2nd Generation Drug-eluting Stent Research Articles

Association of Side-Branch Treatment and Patient Factors in Left Anterior Descending Artery True Bifurcation Lesions: Analysis from the GRAND-DES Pooled Registry.

Methods Patients undergoing PCI to left anterior descending (LAD) bifurcation lesions with contemporary DES were analyzed from a nationwide registry. Baseline risk was assessed using the Age, Creatinine, and Ejection Fraction (ACEF) score. Target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization, was assessed at 3 years. Results Among 1,089 patients with LAD bifurcation lesions, 548 (50.3%) patients underwent SB treatment. The SB treatment group showed a nonsignificant, but numerically lower rate of 3-year TLF (6.6% vs. 9.2%, HR 0.75, 95%CI 0.44–1.28, p = 0.29). In patients with low pretreatment risk (ACEF<1.22), SB treatment was associated with a lower rate of 3-year TLF (HR 0.43, 95%CI 0.19–0.96, p = 0.04), while no significant difference was observed in patients with high risk (ACEF≥1.22). The difference in the low risk group was mostly driven by target lesion revascularization (HR 0.24, 95%CI 0.08–0.75, p = 0.01). Conclusions SB treatment for LAD bifurcation lesions showed favorable long-term outcomes compared with main-branch-only intervention, especially in patients with low pretreatment risk.

Intersection of the Academic Research Consortium – high bleeding risk criteria in patients undergoing PCI for acute coronary syndromes: insights from a high-volume single centre registry

Abstract Introduction Patients presenting for percutaneous coronary intervention (PCI) with acute coronary syndromes (ACS) often have overlapping bleeding and ischaemic risk factors that offset the long-term success of PCI and limit the post stenting therapeutic options. Aiming at improving outcomes following PCI, the Academic Research Consortium (ARC) recently published a set of major and minor criteria that identify, a priori, patients at high bleeding risk (HBR). Indeed, knowledge of these risk factors will help in optimization of pre-procedural therapy and minimization of post intervention complications. Nonetheless, the actual prevalence of these criteria among patients undergoing PCI for ACS is not well known. Purpose To determine the intersection and distribution of ARC-HBR major and minor criteria in a real-world ACS population presenting for PCI. Methods In this analysis, we included all patients who presented with ACS to a high-volume PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent (DES) implantation. Patients were then classified as HBR if they met ≥1 major or ≥2 minor criteria according to the ARC-HBR definition. Baseline clinical and procedural characteristics were extracted from each patient electronic health records. The most common exclusive intersections of ARC-HBR major and minor criteria were quantitatively visualized using an Upset Plot. Results Only 44.6% (n=2,717) of ACS patients (n=6,097) fulfilled the ARC-HBR definition. There were significant differences in baseline clinical characteristics between HBR and non-HBR groups: age (71.4±11.5 vs. 60.9±10.3 years, p&amp;lt;0.001), females (40.7% vs. 25.5%, p&amp;lt;0.001), cerebrovascular disease (19.5% vs. 3.9%, p&amp;lt;0.001), and diabetes (55.4% vs. 42.1%, p&amp;lt;0.001). The prevalence of active smoking, a major risk factor for bleeding, was higher in the non-HBR group (20.6% vs. 9.9%, p&amp;lt;0.001). The most frequent major and minor criteria were severe anemia (n=1,072) and age ≥75 (n=1,264), respectively. The top five criteria intersections were: severe anemia (n=215), age ≥75 and moderate chronic kidney disease (CKD) (n=145); moderate CKD and mild anemia (n=142); age ≥75 and mild anemia (n=140); age ≥75, moderate CKD, and mild anemia (n=130) (Figure 1). Conclusion Among patients who have undergone PCI for ACS, a significant proportion of individuals fulfilled the ARC-HBR definition. Severe anemia was the most prevalent major criteria. Different combinations of minor criteria, mainly age ≥75, moderate CKD and mild anemia, represented the most common intersections. Figure 1 Funding Acknowledgement Type of funding source: None

