Rates Of Adverse Clinical Events Research Articles

Gender Influence on In-hospital Outcomes of Primary Percutaneous Coronary Intervention

Background: Acute myocardial infarction (AMI) is one of the leading cause death and disability all over the world. But, there is a lack of data about the gender influence on in-hospital outcomes of primary percutaneous coronary intervention (pPCI) among Bangladeshi patients. This study was aimed to evaluate the clinical and angiographic differences and to compare their in hospital outcomes of pPCI between male and female patients. Objective: To evaluate the gender influence on in-hospital outcome of primary PCI. Methods: This was a prospective observational study of 90 patients with ST elevation myocardial infarction ( STEMI ) treated with pPCI in the Department of Cardiology, NICVD, Dhaka, Bangladesh from April 2019 to March 2020, followed from admission until hospital discharge or death. The patients were divided equally into two groups, group ‘! (female) and group a! (male). Result : A significant difference was observed for age (61.8±10.9vs.56.5±10.7 years; p=0.02), hypertension (66.7% vs. 42.2%; p=0.02), diabetes (68.9% vs. 44.4%; p=0.01), smoking (0.0% vs. 68.9%; p<0.001), obesity (BMI- 28.3±3.8 vs. 26.5±3.9; p=0.02), troponin I (14.89±20.48 vs. 8.25±7.92; p=0.04) and pain-to-door time (281.90±88.70 vs. 240.33±80.81 minutes; p=0.04). Female had angiographically greater frequency of multivessel disease and similar distribution of infarct related artery in relation to male. The success of the procedure was similar (91.1% vs. 97.8%; p=0.18). Overall, female experienced greater incidence of in-hospital adverse events in comparison to male (28.8% vs. 13.3%; p=0.03) and significantly higher rates of severe bleeding (11.1% vs.2.2%; p=0.03) and vascular access site complications (15.6% vs. 4.4%; p=0.04). Major adverse cardiac events (MACE) were higher among females in comparison to males (11.1% vs. 6.7%; p=0.45). Females experienced significantly higher rates of short-term net adverse clinical events (NACE) than males (20.0% vs. 8.8%; p=0.04). Female sex [odds ratio (OR) 1.94], age e”60 years (OR 1.59) and diabetes (OR 2.75) were identified as independent predictors of adverse in-hospital outcomes among STEMI patients undergoing pPCI. Conclusion: Female sex presented with significantly more risk factors and experienced more in-hospital adverse outcomes than male in STEMI patients undergoing pPCI. They had significantly higher rates of NACE, largely driven by increased rate of major bleeding. Female sex was an independent predictor for the development of in-hospital adverse outcomes in STEMI patients undergoing pPCI. Bangladesh Heart Journal 2022; 37(1): 40-51

Clinical impact of statin intensity according to age in patients with acute myocardial infarction.

The available data are not sufficient to understand the clinical impact of statin intensity in elderly patients who undergo percutaneous coronary intervention (PCI) due to acute myocardial infarction (AMI). Using the COREA-AMI registry, we sought to compare the clinical impact of high- versus low-to-moderate-intensity statin in younger (<75 years old) and elderly (≥75 years old) patients. Of 10,719 patients, we included 8,096 patients treated with drug-eluting stents. All patients were classified into high-intensity versus low-to-moderate-intensity statin group according to statin type and dose at discharge. The primary end point was target-vessel failure (TVF), a composite of cardiovascular death, target-vessel MI, or target-lesion revascularization (TLR) from 1 month to 12 months after index PCI. In younger patients, high-intensity statin showed the better clinical outcomes than low-to-moderate-intensity statin (TVF: 79 [5.4%] vs. 329 [6.8%], adjusted hazard ratio [aHR] 0.76; 95% confidence interval [CI] 0.59-0.99; P = 0.038). However, in elderly patients, the incidence rates of the adverse clinical outcomes were similar between two statin-intensity groups (TVF: 38 [11.4%] vs. 131 [10.6%], aHR 1.1; 95% CI 0.76-1.59; P = 0.63). In this AMI cohort underwent PCI, high-intensity statin showed the better 1-year clinical outcomes than low-to-moderate-intensity statin in younger patients. Meanwhile, the incidence rates of adverse clinical events between high- and low-to-moderate-intensity statin were not statistically different in elderly patients. Further randomized study with large elderly population is warranted.

