Generation DES Research Articles

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

The evolution and revolution of drug coated balloons in coronary angioplasty: An up-to-date review of literature data.

European Society of Cardiology (ESC) guidelines gave class I A indication for use of DCB in in-stent restenosis. However, no indication exists for the usage of DCB in de novo lesions. Although the current generation DES offer excellent results, as we embark more complex lesions such as calcified lesion and chronic total occlusion, restenosis and stent thrombosis are higher and tend to increase within the years. There is increasing desire to leave nothing behind to abolish the risk of restenosis and stent thrombosis and hence the absorbable scaffolds were introduced, but with disappointing results. In addition, they take several years to be absorbed. Drug coated balloons offer an alternative to stents with no permanent implant of metal or polymer. They are already in use in in Europe and Asia and they have been approved for the first time in the United States for clinical trials specifically for restenotic lesions. There is emerging data in de novo lesions which have shown that DCB are noninferior and in some studies maybe even superior to current generation DES especially in small vessels. In this article, we provide a comprehensive review of the literature on this expanding technology focussing on the evidence in both re-stenotic and de novo lesions.

PPCI OUTCOMES

Objectives: Primary percutaneous coronary intervention (PPCI) is the standard of care for ST-elevation myocardial infarction (STEMI) worldwide. Recommended by the latest guidelines (1). In Pakistan only a handful centres offer PPCI services, many others rely on thrombolysis as the reperfusion strategy for STEMI patients which has been shown to be inferior to primary PCI (2). In our province the PPCI facility is even harder to offer where infrastructure and economic conditions of the public is lagging behind many areas in the country. Ours is a study from a public sector hospital in its infancy. We present our data of a single centre and believe that it will help shape the policy of the government in favour of expanding PPCI facilities. To share the primary PCI data of our centre.
 Methodology: It was a retrospective observational study. All comers who underwent PPCI for STEMI in Peshawar Institute of Cardiology from March 2022 to August 2022were enrolled. All procedures were performed by experienced interventional cardiologists or their fellows under their direct supervision.
 Results: A total of 337 patients were enrolled in the study. The mean age was 53 ± 16 years. 73 % (n = 246) were males. Most commonly involved culprit artery was LAD (47%) followed by RCA (34%). 16.9% (n = 57) patients had triple vessel disease, 35 % (n = 119) double vessel disease and 47.7% (n = 161) had only one vessel disease. LMS disease was diagnosed in 18 (5.3%) patients, out of which 4 (1.1%) were stented during the index procedure. In-hospital mortality was 3% (n = 10), out of which 6 (1.8 %) patients were in cardiogenic shock and all were on inotropic support. Four patients (1.1%) needed intubation and balloon pump was used in another 4 (1.1 %) patients. Second and third generation DES were used in 86% (n = 290), POBA in 08% (n = 27), urgent surgical referral was done in 03 % (n = 10) while in 03% (n = 10) patients no stenting was done. Intravascular ultrasound was used in 4 (1.1%) cases.
 Conclusion: Primary PCI can be offered in public sector hospital to our population. The need of the hour is to delegate more resources to this life saving procedure.

Abstract 9440: Acs in a Patient With Amegakaryocytic Thrombocytopenia: A Management Dilemma

Introduction: The management of Acute Coronary Syndrome (ACS) in thrombocytopenia is challenging. This abstract highlights the management dilemma of a patient who presented with high-risk ACS and was found to have Amegakaryocytic thrombocytopenia (AMT). Case Presentation: A fifty-five-year-old man with no cardiovascular risk factors was admitted with high-risk ACS with recurrent ischemic ECG changes and high troponin-T. He was found to have a low platelet count of 9 x10^3/uL. The initial impression was ACS and ITP. Course: No antiplatelet or anticoagulation was commenced. CT coronary angiography showed ostial left main (LM) severe stenosis. The patient received steroids and IVIG. A week later, cyclosporin and eltrombopag were added as the thrombocytopenia was refractory. Bone marrow biopsy showed AMT. His chest pain was persistent with ECG ischemic changes. A multidisciplinary team (MDT) decided that revascularization is urgently required, but the surgical option would have an extremely high bleeding risk. Alternatively, the Percutaneous option using radial access would have significantly less bleeding risk. However, he will need DAPT for at least the first week, which if interrupted, he will be at risk for stent thrombosis. The final decision was for platelet transfusion, then to proceed with the PCI once the platelet count is 50,000 or more, and to maintain the count > 15,000 by transfusion whenever required. Management: After the targeted transfusion, the patient was started on aspirin and clopidogrel, then successful IVUS guided PCI to ostial LM with new generation DES was done via radial access and low therapeutic ACT range. Post PCI, the patient remained asymptomatic; he was observed as an inpatient for 14 days, during which he required platelet transfusion once when his platelet count dropped < 15.000. DAPT was given for a week and then he was maintained on clopidogrel. In 3 months of follow-up, the patient had no cardiac complaints, no bleeding, and platelets were maintained between 15 to 30 on clopidogrel. Conclusion: ACS with severe thrombocytopenia is a management dilemma. Platelets transfusion, radial access, targeting low ACT, and using new generation stents for shorter DAPT duration might decrease the bleeding risk and thrombotic events.

