Neutrophil-to-lymphocyte ratio and prognosis in patients undergoing percutaneous coronary intervention for acute coronary syndrome.

OBJECTIVE: The purpose of this study was to characterize Acute Coronary Syndrome (ACS)-associated inflammation by investigating correlates of the neutrophil-to-lymphocyte ratio (NLR), a surrogate marker of inflammation, and its relation to 1-year mortality in a cohort of patients undergoing percutaneous coronary intervention (PCI) for ACS at a single institution. METHODS: We performed a single-institution, retrospective, observational study of all-comer ACS patients who underwent PCI and were discharged home before the COVID-19 pandemic between September 23, 2011 and July 31, 2017 for who outcomes data were available. RESULTS: NLRhigh group tended to be older, white patients, less likely to smoke, more likely to have a history of heart failure and cardiac arrest, higher creatinine values, lower LVEF, and higher CK-MB (a surrogate for infarct size). Linear regression model demonstrated a strong correlation between increasing NLR and white race (B = 1.103, p = 0.001, hemoglobin (B = -0.30, p < 0.001), peak CK-MB (B = 0.004, p = 0.02), LVEF (B = -0.048, p < 0.001), and serum creatinine (B = 0.47, p = 0.03). There were a total of 87 deaths at one year. NLR > 3.4 was associated with worse one-year survival post-PCI (91.4 % vs. 95.4 %, log-rank p < 0.004), which was confirmed on multivariate analysis. CONCLUSION: Our data confirm the independent prognostic significance of inflammation to mortality after ACS and may provide some insight into the putative benefits of inflammation modulation.

New Criteria to Identify Patients at Higher Risk for Cardiovascular Complications After Percutaneous Coronary Intervention.

A universal definition to identify patients at higher risk of complications after percutaneous coronary intervention (PCI) is lacking. We aimed to validate a recently developed score to identify patients at increased risk of all-cause death after PCI. All consecutive patients from a large PCI registry not presenting with ST-elevation myocardial infarction or cardiogenic shock were included. Each patient was assigned a score obtained by summing the points associated with the following variables: age >80 years (3 points), dialysis (6 points), left ventricular ejection fraction <30% (2 points), and multivessel PCI (2 points). Patients were stratified in 3 groups: low risk (score 0), intermediate risk (score 2 to 3), or high risk (score ≥4). The primary outcome was all-cause death, and the secondary outcomes were major adverse cardiovascular events and major bleeding. Events were assessed at 1 year after PCI. Between January 2014 and December 2019, 12,689 patients underwent PCI. Compared with the 9,884 patients at low risk, those at intermediate and high risk had a fourfold (hazard ratio 3.99, 95% confidence interval 2.95 to 5.38) and ninefold (hazard ratio 9.55, 95% confidence interval 6.89 to 13.2) higher hazard for all-cause death at 1 year, respectively. The score had a good predictive value for all-cause death at 1 year (area under the curve 0.70). The risk of major adverse cardiovascular events and major bleeding increased consistently from the low- to the high-risk group. In conclusion, in patients who underwent PCI for stable ischemic heart disease or non-ST-elevation acute coronary syndrome, a score based on 4 variables well predicted the risk of all-cause death at 1 year.

In-Hospital Mortality of Index Percutaneous Coronary Intervention in Patients With and Without Prior Percutaneous Revascularization: A Single-Institution Analysis.

