Higher Risk Of Primary Endpoint Research Articles

Safety of beta-blocker discontinuation in patients after acute coronary syndromes and preserved left ventricular ejection fraction: long-term clinical outcomes from the SPUM-ACS cohort

Abstract Background While beta-blockers have been shown to improve outcomes after acute coronary syndromes (ACS), most trials predate the advent of reperfusion therapy and modern secondary prevention. Recent trial data in the reperfusion era found no all-cause or cardiovascular mortality benefit in patients with a left ventricular ejection fraction (LVEF) >40%, while myocardial infarction and angina were reduced. We hypothesized that, in patients who receive optimal contemporary treatment following ACS and who have an LVEF >40%, beta-blocker discontinuation within 1 year after ACS is safe and non-inferior to beta-blocker continuation in terms of the 5-year incidence of major adverse cardiovascular events (MACE). Purpose We assessed the safety of beta-blocker discontinuation within 12 months following ACS in patients with an LVEF >40% at discharge, compared to continued long-term beta-blocker therapy, with respect to the 5-year incidence of MACE. Methods Data was derived from the Swiss Special Program University Medicine – Inflammation in ACS (SPUM-ACS) cohort (N=3,762), a multicenter prospective cohort of patients hospitalized for invasive management of ACS between 2009-2017. We included patients with an LVEF >40%, beta-blockers at discharge, and who completed the 5-year follow-up. Patients who continued beta-blockers at one year were compared with those who discontinued beta-blockers at any time throughout the first year after ACS using a target trial emulation design. Adjusted hazard ratios (aHR) were obtained with a Cox model using an inverse probability weighting adjustment for baseline characteristics including demographic parameters, comorbidities, and concomitant medication. The primary endpoint was 5-year MACE (cardiovascular death, myocardial infarction, stroke or transient ischemic attack, unplanned coronary revascularization, and hospitalization for unstable angina). Results Of 2,077 patients with an LVEF >40% and beta-blockers at discharge, 1,758 (85%) continued beta-blockers and 319 (15%) had discontinued beta-blocker therapy at one year. The 5-year risk between the discontinuation and continuation group was similar for the primary endpoint (14.5% vs 14.3%, respectively, aHR 1.00, 95%CI 0.73-1.36, p=0.98). All-cause mortality (aHR 1.08, 95%CI, 0.64-1.81, p=0.79) did not differ between both groups. In a subgroup analysis, there was no effect modification by LVEF, but some evidence for a higher risk of primary endpoint with beta-blocker discontinuation in STEMI (aHR 1.50, 95%CI 1.02-2.21) compared with NSTEMI (aHR 0.69, 95%CI 0.40-1.19, P interaction = 0.022). Conclusion Beta-blocker discontinuation within 12 months following ACS in patients with an LVEF >40% was not associated with an increased risk of MACE at 5 years, compared to long-term continuation of beta-blocker therapy. In the absence of a dedicated randomized controlled trial, beta-blocker discontinuation may be safe, especially after NSTEMI.Kaplan-Meier plot: probability of MACE

Safety of beta-blocker discontinuation after acute coronary syndromes with preserved or mildly reduced left ventricular ejection fraction: a target trial emulation from a real-world cohort.

The benefit of long-term beta-blocker therapy after acute coronary syndromes (ACS) without heart failure in the reperfusion era is uncertain. Two recent randomized trials found conflicting results. The present study assessed the safety of beta-blocker discontinuation within 12 months following ACS with LVEF ≥40%. In a multicentre prospective real-world cohort (N=3,762) of patients hospitalized for ACS, patients with LVEF ≥40% and beta-blockers at discharge were included. Patients who continued beta-blockers at one year were compared with those who discontinued beta-blockers within 12 months post-ACS using target trial emulation and inverse probability weighting over an additional four-year follow-up. The primary endpoint was major adverse cardiovascular events (MACE), a composite of four-year cardiovascular death, myocardial infarction, stroke, transient ischemic attack, unplanned coronary revascularization, or unstable angina hospitalization. Of 2,077 patients, 1,758 (85%) continued beta-blockers and 319 (15%) had discontinued beta-blockers at one year. The risk of primary endpoint was similar in both groups (14.1% versus 14.3% with beta-blocker discontinuation versus continuation; adjusted hazard ratio [aHR]=0.98; 95% confidence interval, 0.72-1.34, P=0.91). Subgroup analysis suggested a higher risk of primary endpoint with beta-blocker discontinuation after STEMI (aHR=1.46 [0.99-2.16]) compared to NSTEMI (aHR=0.70 [0.40-1.22], Pinteraction=0.033), whereas there was no interaction with LVEF (Pinteraction=0.68). Beta-blocker discontinuation within 12 months following ACS with LVEF ≥40% was not associated with an increased risk of MACE compared to long-term beta-blocker therapy. Subgroup analysis suggested potential risk in STEMI patients. Discontinuing beta-blockers 12 months after ACS appears safe in patients with LVEF ≥40%, particularly after NSTEMI.

