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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], P0.001) and elective PCI (HR 0.63 [0.58-0.70], P0.0001). 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 (P

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

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: age80 years (3 points), dialysis (6 points), left ventricular ejection fraction30% (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.

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.

Objectives The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. Background Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. Methods A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. Results Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. Conclusions Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

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.Risk stratification of PCI patients remains difficult because most scoring systems reflect hemodynamic instability and predict early mortality.CHIP-PCI was defined as any of the following: age80 years; ejection fraction30%; dialysis; prior bypass surgery; treatment of left main trunk; chronic total occlusion; or2 lesions in1 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.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: age80 years (3 points); dialysis (6 points); ejection fraction30% (2 points); and number of lesions treated2 (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).Compared with non-CHIP, CHIP-PCI is associated with increased risk of 1-year mortality, which is particularly evident among those fulfilling1 CHIP criterion.

Platelet inhibition is essential in the management of coronary artery disease. The American College of Cardiology/American Heart Association and the European Society of Cardiology have developed guidelines for the management of antiplatelet therapy in acute coronary syndrome and in stable coronary artery disease. In this chapter, we review the evidence for (1) P2Y12 inhibitor selection, (2) de-escalation of antiplatelet therapy, and (3) platelet function and genotype testing. Thereafter, we will discuss and review the available clinical practice guidelines and compare them to the evidence-base that has been generated by large randomized clinical trials.

Atherosclerosis is the principal mechanism explaining the majority of major adverse cardiac and cerebral events, as well as acute limb ischemia and peripheral arterial diseases. Much of the development of atherosclerosis is linked to platelet participation in the inflammatory process underlying it. In this chapter, we explore the basics of initiation, progression, and destabilization of the atherosclerotic plaque, in an attempt to highlight the pivotal importance of platelets in these processes and to glean the potential therapeutic implications of these interactions.

Platelet inhibition is one of the cornerstones of treatment for coronary artery disease. Aspirin and a P2Y12 receptor antagonists such as clopidogrel, prasugrel, or ticagrelor potently inhibit platelets and create the combination commonly referred to as dual antiplatelet therapy (DAPT). Essential in the acute setting after percutaneous coronary intervention and in the months that follow, but controversial when used years after intervention, DAPT—and the optimal duration for use—has been the subject of many studies. In this chapter, we review the evidence and make the case for extended treatment for patients who are particularly vulnerable to recurrent ischemic events.

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (

Conflicting data exist regarding the associations between on-site surgical backup and outcomes after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Thus, we sought to assess the impact of such a backup on periprocedural outcomes of primary PCI using data from the Polish National Registry of PCI. From 2014 to 2016 data on 66,707 patients presenting with STEMI undergoing primary PCI from 154 centers were collected. Patients were divided into 2 groups based on the presence of on-site surgical backup. Of 66,707 patients, 15,040 (22.6%) patients were treated in 28 centers with on-site surgical backup. On-site surgical backup was associated with a higher center PCI annual volume (662.4 ± 301.8 vs 1098.7 ± 483.5; p0.001), but a lower operator PCI annual volume (226.7 ± 126.0 vs 207.8 ± 96.6; p0.001). The periprocedural mortality (1.60% vs 1.09%; p0.001) was lower in patients from centers with on-site cardiac surgery and both on-site surgical backup (odds ratio [95% confidence interval], 0.618 [0.517; 0.738]; p0.001) and the mean number of PCIs by operator per year (odds ratio per 10 [95% confidence interval], 0.990 [0.984; 0.996]; p = 0.001] were independent predictors of periprocedural death. In conclusion, results of our study suggest that periprocedural mortality in patients undergoing primary PCI for STEMI is lower in centers than without on-site cardiac surgical backup. Whether this effect on mortality is attributable to such backup itself and/or whether surgical backup is a marker of overall better medical care and adherence to professional guidelines, this needs clarification in further studies.

Supplemental Digital Content is available in the text., Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P=0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P=0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P=0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P=0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571.

Background Whether the consequences of diabetes mellitus (DM) are worse for women than for men treated with drug-eluting stents (DES) and antiplatelet therapy remain unclear. Methods Patients from the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents study were stratified according to sex and DM status. We investigated the sex-specific effect of DM on high on-clopidogrel platelet reactivity (HPR), defined as a P2Y 12 reaction units ≥208, and the adjusted association of DM on the 2-year risk for coronary thrombotic events (CTE), defined as spontaneous myocardial infarction or definite or probable stent thrombosis. Results Out of 8582 patients included in the study, 829 were women with DM (9.6%) and 1954 were men with DM (16.2%). The prevalence of insulin-treated DM (ITDM) was greater in women ( p int =0.88). Following adjustment for baseline variables and HPR, in women a stepwise increase in risk for CTEs was observed in the transition from no DM to non–ITDM (NITDM) (adjusted hazard ratio [adjHR]: 1.31; 95% CI: 0.78–2.18) to ITDM (adjHR: 2.69; 95% CI: 1.23–3.45). This increase in risk associated with subtypes of DM was of smaller magnitude in men (for NITDM, adjHR: 1.04; 95% CI: 0.77–1.39; for ITDM, adjHR: 1.46; 95% CI: 1.05–2.03; p int =0.016). Conclusions In a population treated with DES and antiplatelet therapy, the risk for CTE associated with DM seems to be greater in women and was independent of HPR.

