Incidence Of Stent Thrombosis Research Articles

The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%. At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

Comparison of Safety and Effectiveness of Bivalirudin Between Diabetic and Nondiabetic Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Background: Recurrent thrombotic events remain significantly high in spite of the currently recommended dual antiplatelet (DAPT) and conventional antithrombotic heparin (± GPI/ glycoprotein IIb/IIIa inhibitor) in diabetic ACS patients after PCI compared with non-diabetic even this drug eluting stent (DES) era. Therefore, more potent antithrombotic therapies are warranted for this group of high-risk patients.Comparison of safety and efficacy of newer anticoagulant bivalirudin between diabetic and non-diabetic ACS patients undergoing PCI using bivalirudin versus heparin (± GPI) is less well defined in Bangladeshi population. Objective: To determine and compare the incidence of 30-day major adverse cardiac events (MACEs), stent thrombosis and hemorrhagic complications between diabetic and non-diabetic ACS patients undergoing PCI. Impact of antithrombotic strategy (bivalirudin vs. heparin ± GPI) on the 30- day post PCI clinical outcome was also evaluated and compared between diabetic and non-diabetic subgroup. Methods: In this randomized controlled study, 500 ACS patients aged 18-75 years (200diabetic and 300 non-diabetics) who underwent PCI from November 2018 to October 2019 at the department of cardiology, BSMMU, were randomly assigned, in an open-label fashion to treatment with bivalirudin alone, heparin alone, or heparin plus eptifibatide (GPI) in a 1:1:1 ratio. Among them, 200 patients received Bivalirudin with a loading dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for up to 4 hours, 153 patients received UFH with a bolus of 70-100 U/kg (targeted ACT: 200-250 s) and 147 patients got heparin plus eptifibatide as 60 IU/kg heparin along with 180 μg/kg eptifibatide i.v. boluses, followed by a 2 μg /kg /min eptifibatide infusion for 18 hr consistent with current guidelines.Other pre- and post-procedural medications got under current guidelines. Both diabetic and non-diabetic subjects were subdivided into bivalirudin and control group (heparin ± GPI). In diabetic cohort, 100 patients were in bivalirudin and 100 patients were in control group. Among non -diabetic patients, 100 were in bivalirudin and 200 were in control group. The outcome measures were 30-day hemorrhagic complications, stent thrombosis, and MACCEs [death, MI, target lesion revascularization (TLR), and stroke] according to diabetic status. The diabetic and non-diabetic subgroup was also analyzed for the same outcome measure according to antithrombotic strategy. Peri and post PCI clinical follow-up comprised checking office visits and telephone contacts. Results: According to diabetic status, net adverse clinical events (NACEs) were significantly higher in diabetic in comparison to non-diabetic (diabetic vs. non-diabetic, 15% vs. 7.6 %, P=0.008) and was associated with higher incidence of MACCEs (10.5% vs. 4.0%, P=0.004), cardiac death (4 % vs. 1 %, P=0.02) and BARC 2,3,5 grade bleeding events (9% vs. 4 %, P=0.02). In diabetic cohort, incidence of 30-day NACEs was significantly lower in bivalirudin than control group(bivalirudin vs. UFH ± GPI, 6 % vs. 24 %, P=0.004) and was associated with lower incidence of MACCEs (2% vs. 8.5%, P=0.03) and bleeding events (3 % vs. 15 %, P=0.003) whereas incidence of stent thrombosis (2 % vs. 3%, P =0.651) was comparable between the bivalirudin and control groups. There was a significant advantage in favor of bivalirudin treatment among insulin-treated patients with regard to cardiac death at 30-day (bivalirudin vs. control group, 0% vs. 16.6%, p = 0.03) compared with non-insulin treat diabetic patients. However, subgroup analysis of the nondiabetic patients showed that there was no significant difference in the incidence of 30-Day NACEs (4% vs. 9.5%, P=0.09) according anticoagulant status. Multivariate analysis showed that bivalirudin (HR: 0. 202, 95% CI: 0.078 – 0.519, P=0.009) was independent protective factor of 30-day NACEs for diabetic patients. Conclusion: Bivalirudin monotherapy is safer and more efficacious for diabetic ACS patients compared with non-diabetic ACS patients undergoing PCI. J Dhaka Med Coll. 2022; 31(1) : 126-136