The impact of discontinuation of aspirin within 24 months among the high risk patients who are receiving prolonged dual antiplatelet therapy after implantation of second-generation drug-eluting stents

Abstract Background The clinical impact of discontinuation of aspirin within 24 months after PCI for high risk patients who are receiving prolonged dual antiplatelet therapy (DAPT) is not known. We investigated the long-term outcomes prolonged DAPT among high risk patients after second-generation drug-eluting stent (DES) implantation. Methods and results Of 2082 consecutive patients undergoing PCI using 2nd generation DES, we studied 637 patients at high risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group (aspirin discontinued within 24 months) and the prolonged DAPT group. The primary outcome was major adverse cardiac and cerebrovascular events (a composite of all-cause death, non-fatal myocardial infarction, or stroke) between 12 and 36 months after the index procedure. In propensity score-matched population, the risk of major adverse cardiac and cerebrovascular events (4.7%, 12/256 versus 4.3%, 11/256, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.42–2.16, p=0.91), all-cause mortality (3.1%, 8/256 versus 2.0%, 5/256, HR 0.70, CI 0.23–2.14), cardiovascular death (0.4%, 1/256 versus 0.8%, 2/256, HR 2.34, CI 0.21–25.80, p=0.49), non-fatal myocardial infarct (0.8%, 2/256 versus 0.4%, 1/256, HR 0.57, CI 0.05–6,32, p=0.65), stroke (0.8%, 2/256 versus 0.8%, 2/256, HR 1.09, CI 0.15–7.76, p=0.93) were not significantly different between patients receiving clopidogrel monotherapy and prolonged DAPT. Conclusion Compared to prolonged DAPT, aspirin discontinuation 12–24 months after PCI for high risk patients who received DAPT has similar long-term risk of major adverse cardiac and cerebrovascular events in patients after second-generation DES implantation. Funding Acknowledgement Type of funding source: None

Long-term outcomes in high-bleeding risk patients undergoing PCI for acute coronary syndromes: results from a large single-center pci registry

Abstract Introduction Current clinical guidelines recommend prolonged dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). However, an extended DAPT duration in high-bleeding risk (HBR) patients amplifies the risk of post procedural complications. Hence, clinicians often face the dilemma of prolonging DAPT duration to prevent recurrent ischaemic events at the expense of increasing the incidence of bleeding in high-risk patients. The actual incidence of ischaemic and bleeding events in this particular population is not well elucidated. Purpose To evaluate one-year ischemic and bleeding outcomes following PCI for ACS in a real-world HBR population as defined by the Academic Research Consortium (ARC) consensus document. Methods We included all patients who presented with ACS to a high-volume single PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent implantation. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the recent ARC-HBR consensus. The outcomes of interest were major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), and target lesion revascularization (TLR), and major bleeding events, including both peri-procedural and post-discharge bleeding. All outcomes were assessed at 1-year follow-up. The Kaplan-Meier method was used for time-to-event analyses. Results Out of 6,097 ACS patients included in this analysis, 2,717 (44.6%) fulfilled the ARC-HBR definition. Compared to non-HBR group, HBR patients were more frequently female, older, more likely to have cardiovascular risk factors (e.g., diabetes, hypertension, and hyperlipidemia) and complex coronary artery disease (e.g., multi-vessel disease, bifurcation lesions, and calcification). The 1-year incidence of MACE was significantly higher in HBR patients (16.3% vs. 8.1%, HR 2.16, 95% CI [1.81–2.59], p&amp;lt;0.001) (Figure 1A). This finding was driven by higher rates of all-cause death and MI (Figure 1B). The 1-year incidence of major bleeding was also significantly higher in HBR patients compared to non-HBR (11.1% vs. 3.1%, HR: 3.92, 95% CI 3.10–4.95; p&amp;lt;0.001). Conclusions HBR patients undergoing PCI for ACS are not only subject to bleeding complications but are also at an increased risk for ischemic events and all-cause mortality. Figure 1 Funding Acknowledgement Type of funding source: None

Use of enhanced stent visualisation compared to angiography alone to guide percutaneous coronary intervention