Overlapping versus single long stents in long chronic total occlusions: insights of the Iberian CTO Registry.

It is unknown whether the availability of long drug-eluting stents modify the PCI strategy of long CTO. To describe the contemporary PCI strategy of long chronic total occlusions (CTO) using overlapping (OS) or single long stents (SS) and to analyze its results. 2842 consecutive CTO PCIs were included. Those with an occlusion length ≥20 mm in which ≥1 drug eluting stent (DES) was implanted were analyzed. We compared procedural characteristics and clinical outcomes of CTO treated with OS or SS. 1088 CTO PCIs were analyzed (79.9% males; 64.7±10.6 years). Mean J-score was 2.8±0.9. A SS was used in 38.5% of cases and OS in 61.5%. Total stent length was 64.1±29.9 mm; it was higher in the OS group (OS: 79.9±25.5 mm vs. SS: 38.3±14.7 mm; P<0.0001). Mean number of stents in the OS group was 2.3±1. Very long stents (≥40 mm) were used in 27.4% of cases, more frequently in the OS group (OS:32.4% vs. SS:19.3%; P<0.0001). After a mean follow-up of 19±15.9 months, the rate of adverse events (MACE) was 2% (cardiac death: 1.6%, myocardial infarction: 1.6%, target lesion revascularization: 1.9% and stent thrombosis: 0.18%) with no significant differences between both groups. Overlapping was not an independent predictor of MACE. In long CTO PCIs, OS is more frequently used than single stenting, especially in more complex procedures. Clinical outcomes at a mid-term follow-up are favorable. Using newer generation DES, overlapping was not an independent predictor of MACE; however, a trend toward a higher event rate was observed in the OS group.

Coronary Revascularization for Patients with Diabetes Mellitus: A Contemporary Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aims to review the contemporary literature comparing CABG and PCI in diabetic patients providing an up-to-date perspective on the differences between the interventions. Diabetes is common and diabetic patients are at a 2-to-4-fold increased risk of developing coronary artery disease. Approximately 75% of diabetic patients die of cardiovascular disease. Previous literature has identified CABG as superior to PCI for revascularization in diabetic patients with complex coronary artery diseas. PubMed and Medline were systematically searched for articles published from January 1, 2015 to April 15, 2021. This systematic review included all retrospective, prospective, and randomized trial studies comparing CABG and PCI in diabetic patients. 1552 abstracts were reviewed and 25 studies were included in this review. The data was analyzed using the RevMan 5.4 software. Diabetic patients undergoing CABG experienced significantly reduced rates of 5-year mortality, major adverse cardiovascular and cerebrovascular events, myocardial infarction, and required repeat revascularization. Patients who underwent PCI experienced improved rates of stroke that trended toward significance. Previous literature regarding coronary revascularization in diabetic patients has consistently demonstrated superior outcomes for patients undergoing CABG over PCI. The development of 1st and 2nd generation DES have narrowed the gap between CABG and PCI, but CABG continues to be superior. Continued investigation with large randomized trials and retrospective studies including long term follow-up comparing CABG and 2nd generation DES is necessary to confirm the optimal intervention for diabetic patients.