Clopidogrel vs. aspirin in the chronic maintenance period following percutaneous coronary intervention in high thrombotic and high bleeding risk patients:sub-analysis of the HOST-EXAM Extended study

Abstract Background The HOST-EXAM Extended study evaluated the long-term follow-up results of the original HOST-EXAM trial, which demonstrated that clopidogrel monotherapy was associated with a lower risk of thrombotic and bleeding events compared to aspirin monotherapy. However, the optimal single antiplatelet agent during the chronic maintenance period in patients with high thrombotic risk and/or high bleeding risk has not been assessed. Purpose This study aimed to compare the efficacy of clopidogrel versus aspirin monotherapy in patients with high thrombotic risk and/or high bleeding risk who were stabilized after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods A post-hoc subgroup analysis of the HOST-EXAM Extended study was conducted. High thrombotic risk was defined as patients who had at least one of the following procedural features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. High bleeding risk was defined according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium bleeding type 3 or 5. Clinical outcome was analyzed according to the patients’ initial thrombotic and bleeding risk. Results Among the total population, 28.2% had high thrombotic risk and 27.0% had high bleeding risk. Patients with high thrombotic risk was not associated with a higher risk of primary endpoint, whereas those of high bleeding risk was associated with a increased risk of the clincical event (Hazard ratio [HR] 2.70, 95% Confidence interval [CI] 2.29-3.18, Log-rank p < 0.001). Clopidogrel consistently reduced the risk of primary endpoint, regardless of the presence of high thrombotic risk or high bleeding risk (Absolute risk difference [ARD] 7.5%, 95% CI 2.7-12.3, HR 0.59, 95% CI 0.43-0.82, Log-rank p=0.001 vs ARD 4.1%, 95% CI 1.5-6.7, HR 0.78, 95% CI 0.66-0.92, Log-rank p=0.004 with or without high thrombotic risk, respectively. P-interaction=0.133; ARD 9.2%, 95% CI 2.4-16.0, HR 0.71, 95% CI 0.55-0.92, Log-rank p=0.008 vs ARD 4.0%, 95% CI 1.6-6.4, HR 0.74, 95% CI 0.60-0.90, Log-rank p=0.003 with or without high bleeding risk, respectively. P-interaction=0.860; Figure 1). The beneficial effect of clopidogrel was consistent across patients divided into four groups based on the presence or absence of high thrombotic risk and high bleeding risk (Figure 2). Conclusion In chronic maintenance period of patients who received PCI with DES, the beneficial effect of clopidogrel was maintained in patients regardless of the presence or absence of high thrombotic risk and high bleeding risk.

Effect of blood pressure index on clinical outcomes in patients with heart failure and chronic kidney disease.