ObjectiveWe aimed to assess the use of enhanced stent visualisation (ESV) on outcomes, after PCI with overlapping stents, specifically using CLEARstent technology. BackgroundStent underexpansion and overlap are both significant risk factors for restenosis and stent thrombosis. Enhanced stent visualisation (e.g. CLEARstent) systems could provide important data to reduce under-expansion and stent overlap. MethodsThis was a cohort study based on this institution's percutaneous coronary intervention (PCI) registry. A total of 2614 patients who had PCI for stable angina or acute coronary syndromes (ACS, excluding cardiogenic shock) with overlapping 2nd generation drug eluting stents (DES) in the same vessel between May 2015 and January 2018 were included in the analysis. Patients were divided into ESV (n = 1354) and no ESV guided intervention (n = 1260). The primary end-point was major adverse cardiovascular events (MACE: target vessel revascularisation, target vessel myocardial infarction and all-cause mortality) recorded at a median follow up of 2.4 years. ResultsGroups were comparable for patient characteristics (age, diabetes mellitus, ACS presentation). A significant difference in MACE was observed between patients who underwent ESV-guided PCI (9.5%) compared with patients who underwent Standard PCI (14.4%, p = .018). This difference was mainly driven by reduced rates of target vessel revascularisation and recurrent myocardial infarction. Overall this difference persisted after multivariate Cox analysis (HR 0.86, 95% CI: 0.73–0.98) and propensity matching (HR = 0.88, 95% CI: 0.69–0.99). ConclusionWe suggest that routine clinical use of ESV technology during PCI can be useful, and is associated with better medium-term angiographic and clinical outcomes. Further study is required to build on this promising signal.

Optimal Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: Insights From a Network Meta-Analysis of Randomized Trials

BackgroundWith newer generation drug eluting stents (DES), the minimal duration of dual antiplatelet therapy (DAPT) recommended by guidelines has been reduced to 6 months in patients with stable coronary artery disease. Whether shorter duration of DAPT is safe in patients presenting with acute coronary syndrome (ACS) remains controversial. Our aim of this study was to investigate the optimal DAPT duration (≤3 months vs. 6 months vs. 12 months vs. >12 months) among patients with ACS undergoing percutaneous coronary intervention (PCI). MethodsPUBMED and EMBASE were searched through January 2020 for randomized controlled trials of DAPT duration in patients with ACS. The ischemic outcomes were all-cause death, myocardial infarction, and stent thrombosis. The safety outcome was major and/or clinically relevant bleeding. ResultsOur search identified 14 eligible trials enrolling a total of 31,837 patients comparing different DAPT duration in patients with ACS. Short-term DAPT (≤3 months or 6 months) did not increase ischemic outcomes compared to long-term DAPT (12 months and >12 months). For bleeding outcomes, ≤3 months DAPT was associated with significant reduction in bleeding compared to 6 months, 12 months or >12 months DAPT (OR [95% CI]: 0.60 [0.37–0.98]; 0.68 [0.54–0.85] and 0.43 [0.34–0.54], respectively). These findings were similar when limited to 2nd generation DES. ConclusionsData from this meta-analysis of randomized trials support short-term (≤3 months and 6 months) DAPT in patients with ACS undergoing PCI. Guidelines might need to consider short-term DAPT even in patients presenting with ACS, especially in this era of newer generation DES.

Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment.

Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function.Large-scale, international, single-armed, multicenter, ‘all comers’ observational studies (ClinicalTrials.gov Identifier: NCT02629575 and NCT02905214) were used for this post-hoc subgroup analysis to compare the clinical outcomes in patients with normal renal function (NRF) to those with renal insufficiency (CKD, dialysis dependence). The accumulated target lesion revascularization rate was the primary endpoint at 9 to 12 months whereas the accumulated major adverse cardiac event, stent thrombosis (ST) and procedural success rates were part of the secondary endpoints.There were 6791 patients with NRF, whereas 369 patients had CKD and 83 patients were dialysis dependent. The target lesion revascularization rate at 9 to 12 months was significantly higher in dialysis patients (2.1% vs 3.3% vs 6.7%, P = .011). The accumulated major adverse cardiac events rates in the dialysis and in the CKD group were significantly higher as compared to patients with NRF (13.3% vs 4.0%, P < .001; 6.5% vs 4.0%, P = .024). Finally, ST rates (NRF: 0.7%, CKD: 0.6%, dialysis: 1.3%) were not statistically different between subgroups (P = .768). All-cause cumulative mortality rates were 3.3% (CKD) and 4.0% (dialysis) respectively.Percutaneous coronary interventions with polymer-free, ultra-thin strut sirolimus-eluting stents have comparable revascularization rates in CKD and dialysis dependent patients as compared to percutaneous coronary interventions with other 2nd generation drug-eluting stents. ST and all-cause mortality rates were low as compared to available literature references.

Clinical Implications of Bifurcation Angles in Left Main Bifurcation Intervention Using a Two-Stent Technique.

Objectives The aim of this study was to assess the clinical impact of 3 bifurcation angles in left main (LM) bifurcation treated with the 2-stent technique. Background Data are limited regarding the impact of bifurcation angles after LM percutaneous coronary intervention (PCI). Methods Using patient-level 4 multicenter registries in Korea, 462 patients undergoing LM bifurcation PCI with the 2-stent technique were identified (181 crush, 167 T-stenting; 63% 1st generation drug-eluting stent (DES), 37% 2nd generation DES). Three bifurcation angles, between the LM and left anterior descending (LAD), the LM and left circumflex (LCX), and the LAD and LCX, were measured. The primary outcome was target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). Results In patients treated with the crush technique, the best cutoff value (BCV) to predict TLF was 152° of the LM-LAD angle. In the crush group, a significantly higher TLF rate, mostly driven by TLR, was observed in the LM-LAD angle ≥152° group compared with the <152° group (35.7% vs. 14.6%; adjusted hazard ratio 3.476; 95% confidence interval 1.612–7.492). An LM-LAD angle ≥152° was an independent predictor of TLF. In the T-stenting, no bifurcation angle affected the clinical outcomes. Conclusions In LM bifurcation PCI using the 2-stent technique, wide LM-LAD angle (≥152°) was associated with a greater risk of TLF in the crush, whereas none of the bifurcation angles affected T-stenting outcomes.

Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation.

Determining the optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important clinical issue. We evaluated the effects of ischemia (by DAPT score) and bleeding (by PRECISE-DAPT score), as well as the impact of DAPT duration, on clinical outcomes. From pooled analysis of four randomized clinical trials, 5131 patients undergoing second-generation DES implantation were randomized to short-duration (n=2575; ≤ 6months) or standard-duration (n = 2556; ≥ 12months) DAPT groups. This population was further divided into four subgroups according to PRECISE-DAPT (high bleeding risk ≥ 25) and DAPT (high ischemic risk ≥ 2) scores. Net clinical outcomes (1.3% vs. 1.3%; p = 0.89) and ischemic events (5.0% vs. 4.5%; p = 0.44) did not differ between the two duration groups, although bleeding events were more frequent in patients with standard-duration DAPT (0.4% vs. 0.9%; p = 0.04). Standard-duration DAPT was associated with fewer ischemic events (6.9% vs. 4.0%; p = 0.02) and no increase in bleeding events only among patients at low bleeding risk and high ischemic risk. The other groups show no differences in net clinical outcomes, ischemic events, or bleeding events according to DAPT duration. Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12months after second-generation DES implantation. However, standard-duration DAPT reduced ischemic events without increasing bleeding events among patients at low bleeding and high ischemic risk. When determining DAPT duration, considering both ischemic and bleeding risk can help optimize patient benefits. EXCELLENT (NCT00698607), RESET (NCT01145079), IVUS-XPL (NCT01308281), OPTIMA-C (NCT03056118).