Mid-term mortality after stenting of distal left main stenosis with regular, third generation drug eluting stent or dedicated bifurcation stent or surgery-registry based,all-comers data

Abstract Background Distal left main (LM) bifurcation lesions remain a challenge for interventional cardiologists and they are associated with significant morbidity and mortality. The aim of the current study was to identify predictors of cardiac mortality at mid-term follow up after PCI (DES vs. dedicated bifurcation stent) or CABG. Methods All patients with distal LM stenosis ≥50% were included in prospective registry starting from 01.2015. The exclusion criteria for registry are cardiogenic shock, a priory life expectancy duration &amp;lt;1 year, lack of inform consent. All patients were prospectively followed about the alive status through the national security number data base. All deaths were deemed cardiac if proof otherwise (the data patient families or family's physicians were contacted through phone call about the reason of death) Results For three year follow up period (median 35 months, IQR 18–50) 303 patients were included. 220 patients were stented with 3rd generation DES, 43 with dedicated bifurcation stent BiOSS (Balton, Poland), and rest were sent for CABG. The mean age was 67±10 years, 72% were males, 37% diabetics, all with hypertension, 97% dyslipidemia, 15% PAD, 9% COPD, 16% carotid artery disease, previous MI 28%, previous PCI 50% - without significant difference between three groups. The frequency of acute coronary syndrome during admission was 11% - without difference in frequency between groups. The patient referred to CABG had significantly lower left ventricular EDV and ESV, more severe mitral regurgitation and kinetic disturbances, higher SYNTAX score and longer lesion length. On univariate COX regression analysis, the following factors were associated with mortality: age, NYHA class, GFR, baseline troponin, hemoglobin, LV EF, mitral regurgitation, kinetics disturbances, treatment with beta blockers, ACE inhibitors, statin, atrial fibrillation, SYNTAX score, lesion length. The type of treatment was not associated with differences in mortality (figure). On COX multiple regression survival analysis independent predictors of survival were: age (HR=1.036, CI 1.005–1.068, p=0.023); COPD (HR=2.313, CI 1.170–4.572, p=0.016); GFR (HR=0.988, CI 0.978–1.000, p=0.048); hemoglobin (HR=0.970, CI 0.955–0.986, p=0.000); left ventricular EF (HR=0.958, CI 0.832–0.985, p=0.003). Conclusions The type of treatment was not associated with mid-term mortality. Our data demonstrate that dedicated bifurcation stent could be used safely for distal LM stenosis treatment with similar safety as 3rd generation DES. Funding Acknowledgement Type of funding sources: None.

Clinical practice and outcomes in elderly STEMI patients undergoing PCI with new generation DES – data from a large worldwide registry

Abstract Background The best treatment option for elderly patients with acute myocardial infarction (MI) remains unclear. Purpose We aimed to determine clinical practice and outcomes of PCI with a new generation DES in patients with ST-elevated MI (STEMI), aged ≥80 years included in a one of the largest real-world PCI registries. Methods e-Ultimaster is a prospective, world-wide, multi-centre registry that enrolled 36,671 patients with coronary artery disease, treated with a thin strut sirolimus-eluting stent with abluminal bioresorbable polymer coating, across 50 countries. 34,538 patients who completed 1-year follow-up or who died were included in the analysis. The primary endpoint was 1-year target lesion failure (TLF: cardiac death, target vessel (TV) MI, clinically driven (CD) target lesion revascularization (TLR)). An Clinical Event Committee adjudicated all endpoint-related adverse events. Results 6863 presented with STEMI at baseline (19.9%). Mean age of STEMI patients was 61.0±11.7 years, with 78.8% males. Diabetes was present in 20.9% and hypertension in 52.4%. Of 6863 STEMI patients, 430 patients (6.2%) were aged ≥80 years, with 46.5% females compared to 19.5% females in the younger group. Patients in the older group had more comorbidities (hypertension and renal impairment) and more often took oral anticoagulant medication (9.2% vs 3.9%; p&amp;lt;0.001). At discharge 94.9% of older STEMI patients were on dual antiplatelet therapy (DAPT) as compared to 97.6% of younger STEMI patients (p=0.002). Older STEMI patients more often took clopidogrel as second antiplatelet agent (54.7% vs 39.8%; p&amp;lt;0.001) and were less often on prasurgrel (2.3%vs 10.9%; p&amp;lt;0.001) and ticagrelor (41.2% vs 48.1%; p=0.005). STEMI patients in the older group more often had multivessel disease (52.1 vs 45.8%; p=0.01), treatment of the left main artery (4.7 vs 1.4%; p&amp;lt;0.001) and more calcified lesions (18.8 vs 11.2%; p&amp;lt;0.001). Other lesion characteristics were similar between the two groups. Preferred access approach was radial and was alike in the two groups (87.0 vs 84.0%; p=0.10) In-hospital mortality was more frequent in older STEMI patients (2.3% vs 0.8%; p=0.003). More bleedings were observed in older vs younger STEMI patients at discharge. One-year TLF was significantly higher in older age group (7.0% vs 3.0%; p&amp;lt;0.01), mainly driven by increased rates of cardiac death. All-cause mortality and bleedings were also more frequent in older STEMI patients. No differences were observed in revascularization or ST rates (1.4 vs 1.1%; p=0.48). Conclusions In elderly patients with STEMI, in-hospital mortality rates as well as bleeding rates were higher as compared to younger patients, while 1-year rates of revascularization and ST did not differ between the groups. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Terumo Europe