Percutaneous coronary intervention (PCI) is increasingly performed for symptom relief and survival benefit, particularly in patients presenting with acute coronary syndromes. It remains controversial whether prior PCI, and specifically when index PCI is performed on previously treated lesion(s), affects peri-procedural and in-hospital mortality. We queried an institutional PCI registry for all unique patients undergoing PCI during a 4-year period and classified them as having had or not prior PCI. If prior PCI had occurred, we further defined index PCI as a target lesion (TLR) PCI or non-TLR PCI, according to lesion(s) treated during the prior PCI. Multivariable analysis was performed to identify predictors of in-hospital mortality. Prior PCI was an independent predictor of in-hospital survival or lower mortality (HR 0.41 [0.22-0.76], P = 0.004), together with lower age (per 5 years, HR 0.73 [0.66-0.82], P < 0.001) and elective PCI (HR 0.63 [0.58-0.70], P < 0.0001). Among prior PCI patients, TLR PCI was associated with higher mortality (HR 3.03 [1.05-8.33]. P = 0.045), while elective PCI status was associated with lower mortality (HR 0.10 [0.01-0.80], P = 0.03). This excess mortality was only present in non-elective PCI cases (PINT = 0.02). We conclude that PCI mortality risk is decreased in patients with prior PCI, particularly when index PCI is performed electively on a lesion not previously treated.

Prediction of Death or HF Hospitalization in Patients With Severe FMR: The COAPT Risk Score.

BACKGROUND: There are limited data on the predictors of death or heart failure hospitalization (HFH) in patients with heart failure (HF) with functional mitral regurgitation (FMR). OBJECTIVES: The aim of this study was to develop a predictive risk score using the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial database. METHODS: In COAPT, 614 symptomatic patients with HF and moderate to severe or severe FMR were randomized to MitraClip implantation plus guideline-directed medical therapy (GDMT) or GDMT alone. A risk score for the 2-year rate of death or HFH was generated from Cox proportional hazards models. The predictive value of the model was assessed using the area under the curve of receiver-operating characteristic plots. Kaplan-Meier curves were generated to estimate the proportion of patients experiencing death or HFH across quartiles of risk. RESULTS: During 2-year follow-up, 201 patients (64.4%) in the GDMT-alone group and 133 patients (44.0%) in the MitraClip group experienced death or HFH (P < 0.001). A risk score containing 4 clinical variables (New York Heart Association functional class, chronic obstructive pulmonary disease, atrial fibrillation or flutter, and chronic kidney disease) and 4 echocardiographic variables (left ventricular ejection fraction, left ventricular end-systolic dimension, right ventricular systolic pressure, and tricuspid regurgitation) in addition to MitraClip treatment was generated. The area under the curve of the risk score model was 0.74, and excellent calibration was present. The relative benefit of MitraClip therapy in reducing the 2-year hazard of death or HFH was consistent across the range of baseline risk. CONCLUSIONS: A simple risk score of clinical, echocardiographic, and treatment variables may provide useful prognostication in patients with HF and severe FMR.

Descending Aortic Distensibility and Cardiovascular Outcomes: A Cardiac Magnetic Resonance Imaging Study.

Background: Aortic distensibility (AD) is an important determinant of cardiovascular (CV) morbidity and mortality. There is scant data on the association between AD measured within the descending thoracic aorta and CV outcomes. Objective: We evaluated the association of AD at the descending thoracic aorta (AD desc) with the primary outcome of all-cause mortality, myocardial infarction (MI), stroke or coronary revascularization in patients referred for a cardiovascular magnetic resonance (CMR) study. Methods: 928 consecutive patients [(mean age 60 ± 17; 33% with prior cardiovascular disease (CVD))] were evaluated. AD desc was measured at the cross-section of the descending thoracic aorta in the 4-chamber view (via steady-state free precession [SSFP] cine sequences) and was grouped into quintiles (with the 1st quintile corresponding to the least AD, i.e., the stiffest aorta). Cox proportional-hazards regression analysis were performed for the primary outcome. Results: A total of 315 patients (34%) experienced the primary outcome during a median (25% IQR, 75% IQR) follow-up of 5.0 (0.56, 9.3) years. A decreased AD was significantly associated with hypertension, diabetes, renal disease, and dyslipidemia (p <0.0001). A primary outcome occurred in 43% of patients with AD desc ≤ median compared to 25% with AD desc > median, p <0.0001, and in 44% of patients with AD desc in the 1st quintile compared to 31% with AD desc in the other quintiles (p = 0.0004). Event free survival was incrementally reduced amongst quintiles (p <0.0001). However, AD desc ≤ median was not an independent predictor of the primary endpoint after multivariable adjustment in the overall population [adjusted HR 1.09 (95% CI:0.82-1.45), p = 0.518] or in the subgroup analysis of patients with or without prior CVD. Conclusion: In this real-world cohort of 928 patients referred for CMR, AD desc is not an independent predictor of CV outcomes.