Clinical impact of FFR‐guided PCI compared to angio‐guided PCI from the France PCI registry

We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve(FFR)-guided percutaneous coronary intervention(PCI) compared with angio-guided PCI at 1year. FFRhas become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCIcompared to angiography (angio). We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE). Fourteen thousand three hundred eighty-fourpatients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. FFR-guided PCI improves outcome at 1year compared to angio-guided PCI with a reduction of 64% of death.

Low-Density Lipoprotein Cholesterol and Mortality Risk in Elderly Patients Undergoing Valve Replacement Surgery: A Propensity Score Matching Analysis.

BackgroundThe prognostic value of low-density lipoprotein cholesterol (LDL-C) in elderly patients is controversial. This study aimed to elucidate the relationship between the preoperative LDL-C and adverse outcomes in elderly patients undergoing valve replacement surgery (VRS).MethodsA total of 2,552 aged patients (age ≥ 60 years) undergoing VRS were retrospectively recruited and divided into two groups according to LDL-C level on admission: low LDL-C (<70 mg/dL, n = 205) and high LDL-C groups (≥ 70 mg/dL, n = 2,347). The association between the preoperative LDL-C with in-hospital and one-year mortality was evaluated by propensity score matching analysis and multivariate analysis.ResultsThe mean age was 65 ± 4 years and 1,263 (49.5%) were men. Patients in the low LDL-C group were significantly older (65.9 ± 4.6 vs. 64.9 ± 4.1, p = 0.002), with more male (65.4 vs. 48.1%, p < 0.001), higher alanine transaminase (ALT) (21 vs. 19, p = 0.001), lower serum albumin (35.3 ± 4.6 vs. 37.1 ± 4.1, p < 0.001), higher serum creatinine (92.2 ± 38.2 vs.84.6 ± 26.1, p = 0.006), lower lymphocyte count (1.7 ± 0.7 vs. 1.9 ± 0.6, p < 0.001), lower hemoglobin (121.9 ± 22.3 vs. 130.2 ± 16.5, p < 0.001), lower platelet count (171.3 ± 64.3 vs. 187.7 ± 58.7, p < 0.001), lower prognostic nutrition index (44 ± 6.2 vs. 46.7 ± 5.8, p < 0.001), and more severe tricuspid regurgitation (33.7 vs. 25.1%, p = 0.008). The rates of in-hospital death (11.2 vs. 3.7%, p < 0.001) and major adverse clinical events (17.6 vs. 9.6%, p < 0.001) were significantly higher in the low LDL-C group. The cumulative one-year death rate was significantly higher in the low LDL-C group (Log-Rank = 16.6, p < 0.001). After matching analysis and multivariate analysis, no association between LDL-C level and adverse outcomes was detected (all p > 0.05).ConclusionOur study did not support the negative relationship between LDL-C level and mortality risk in elderly patients undergoing VRS.

Prognostic value of microvascular resistance and its association to fractional flow reserve: a DEFINE-FLOW substudy

ObjectiveThis study aimed to evaluate the prognostic value of hyperemic microvascular resistance (HMR) and its relationship with hyperemic stenosis resistance (HSR) index and fractional flow reserve (FFR) in stable coronary...

Long-Term Clinical Impact of Contrast-Associated Acute Kidney Injury Following PCI: AnADAPT-DES Substudy.