Five-Year Clinical Outcomes After XIENCE PRIME Everolimus Elution Coronary Stent System (EECSS) Implantation

Background/aim: This study was aimed at evaluating 5-year effectiveness and safety in participants after XIENCE PRIME Everolimus Elution Coronary Stent System (EECSS) implantation. Materials and methods: From December 2013 to May 2014, 108 patients (127 lesions) were treated with the XIENCE PRIME EECSS. The entire follow-up included annual assessments for 5 years after treatment or until one of the clinical endpoints was reached. We evaluated the 5-year clinical outcomes with Kaplan-Meier analysis and the Cox regression model. Results: Nearly three-quarters of the participants were men (76.8%), and the average age was 65.6 ± 10.8 years. Bifurcation lesions accounted for 96.1% (122 lesions), and left main lesions accounted for 3.9% (five lesions), with a total count of 127 lesions. The cumulative rate of major adverse cardiac events was as follows: 1 year, 1.9%; 2 year, 4.0%; and 5 year, 10.0%. No definite or probable stent thrombosis was observed, and the rate of target lesion failure was only 3.3% over 5 years. The cumulative rate of major bleeding eventually increased to only 4.4%. Conclusions: The 5-year clinical outcomes were favorable in patients treated with XIENCE PRIME EECSS, and the incidence of stent thrombosis and target lesion failure was relatively low. The incidence of major bleeding gradually increased but remained moderate.

Abstract 13986: Efficacy and Safety of Cangrelor in Patients Undergoing PCI After Cardio-Pulmonary Resuscitation and/or Cardiogenic Shock. Results of the CAN-SHOCK Registry

Background. Cangrelor is an intravenous P2Y12 inhibitor with an immediate onset of action and a short half-life. Its use seems especially attractive in patients who cannot swallow oral drugs, e.g. after CPR or in cardiogenic shock. Purpose. To determine the efficacy and safety of the intravenous P2Y12 inhibitor cangrelor undergoing PCI after prehospital cardiopulmonary resuscitation (CPR) and/or cardiogenic shock (CS) in real life. Methods: The CAN-SHOCK registry included patients undergoing PCI for acute myocardial infarction after CPR. Baseline characteristics, procedural features, and in-hospital outcomes were centrally collected and analysed. The primary endpoint was the incidence of stent thrombosis and/or myocardial reinfarction until 48 hours after PCI. Results. A total of 303 patients were included in 10 centers in Austria and Germany. The inclusion criteria were CPR before PCI (n=169, 55.8 %), cardiogenic shock (n=68, 22.4 %) and CPR and cardiogenic shock (n=59, 19.5 %). The baseline characteristics, in-hospital procedures and outcomes are listed in the table. Conclusions. In this large multicentre registry cangrelor in patients undergoing PCI after CPR and/or CS cangrelor was effective in preventing stent thrombosis and re-infarction and associated with an acceptable bleeding rate.

Long-term clinical outcomes of Chinese diabetic patients after coronary revascularization with drug-eluting stents: a retrospective comparative cohort study