Comparison between optical frequency domain imaging and intravascular ultrasound in PCI guidance for Biolimus A9 eluting stent implantation

Abstract Background It has been reported that intravascular ultrasound (IVUS) guided PCI reduced a risk of major adverse cardiac event compared to conventional angiography guided PCI, while comparison between IVUS-guided and optical frequency domain imaging (OFDI)-guided PCI specifically in long-term clinical outcomes (&amp;gt;1 year) has been unexplored. Purpose We sought to compare imaging surrogates at 8 months and clinical outcomes beyond 1 year after drug-eluting stent implantation between IVUS and OFDI guidance. Methods The MISTIC-1 is a prospective, multi-centre, single-blinded, randomised-controlled, non-inferiority trial comparing OFDI-guided and IVUS-guided PCI using Biolimus A9 eluting Nobori stent. We enrolled patients with stable coronary artery disease who have symptoms or clinically relevant myocardial ischemia. Stent landing zones were selected in the most normal looking sites with largest lumen and without percentage plaque area &amp;gt;50% in IVUS group while without lipidic plaque of &amp;gt;2 quadrants or suggestive thin-cap fibroatheroma in OFDI group. Stent sizing was based on external elastic lamina (EEL) in IVUS group, while by taking 10% or 0.25mm larger than mean lumen diameter at reference sites in OFDI group. Stent optimisation with in-stent minimum lumen area ≥80% of the average lumen area at proximal and distal reference sites was encouraged in both groups. Primary efficacy endpoint is in-segment minimum lumen area (MLA) assessed by OFDI at 8 months. Secondary safety endpoint is a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation. Based on the assumption that mean in-segment MLA at follow-up was 4.5mm2 with a standard deviation of 2.0mm2 in the control (IVUS) group and a non-inferiority limit of 1.2mm2 for OFDI group, sample size was estimated as 48 cases in each group with 5% type I error and 90% statistical power. Results Since June-2014 and August-2016, we prospectively enrolled 109 patients (mean age 70 years, male 78%) with 126 lesions. Baseline patient and lesion characteristics were well balanced and average nominal size and length of stent used did not differ between OFDI-guided and IVUS-guided PCI (3.0 and 19.1mm vs. 3.1 and 19.3mm, respectively). Post-procedural minimum stent area was 6.24mm2 in OFDI group and 6.72mm2 in IVUS group (p=0.20). At 8-month follow-up, in-segment MLA was 4.56mm2 in OFDI group and 4.13mm2 in IVUS group (P for non-inferiority &amp;lt;0.001). During the follow-up (median 4.5 years [1654 days]), incidence rates of major adverse cardiac event were comparable between the two groups (7.4% in OFDI group and 7.3% in IVUS group, hazard ratio 0.96, 95% CI 0.24–3.83, p=0.95). No definite or probable stent thrombosis were documented in both groups. Conclusion OFDI-guided PCI demonstrated comparable results in achieving satisfactory imaging surrogates as well as long-term clinical outcomes after newer generation DES implantation as compared to IVUS-guided PCI. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Suzuken Memorial Foundation

Impact of diabetes mellitus on 2-year outcomes of Absorb BVS compared to Xience EES: a pooled analysis of the COMPARE-ABSORB and AIDA trial