This study aimed to assess the effect of blood pressure (BP) index, in terms of level and variability, on the progression of cardiovascular and renal diseases in patients with both heart failure (HF) and chronic kidney disease (CKD). The study involved patients with HF and CKD from the database of the Chronic Renal Insufficiency Cohort (CRIC) study. The study endpoint includes the following: (i) primary endpoint, including cardiovascular disease (CVD) events, renal events, and all-cause death; (ii) CVD events; (iii) renal events; and (iv) all-cause death. Among 3939 participants in the CRIC study, a total of 382 patients were included. The duration of the follow-up was 6.3±2.7years, the age was 60.2±8.9years, and 57.6% were male. BP index included 20 indicators in relation to BP level and variability, 4 of which were analysed including baseline systolic BP (SBP), standard deviation of SBP, coefficient of variation of diastolic BP (DBP CV), and average real variability of pulse pressure. In the Cox regression analysis after adjustment, baseline SBP was significant for the risk of primary endpoint [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.03-1.44, P=0.02] and renal events (HR 1.54, 95% CI 1.22-1.95, P<0.001), and DBP CV was significant for the risk of primary endpoint (HR 1.03, 95% CI 1.01-1.06, P=0.02) and CVD events (HR 1.04, 95% CI 1.02-1.07, P<0.01). The result of the forest plot depicted that baseline SBP had a linear association with the risk of CVD and renal events (P=0.04 and 0.001, respectively) and DBP CV with CVD events (P=0.02). As the restricted cubic spline models displayed, DBP CV featured a J- or L-curved association with the primary endpoint, renal events, and all-cause death (P for nonlinearity=0.01, <0.001, and 0.01, respectively). The baseline SBP and DBP CV may remain significant for clinical outcomes in patients with both HF and CKD. The increase in baseline SBP is associated with a higher risk of primary endpoint, CVD events, and renal events,and the increase in DBP CV with a higher risk of CVD events. Concerning nonlinear association, DBP CV features a J- or L-curved relationship with the primary endpoint, renal events, and all-cause death, with a higher risk at both low and high values. https://www. gov; unique identifier: NCT00304148.

PO-02-018 SIGNIFICANCE OF VENTRICULAR ARRHYTHMIA SUBSTRATE AS A PROGNOSTIC MARKER OF CARDIAC RESYNCHRONIZATION THERAPY

Implantable cardioverter-defibrillator (ICD) shock is associated with mortality. There are, however, conflicting data whether ventricular arrhythmia (VA) leading to ICD shock or shock itself increases mortality. In addition, paced electrical delay is related to both VA substrate and cardiac resynchronization therapy (CRT) response. Little is known about the significance of VA substrate as a prognostic marker of CRT. The aim of this study is to assess the relationship between VA substrate and prognosis such as cardiac death and/or heart failure (HF) hospitalization. We investigated consecutive 330 CRT patients with the follow-up data one year after CRT implantation. VA was defined as lasted ≥30s or treated by anti-tachycardia pacing (ATP) or shock. CRT responder was defined as more than 15% reduction of left ventricular end-systolic volume. Primary endpoint was composite endpoint of cardiac death and/or HF hospitalization. Forty-three patients had VA within one year after CRT implantation. During median follow-up of 2.8 years (interquartile range 1.5-5.0 years), the patients with VA within one year had higher risk of primary endpoint (p<0.01). VA >200bpm was associated with increased risk of primary endpoint (VA >200bpm vs VA ≤200bpm, hazard ratio [HR] 2.34; 95% confidence interval [CI] 1.08-5.08, p=0.03), though shock was not associated with primary endpoint (shock vs anti-tachycardia pacing, HR 1.66; 95%CI 0.76-3.61, p=0.20). The patients with VA within one year had lower prevalence of CRT responder (19 [44%] vs 184 [64%], p=0.01) and longer time of left-ventricular pacing to right ventricular sensing (174±23ms vs 143±36ms, p<0.01) than the patients without. VA occurrence within one year was related to paced electrical delay and poor response to CRT. VA substrate could be associated with poor prognosis among the CRT patients.

Abstract 10126: Impact of Albuminuria on Prognosis After Transcatheter Aortic Valve Replacement for Aortic Stenosis

Introduction: Albuminuria is a well-known risk factor of cardiovascular events. However, the impact of albuminuria on the prognosis in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) has not been studied. Methods: This is a single-center retrospective observational study. Consecutive patients who underwent TAVI for severe AS and whose preoperative urinary data were available were included. Finally, 228 patients were investigated. Patients were divided into two groups according to the preoperative urinary albumin-to-creatinine ratio (ACR): high (ACR≥ 30 mg/g) and low (ACR&lt;30 mg/g). Total protein to creatinine ratio (PCR) and dipstick proteinuria were also evaluated. The primary outcome was a composite endpoint of all-cause death and readmission due to heart failure. Results: There were 117 patients with a high ACR and 111 patients with a low ACR. At baseline, patients with a high ACR had significantly lower eGFR than those with a low ACR. During the median follow-up period of 467 days, the patients with a high ACR had higher incidence of a primary endpoint than those with a low ACR (p&lt;0.001). The individual incidence of all-cause death, cardiac death and heart failure readmission were also significantly higher in patients with a high ACR than those with a low ACR. Patients with PCR≥150mg/g or positive dipstick proteinuria were at a higher risk of primary endpoint as well (p&lt;0.001 and p=0.008, respectively), however, there was no significant difference between the patients with eGFR&lt;60 and ≥60 mL/min/1.73m 2 (Figure). Multivariate Cox proportional hazards analysis showed a high ACR was independently associated with a primary endpoint (HR, 4.98; 95% CI, 1.84-13.49; p=0.002). Conclusions: Preoperative albuminuria (ACR≥ 30 mg/g) is an independent predictor of cardiac events in the patients with severe AS undergoing TAVI. PCR≥150 mg/g and positive dipstick albuminuria are also useful for risk prediction.