Compared to bare-metal stent implantation, coronary drug-eluting stent (DES) implantation is more likely to reduce restenosis and the need for a subsequent repeat revascularization procedure. Diabetes increases the risk of coronary heart disease and the population of diabetic patients has increased significantly in China in recent years. It's essential to know more about the outcome in these patients underwent DES implantation. To date, the long-term safety and efficacy of coronary DES implantation in Chinese patients with diabetes has rarely been investigated. In this study, according to inclusion and exclusion criteria, 580 patients who underwent DES implantations between July 2014 and January 2016 were included and divided into the diabetic group (n=173) and non-diabetic group (n=407). Clinical baseline characteristics and follow-up outcomes were collected from electronic medical record. Serial clinical follow-up was conducted at 1-, 3-, and 5-year. The primary end point was a composite of major adverse cardiac events (MACEs), including cardiac death, recurrent myocardial infarction (re-MI), and target lesion revascularization (TLR) in 5-year follow-up. The long-term outcomes observed in the 5-year follow-up period were compared between the diabetic and non-diabetic patients. Non-cardiac death was more common in the diabetic than non-diabetic patients in the 5-year follow-up period (8.7% vs. 3.2% P=0.00). Conversely, the risk of occurrence of MACEs, cardiac death, re-MI, and TLR were comparable. The all-cause mortality rate in 5-year follow-up was higher in the diabetic than non-diabetic patients (14.5% vs. 6.1%, P=0.00). The incidence of stent thrombosis was also comparable between the diabetic and non-diabetic patients. Compared to the non-diabetic patients, the diabetic patients were at higher risk for all-cause mortality after coronary DES implantation during the long-term follow-up period.

Timing and predictors of definite stent thrombosis in comatose survivors of out-of-hospital cardiac arrest undergoing percutaneous coronary intervention and therapeutic hypothermia (ST-OHCA study).

Incidence of stent thrombosis (ST) in comatose survivors of out-of-hospital cardiac arrest (OHCA) undergoing immediate percutaneous coronary intervention (PCI) and therapeutic hypothermia (TH) varies considerably, from 2.7% to 31.2%, in retrospective studies. We aimed to investigate occurrence, timing and predictors of definite ST. We prospectively investigated consecutive comatose survivors of OHCA with presumed cardiac aetiology undergoing immediate PCI with drug-eluting stents (DES) and TH targeted at 32-34°C admitted between August 2016 and July 2021. Repeat coronary angiography (CAG) was performed if ST was suspected and systematically between day 8-12 in the absence of clinical signs. All deceased patients underwent autopsy and histopathological analysis. Results: Among 362 comatose survivors of OHCA, immediate PCI with stenting was performed in 169 patients (47%). Since 18 patients did not complete follow-up, 151 patients were ultimately enrolled in ST analysis. Definite ST was confirmed in 29 patients (19.2%; 95% confidence interval [CI]: 12.9%-25.6%) either by CAG (n=18) or autopsy (n=11). ST occurred within 3 days in 62% and presented with at least one clinical sign in 79%. Survival with good neurological recovery was observed in 17% of patients with ST and in 60% of patients without ST (p<0.001). Independent predictors of ST were longer prehospital resuscitation, lower arterial pH and increased creatinine on admission. The incidence of definite ST in comatose survivors of OHCA undergoing immediate PCI and TH targeted at 32-34°C is substantial (19.2%) and significantly higher than in other PCI subsets despite systematic use of contemporary DES and anticoagulation/antiplatelet treatment.

Coronary Revascularization in Diabetes Patients

India has become the diabetes capital of the world. Coronary artery disease in diabetes patients are often silent and complex. Incidence of diffuse and multi vessel disease are more predominant in diabetes patients. Triple vessel disease and diffuse disease are common and often bring challenges in selecting treatment option. The incidence of stent thrombosis, in stent restenosis and repeat interventional procedures are more common in diabetes patients. Though coronary artery bypass surgery is known to achieve better long -term outcome in triple vessel disease in diabetes patients but coronary interventions with latest generation drug eluting stents are also shown to achieve similar type of outcome. Careful selection of cases with consideration of coronary anatomy and a multidisciplinary approach in treatment of complex coronary disease are the keys of success and better long -term result.