Abstract Background and purpose Diabetes mellitus (DM) is associated with increased risk of cardiovascular events after percutaneous coronary intervention (PCI). To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in patients with DM, we aimed to compare the 2-year outcomes of Absorb BVS versus 2nd generation drug eluting stents Xience (EES) by pooling diabetic patients treated with BVS or EES from two large, randomized controlled trial. Methods Patients with medically-treated DM and treated by Absorb BVS in the COMPARE-ABSORB and AIDA trial were pooled for analysis. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results Out of a total 3515 enrolled subjects in the two trials, 913 were diabetics. Compared with the non-diabetic patients, those with DM were older, more often to have a history of hypercholesterolemia, chronic renal failure, stroke, hypertension, heart failure, peripheral vascular disease and previous PCI. At 2-years, target lesion failure occurred in 10.8% of BVS DM patients and 7.6% of EES DM patients (adjusted HR 1.43, 95% CI: 0.87–2.34, P=0.115). The 2-year rates of cardiac death (2.4% vs 1.6%, P=0.385), TV-MI (5% vs 1.6%, P=0.123) and TLR (7.8% vs 5.8%, P=0.416) showed not significant difference. The 2-year incidence of definite device thrombosis was 3.2% in Absorb BVS versus 0.7% in Xience EES (adjusted HR 4.77, 95% CI: 1.01–22.43, P=0.048). Conclusion This pooling of the diabetic patients from two large scale RCTs compared BVS versus 2nd generation DES, showed an increased rate of device thrombosis in BVS-treated patients at 2 years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Intravascular imaging to guide lithotripsy in concentric and eccentric calcific coronary lesions

Abstract Background Calcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure. Purpose The study aimed at the evaluation of the immediate procedural outcome of a novel treatment algorithm based on IVUS and/or OCT and including lithotripsy into a real-world consecutive based on intravascular imaging assessment by IVUS or OCT. Methods and results Thirty-one calcified stenoses (28 patients) out of a total of 455 lesions in 370 patients treated between November 2018 and May 2019 met the clinical and angiographic criteria for treatment with IVL under intravascular imaging guidance. Patients were divided into two subgroups depending on the calcium arc measured with intravascular imaging. Twenty lesions showed a calcium arc greater than 180 degrees (289±53 degrees) and 11 lesions smaller than 180 (140±24 degrees). The following parameters were assessed with OCT and/or IVUS: post stent minimal lumen area (MLA) and area stenosis (AS), incomplete strut apposition (ISA), eccentricity index, strut fracture, and edge dissection. After optimization a satisfactory lumen enlargement (acute gain 1.28±0.46 mm; minimal stent area 7.09±2.77 mm2) was observed with good stent expansion (residual area stenosis &amp;lt;20% in 29 lesions, 93.5%) and OCT calcium fractures in 71% of cases. Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no in-hospital coronary perforations, no pericardial effusions, no stent failure or thrombosis, no deaths. Conclusions A standardized algorithm applying multimodality imaging to guide selection and application of IVL facilitated second generation DES implantation with final post-dilatation delivers excellent immediate procedural results and patient outcome, both in concentric or eccentric calcifications. Funding Acknowledgement Type of funding source: None

Intravascular Imaging to Guide Lithotripsy in Concentric and Eccentric Calcific Coronary Lesions

BackgroundCalcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure. PurposeThe study aimed at the evaluation of the immediate procedural outcome in a real-world consecutive population of a selective use of lithotripsy based on the intravascular imaging assessment with IVUS or OCT. Methods and resultsThirty-one calcified stenoses (28 patients) out of a total of 455 lesions (370 patients) treated between November 2018 and May 2019 received IVL under intravascular imaging guidance. The majority of the IVL lesions had angiographically severe calcifications and were selected after intravascular imaging. A smaller group was identified by poor expansion after high-pressure balloon dilatation, in one case despite preliminary small burr Rotablation. After IVL, when OCT was performed calcium fractures were observed in 71% of cases. After OCT/IVUS guided stent optimization a satisfactory lumen enlargement (minimal stent area 7.09 ± 2.77 mm2) was observed with good stent expansion (residual area stenosis<20% in 29 lesions, 93.5%) Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no periprocedural coronary perforations or pericardial effusions, and no in-hospital or 30 days stent thrombosis.When patients were divided into two subgroups according to a calcium arc ≤180° (Group A: 10 lesions, calcium arc 140 ± 24°; Group B: 21 lesions, calcium arc 289 ± 53°), at OCT Group B presented also a higher number of calcium fractures post IVL than group A (group A: 38% vs group B: 92%, p = 0.03). The in-stent minimum lumen diameter (MSD), the in stent minimal lumen area (MSA) and the acute gain, however, were similar between the two groups (acute gain group A: 1.22 ± 0.29 mm; group B: 1.31 ± 0.52 mm, p = 0.63). ConclusionsA standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications.