This study sought to determine correlates and consequences of contrast-associated acute kidney injury (CA-AKI) on clinical outcomes in patients with or without pre-existing chronic kidney disease (CKD). The incidence and impact of CA-AKI on clinical outcomes during contemporary percutaneous coronary intervention (PCI) are not fully defined. The ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study was a prospective, multicenter registry of 8,582 patients treated with≥1 drug-eluting stent(s). CA-AKI was defined as a post-PCI increase in serum creatinine of >0.5mg/dL or a relative increase of≥25% compared with pre-PCI. CKD was defined as estimated glomerular filtration rate<60mL/min/1.73m2. The primary endpoint was the 2-year rate of net adverse clinical events (NACE): All-cause mortality, myocardial infarction (MI), definite or probable stent thrombosis, or major bleeding. Of 7287 (85%) patients with evaluable data, 476 (6.5%) developed CA-AKI. In a multivariable model, older age, female sex, Caucasian race, congestive heart failure, diabetes, hypertension, CKD, presentation with ST-segment elevation MI, Killip class II to IV, radial access, intra-aortic balloon pump use, hypotension, and number of stents were independent predictors of CA-AKI. The 2-year NACE rate was higher in patients with CA-AKI (adjusted HR: 1.88; 95% CI: 1.42-2.49), as was each component of NACE (all-cause mortality, HR: 1.77; 95%CI: 1.22-2.55; MI, HR: 1.67; 95%CI: 1.18-2.36; definite/probable stent thrombosis, HR: 1.71; 95%CI: 1.10-2.65; and major bleeding, HR: 1.38; 95%CI: 1.06-1.80). Compared with the CA-AKI-/CKD- group, the CA-AKI+/CKD- (HR: 1.83; 95%CI: 1.33-2.52), CA-AKI-/CKD+ (HR: 1.56; 95%CI: 1.15-2.13), CA-AKI+/CKD+ (HR: 3.29; 95%CI: 1.92-5.67), and maintenance dialysis (HR: 2.67; 95%CI: 1.65-4.31) groups were at higher risk of NACE. CA-AKI was relatively common after contemporary PCI and was associated with increased 2-year rates of NACE. Patients with pre-existing CKD were at particularly high risk for NACE after CA-AKI.

Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial

Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions. ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years. ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.

Hidden No More: Capturing the Full Picture of Prolonged Perioperative Antibiotic Prophylaxis.

Hidden No More: Capturing the Full Picture of Prolonged Perioperative Antibiotic Prophylaxis.

Thrombotic vs. Bleeding Events of Interruption of Dual Antiplatelet Therapy within 12 Months among Patients with Stent-Driven High Ischemic Risk Definition following PCI.

Background There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. Methods This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. Results DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients' noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236–3.399]; IPTW-adjusted HR: 1.843 [1.250–2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128–2.216]; PS matching-HR: 1.639 [1.075–2.499]; IPTW-adjusted HR: 1.554 [1.110–2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. Conclusions In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.

Season of Birth and Cardiovascular Mortality in Atrial Fibrillation: A Population-Based Cohort Study.

Background: The fetal origins hypothesis have associated early life exposures with the development of adverse health outcomes in adulthood. Season of birth has been shown to be associated with overall and cardiovascular mortality. Methods: We performed a retrospective database study to explore the association between season of birth and mortality in patients with atrial fibrillation. Results: A total of 8962 patients with AF were identified in the database with 1253 deaths recorded. AF patients born in spring and summer had a higher mortality rate when compared to those born in autumn and winter (hazard ratio (HR) 1.13, 95% confidence interval (CI) 1.01–1.26, p = 0.03). This effect was consistent in the male subgroup (HR 1.25, 95% CI 1.03–1.51, p = 0.02 for males born in spring; HR 1.24, 95% CI 1.03–1.51, p = 0.03 for males born in summer when compared to winter as the reference) but not in females (HR 1.02, 95% CI 0.79–1.31, p = 0.88 for females born in spring; HR 1.11, 95% CI 0.87–1.42, p = 0.39 for females born in summer when compared to winter as the reference). Results persisted after adjustment for baseline characteristics and clinical risk profile. A similar pattern was observed with cardiovascular mortality. Conclusion: Birth in spring or summer is associated with a higher risk of cardiovascular mortality in male AF patients, but not in females. This could be related to the underlying differences in rates of major adverse clinical events between genders. Further studies should aim at clarifying the mechanisms behind this association, which may help us understand the higher level of risk in female patients with AF.

Optimal Antithrombotic Therapy after Implantation of a Transcatheter Aortic Valve: Warfarin, Aspirin, or Non-Vitamin K Antagonist Oral Anticoagulants? A Systematic Review and Meta-Analysis