Analysis of clinical risk models vs. clinician's assessment for prediction of coronary artery disease among predominantly female population.

INTRODUCTION: Multiple risk models are used to predict the presence of obstructive coronary artery disease (CAD) in patients with chest pain. We aimed to compare the performance of these models to an experienced cardiologist's assessment utilizing coronary angiography (CA) as a reference. MATERIALS AND METHODS: We prospectively enrolled patients without known CAD referred for elective CA. We assessed pretest probability of CAD using the following risk models: Diamond-Forrester (original and updated), Duke Clinical score, ACC/AHA, CAD consortium (basic and clinical) and PROMISE minimal risk tool. All patients completed self-administrative Rose angina questionnaire. Independently, an experienced cardiologist assessed the patients to provide a binary prediction of obstructive CAD prior to CA. Obstructive CAD was defined as >80% stenosis in epicardial coronary arteries by visual assessment, or fractional flow reserve <0.80 in intermediate lesions (30-80%). RESULTS: A total of 150 patients were recruited (100 women, 50 men). Mean age was 58 (32-78) years. Obstructive CAD was found in 31 patients (21%). The area under the curve (AUC) for all the clinical risk prediction models (except the Duke Clinical Score, AUC 0.73, P = 0.07) was significantly lower compared with the clinician's assessment (AUC 0.51-0.65 vs. 0.81, respectively, P < 0.01). The clinician's assessment had sensitivity comparable to the Duke Clinical score, which was higher than all other clinical models. There was no difference in prediction performance on the basis of sex in this predominantly female population. DISCUSSION/CONCLUSION: In stable patients with chest pain and suspected CAD, current clinical risk models which are universally based upon the characteristics of the chest pain, show suboptimal performance in predicting obstructive CAD. These findings have important clinical implications, as current appropriateness criteria for recommending CA are on the basis of these risk models.

A Novel Risk Score to Predict One-Year Mortality in Patients Undergoing Complex High-Risk Indicated Percutaneous Coronary Intervention (CHIP-PCI).

OBJECTIVE: To identify patients undergoing complex, high-risk indicated percutaneous coronary intervention (CHIP-PCI) and compare their outcomes with non-CHIP patients. We created a CHIP score to risk stratify these patients. BACKGROUND: Risk stratification of PCI patients remains difficult because most scoring systems reflect hemodynamic instability and predict early mortality. METHODS: CHIP-PCI was defined as any of the following: age >80 years; ejection fraction <30%; dialysis; prior bypass surgery; treatment of left main trunk; chronic total occlusion; or >2 lesions in >1 coronary artery. The primary endpoint was 1-year all-cause mortality. Logistic regression identified independent predictors of 1-year mortality and the odds ratios (ORs) for those predictors were used to create a CHIP score. Patients were then classified as low, intermediate, and high risk. RESULTS: Among 4478 patients, a total of 1730 (38.6%) were CHIP. There were 85 deaths (2.2%) at 1 year (4.1% in CHIP patients and 1.0% in non-CHIP patients; P<.001). CHIP-PCI was an independent predictor of mortality (OR, 2.57; 955 confidence interval, 1.52-4.32; P<.001). Four CHIP criteria were independent predictors of mortality: age >80 years (3 points); dialysis (6 points); ejection fraction <30% (2 points); and number of lesions treated >2 (2 points). Accordingly, there were 2752 low-risk (score of 0), 889 intermediate-risk (score of 2-3), and 267 high-risk patients (score of 4-13). The 1-year mortality rates among these 3 groups were 1.24%, 2.47%, and 10.86%, respectively (P<.001). CONCLUSION: Compared with non-CHIP, CHIP-PCI is associated with increased risk of 1-year mortality, which is particularly evident among those fulfilling >1 CHIP criterion.

Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial.

OBJECTIVES: We compared the effect of bivalirudin or heparin and use or nonuse of glycoprotein IIb/IIIa inhibitors (GPI) on the outcome of left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the randomized EXCEL trial. BACKGROUND: The optimal antithrombotic regimen to support PCI of the LMCA remains controversial because of low representation of this subset in clinical trials. METHODS: The PCI cohort (n = 928) in EXCEL was divided according to bivalirudin versus heparin antithrombin treatment and compared for the primary composite endpoint of death, myocardial infarction (MI), or stroke at 30 days and 5 years. RESULTS: Bivalirudin was used in 319 patients (34.4%). The composite endpoint at 30 days occurred in 7.2% versus 3.8% bivalirudin and heparin patients, respectively, p = .02; at 5 years, the composite endpoint occurred in 26.3% versus 19.9% bivalirudin and heparin patients, respectively, p = .02. Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008). There were no differences in stent thrombosis between the groups. Bivalirudin use was an independent predictor of the 30-day composite endpoint (OR 2.88, 95% CI 1.28-6.48, p = .01) but not of the 5-year composite endpoint (OR 1.30, 95% CI 0.84-2.02, p = .23). GPI use was infrequent (n = 67, 7.2%) and was not associated with adverse outcomes. CONCLUSION: Among patients undergoing LMCA PCI in the EXCEL trial, procedural use of bivalirudin was associated with greater rates of periprocedural MI and the 30-day composite endpoint without reducing bleeding complications. Five-year outcomes were similar. GPIs were used infrequently and were not associated with clinical outcomes.

The impact of pre-existing peripheral artery disease on transcatheter aortic valve implantation outcomes: A systematic review and meta-analysis.

BACKGROUND: Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS: Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS: A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p < .0001) follow-up, and higher risk of VC (RR 1.55, 95% CI 1.27; 1.89, p < .0001). Moreover, the adoption of smaller sheaths during TAVI procedures was associated with fewer VC both in PAD and non-PAD patients, but the latter group had a more pronounced benefit. CONCLUSIONS: Patients with pre-existent PAD are at increased risk of all-cause mortality and VC after TAVI. The adoption of smaller sheaths during the procedure seems to be associated with fewer peri-procedural VC both in PAD and non-PAD patients.

High-throughput targeted proteomics discovery approach and spontaneous reperfusion in ST-segment elevation myocardial infarction.