ASSOCIATION OF GENDER WITH STENT THROMBOSIS AND SHORT-TERM MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION

Objectives: Gender has been reported to be an independent predictor of stent thrombosis (ST), however, very limited data are available regarding gender disparities in the incidence of ST after primary percutaneous coronary intervention (PCI). Therefore, the objective of this study was to compare the incidence of ST among males and females after primary PCI. Methodology: In this study, we included consecutive patients diagnosed with ST-elevation myocardial infarction undergoing primary PCI. The incidence of ST and short-term major adverse cardiovascular events (MACE) were compared between male and female cohorts. Results: The gender distribution was 21% (368) female and 79% (1388) male patients. In the unmatched cohorts of females and males, the incidence of ST was 3.3% (12) vs. 5.3% (74); p=0.102, respectively. Short-term all-cause mortality rate was 12.2% (45) vs. 8.6% (119); p=0.032 among female and male patients, respectively. After propensity matching of the baseline characteristics, the incidence of stent thrombosis was 3.3% (12) vs. 4.9% (18); p=0.263 among females and male counterparts, respectively. The short-term all-cause mortality rate was 12.2% (45) vs. 10.6% (39); p=0.487 among female and propensity-matched male cohorts, respectively. Conclusion: There are no gender-based disparities in the incidence of ST as well as short-term MACE after primary PCI. The gender of the patient itself does not determine the prognosis of the patient, but longer ischemic time, older age, and consequently higher burden of risk factors confound the effect of the female gender.

Coronary Heart Disease and Coronavirus Disease 2019: Pathogenesis, Epidemiology, Association with Myocardial Revascularization

BACKGROUND: Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state with a high incidence of thrombotic complications. Patients with a history of myocardial revascularization have more severe complications due to COVID-19. Coronary stent thrombosis has become significantly more common during the COVID-19 pandemic. AIM: The aim of our study is to analyze scientific information on the risks of stent thrombosis in patients who underwent COVID-19. METHODS: A search was made for scientific publications in evidence-based medicine databases and web resources: PubMed, MEDLINE, UpToDate, TripDatabase, ResearchGate, and Google Scholar. Inclusion criteria were: (1) Observational studies or case series involving patients with a confirmed diagnosis of COVID-19 and myocardial infarction requiring myocardial revascularization; (2) the division of the population into survivors and non-survivors; and (3) data on the presence of the previous myocardial revascularization. Exclusion criteria: Case description and editorials/bulletins. In all articles selected for further analysis, 49 sources were considered that met the inclusion criteria and excluded duplication or repetition of information. RESULTS: Coronavirus infection has contributed to the change in the course of myocardial infarction in patients undergoing myocardial revascularization. The incidence of stent thrombosis has a positive correlation with the severity of the coronavirus infection. The previous myocardial revascularization procedures significantly increase the risk of mortality in patients with coronavirus infection. This is especially actual for elderly patients. CONCLUSION: One of the most vulnerable groups is elderly patients who have undergone myocardial revascularization after myocardial infarction in the past and have concomitant diseases. An analysis of scientific publications has shown that further larger-scale clinical studies are needed to confirm the hypothesis about the negative impact of coronavirus infection on stent thrombosis in patients who have undergone COVID-19.

Evaluation of Effectiveness and Tolerability of Fondaparinux in the Management of Symptomatic Acute Coronary Syndrome: A Real-World Evidence-Based Study on an Indian Population