Ultrasound-assessed diaphragm dysfunction predicts clinical outcomes in hemodialysis patients

Skeletal muscle atrophy is prevalent and remarkably increases the risk of cardiovascular (CV) events and mortality in hemodialysis (HD) patients. However, whether diaphragm dysfunction predicts clinical outcomes in HD patients is unknown. This was a prospective cohort study of 103 HD patients. After assessment of diaphragm function by ultrasonography and collection of other baseline data, a 36-month follow-up was then initiated. Participants were divided into diaphragm dysfunction (DD+) group and normal diaphragm function (DD−) group, according to cutoff value of thickening ratio (i.e. the change ratio of diaphragm thickness) at force respiration. The primary endpoint was the first nonfatal CV event or all-cause mortality. A secondary endpoint was less serious CV events (LSCEs, a composite of heart failure readmission, cardiac arrhythmia or myocardial ischemia needed pharmacological intervention in hospital). 98 patients were eligible to analysis and 57 (58.16%) were men. 28 of 44 patients(63.64%) in DD+ group and 23 of 54 patients (42.59%) in DD− group had at least one nonfatal CV event or death (p = 0.038). Compared to DD− group, DD+ group had significantly higher incidence of LSCEs (21 vs.14, p = 0.025) and shorter survival time (22.02 ± 12.98 months vs. 26.74 ± 12.59 months, p = 0.046). Kaplan–Meier analysis revealed significantly higher risks of primary endpoint (p = 0.039), and LSCEs (p = 0.040) in DD+ group. Multivariate hazard analysis showed that DD+ group had significantly higher risk of primary endpoint [hazard ratio (HR) 1.59; 95% confident interval (CI) 1.54–1.63], and LSCEs (HR 1.47; 95%CI 1.40–1.55). Ultrasound-assessed diaphragm dysfunction predicts clinical outcomes in HD patients.Trial registration: This study was registered with Chinese Clinical Trials Registry (www.chictr.org.cn) as ChiCTR1800016500 on Jun 05, 2018.

Abstract 13173: Early Determination of Residual Inflammatory Risk and Its Association With Adverse Clinical Events in East Asian Patients Treated With Percutaneous Coronary Intervention

Background: East Asian population has substantially low level of inflammation compared with Western population. It remains uncertain that early determination of residual inflammatory risk (RIR) and its clinical impact in East Asian patients with coronary artery disease (CAD). Methods: This was a cohort analysis with CAD patients (n=5,840) undergoing percutaneous coronary intervention (PCI) with serial assessment of inflammatory status from East Asian registry. Inflammatory status was determined by measuring high-sensitivity C-reactive protein (hs-CRP) at on-admission and 1-month follow-up. Patients were stratified into 4 groups according to hs-CRP criteria (≥2 mg/L): (1) persistent low RIR (51.0%); (2) fortified RIR (low on-admission -high 1-month ) (10.3%); (3) attenuated RIR (high on-admission -low 1-month ) (12.1%); and (4) persistent high RIR (18.3%). Primary endpoint was defined as a composite of CV death, non-fatal MI, and non-fatal stroke. Results: With a median follow-up of 37.0 (IQR: 19.9, 72.9) months, primary endpoint was occurred in 11.4% of the cohort. Levels of hs-CRP were decreased over time (on-admission vs. 1-month: median 1.3 vs. 0.9 mg/L; P &lt;0.001), which association with primary outcome appeared incremental. Risk of primary endpoint was significantly different across the groups (log-rank test, P &lt;0.001). After adjustment, patients with persistent high RIR showed a higher risk of primary endpoint compared to subjects with persistent low RIR (adjusted HR, 1.41; 95% confidence interval, 1.12 to 1.78; P &lt;0.001). Conclusion: About one-fifth of East Asian patients with CAD have persistent high RIR, which impact on ischemic events appears robust. Unique RIR profile of these patients may explain their better clinical outcomes compared with Western populations.