ABBREVIATED DAPT FOLLOWED BY P2Y12 MONOTHERAPY AS COMPARED TO STANDARD DAPT POST-PCI: A SYSTEMATIC REVIEW AND META-ANALYSIS

At least 12 months of dual antiplatelet therapy [DAPT] after percutaneous coronary intervention [PCI] was recommended following reports of increased stent thrombosis in patients treated with first generation drug eluting stents [DES]. However in the present era of second generation and newer DES,

P6530Clinical outcomes of dialysis patients treated with current generation DES for left main distal bifurcation

Abstract Objectives We assessed clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) using current generation drug eluting stents (cDES) in hemodialysis (HD) patients compared to general populations. Methods We identified 1269 consecutive patients who underwent PCI for ULM distal bifurcation lesions. Of them, 563 patients were treated with cDES (512 non HD and 51 HD patients). The primary endpoint was target lesion failure (TLF) at 3 years, defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI). Results HD group was more likely to have diabetes mellitus (70.0% vs. 45.8%, p=0.002), peripheral artery disease (56.0% vs. 14.9%, p&lt;0.001), and lower ejection fraction (52.6% vs. 56.3%, p=0.026). The rate of TLF at 3 years was significantly higher in the HD group (adjusted Hazard ratio [HR] 2.59; 95% confidence interval [CI], 1.54–4.37; p&lt;0.001). Cardiac mortality was significantly higher in the HD group (adjusted HR 4.49; 95% CI, 2.07–9.74; p&lt;0.001). The rates of TLR for LM-left anterior descending artery (LAD) and left circumflex ostium (LCXos) were significantly higher in the HD group (LMT-LAD: adjusted HR 3.10; 95% CI, 1.31–7.33; p=0.01, LCXos: adjusted HR 2.56; 95% CI, 1.32–4.94; p=0.005). The rate of MI was similar between the 2 groups. Conclusions Hemodialysis was strongly associated with adverse events after PCI for ULM distal bifurcation lesions even with cDES.

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

BackgroundThin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AimTo evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). MethodsXLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. ConclusionsA clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. Trial registrationClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.

Real World Experience of a Biodegradable Polymer Sirolimus-Eluting Stent (Yukon Choice PC Elite) in Patients with Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Angioplasty: A Multicentric Observational Study (The Elite India Study).

BACKGROUND:The durable polymer drug-eluting stents (DPDES) reduce the risk of repeated target vessel revascularisation (TLR) compared with BMS, but are associated with increased risk of late adverse events. In broadly inclusive populations, the biodegradable-polymer drug-eluting stents (BPDES) have favourable results compared with DPDES in the long term. However, its use in primary angioplasty has not been adequately studied, and data of real-world clinical experience is lacking.AIM:Aim of this study was to assess the safety and efficacy of Yukon Choice PC Elite sirolimus-eluting stent (a novel BPDES) in STEMI patients undergoing primary angioplasty.METHODS:We have presented here one-year clinical follow-up data of the Yukon Choice PC Elite sirolimus-eluting stent in patients undergoing primary angioplasty. A total of 636 patients were enrolled in this single arm, prospective observational study from five centres.RESULTS:This multicentric observational study showed excellent safety and efficacy profile of the novel device at one year follow up. The device-oriented composite endpoint (DOCE) of cardiac death, target-vessel reinfarction, and target-lesion revascularisation (TLR) was 2.7%, and the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, and any revascularisation was 4.2% at one year. Definite or probable stent thrombosis rate was 0.6%, and no events were recorded beyond 6 months of follow up.CONCLUSIONS:In patients with STEMI undergoing primary angioplasty, the use of Yukon Choice PC Elite (biodegradable polymer sirolimus-eluting stent) has excellent results at one year. It, therefore, represents an attractive alternative to second generation DES in this high-risk population.

TRIPLE THERAPY - WALKING ON A TIGHT ROPE!