Introduction Fondaparinux is a low molecular weight heparin anticoagulant used to manage the full spectrum of acute coronary syndrome (ACS) patients and has proved its efficacy and safety in multiple clinical trials. However, there are limited data available showing whether the same results could be reproduced in real-world practice on an Indian population. Our objective was to determine the effectiveness and tolerability of fondaparinux in the management of symptomatic ACS in real-world clinical practice.MethodsThe EMR data of hospitalized ACS patients (n = 611), from January 2015 to January 2020, representing UA or NSTEMI or STEMI and were prescribed fondaparinux (2.5 mg once daily) to manage ACS were analyzed. The effectiveness was analyzed as recurrence of ACS and tolerability as total incidence of major bleeding during hospitalization, at 30 days and 180 days. Appropriate statistical analysis was used with a statistically significance of p value < 0.05.ResultsThe incidence of recurrent ACS was not seen during hospitalization and in the first 30 days, while in only 0.65% (n = 4) patients, ACS reoccurred within 180 days. In a mean duration of 172.75 ± 3.20 days, UA was reported in 0.49% (n = 3) patients, NSTEMI in 0.16% (n = 1) of patients, and STEMI was not documented. None of the major bleeding events occurred during the entire study period, whereas minor bleeding events were reported during hospitalization 0.98% (n = 6) and at 30 days 0.16% (n = 1). The bleeding events were statistically insignificant (p value > 0.05). No incidences of stent thrombosis were reported during the entire study period.ConclusionsIn the real world, fondaparinux was found to be effective and tolerable when used to manage symptomatic ACS patients regardless of revascularization procedure with no incidence of stent thrombosis, and minimal recurrent ACS and insignificant increase in bleeding events.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40119-022-00253-x.

Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

BackgroundClopidogrel is the most frequently used P2Y12 inhibitor as a component of the dual antiplatelet regimen in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Prior studies have shown the variable efficacy of clopidogrel due to genotypic differences in the CYP2C19 enzyme function, which converts clopidogrel to its active metabolite. The aim of this meta-analysis is to evaluate the effectiveness of genotype testing-guided P2Y12 inhibitor prescription therapy to patients after PCI for ACS compared to non-genotype guided conventional treatment. MethodsA comprehensive literature search was performed in PubMed, Embase, and Cochrane to identify relevant trials. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio with 95% confidence intervals for all the clinical endpoints. ResultsSeven studies with 9617 patients were included. Genotype-guided strategy arm included prasugrel or ticagrelor prescription to patients with loss of function (LOF) of CYP219 alleles (most commonly alleles being *2 and *3) and clopidogrel prescription to those without the LOF allele. The conventional arm included patients treated with clopidogrel without genotype testing. Comparison of genotype arm with conventional arm showed decreased major adverse cardiovascular events (MACE), improved cardiovascular (CV) mortality, and reduced incidence of myocardial infarction (MI) in the genotype arm, and a similar stroke incidence in the two arms. Regarding adverse events, the incidence of stent thrombosis was lower in the genotype arm than the conventional arm. ConclusionOur analysis illustrates the possible advantages of genotype-guided P2Y12 inhibitor prescription strategy compared to non-genotype-guided strategy with reductions in MACE, CV mortality, MI, and stent thrombosis. This analysis can be used as a stepping stone to conducting further trials determining the efficacy of this treatment strategy in various ACS subtypes.

Abstract 11621: Effect of Genotype Guided Oral P2y12 Inhibitor Selection After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Introduction: Clopidogrel is the most frequently used P2Y12 inhibitor as a component of the dual antiplatelet regimen in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Prior studies have shown the variable efficacy of clopidogrel due to genotypic differences in the CYP2C19 enzyme function, which converts clopidogrel to its active metabolite. Hypothesis: The aim of this meta-analysis is to evaluate the effectiveness of genotype testing-guided P2Y12 inhibitor prescription therapy to patients after PCI for ACS compared to non-genotype guided conventional treatment. Methods: A comprehensive literature search was performed in PubMed, Embase, and Cochrane to identify relevant trials. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio with 95% confidence intervals for all the clinical endpoints. Results: Seven studies with 9617 patients were included. Genotype-guided strategy arm included prasugrel or ticagrelor prescription to patients with loss of function (LOF) of CYP219 alleles (most commonly alleles being *2 and *3) and clopidogrel prescription to those without the LOF allele. The conventional arm included patients treated with clopidogrel without genotype testing. Comparison of genotype arm with conventional arm showed decreased major adverse cardiovascular events (MACE) (RR 0.72, 95% CI 0.55-0.95; p=0.02, I 2 =23), improved cardiovascular (CV) mortality (RR 0.62, 95% CI 0.43-0.90; p=0.01, I 2 =0) and reduced incidence of myocardial infarction (MI) (RR 0.57, 95% CI 0.41-0.97; p&lt; 0.01), and a similar stroke incidence (RR 0.65, 95% CI 0.35-1.21; p= 0.18). Regarding adverse events, the incidence of stent thrombosis was lower in the genotype arm than the conventional arm (RR 0.52, 95% CI 0.28-0.96; p=0.04). Conclusions: Our analysis illustrates the possible advantages of genotype-guided P2Y12 inhibitor prescription strategy compared to non-genotype-guided strategy with reductions in MACE, CV mortality, MI, and stent thrombosis. This analysis can be used as a stepping stone to conducting further trials determining the efficacy of this treatment strategy in various ACS subtypes.