Multivariable prediction model to estimate the probability of restenosis at proximal edge after 2nd-generation drug-eluting-stent implantation: development and internal validation using a quantitative coronary angiography from the post-marketing surveillance studies of everolimus-eluting stent in Japan

Edge restenosis has still been reported after second-generation drug-eluting stent (DES) implantation. It was more likely attributable to post-procedural angiographic results than to the patient's background. The aim of this study was to develop and internally validate a prediction model for restenosis in proximal edge after 2nd-generation DES stent implantation using angiographic data. Data were obtained from several post-marketing surveillance (PMS) studies of the cobalt-chromium everolimus-eluting stent (CoCr-EES) and platinum-chromium everolimus-eluting stent (PtCr-EES), second-generation DES, in Japan. Angiographic analysis was conducted at baseline and after 8 or 12months. We focused on the proximal edge of angiographic analysis. The main outcome was restenosis defined as ≥ 50% diameter stenosis at follow-up. The predictive performance of the prediction model based on multivariable logistic regression was assessed in terms of discrimination and calibration, which were internally validated by the bootstrap method. We also performed decision curve analysis to assess threshold of predicted probability of restenosis at which additional intervention was considered. Among 2053 lesions in 1860 patients, restenosis rates in proximal edge was 2.8%. The final model was constructed with % post-procedural diameter stenosis (DS) and post-procedural reference diameter (RD) as strong predictors for edge restenosis. Discrimination and calibration were satisfactory with optimism-corrected C-statistics 0.75. Predicted probability between 0.03 and 0.24 was preferable threshold for restenosis treatments. Our prediction model can be used to obtain valid prediction for restenosis in proximal edge, assisting to know complete stent coverage of lesion.

IRREGULAR PROTRUSION IS CORRELATED WITH DEVELOPMENT OF NEOATHEROSCLEROSIS AFTER 2NDAND 3RDGENERATION DRUG-ELUTING STENT IMPLANTATION: OPTICAL COHERENCE TOMOGRAPHIC STUDY

We examined the correlation between irregular protrusion area and the 8-month development of the neoatherosclerosis after new generation drug-eluting stent (DES) implantation. We enrolled 117 consecutive patients (134 lesions) with 2nd and 3rd generation DES who received pre and post-stenting

Efficacy and Safety of Guideline-Recommended Risk Score-Directed Dual Antiplatelet Therapy After 2nd-Generation Drug-Eluting Stents.

Evaluate the safety and efficacy of guideline-recommended risk score-directed dual antiplatelet therapy (GD-DAPT) based on THE PRECISE-DAPT score after 2nd-generation drug-eluting stent (DES) implantation.Methods and Results:We analyzed 5,131 patients pooled from 4 clinical trials. Patients were divided into 3 groups according to current recommendations on the duration of DAPT and their actual DAPT duration: GD-DAPT (n=2,183), shorter DAPT (n=1,540), longer DAPT (n=1,408). The primary endpoint was the rate of net adverse clinical events (NACE) during the first 12 months. The secondary endpoints were ischemic or bleeding events. Overall, GD-DAPT did not affect NACE (1.2% vs. 1.2% for shorter DAPT and 1.7% for longer DAPT) or bleeding events (0.6% vs. 0.5% and 0.9%), and there were fewer ischemic events (2.8% vs. 4.4% and 4.0%, P=0.03) than with shorter DAPT. Especially in acute coronary syndrome (ACS) patients, GD-DAPT had fewer NACE (1.5% vs. 1.4% and 4.2%; P=0.006) and bleeding events (0.8% vs. 0.5% and 2.8%; P=0.001) than longer DAPT as well as fewer ischemic events (2.8% vs. 4.4% and 4.7%; P=0.03) than shorter DAPT. GD-DAPT did not affect NACE or bleeding events and reduced the number of ischemic events at 12 months compared with shorter DAPT. For ACS, GD-DAPT was associated with favorable outcomes compared with non-GD-DAPT. Therefore, GD-DAPT may optimize efficacy and safety.