BACKGROUND: Although spontaneous reperfusion (SR) prior to primary percutaneous coronary intervention (pPCI) is associated with improved outcomes, its pathophysiology remains unclear. The objective of the study was to explore associations between SR in ST-segment elevation myocardial infarction (STEMI) using a multimarker cardiovascular proteins strategy METHODS: We evaluated STEMI patients from the Assessment of Pexelizumab in Acute Myocardial Infarction trial treated with pPCI within 6 hours from symptom onset. SR was core laboratory-defined as pre-PCI Thrombolysis in Myocardial Infarction flow 2 or 3. Ninety-one cardiovascular disease-related serum biomarkers drawn prior to PCI were analyzed using a high-throughput "targeted discovery" panel. Expression levels for individual biomarkers were compared between patients with/without SR. A hierarchical clustering method of biomarkers identified clusters of biomarkers that differentiated the 2 groups. Associations between individual biomarkers and clusters with SR were further evaluated by multivariable logistic regression. RESULTS: Of 683 patients studied, 290 had spontaneous reperfusion; those with compared to without SR were more likely noninferior STEMI and had lower clinical acuity and lower baseline levels of troponin and creatine kinase. SR was associated with a lower occurrence of 90-day composite of death, heart failure, or cardiogenic shock. Fifty-two of 91 individual biomarkers were significantly univariably associated with SR. Forty-five remained significant with adjustment for false discovery rate. Using cluster analysis, 26 biomarkers clusters were identified, explaining 72% of total covariance, and 13 biomarker clusters were significantly associated with SR after multivariable adjustment. SR was associated with higher mean expression levels of proteins in all 13 clusters. The cluster most strongly associated with SR consisted of novel proteins across various distinct, yet interlinked, pathobiological processes (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3, and elafin). CONCLUSIONS: Spontaneous reperfusion prior to pPCI in STEMI was associated with a lower risk of adverse clinical events. These exploratory data from a targeted discovery proteomics platform identifies novel proteins across diverse, yet complementary, pathobiological axes that show promise in providing mechanistic insights into spontaneous reperfusion in STEMI. CONDENSED ABSTRACT: Spontaneous reperfusion has been established with improved STEMI outcomes, yet its pathobiology is unclear and appears to involve diverse physiological processes. Using a 91-biomarker high-throughput proteomics platform, we studied 683 STEMI patients in the APEX AMI trial (290 had core laboratory-adjudicated pre-PCI TIMI 2/3 flow) and identified 52 proteins that univariably associate with spontaneous reperfusion. Cluster analysis identified 26 biomarker clusters (explaining 72% of total variance), 13 of which, after multivariable adjustment, were significantly associated with spontaneous reperfusion. Four proteins (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3, and elafin) across diverse, yet complementary, pathways appear to be associated most strongly with spontaneous reperfusion.

Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triage Strategy trial.

OBJECTIVES: There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatine kinase-myocardial band isoenzyme). We sought to evaluate the safety and efficacy of bivalirudin monotherapy in patients with positive biomarkers from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. PATIENTS AND METHODS: We compared the net adverse clinical events [composite ischemia - (death, myocardial infarction, or unplanned ischemic revascularization) - or noncoronary artery bypass graft surgery (CABG)-related major bleeding] among patients with biomarker-positive NSTE-ACS in the ACUITY trial overall and by antithrombotic strategy. RESULTS: Among 13 819 patients with NSTE-ACS enrolled in ACUITY, 4728 patients presented with positive biomarkers and underwent an early invasive strategy. Of those, 1547 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), 1555 to bivalirudin plus GPI, and 1626 to bivalirudin monotherapy. Compared with biomarker-negative patients, biomarker-positive patients had higher 30-day rates of net adverse clinical events (14.0 vs. 12.4%; P = 0.04), all-cause death (1.3 vs. 0.5%; P = 0.001), cardiac death (1.1 vs. 0.5%; P = 0.005), and non-CABG-related major bleeding (6.5 vs. 5.2%, P = 0.03). At 30 days, bivalirudin monotherapy was associated with significantly less non-CABG-related major bleeding (bivalirudin monotherapy 4.1% vs. bivalirudin plus GPI 8.4% vs. heparin plus GPI 7.1%) with comparable rates of composite ischemia (bivalirudin monotherapy 9.2% vs. bivalirudin plus GPI 9.9% vs. heparin plus GPI 8.4%). In a multivariable model, bivalirudin monotherapy was associated with a significant reduction in non-CABG-related major bleeding but was not associated with an increased risk of death, myocardial infarction, unplanned revascularization or stent thrombosis. CONCLUSION: Compared with heparin plus GPI or bivalirudin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding at 30 days among patients with NSTE-ACS and positive biomarkers.

Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: A systematic review and meta-analysis.

BACKGROUND: Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. METHODS: With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. RESULTS: Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88-1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77-1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30-4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31-3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29-2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02-1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. CONCLUSIONS: BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.