The efficacy and safety of the short-term combination therapy with ticagrelor and PPIs or H2RA in patients with acute STEMI who underwent emergency PCI.

Combination therapy with platelet inhibitors and acid‐suppressive agents is recommended for patients with acute ST‐segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI), but there remains a paucity of data to evaluate both the efficacy and safety of these combinations. In this prospective study, a total of 170 patients with acute STEMI who underwent PCI were divided into four groups: pantoprazole + ticagrelor, omeprazole + ticagrelor, ranitidine + ticagrelor, and ticagrelor only. The risk of PCI, antithrombotic efficacy, cardiac function, and main end points were evaluated and compared. No significant differences were found in infarction‐related artery perfusion indexes (thrombolysis in myocardial infarction [TIMI], corrected TIMI frame count), the incidence of stent thrombosis after PCI, platelet indicators (platelet count, mean platelet volume, and platelet distribution width), platelet activation (P‐selectin and glycoprotein IIb/IIIa levels), platelet aggregation (thrombelastography indicators, such as ADP% and MAADP), myocardial necrosis biomarker (creatine kinase isoenzyme‐MB and cardiac troponin I) levels, brain natriuretic peptide levels, the incidence of ischemic end point events, and the incidence of other tissue and organ bleeding events among the four groups. The incidence of gastrointestinal (GI) bleeding events in the proton pump‐inhibitor (PPI) group was significantly lower than that in the control group, whereas in the H2 receptor antagonist (H2RA) group it was not significantly different from the control group. The short‐term combination therapy with ticagrelor and PPIs or H2RA is safe and effective in patients with acute STEMI after PCI. In addition, the PPIs combined with ticagrelor could reduce the incidence of GI bleeding events without increasing the incidence of ischemic events.

Ten-year outcomes of early generation sirolimus- versus paclitaxel-eluting stents in patients with left main coronary artery disease.

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n=607) or PES (n=171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.

Clinical Impact of Stent Graft Thrombosis in Femoropopliteal Arterial Lesions.

This study sought to elucidate the clinical impact and prognosis of stent graft (SG) thrombosis. The VIABAHN SG offers a favorable outcome in long peripheral artery occlusive disease (PAOD) lesions in the femoropopliteal artery. One concern after SG deployment is the incidence of stent thrombosis and consequent acute limb ischemia (ALI). In this retrospective multicenter study, we collected the clinical data of PAOD patients treated with VIABAHN SG who subsequently experienced SG thrombosis. The clinical symptoms of SG thrombosis, patency after reintervention, and predictors of loss of patency after reintervention were examined. VIABAHN SGs were used for 1,215 patients; SG thrombosis occurred in 159 (13%) patients at a median of 6.4 months (interquartile range: 2.8 to 13.5 months) after SG implantation; 21 (13%) patients presented with ALI. A total of 131 (82%) patients underwent reintervention for SG thrombosis, whereas 2 (1%) underwent primary major amputation and the remaining 26 (16%) were treated conservatively. The patency rate 1 year after reintervention, freedom from major adverse limb events, and limb salvage after reintervention were 54.9%, 73.6%, and 92.5%, respectively. Critical limb-threatening ischemia at SG implantation and ALI presentation at SG thrombosis were positively associated with an increased risk of rethrombosis, whereas distal stent diameter was negatively associated with the risk of rethrombosis. SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal.