P2696Clinical characteristics of late catch-up phenomenon after implantation of 2nd generation drug eluting stent

Abstract Introduction Late catch-up phenomenon (LCU) of 1st generation drug eluting stent (DES) has been increasing yearly despite the rate of restenosis in 1 year has reduced compared with bare metal stent (BMS). 2nd generation DES was more improved than 1st generation DES and suggested more benefits about clinical outcome. Purpose To investigate the incidence and predictor of LCU after implantation of 2nd generation DES and to evaluate the association between LCU phenomenon and adverse events. Methods Between August 2012 and July 2013, a total of 1665 consecutive patients (1956 lesions with elective/urgent PCI) were enrolled in SHINANO 5 years Registry (a prospective observational multicenter cohort study) from 13 institutions in Nagano, Japan. 711 patients that were treated with 2nd generation DES and 576 patients with BMS were selected. Exclusion criterias were cases of 1st DES, only POBA, only aspiration and chronic total occulusion. Results There were significant difference about patients background between BMS and 2nd generation DES groups. Those groups were matched with propensity score. After matching, 822 patients (BMS group 411 patients, 2nd generation group 411 patients) were analyzed. The rates of 2nd DES and BMS restenosis 5 years after initial PCI were 9.2% and 8.5% (p=0.572), those of LCU were 2.6% and 5.6% (p=0.043) by 1 year landmark analysis. Cox proportional hazards analysis revealed that the DES in-stent restenosis (ISR) lesion and higher HbA1c were independent predictors for LCU from 1year to 5year (HR 5.304, p=0.009, HR 1.254, p=0.015), but 2nd generation DES was not. Kaplan Meier curve showed no association between LCU phenomenon and all cause death (p=0.446). Cox regression analysis showed LCU was not independent predictor for all cause death (p=0.414). Conclusions Implantation to DES-ISR lesion with 2nd generation DES was associated with higher LCU. Despite of more complex lesions with 2nd generation DES, there were no differences of LCU incidence between 2nd generation DES and BMS. Acknowledgement/Funding None

P974Efficacy of plaque debulking for bifurcated or ostial lesion by directional coronary atherectomy before 2nd generation drug eluting stent (PERFECT2)

Abstract Objectives We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) before 2nd generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. Background Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting used. Methods Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-2nd generation DES plaque debulking with a novel DCA was conducted. All patients were scheduled to perform a follow up (9–12 months) angiography (coronary angiography or coronary computed tomography). The primary end point was the target vessel failure (TVF) at follow-up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. Results A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all without any major procedure-related event and only 1 case needed complex stenting. TVF rate at 9–12 months follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at ostial of main-branch in 3cases. No death, no coronary artery bypass grafting, and no myocardial infarction were reported in the patients within the first year. Figure1 Conclusion DCA before 2nd generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions. Acknowledgement/Funding None

Clinical Outcomes in Diabetic Patients with Stable Coronary Artery Disease Treated with Second- Generation Drug Eluting Stents (Short and Mid-Term Follow Up)

Buckhound: The increased prevalence of type 2 diabetes mellitus (DM) is an important public health problem. The number of patients with DM worldwide is estimated to rise to 366 million by the year 2030. In general, individuals with DM have more severe and diffuse atherosclerotic disease, which accounts for the significantly higher incidence of cardiovascular events in their native coronary, cerebrovascular, and peripheral arteries. Objective: The aim of this study was to assess the short and mid-term clinical outcomes in type 2 diabetic patients with stable coronary artery disease treated with 2nd generation drug eluting stents. Patients and Methods: This prospective observational study included a total of 100 type 2 DM-CAD patients, attending at Department of Cardiology, Tanta University Hospitals. This study was conducted between January 2018 till January 2019. Assessment of the mid and short-term clinical outcomes in patients was done. Results: Non-significant difference as regards age, sex and family history (p > 0.05) was found. Non-significant difference as regards height, weight, BMI, HTN and smoking (p > 0.05) was found. Significant increase in inverted T wave in Major Adverse Cardiovascular Events (MACE) group; compared to normal group; with significant statistical difference (p = 0.015). Non-significant difference as regards creatinine, ST elevation, ST depression, pathological Q, LBBB and RBBB (p > 0.05) were found. Highly significant decrease in EF in MACE group; compared to normal group; with highly significant statistical difference (p < 0.01) were found. Conclusion: Diabetes mellitus is a condition in which the use of 2nd generation zotarolimus-eluting stents is preferable, in order to reduce the incidence of MACE adverse events.