Background: The determinants and significance of early (30-day) heart failure symptoms after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) remain unclear. We investigated the clinical and imaging correlates of early post-discharge heart failure in patients with STEMI, and evaluated its impact on clinical outcomes. Methods: Patients from the INFUSE-AMI trial were categorized according to New York Heart Association (NYHA) functional classification at their 30-day visit (NYHA class ≥2 versus 1). Independent correlates of NYHA class ≥2 were determined by multivariable logistic regression. A landmark analysis beyond 30 days was performed to assess the impact of 30-day NYHA class ≥2 on 1-year risk of death or hospitalization for heart failure. Results: Among 402 patients enrolled in the INFUSE-AMI trial with data on NYHA class at 30 days, 76 (18.9%) had NYHA class ≥2. Independent correlates of 30-day NYHA class ≥2 were age, Killip class ≥2 at presentation, heart rate at presentation, intraprocedural no-reflow, and 30-day infarct size (% total ventricular mass). After adjustment for infarct size, patients with NYHA class ≥2 remained at higher risk of death or hospitalization for heart failure at 1-year follow-up compared to those in NYHA class 1 (11.8% vs. 2.8%, adjusted hazard ratio 3.78, 95% confidence interval 1.16–12.22, P=0.03). Conclusions: Clinical, procedural, and imaging variables predict the development of clinical heart failure after primary percutaneous coronary intervention in patients with STEMI. Early post-discharge heart failure symptoms identify a high-risk patient cohort for subsequent heart failure hospitalization and death, independent of infarct size. Trial Registration: ClinicalTrials.gov ; NCT00976521

We thank Dr. Tamis-Holland and colleagues for their interest in our article [(1)][1]. We recognize that combining prospective observational studies with randomized controlled trials (RCTs) might be a limitation, but this was done to increase the statistical power of our observations. We acknowledge

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.

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.

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.

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.

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

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

We sought to investigate the effect of smoking on infarct size (IS) and major adverse cardiac events (MACE) in patients with large anterior ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Participants from the Intracoronary Abciximab and Aspiration Thrombectomy in Patients with Large Anterior Myocardial Infarction study were categorized according to smoking status (current or previous smoking vs no history of smoking). The primary imaging outcome was cardiac magnetic resonance imaging-assessed IS of left ventricular mass (%) at 30 days. The primary clinical outcome was the rate of MACE at 30 days and 1 year, defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization. Of 447 patients enrolled in Intracoronary Abciximab and Aspiration Thrombectomy in Patients with Large Anterior Myocardial Infarction, 271 (60.6%) were current or past smokers. Compared with nonsmokers, smokers were almost 10 years younger and had a lower prevalence of clinical co-morbidities. Smokers had better procedural success and angiographic reperfusion compared with nonsmokers. At 30 days, there were no differences between smokers and nonsmokers in median IS (16.8% vs 17.4%, p = 0.67) or metrics of left ventricular function. By multivariable linear regression analysis, smoking was not significantly associated with IS at 30 days (beta coefficient: 0.83, p = 0.42). At 1 year, smokers had lower crude rates of MACE (7.6% vs 15%, p = 0.01). After multivariable adjustment, there were no significant differences in 1-year MACE between smokers and nonsmokers (adjusted hazard ratio 0.73, 95% CI 0.40 to 1.33, p = 0.30). In conclusion, smoking history had no significant effect on IS at 30 days. Although current or previous smokers had lower rates of 1-year MACE than those with no history of smoking, adjustment for baseline characteristics rendered this association nonsignificant. These findings support the hypothesis that the smoker's paradox is largely attributable to differences in demographic and clinical baseline risk, rather than differences in IS after primary percutaneous coronary intervention.