Impacts of triglyceride-glucose index on prognosis of patients with type 2 diabetes mellitus and non-ST-segment elevation acute coronary syndrome: results from an observational cohort study in China

BackgroundThe relationship between triglyceride-glucose index (TyG index) and the prevalence and prognosis of cardiovascular disease has been confirmed by former studies. However, it remains uncertain whether TyG index has a prognostic impact in patients with type 2 diabetes mellitus (T2DM) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).MethodsThe study retrospectively enrolled 798 patients (mean age: 60.9 ± 8.3 years; 68.3% men) with T2DM and NSTE-ACS who underwent PCI at Beijing Anzhen Hospital from January to December 2015. TyG index was calculated as previously reported: ln [fasting TGs (mg/dL) * FBG (mg/dL)/2]. The primary endpoint was a composite of adverse events as follows: all-cause death, non-fatal myocardial infarction (MI) and ischemia-driven revascularization.ResultsTyG index was significantly higher in patients with a primary endpoint event compared with those without. Multivariate Cox proportional hazards analysis showed that 1-unit increase of TyG index was independently associated with higher risk of primary endpoint, independent of other risk factors [hazard ratio (HR) 3.208 per 1-unit increase, 95% confidence interval (CI) 2.400–4.289, P < 0.001]. The addition of TyG index to a baseline risk model had an incremental effect on the predictive value for adverse prognosis [AUC: baseline risk model, 0.800 vs. baseline risk model + TyG index, 0.856, P for comparison < 0.001; category-free net reclassification improvement (NRI) 0.346, P < 0.001; integrated discrimination improvement (IDI) 0.087, P < 0.001].ConclusionsIncreased TyG index is a significant predictor of adverse prognosis in patients with T2DM and NSTE-ACS undergoing PCI. Further studies need to be performed to determine whether interventions for TyG index have a positive impact on improving clinical prognosis.

Abstract WP182: Re-Analysis of Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) Trial Using the New Food and Drug Administration (FDA) “On Label” Criteria

Background: Due to higher rates of 1-month stroke and death with Wingspan intracranial stent placement observed in SAMMPRIS, FDA announced a more limited indication for Wingspan stent. We compared the results of intracranial stent placement with best medical treatment in patients who met “on label” criteria with those who were treated as “off label”. Methods: Patients recruited in the SAMMPRIS trial were classified as “on label” if: age 22 to 80 years, stenosis of 70%-99%, baseline modified Rankin Scale score ≤ 3, ≥2 ischemic events in the vascular territory of the stenotic lesion with at least 1 ischemic event while on medical therapy, and stent placement ≥8 days after the last stroke. All other patients were classified as “off label”. The primary endpoint was any stroke or death occurring within 30 days of enrollment, or any stroke or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up. Results: A total of 31 (6.87%) among 451 recruited patients met the “on label” criteria. The relative risk of primary endpoint was lower in “on label” patients treated with stent placement compared with best medical treatment (RR 0.8, 95 % CI 0.2 - 2.9) but higher in “off label” patients (RR 1.65, 95 % CI 1.0-2.4). Primary endpoint was seen in 20% and 23.4% of patients treated with stent placement in “on label” and “off label” patients, respectively. Primary endpoint was seen in 25% and 14.2% of patients treated with best medical treatment in “on label” and “off label” patients, respectively. In Cox Proportional Hazards analysis with primary endpoint as dependent variable, the interaction between “on label” and treatment (stent versus best medical treatment) was not significant (p=0.6713). Conclusion: The new FDA “on label” criteria may identify a group of who may benefit from intracranial stent placement due to higher risk of primary endpoint in those treated with best medical treatment. However, the criteria appears to be very stringent and only a small proportion of patients may meet the “on label” criteria.

Association of diabetes with outcomes in patients undergoing contemporary percutaneous coronary intervention: Pre-specified subgroup analysis from the randomized GLOBAL LEADERS study

Background and aimsDiabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status. MethodsWe studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5. ResultsA quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17–1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22–1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86–1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes. ConclusionsDiabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.