P2697Percutaneous coronary intervention with 2nd generation drug eluting stent versus coronary artery bypass grafting in patients with unprotected left main disease: clinical outcome from a referral center

Abstract Background Percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease is currently recommended as an alternative to coronary artery bypass grafting (CABG) in patients with low and intermediate SYNTAX score. Purpose We sought to compare clinical outcomes of unprotected left main coronary artery disease by PCI or CABG in a “real world” population referred to high volume center. Methods All consecutive patients with unprotected left main coronary artery disease treated by PCI with second-generation drug-eluting stent were compared to those treated by CABG. The primary endpoint was the composite of death, non-fatal myocardial infarction (MI) or stroke at 2 years follow-up. Results A total of 558 patients were included. The mean age was 71±9 years, diabetes was present in 29%, and 56% of the patients presented with acute coronary syndrome. The distal left main coronary artery was involved in 84.6% of the lesions, the rate of Syntax score &gt;32 was 50%. At 2 years, the primary end-point occurred in 10% of the patients in the PCI group and in 9.6% in the CABG group (p=0.862). The rates of death, non-fatal MI or stroke at 2 years were comparable; conversely the rate of ischemia driven revascularization at 2 years was higher in PCI group than CABG (5.5% and 1.5% p=0.010, respectively in PCI and CABG group). Kaplan-Meier curves of MACCE Conclusions In a “real world” population with unprotected left main coronary artery disease, PCI with second generation stent, as compared to CABG, showed similar rates of the composite end point of death, non-fatal MI or stroke at 2 years, irrespective of coronary anatomy complexity.

Clinical Outcomes in Diabetic Patients with Stable Coronary Artery Disease Treated with Second- Generation Drug Eluting Stents (Short and Mid-Term Follow Up)

Buckhound: The increased prevalence of type 2 diabetes mellitus (DM) is an important public health problem. The number of patients with DM worldwide is estimated to rise to 366 million by the year 2030. In general, individuals with DM have more severe and diffuse atherosclerotic disease, which accounts for the significantly higher incidence of cardiovascular events in their native coronary, cerebrovascular, and peripheral arteries. Objective: The aim of this study was to assess the short and mid-term clinical outcomes in type 2 diabetic patients with stable coronary artery disease treated with 2nd generation drug eluting stents. Patients and Methods: This prospective observational study included a total of 100 type 2 DM-CAD patients, attending at Department of Cardiology, Tanta University Hospitals. This study was conducted between January 2018 till January 2019. Assessment of the mid and short-term clinical outcomes in patients was done. Results: Non-significant difference as regards age, sex and family history (p > 0.05) was found. Non-significant difference as regards height, weight, BMI, HTN and smoking (p > 0.05) was found. Significant increase in inverted T wave in Major Adverse Cardiovascular Events (MACE) group; compared to normal group; with significant statistical difference (p = 0.015). Non-significant difference as regards creatinine, ST elevation, ST depression, pathological Q, LBBB and RBBB (p > 0.05) were found. Highly significant decrease in EF in MACE group; compared to normal group; with highly significant statistical difference (p < 0.01) were found. Conclusion: Diabetes mellitus is a condition in which the use of 2nd generation zotarolimus-eluting stents is preferable, in order to reduce the incidence of MACE adverse events.

