronary vessel previously treated with angioplasty It is the result of two histopathological processes: vascular remodeling and neointimal hyperplasia due to smooth muscle migration and proliferation, with the latter mechanism predominating. It manifests clinically with symptoms of ischemia and angiographic findings showing at least a 50% reduction in the lumen of a vessel previously treated with balloon angioplasty or a stent. Second generation drug eluting stents or drug eluting balloons are recommended for treatment, depending on the type of restenosis being treated. We present a review of the literature about of the various aspects of this topic which remains a clinical challenge for interventional cardiologists, starting from its origin its historical background.to various treatment options.

A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial.

Third generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES. A total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected. Most of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints. The study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy. ClinicalTrials.gov, identifier (NCT03745053).

Severely calcified coronary artery lesions: focus on interventional management

Severe coronary artery calcifications remain a challenge for the contemporary interventional cardiologist in the light of the growing demand for diagnostic procedures and interventions in elderly patients; in addition, the general prognostic improvement after percutaneous coronary intervention (PCI) is expanding the indications to PCI to increasingly complex anatomies. In the last decade, a renewed interest in the treatment of calcific lesions has been observed, with the aim to optimize the mechanic effects of balloon angioplasty and the expansion and apposition of DES to the vessel wall. However, patients with calcific coronary artery disease represent a subset with a high risk of adverse outcomes, both intra-procedural and in the long-term. The need to guarantee a targeted and tailored treatment based on the coronary anatomy of any individual patient is a current priority of the interventional community. The efficacy of rotational atherectomy in improving procedural success for the treatment of calcified lesions has been widely demonstrated. The advent of new technologies -especially of intravascular lithotripsy (IVL)-, the application of techniques and materials initially developed for as complex procedures as chronic total occlusions (CTO), the increasing experience of contemporary operators and the introduction of latest generation drug-eluting stents (DES) with excellent technical and structural properties, are further contributing to improving outcomes of current PCI for calcific lesions.