Managing patients with atrial fibrillation (AF) requiring percutaneous interventionor those on anticoagulant therapy needing an intervention is an act of greatbalancing like walking on a tight rope. The premise revolves around three basicconsiderations - the risk of embolism and stroke due to AF, the possibility ofthrombosis due to underlying coronary obstructive disease and interventionsand more importantly the hazard of bleeding in combining different therapeuticagents. Risk of thromboembolic stroke is determined by a host of factors. CHA DS VASC score is well-validated risk score based onage, gender and comorbidities. It identifies patients at higher risk of thromboembolism who require anticoagulants to preventstroke. HASBLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile internationalnormalized ratio [INR], elderly [>65 years], drugs/alcohol concomitantly) has been recommended as a bleeding risk score forpatients with AF, with scores Ý3 considered high risk. Both scores have to be used with a grain of common sense andconsidering patient as a whole, though the HAS-BLED score has been credited to predict bleeding significantly; thediscriminating value is overall limited and similar to CHA DS VASC score. A brief period of washout from the anticoagulant effect of OAC is preferable whenever possible in elective and non-emergentprocedures. In patients on Vit K antagonists, those being subjected to radial approach, INR should be preferably U2.0 and iffemoral approach is used INR has to be U 1.5. In patients on NOAC, irrespective of vascular access site, treatment may bewithheld for 24 hours (or 48 hours for patients with impaired renal function with dabigatran). Although in stable CAD patientsbridging with parenteral anticoagulation can be omitted yet this should be considered for patients presenting with an ACS. To conclude, treating patients with triple therapy in the setting of AF and PCI is like walking on a tight rope. Three importantconsiderations for all decisions making are risk of thrombo-embolism and stroke, risk for thrombotic complications and risk ofbleeding. Meticulous management is recommended pre, intra and post procedure. This entails selecting patients usingappropriate criteria, employing radial approach, using latest generation DES, starting triple therapy and then changing over toSAPT earlier or later balancing thrombotic versus bleeding risks.

TCT-459 Drug-eluting balloons versus new generation drug-eluting stents for the management of in-stent restenosis: An updated meta-analysis of randomized studies

DEB and new generation DES were available strategies in treatment of BMS/DES-ISR. Six new randomized trials have recently examined the one-year clinical outcomes and angiographic outcomes of DEB and new generation DES in BMS/DES-ISR. However, the optimal management for BMS/DES-ISR lesions remains

TCT-509 Eighteen-month results of high-risk patients treated with ultrathin-strut biodegradable-polymer Orsiro DES. The Bioflow-III Satellite Italy Subgroups analysis.

Thin-strut biodegradable-polymer DES (Orsiro), a new generation DES, shows a performance similar to last generation DES and very low LLL if compared with everolimus-eluting stents in general population. We aimed to evaluate global performance in high-risk subgroups: diabetics, AMI and small vessels

P5525A meta-analysis of randomised controlled trials to compare safety and efficacy of everolimus/sirolimus bioabsorbable polymer with second-generation durable-polymer drug eluting stents

Background: Progress in the platforms for DES is aimed at improving safety and outcomes. Second-generation DESs have a biocompatible durable polymer (DP), in addition to bioabsorbable polymers (BP). The benefit of BP is to remove the polymer-triggered inflammatory stimulation associated with DP. There is evidence to suggest BP-DESs are non-inferior to the current generation DES at 12 months. The time course for polymer absorption varies between stents and may take from 4 to 15 months. Hence the potential benefits of BP-DES over DP-DES can only be tested over a longer period, to overcome the time taken for polymer absorption. Purpose: The purpose of the meta-analysis was to compare the safety and efficacy outcomes of BP-DES over a long-term follow-up. Methods: A thorough computer-based search using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases was conducted up to 11 November 2017. We only included randomised studies (RCT) comparing clinical outcomes between the BP-DESs and DP-DESs. Only studies where data were available for a minimum of 5 years were included. Safety (Stent thrombosis (ST) and reinfarction) and efficacy (target lesion revascularization (TLR), cardiac mortality) were analysed. Results: The literature search yielded 445 citations. After going through the abstracts and full-texts of the articles we included 5 RCTs where 5-year follow-up data was available. The information about the included studies, stent platform, drug and type of polymer is provided in Table 1.There was no difference in the ST (OR 0.71, 95% CI 0.47 –1.09, I2 = 31%, P=0.12), reinfarction (OR 1.01, 95% CI 0.85 –1.21, I2 = 0%, P=0.89), cardiac mortality (OR 1.00, 95% CI 0.81 –1.23, I2 = 0%, P=0.98), all cause mortality (OR 0.95, 95% CI 0.80 –1.14, I2 = 21%, P=0.61) and TLR (OR 0.80, 95% CI 0.58–1.11, I2 = 68%, P=0.18). Furthermore, there was no difference in the very late ST (OR 0.49, 95% CI 0.19 –1.30, I2 = 56%, P=0.15).