Abstract Objective: Diverse antithrombotic strategies were applied to patients undergoing aortic valve replacement. However, the optimal therapeutic regimen for patients undergoing transcatheter aortic valve implantation/replacement (TAVI/TAVR) remains unclear. The purpose of this study was to compare the efficacy and safety of various antithrombotic therapies following TAVI/TAVR. Methods: Relevant clinical trials evaluating the effect of anticoagulation or antiplatelet regimens on patients after TAVI/TAVR from inception to September 2020 were identified using the PubMed, EMBASE, and the Cochrane Library databases. The inclusion criteria including (1) all patients underwent TAVI/TAVR; (2) the interventions were antithrombotic strategies that prevent the occurrence of thrombotic events in patients; (3) randomized controlled trials or prospective observational studies; and (4) investigation of at least 1 outcome with a follow-up period of ≥3 months. The exclusion criteria including (1) research content was identical or irrelevant to the purpose of the present study; (2) lack of the required outcome index or availability of fragmentary original information; and (3) the full text is not available. The major outcomes were all-cause mortality, thromboembolic complications, and bleeding events. The Cochrane Collaboration's tool and the Newcastle-Ottawa Scale were used for assessing the risk of bias in included studies. Results: Thirteen studies (3 randomized controlled trials and 10 non-randomized studies) were identified, with a total of 23,497 patients. Four studies compared direct oral anticoagulants (DOACs) with warfarin, 1 study compared aspirin with warfarin, 6 studies compared aspirin plus clopidogrel (dual antiplatelet therapy (DAPT)) with aspirin monotherapy, and 2 studies compared DAPT and aspirin monotherapy with warfarin concurrently. There were no significant differences found between the DOAC and warfarin groups regarding all-cause mortality (risk ratio (RR): 1.03; 95% confidence interval (CI): 0.65–1.64; P = 0.909; P het = 0.105), clinical adverse events (RR: 1.59; 95% CI: 0.99–2.58; P = 0.057; P het = 0.738), or bleeding events (RR: 0.93; 95% CI: 0.78–1.11; P = 0.437; P het = 0.338). The rates of all-cause mortality (RR: 0.71; 95% CI: 0.54–0.93; P = 0.012; P het = 0.845) and bleeding events (RR: 0.43; 95% CI: 0.22–0.83; P = 0.012; P het = 0.569) were lower in the aspirin group versus the warfarin group; however, there was no difference in the rate of clinical adverse events (RR: 0.38; 95% CI: 0.14–1.07; P = 0.068; P het = 0.593). The DAPT group had an advantage versus the aspirin group in all-cause mortality (RR: 0.89; 95% CI: 0.82–0.98; P = 0.013; P het = 0.299); however, the incidence of bleeding events (RR: 2.06; 95% CI: 1.39–3.07; P &lt; 0.001; P het = 0.001) exhibited an increasing trend. Notably, there was a slight decrease in the incidence of clinical adverse events (RR: 1.09; 95% CI: 0.94–1.26; P = 0.268; P het = 0.554). Conclusion: The present meta-analysis integrates the latest published results on antithrombotic strategies in patients after TAVI/TAVR. Aspirin showed a favorable risk-benefit profile versus warfarin, with lower rates of all-cause mortality and bleeding events. Although DAPT was also associated with a significantly lower rate of all-cause mortality, it was linked to a higher incidence of bleeding events. The DOACs did not show significant benefits compared with warfarin. Some certain limitations should be noted, such as different types of trails produce heterogeneity and finite inclusion of TAVI/TAVR patients increased selection bias.

The CADILLAC risk score accurately identifies patients at low risk for in-hospital mortality and adverse cardiovascular events following ST elevation myocardial infarction

BackgroundThe CADILLAC risk score was developed to identify patients at low risk for adverse cardiovascular events following ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI).MethodsWe performed a single center retrospective review of STEMI hospitalizations treated with PPCI from 2014 to 2018. Patients were stratified using the CADILLAC risk score into low risk, intermediate risk and high risk groups. Patients presenting with cardiac arrest or cardiogenic shock were excluded from the study. The primary outcome was adverse clinical events during initial hospitalization. Secondary outcomes were adverse clinical events at 30 days and 1 year following index hospitalization.ResultsThe study included 341 patients. Compared to patients with a low CADILLAC score, adverse clinical events were similar in the intermediate risk group during hospitalization (OR 1.23, CI 0.37–4.05, p 0.733) and at 30 days (OR 2.27, CI 0.93–5.56, p 0.0733) while adverse clinical events were significantly elevated in the high risk group during hospitalization (OR 4.75, CI 1.91–11.84, p 0.0008) and at 30 days (OR 8.73, CI 4.02–18.96, p < 0.0001). At 1 year follow-up, compared to the low risk CADILLAC group (9.4% adverse clinical event rate), cumulative adverse clinical events were significantly higher in the intermediate risk group (22.9% event rate, OR 2.86, CI 1.39–5.89, p 0.0044) and in the elevated risk group (58.6% event rate, OR 13.67, CI 6.81–27.43, p < 0.0001). The mortality rate was 0% for patients defined at low risk by CADILLAC score during hospitalization, as well up to 1 year follow up. On receiver operating curve analysis, discrimination of in-hospital adverse clinical events was fair using CADILLAC (C = 0.66, odds ratio 1.18; 95% CI 1.04–1.33; p = 0.0064) with somewhat better discrimination at 30-day follow-up (C = 0.719) and 1-year follow-up (C = 0.715).ConclusionPatients defined as low risk by the CADILLAC score following a STEMI were associated with lower mortality and adverse clinical event rates during hospitalization and up to 1 year following STEMI when compared to those with an intermediate or high CADILLAC score.