3331Impact of baseline hemoglobin level and white blood cell count in real-world patients undergoing contemporary percutaneous coronary intervention: insights from the GLOBAL LEADER study

Abstract Introduction The impact of hemoglobin (Hb) level and white blood cell count (WBC) on the outcomes in all-comers PCI patients is unknown. Purpose We sought to assess the association between baseline Hb level, WBC count on 2-year outcomes after PCI in all-comers patients in the GLOBAL LEADERS study. We compared the outcomes between anemic and non-anemic patients according to WHO definition. Methods GLOBAL LEADERS study assessed the efficacy and safety of two antiplatelet strategies in 15,991 patients undergoing PCI. The primary endpoint was all-cause mortality or new Q wave myocardial infarction (MI) at 2 years. Secondary safety endpoint was BARC 3 or 5 bleeding at 2 years. The association between WBC count, Hb level and outcomes at 2 years were assessed in the multivariable Cox model adjusted for age, diabetes, ejection fraction and renal impairment. For Hb level, patients were categorized according to the WHO definition of anemia (Hb &lt;12 g/dL in women, Hb &lt;13 g/dL in men). Results Of 15991 patients randomized in the GLOBAL LEADER study, baseline WBC count and Hb levels were available in 14960 (93.7%) patients and 15215 (95.3%) patients, respectively. Hb level had an inverse association with adverse events after PCI. In the multivariable Cox model, Hb level was an independent predictor for ischemic and bleeding outcomes at 2 years while the WBC count was not (see table). Compared with non-anemic patients, anemic patients had significantly higher risk of primary endpoint (adjusted HR 2.07, 95% CI 1.72–2.49), BARC 3 or 5 bleeding (adjusted HR 1.49 95% CI 1.14–1.96), all-cause mortality (adjusted HR 2.33, 95% CI 1.89–2.86), any MI (adjusted HR 1.41, 95% CI 1.11–1.80), and any revascularization (adjusted HR 1.20, 95% CI 1.03–1.39). Hb level, WBC count and 2-year outcomes Outcomes at 2 years Hemoglobin level (mg/dL) WBC count (109/L) HR (95% CI) P value HR (95% CI) P value All-cause mortality or new Q wave MI 0.87 (0.82–0.91) &lt;0.0001 1.00 (0.999–1.002) 0.33 All-cause mortality 0.82 (0.78–0.87) &lt;0.0001 1.00 (0.999–1.002) 0.37 Any myocardial infarction 0.93 (0.87–0.99) 0.0165 1.00 (0.996–1.001) 0.23 Any revascularization 0.96 (0.93–1.00) 0.0302 1.00 (1.00–1.001) 0.25 BARC 3 or 5 bleeding 0.85 (0.79–0.91) &lt;0.0001 1.00 (0.997–1.002) 0.76 Conclusion In the all-comers patients undergoing PCI, the baseline Hb level was significantly associated with the ischemic and bleeding outcomes at 2 years whereas baseline WBC count was not. Baseline WBC count may not be useful as a prognostic factor after PCI.

Impact of Occluded Culprit Arteries on Long‐Term Clinical Outcome in Patients with Non‐ST‐Elevation Myocardial Infarction: 48‐Month Follow‐Up Results in the COREA‐AMI Registry

The prognostic impact of occluded culprit arteries in non-ST-elevation myocardial infarction (NSTEMI) patients beyond 12 months has not been investigated. The impact of occluded culprit arteries on a composite of cardiac death (CD), recurrent nonfatal MI (RMI), and target vessel revascularization (TVR) in patients who presented with NSTEMI was investigated during a 48-month follow-up using propensity-score (PS) matching. A total of 2,878 NSTEMI patients in the COREA-AMI (COnvergent REgistry of cAtholic and chonnAm university for Acute MI) Registry were classified according to the angiographic flow of culprit arteries (occlusion [OC], n = 1,070; nonocclusion, n = 1,808). After PS matching, the incidence of the primary end-point, a composite of CD, RMI, and TVR was compared. The median follow-up duration was 47.3 months (IQR 32.7-66.2). In the PS-matched population, the 48-month cumulative rates of the primary end-point (27.5% vs. 17.9%, P < 0.001) and each event were higher in the OC group (CD: 9.0% vs. 5.4%, RMI: 16.3% vs. 9.4%, TVR: 10.5% vs. 5.6%, respectively, P < 0.05). In multivariate Cox regression analysis, occluded culprit arteries showed the significant statistical impact on the primary end-point (HR 1.689 [1.385-2.059], P < 0.001) and each event (CD: 1.736 [1.218-2.475], RMI: 1.918 [1.468-2.505], TVR: 2.042 [1.453-2.869], respectively, P < 0.05). Furthermore, in the 12-month landmark analysis, occluded culprit arteries were still associated with higher risk of primary end-point beyond 12 months (P < 0.001). Occluded culprit arteries were independently associated with the higher risk of CD, RMI, and TVR in NSTEMI patients during the 48-month follow-up.