P2688A novel risk factor of stent restenosis after drug-eluting stent implantation; Involvement of triglyceride deposit cardiomyovasculopathy, coronary atherosclerosis with triglyceride deposition

Abstract Background Triglyceride deposit cardiomyovasculopathy (TGCV) is a novel disease concept characterized by the excessive accumulation of triglyceride in cardiomyocytes and vascular smooth muscle cells, leading to coronary artery disease (CAD), heart failure, and arrhythmia. However, it is rarely known whether TGCV contributes to the increased risk of vascular failure after drug eluting stent (DES) implantation. Purpose The aim of this study was to evaluate vascular failure after 2nd generation DES implantation in patients with TGCV. Methods Among 637 consecutive patients suspected of having CAD who underwent both coronary angiography and iodine-123-β-methyliodophenyl-pentadecanoic acid (BMIPP) scintigraphy between 2010 and 2018, we analyzed the data from 92 patients who met the inclusion criteria (shown in Table and Figure). Ninety-two patients were allocated to the presence (TGCV group, 11 patients) or absence (control group, 81 patients) of TGCV. All of 92 patients were implanted 2nd generation DES and underwent planned follow up coronary angiography. Control patients were diagnosed of diabetes mellitus. Binary restenosis (ISR), defined as angiographic luminal diameter ≥50% by quantitative coronary angiography, target lesion revascularization (TLR), In-stent late loss and restenosis morphology were assessed in 23 stents of TGCV group and 120 stents of control group. Results There were no significant differences in baseline characteristics between the two groups except for the prevalence of hypertension. In-stent late loss was greater in TGCV than in control (0.45 (−0.04 to 3.33) vs. 0.15 (−0.18 to 2.75), p=0.ehz748.10067), resulting in greater incidence of ISR and TLR in TGCV than in control (34.8% vs. 10.0%, p=0.0017; 21.7% vs. 6.7%, p=0.021, respectively). On multivariable logistic regression analysis, TGCV was found to be a significant and independent predictor for ISR after 2nd generation DES implantation. Regarding restenosis morphology, diffuse and occlusive pattern of ISR, were more frequently observed in TGCV than control (87.5% and 33.3%, Fisher's exact test p=0.028). Table 1.The 4th edition diagnostic criteria for TGCV Items Clinical findings 2 points I) BMIPP scintigraphy Wash-Out Rare &lt;10% II) Diffuse narrowng coronary arteries 1 point III) Jordans anomaly in peripheral blood smear IV) Diabetes Decision 4 points or more → Definite TGCV Figure 1 Conclusion Patients with TGCV showed the greater incidence of vascular failure even after 2nd generation DES implantation, contributing to the novel risk factor for coronary intervention even in the 2nd DES era.

P2689Irregular protrusion area is associated with incidence of cardiac events after implantation of new generation drug-eluting stents - optical coherence tomography study

Abstract Background Several studies using optical coherence tomography (OCT) have shown that the prevalence of irregular protrusion was associated with the incidence of adverse cardiac events. However, the correlation between cardiac events and protrusion area is not well investigated. Method One hundred twenty-nine consecutive patients with 138 clesions with 2nd and 3rd generation drug-eluting stents (DES) which had pre-stenting and post-stenting OCT imaging between April 2016 and April 2018 were evaluated. We compared baseline characteristics, procedure findings and OCT findings including minimum stent area, protrusion type and maximum protrusion area between target lesion revascularization (TLR) group and non-TLR group. Results TLR occurred in 12 (9.3%) in 129 patients. The baseline characteristics and procedure findings were similar between TLR group and non-TLR group. Univariate analysis revealed that maximum irregular protrusion area was significantly larger (0.51 [0.00–0.63] vs 0.00 [0.00–0.27], p=0.036) in TLR group than non-TLR group. Receiver operating characteristic curve analysis revealed that the suitable cutoff value of maximum irregular protrusion area were 0.43mm2 for TLR. In multivariate analysis using the parameters with p value&lt;0.10 determined by univariate analysis, maximum irregular protrusion (≥0.43mm2) and minimum stent area (MSA) were independently correlated with TLR (table). Odd's ratio (95% CI) P value Major irregular protrusion (≥0.43mm2) 17.3 (3.63–82.6) &lt;0.001 MSA 2.13 (1.15–3.93) 0.002 Conclusion Major irregular protrusion (&gt;0.43mm2) in post-stenting OCT findings may be a powerful predictor of TLR in the patients with new generation DES.

The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era.

Objectives The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).