Performance of Thin-Strut Stents in Non-Left Main Bifurcation Coronary Lesions: A RAIN Subanalysis.

This study assesses the safety and efficacy of thin-strut stents in non-left main (non-LM) bifurcation coronary lesions. Thinner struts of recent drug-eluting stent (DES) devices are associated with improved outcomes, but data about their performance in challenging scenarios are scant. RAIN was a retrospective multicenter registry enrolling patients with coronary bifurcation lesions or left main (LM) disease treated with thin-strut DESs. Target-lesion revascularization (TLR) was the primary endpoint, while major adverse clinical event (MACE) rate, a composite of all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), TLR, and stent thrombosis (ST), and its single components were the secondary endpoints. Multivariable analysis was performed to identify predictors of TLR. Outcome incidences according to stenting strategy (provisional vs 2-stent technique), use of final kissing balloon (FKB), and intravascular ultrasound/optical coherence tomography optimization were further investigated in prespecified subanalyses. A total of 1803 patients (59% acute coronary syndrome, 41% stable coronary artery disease) with non-LM bifurcations were enrolled. After a median follow-up of 12 months, TLR incidence was 2.5% (2.2% for provisional stenting and 3.5% for 2-stent technique). MACE rate was 9.4% (all-cause death, 4.1%; MI, 3.2%; TVR, 3.7%; definite ST, 1.1%). After multivariable adjustment, postdilation (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.15-0.71; P<.01) and provisional stenting (HR, 0.62; 95% CI, 0.55-0.89; P=.03) were associated with lower TLR rates. FKB was associated with a lower incidence of TLR in the 2-stent subgroup (P=.03). Intracoronary imaging had no significant impact on the primary endpoint. Thin-strut DES options represent an effective choice in bifurcation lesions. Postdilation and provisional stenting are associated with a reduced risk of TLR. FKB should be recommended in 2-stent techniques.

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.

Increases in early discharge following acute coronary syndrome hospitalisations and associated clinical outcomes in New Zealand between 2006 and 2015: ANZACS-QI-43 study.

International guidelines recommend early discharge for uncomplicated acute coronary syndrome (ACS) patients within 3 days; however, there is a paucity of contemporary literature regarding the safety of this strategy. To report the trends in the proportion of ACS hospitalisations discharged within 3 days and their outcomes in New Zealand. ACS hospitalisations 2006-2015 using national routinely collected data were categorised by length of stay (LOS) into ≤3, 4-5 and >5 days, excluding deaths during the index admission. Trend analysis of death, cardiovascular and bleeding events and their composites (net adverse clinical events) at 30-day and 1-year post-discharge were performed using generalised linear mixed regression models adjusting for covariates by LOS subgroups. Among 130 037 ACS hospitalisations, LOS ≤ 3 days increased from 32% in 2006 to 44% in 2016. This trend was observed for all demographics, ACS subtypes and management strategies. Event rates at 30 days and 1year were the lowest for the LOS ≤3 days subgroup (all-cause mortality 1.6% and 9.1% respectively). Thirty-day and 1-year all-cause mortality rates were unchanged over time for this subgroup (adjusted odds ratio (95% confidence interval) of 1.011 (0.985-1.038) and 0.991 (0.979-1.003)), while net adverse clinical event rates significantly decreased (0.962 (0.950-0.973) and 0.972 (0.964-0.980) respectively). There was a substantial increase in early discharge post-ACS over 10 years. These patients were associated with reduction in adverse clinical events up to 1year and no increase in all-cause mortality. These findings from a comprehensive national register suggest that guideline recommendations on early discharge after uncomplicated ACS are safe and appropriate.

'Ticagrelor alone vs. dual antiplatelet therapy from 1 month after drug-eluting coronary stenting among patients with STEMI': a post hoc analysis of the randomized GLOBAL LEADERS trial.