An Updated Healthcare System-Wide Clinical Pathway for Managing Patients With Chest Pain and Acute Coronary Syndromes.

Clinical pathways reinforce best practices and help healthcare institutions standardize care delivery. The NewYork-Presbyterian/Columbia University Irving Medical Center has used such a pathway for the management of patients with chest pain and acute coronary syndromes for almost 2 decades. A multidisciplinary panel of stakeholders serially updates the algorithm according to new data and recently published guidelines. Herein, we present the 2019 version of the clinical pathway. We explain the rationale for changes to the algorithm and describe our experience expanding the pathway to all the 8 affiliated institutions within the NewYork Presbyterian healthcare system.

Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: Insights From a Single Institution Registry.

Dual-antiplatelet therapy is recommended for all patients with acute coronary syndromes (ACS), regardless of performance of revascularization. Ticagrelor (T) was shown to be superior to clopidogrel (C) in a large, randomized clinical trial, but data from real-world practice are lacking. We identified ACS patients from our institutional registry who underwent percutaneous coronary intervention and received one of the two drugs at hospital discharge based on physician preference. Among 1439 patients, there were 774 patients (53.8%) in the C group and 665 patients (46.2%) in the T group. T and C patients were similar except for a higher incidence of ST-elevation myocardial infarction (MI) and lower frequency of prior MI in the T group (P<.05 for both). The primary endpoint - 1-year all-cause death - occurred in 58 C patients and 48 T patients (6.9% vs 7.9%, respectively; P=.42). Sixty percent of these deaths (n = 62; 31 C and 31 T) were considered cardiovascular in nature based on chart review. By multivariable logistic regression model, only dialysis (hazard ratio [HR], 2.64; 95% confidence interval [CI], 1.50-4.64; P=.01), age (HR, 1.83; 95% CI, 1.49-2.24 per 10 years; P<.001), and prior heart failure (HR, 1.78; 95% CI, 1.12-2.82; P=.02) were independent predictors of 1-year death. Treatment with T was not a predictor of death (HR, 1.21; 95% CI, 0.81-1.82; P=.35) or cardiovascular death (HR, 1.18; 95% CI, 0.72-1.94; P=.52). Landmark analysis from day 10 showed similar results (HR, 1.13; 95% CI, 0.71-1.84; P=.59). Thus, we conclude that C and T have similar rates of 1-year all-cause mortality, which is predominantly affected by age, end-stage renal disease, and pre-existing heart failure.

Derivation and external validation of a novel risk score for prediction of 30-day mortality after percutaneous coronary intervention.

AIMS: Early mortality after percutaneous coronary intervention (PCI) is relatively rare. Current risk prediction models for this event are outdated. We sought to derive a 30-day mortality risk score after PCI. METHODS AND RESULTS: The score was derived from a pooled database of 21 randomised clinical trials using a logistic regression model incorporating clinical and angiographic variables. The score was validated in a separate unrestricted study population, the Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES) registry. Of 32,882 eligible patients, 75% had data for all 19 variables used for score derivation. The independent predictors of 30-day mortality were age, presentation with ACS, diabetes mellitus, use of first-generation drug-eluting stents, left main or left anterior descending artery lesion, prior myocardial infarction (MI), and suboptimal flow in the artery before or after PCI. The median [interquartile range] score in the derivation cohort was 5 [3, 6] and overall mortality was 0.49%, ranging from 0.08% to 1.64% with scores of 0-16. The 30-day mortality rate was approximately tenfold higher in patients with a score at or above versus below the median of 5 (0.86% versus 0.08%, p<0.0001). Discrimination in both cohorts was very good (C statistic=0.848 and 0.828, respectively), and calibration was satisfactory. CONCLUSIONS: A novel risk score incorporating eight readily available clinical and angiographic variables had high discrimination for 30-day death after PCI across a wide range of clinical scenarios.