Bivalirudin in patients undergoing percutaneous coronary intervention and independent predictors of postoperative adverse events in these patients: A real world retrospective study.

The efficacy and safety of bivalirudin in percutaneous coronary intervention (PCI) has always been a hot topic in perioperative antithrombotic therapy, but there are still some controversies. So studies are needed to provide more evidence, especially the real world study which includes patients excluded from previous RCT studys. Our study aimed to investigate these information and analyze the independent predictors of postoperative adverse events.A retrospective study enrolled 1416 patients underwent PCI in Tianjin Chest Hospital from May 2016 to October 2017. The incidence of stent-thrombosis and net clinical adverse events, including all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization and bleeding, were followed up for 30 days and 1 year. Logistic regression and COX regression were respectively used to analyze independent predictors of bleeding events within 30-days, and independent predictors of Major adverse cardiovascular and cerebrovascular events (MACCE) in patients with stent implantation within 1-year.Seven hundred six patients were treated with bivalirudin while 710 with unfractionated heparin (UFH). The proportions of diabetes, hypertension, anemia, myocardial-infarction history, PCI history, moderate-to-severe renal-impairment, gastrointestinal-bleeding history in the bivalirudin group were significantly higher (P < .05). Women, anemia were independent risk factors for bleeding within 30-days (P < .05). Among 682 patients with stent implantation in bivalirudin group, anemia, Body Mass Index (BMI) >25 kg/m2, KILLIP ≥2, ejection fraction (EF) <45%, eGFR <60 ml/minutes were independent risk factors for MACCE, while Statins, proton pump inhibitor (PPI) were independent protective factors for MACCE with-in 1-year (P < .05).Bivalirudin have good anticoagulant effect and lower bleeding risk during PCI, especially in patients with higher bleeding risk. In patients treated with bivalirudin, female, anemia were independent predictors of bleeding within 30-days, BMI >25 kg/m2, anemia, KILLIP ≥2, EF <45%, eGFR <60 ml/minutes were independent risk factors and Statins, PPI were independent protective factors of MACCE within 1-year.

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor™ SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor™ SES.

Direct Oral Anticoagulants Versus Vitamin-K Antagonist After PCIs in Patients With AF: A Meta-analysis of Cardiac Ischemic Events.

Clinical trials have assessed the effect of direct oral antagonists (DOACs) in patients with atrial fibrillation (AF) after percutaneous coronary interventions (PCI). Studies were designed to test the effect on bleeding incidence, but concerns related to safety on ischemic events remain. We performed a meta-analysis with currently available studies involving DOACs versus Vitamin-K antagonist (VKA) in patients with AF after PCI. The primary endpoint was the incidence of cardiac ischemic events, including myocardial infarction and stent thrombosis. Secondary endpoints were the incidence of stroke, all-cause mortality, and major bleeding. Eleven thousand twenty-three patients were included in the analysis: 5510 receiving DOACs and 5513 VKA. A total of 190 cases of myocardial infarction were registered in patients treated with DOACs and 177 in patients on VKA, and no statistical difference was noted [relative risk (RR): 1.07 95% confidence interval (CI) 0.88-1.31]. The incidence of stent thrombosis was very low with no differences between both treatment strategies (RR: 1.14 95% CI 0.76-1.71). The incidence of cardiac ischemic events was the same in patients receiving DOACs or VKA (HR 1.09 95% CI 0.91-1.30). No differences were observed in the incidence of stroke (RR: 0.86 95% CI 0.61-1.23) or mortality (RR: 1.09, 95% CI 0.90-1.31). Treatment with DOACs was associated with 34% reduction in major bleeding (RR: 0.66, 95% CI 0.54-0.81). Treatment with DOACs in patients with AF after a PCI do not increase the risk of cardiac ischemic events, stroke, or death and reduce the incidence of major bleeding by 34% as compared with VKA.