AimTo evaluate the efficacy and safety of ticagrelor monotherapy beyond 1 month and up to 24 months vs. standard 12-month dual antiplatelet therapy (DAPT) with aspirin and ticagrelor followed by aspirin monotherapy among ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the GLOBAL LEADERS trial.Methods and resultsWe performed a post hoc analysis of STEMI patients in the GLOBAL LEADERS trial comparing experimental ticagrelor monotherapy (1062 patients) with standard 12-month DAPT (1030 patients). We evaluated predefined primary and secondary endpoints in both treatment arms. Rates of net adverse clinical events (NACE), patient-oriented composite endpoints (POCE), and bleeding academic research consortium (BARC)-defined bleeding Type 3 or 5 were also evaluated. At 2 years, there were no significant differences in rates of primary endpoints in patients who had STEMI [0.89 (0.61–1.31)]. There were similar rates of NACE and POCE in both experimental and reference treatment groups at 2 years post-PCI [hazard ratio (HR) 0.96 (0.77–1.20) and 0.96 (0.77–1.21), respectively]. BARC 3 or 5 bleeding events were numerically less in experimental compared to reference treatment groups at 1 year [HR 0.55 (0.27–1.13)] and 2 years [0.61 (0.32–1.16)].ConclusionPresentation with STEMI has not influenced the incidence of GLOBAL LEADERS defined primary endpoints. There were no significant differences in rates of NACE, POCE, and BARC bleeding between the two treatment groups up to 2 years of follow-up. Although these findings should be viewed as exploratory, they expand the evidence on potential safety of aspirin-free antiplatelet strategies after PCI in STEMI.

Incidence of Uncommon Clinical Events in USA Patients with Dialysis-Dependent and Nondialysis-Dependent Chronic Kidney Disease: Analysis of Electronic Health Records from TriNetX

Introduction: Further understanding of adverse clinical events in patients with chronic kidney disease (CKD) is needed. This study aimed to describe characteristics of patients with nondialysis-dependent (NDD) and dialysis-dependent (DD) CKD and to assess incidence rates of uncommon adverse clinical events of interest in these patients. Methods: This retrospective study used electronic medical record data from USA CKD patients (≥18 years) with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² between January 1, 2010, and December 31, 2018, obtained from the USA-based TriNetX database. NDD-CKD and DD-CKD were diagnosed and staged from ≥2 consecutive eGFR readings, recorded ≥90 days apart. Dialysis was identified using procedure codes for renal replacement therapy. Outcomes assessed were select uncommon adverse clinical events, defined by International Classification of Disease, 9th and 10th Revision codes. Results: Incidence rates of adverse clinical events per 100 person-years (95% confidence interval) were generally higher in patients with DD-CKD versus NDD-CKD. Differences were particularly pronounced for hyperkalemia (26.9 [26.2–27.6] vs. 4.5 [4.5–4.6]), acidosis (15.1 [14.7–15.6] vs. 3.4 [3.4–3.4]), and sepsis (14.6 [14.2–15.1] vs. 3.3 [3.3–3.4]). Among DD-CKD patients, incidence rates of adverse events were particularly high during the first 3 months following dialysis initiation. Incidence of adverse clinical events generally increased with decreasing eGFR among patients with NDD-CKD and with hemoglobin <10 g/dL in both NDD- and DD-CKD patients. Conclusions: Our results help establish baseline rates of uncommon adverse clinical events and provide additional evidence of increased morbidity for patients with DD-CKD versus NDD-CKD.

Prognostic significance of myocardial fibrosis and CMR characteristics in bicuspid aortic valve with moderate and severe aortic insufficiency.