Prognostic significance of mean platelet volume on admission in an unselected cohort of patients with non ST-segment elevation acute coronary syndrome

Mean platelet volume (MPV) has been proposed as a marker of platelet reactivity and cardiovascular risk. Its prognostic significance has not been thoroughly investigated in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). We included 1,041 consecutive patients with NSTE-ACS. Patients were divided in quartiles according to the MPV value on admission (fl) i.e. Q1<7.5; Q2=7.5-8.0; Q3=8.1-8.8; Q4≥8.9. The primary study endpoint was the composite of cardiovascular death and re-myocardial infarction (MI) at one year. Secondary study endpoints were individual cardiovascular death and re-MI. Patients in Q4 were older, had a higher prevalence of previous MI, peripheral artery disease and advanced Killip class compared to patients in Q1-Q3. Elevated MPV levels (Q4) was independently associated with gender, smoking status, platelet count and creatinine level. Overall, 210 patients (20.2%) reached the primary endpoint, 124 (12.1%) died from cardiovascular causes and 125 (12.0%) suffered from re-MI. On multivariable analysis patients in Q4 were at higher risk of primary endpoint (HR=1.41; 95%CI 1.06-1.89; p=0.02) whilst the association with cardiovascular death and re-MI was attenuated. MPV as continuous variable was independently associated with both primary endpoint (HR=1.19; 95%CI 1.06-1.33; p=0.003) and cardiovascular death (HR=1.23; 95%CI 1.06-1.42, p=0.006). The incorporation of MPV into a comprehensive model of risk significantly increased the likelihood ratio chi-square for prediction of both the composite endpoint (p=0.004) and cardiovascular death (p=0.009). Therefore, MPV may be useful to improve risk stratification in NSTE-ACS patients and should be included in future prospective studies evaluating the role of platelet function in promoting cardiovascular events.

Preoperative Statin Therapy and Troponin T Predict Early Complications of Coronary Artery Surgery

Pretreatment with statins reduces early ischemic events after percutaneous coronary interventions, primarily in patients with a high level of inflammation markers. We sought to examine the association between preoperative statin therapy, systemic inflammation, and myocardial ischemia with the occurrence of early cardiac complications after coronary artery bypass grafting surgery. One hundred forty-one consecutive patients who underwent coronary artery bypass grafting surgery from two university tertiary hospitals were stratified according to their preoperative status of statin therapy (87 treated and 54 nontreated). Preoperative blood samples were collected for measurement of lipid parameters, C-reactive protein, interleukin-6, and troponin T. The evaluated primary endpoint was a composite of death and myocardial infarction at 30 days. Patients undergoing preoperative statin therapy showed a reduced incidence of death (2.3% versus 13.0%, p = 0.012), myocardial infarction (5.7% versus 18.5%, p = 0.017), and primary combined endpoint (8.0% versus 22.2%, p = 0.017). In the multivariate model, preoperative troponin T greater than 0.01 ng/mL (odds ratio 6.85, p = 0.001) and nonstatin therapy (odds ratio 4.2, p = 0.01) predicted a higher risk of primary endpoint. Statins showed a significant interaction with troponin T status and benefited primarily those patients with positive troponin T. Among 19 patients with troponin T greater than 0.01 ng/mL, the primary endpoint occurred in all 6 nonstatin-treated patients, but it occurred in only 1 of 13 statin-treated patients (p < 0.001). Neither C-reactive protein nor interleukin-6 predicted early complications, nor did they interact with statin therapy (p = not significant). Preoperative statin therapy reduces early complications and offers additional protection in patients with positive troponin T status, regardless of inflammatory markers.