The Safety Profile of the Short-Term Combination Therapy of Ticagrelor With PPI or H2RA in Patients With Acute STEMI Underwent PCI

Background: The combination therapy of anti-platelet medication and PPI/H2RA was recommended but yet being controversial due to the safety issue. To evaluate the efficacy and safety of the combination therapy of ticagrelor and PPI/H2RA on patients with acute STEMI receiving PCI. Methods: A total of 170 patients were hospitalized for PCI due to acute STEMI. The patients were divided into 4 groups receiving pantoprazole+ ticagrelor, omeprazole+ ticagrelor, ranitidine+ ticagrelor and ticagrelor only, respectively. The the prognosis of the therapy was evaluated and compared to verify the efficacy and safety of the combination therapy. Findings: No significant differences were found in IRA perfusion indexes (TIMI, CTFC), incidence of stent thrombosis after PCI, platelets indicators (PLT, MPV, PDW), platelets activation (P-selectin and GPIIb/IIIa levels), TEG indicators (ADP%, MAADP), myocardial necrosis biomarker (CK-MB, cTnI) and BNP levels between the 4 groups of patients after 7 days of follow-up. Patients receiving PPI+tecagrelor had significantly better safety profile than those who were given ticagrelor only. Interpretation: Based on our findings, the combinational application of tecagrelor and PPI yielded a satisfying safety profile in patients with acute STEMI after PCI. Funding Statement: None. Declaration of Interests: The authors declare that they had no competing interests. Ethics Approval Statement: This work was approved by the Ethics Committee of The First Affiliated Hospital with Nanjing Medical University. Written informed consent was obtained from all patients.

Abstract 16748: Stent Type and Outcomes in Patients With Malignancy Undergoing Percutaneous Coronary Intervention

Background: Coronary artery disease and cancer share some of the same risk factors, so it is not uncommon to find them in same patient. So PCI is increasingly performed in these patients. However type of stent and its impact on mortality is largely unknown. Methods: Nationwide Inpatient Sample (HCUP-NIS) database was utilized to identify patient who have underwent BMS or DES placement and had active cancer. Appropriate ICD 9 codes was used to identify lung, colon, breast, prostrate, hematological, liver, brain and kidney cancer as well as metastatic cancer. Patient were randomly assigned in 1:1 ratio to BMS and DES group. Propensity score analysis was performed using neighborhood matching to baseline co-variates and reduce confounding bias. Percentage of patients getting BMS and DES were analyzed and compared to general population. While comparing DES and BMS group, outcomes included in-hospital mortality, stent thrombosis, length of stay, acute kidney injury and bleeding complications.R esults: A total of 8755 patients were selected in BMS group and 11,611 patients were selected in DES group. Following propensity matching, 4313 patients were selected in both groups and randomly assigned 1:1 ratio to BMS and DES. As compared to general population (BMS 23.2%, DES 76.8%), there is high use of BMS stent in cancer patient (BMS 43.0%, DES 57.2%). When comparing BMS to DES group, there is no statistically significant difference in mortality (4.7 vs 3.8 percent p=0.097), acute kidney injury (11.3 in BMS vs 10.6 in DES p = 0.425), bleeding complications (3.50 in BMS vs 3.45 in DES p = 0.914) and length of stay (5.4 in BMS vs 5.2 in DES p = 0.119). There is increased incidence of stent thrombosis in DES group (4.26% vs 3.01%, p-value 0.02). Among the cancers, adjusted for type of stent placed, liver and pancreatic cancer was associated with significant increase in stent thrombosis Conclusion: In patients with active malignancy, there is higher incidence of BMS placement as compared to general population. There is high incidence of stent thrombosis is DES without increase in mortality. Among the cancers, adjusted for type of stent placed, liver and pancreatic cancer was associated with significant increase in stent thrombosis