This study attempted to evaluate the characteristics and prognostic value of myocardial fibrosis (MF) in aortic insufficiency (AI) patients with bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) by cardiac magnetic resonance (CMR). A total of 314 adults with CMR-diagnosed AI were retrospectively retrieved. Of them, 166 patients with moderate or severe AI were included and divided into two groups: BAV group (N = 46) and a TAV group (N = 120). The presence and characteristics of MF were assessed with CMR. The patients were followed for adverse clinical events. The prognostic capability of the parameters was assessed using Cox regression model. LV fibrosis was more common in the BAV group than in the TAV group (65.2% vs. 45.0%; p = 0.020). There was a strong association between BAV and MF even after adjusting for clinical and imaging variables (odds ratio: 3.57; p = 0.031). Kaplan-Meier analysis showed a higher rate of clinical adverse events in AI+BAV patients with MF during a median follow-up of 4.7 years. Multivariate Cox regression analysis showed that late gadolinium enhancement (LGE) was an independent predictor of clinical adverse outcome. MF is more common in AI with BAV than with TAV and is a predictor of clinical adverse events. • The presence and extent of late gadolinium enhancement of left ventricular were more common and severer in the bicuspid aortic valve group than in the tricuspid aortic valve group in aortic insufficiency patients. • Bicuspid aortic valve was an independent factor for myocardial fibrosis in aortic insufficiency patients. • Late gadolinium enhancement could be used as an independent predictor of adverse clinical events in this population.

Post-discharge antithrombotic management and clinical outcomes of patients with new-onset or pre-existing atrial fibrillation and acute coronary syndromes undergoing coronary stenting: Follow-up data of the MATADOR-PCI study

Background. Patients with concomitant atrial fibrillation (AF) and acute coronary syndromes (ACS) do not seem to receive proper antithrombotic therapies and present high rates of adverse clinical events. Methods. We analyzed the follow-up data of the prospective, nationwide MATADOR-PCI registry. We assessed the use of antithrombotic strategies and the incidence of major adverse cardiovascular events (MACE) and net adverse clinical events (NACE) at 6 months, in patients with new-onset or pre-existing AF admitted for ACS and treated with percutaneous coronary intervention (PCI). Results. Out of the 588 patients enrolled in the registry and discharged alive (287 with pre-existing and 301 with new-onset AF), data at 6 months were obtained for 579 (98.5%) patients. Compared to hospital discharge, the rate of triple antithrombotic therapy was significantly reduced (from 76.4% to 23.6% and from 53.8% to 23.6%; both p<0.0001) while dual antithrombotic therapy (DAT) increased (from 11.8% to 56.3% and from 5.8% to 30.9%; both p<0.0001) at follow-up, in patients with pre-existing and new-onset AF, respectively. Among patients with a class IA indication to receive oral anticoagulation therapy (OAT), it was prescribed in 91% and 88% of patients with pre-existing and 64% and 62% of new-onset AF, at discharge and follow-up, respectively. At 6 months from discharge the overall rate of MACE was 8.4% and 7.6% (p=0.75), while NACE occurred in 10.8% vs 10.0% (p=0.74) of patients with pre-existing or new-onset AF, respectively. Conclusions. At follow-up, DAT was the most used antithrombotic strategy for both patients with pre-existing and new-onset AF with concomitant ACS. These two groups of patients presented comparable rates of MACE and NACE at 6 months.

Clinical Impact of FFR-Guided PCI Compared to Angio-Guided PCI From the France PCI Registry

Background: Fractional Flow Reserve (FFR) has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide percutaneous coronary intervention (PCI) compared to angiography (angio). Methods: We sought to compare, in a national French registry (France PCI), the clinical impact of FFR-guided PCI compared with angio-guided PCI at one year. We extracted from the France PCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE) defined as the composite of the following endpoints: rates of death, myocardial infarction, stent thrombosis, revascularisation, stroke, and bleeding with a BARC score ≥ 3. Findings: 14384 patients with one-year clinical follow-up were included. Among them, 13125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11·3%) versus 100 (7·9%) (p<0·0001), respectively, with Hazard Ratio (HR) of 1·440, 95% confidence Interval (CI) [1·211-1·713] (p=0·0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3·9%) versus 17 (1·4%) (p<0·0001), respectively, with HR of 2·845, 95% CI [2·099-3·856] (p<0·0001). After adjustment for potential confounding factors, HRs were 1·287, 95% CI [1·028-1·613] (p=0·028) for MACE and 2·527, 95% CI [1·452-4·399] (p=0·001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. Interpretation: Our study showed that FFR was the most important predictor of death after adjustment for confounding factors. PCI guided with FFR improves outcome at one year compared to angio-guided PCI with a reduction of 64M of death at one year. Funding: None Declaration of Interest: The authors do not have any conflict of interest to report related to this manuscript. Ethical Approval: The French Persons Protection Committee (IR3888) approved the study protocol (no. 15-231). Data file collection and storage were approved by the French National Commission for Data Protection and Liberties (no. 2014-073).