Objectives The authors conducted a systematic pairwise and network meta-analysis to assess optimal treatment strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MV-CAD) undergoing primary percutaneous coronary intervention (PCI). Background Patients with STEMI and MV-CAD have a worse prognosis than those with single-vessel CAD. The optimal revascularization strategy for these patients is uncertain. Methods Studies of revascularization strategies for MV-CAD in STEMI patients undergoing primary PCI published between 2001 and 2015 were identified using an electronic search. Pairwise and network meta-analyses were performed for 3 PCI strategies in prospective and retrospective studies: 1) infarct-related artery (IRA)-only PCI; 2) single procedure MV-PCI; and 3) staged MV-PCI. Information on study design, inclusion and exclusion criteria, and clinical outcomes was extracted. The outcomes of interest were short-term and long-term mortality. Results Thirty-two studies (13 prospective and 19 retrospective) with 54,148 patients (IRA-only PCI [n = 42,112], single procedure MV-PCI [n = 8,138], and staged MV-PCI [n = 3,898]) were included in the analysis. Pairwise meta-analyses showed that staged MV-PCI was associated with lower short-term and long-term mortality compared with both IRA-only PCI and single stage MV-PCI, whereas IRA-only PCI was associated with lower mortality compared with single stage MV-PCI. Staged MV-PCI was also associated consistently with improved survival in network analyses. Conclusions The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.

Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non–coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; p interaction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; p interaction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non–access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (p interaction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.

Cardiac amyloidosis is an infiltrative disorder of the myocardium. It is the result of one of 4 types of amyloidosis: primary systemic (immunoglobulin light chain), secondary, familial (hereditary), or senile. Cardiac amyloidosis ultimately causes congestive heart failure due to irreversible restrictive cardiomyopathy. Because of the rapid progression of the disease, early recognition and determination of underlying etiology are important for tailored therapy. Current interventions range from conservative heart failure management to autologous stem cell and heart transplantation. We present a case of cardiac amyloidosis accompanying undiagnosed multiple myeloma to illustrate the rapid progression of the disease and the complexities of diagnosing and treating this disorder.

Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality. Background These events have been strongly associated with subsequent death. Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period. Results Among 8,582 patients, 1,060 (12.4%) had events—691 (8.1%) had CB, 294 (3.4%) had MI, and 75 (0.9%) had ST—and 7,522 (87.6%) had no events. The highest risk was associated with early ST (38.5% mortality at 30 days after the event), whereas very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.

Aims: Prior percutaneous coronary intervention (PCI) is increasingly encountered in acute coronary syndrome (ACS) patients, with uncertain significance. We sought to evaluate the impact of prior PCI in ACS patients. Methods and results: Patients with ACS enrolled in the prospective PROSPECT registry underwent three-vessel intravascular ultrasound and virtual histology evaluation after successful PCI of the culprit lesion(s). We identified patients with prior PCI (>6 months before index ACS) and compared their outcomes to those without prior PCI. Time-to-event for major adverse cardiac events (MACE) was estimated up to three years, and the independent association between prior PCI and MACE was evaluated in a multivariable model. Among 696 patients enrolled, 77 (11.1%) had prior PCI. They were older and more likely to have prior myocardial infarction, chronic kidney disease, and congestive heart failure. At three years, patients with prior PCI had significantly higher rates of cardiac death, rehospitalisation for worsening angina, and MACE (adjusted HR=1.73 [95% CI: 1.09, 2.75], p=0.02), independent of other comorbidities and intravascular ultrasound findings. Conclusions: Prior PCI was noted in over 10% of patients with ACS and was associated with higher mortality and morbidity, independent of other comorbidities. Prior PCI should be considered a high-risk feature when evaluating ACS patients.

Objectives This study sought to determine the extent to which individual components of intraprocedural thrombotic events (IPTEs) are associated with adverse events. Background IPTEs occurring during percutaneous coronary intervention (PCI) are associated with adverse in-hospital and late outcomes in patients with acute coronary syndromes. Methods A total of 6,591 patients who underwent PCI for non–ST-segment elevation acute coronary syndromes/ST-segment elevation myocardial infarction in the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) and HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trials underwent detailed frame-by-frame core laboratory angiographic analysis to assess for IPTEs. The associations of IPTE components with death, major bleeding, and major adverse cardiac events at 30 days were assessed using univariable analyses and multivariable models. Results The overall incidence of IPTEs was 7.7%, with a greater incidence in ST-segment elevation myocardial infarction patients (12.2%) compared with non–ST-segment elevation acute coronary syndromes patients (3.5%). Specific components of IPTEs included no-reflow/slow reflow in 58.0%, new/worsened thrombus in 35.3%, distal embolization in 34.9%, abrupt closure in 19.8%, and intraprocedural stent thrombosis (IPST) in 9.5% of patients. Each IPTE component was independently associated with 30-day death, major bleeding, and MACE in multivariable models, with the strongest association observed for IPST (MACE hazard ratio: 7.51 [95% confidence interval: 4.36 to 12.94]). Conclusions The occurrence of IPTEs is not infrequent among high-risk acute coronary syndromes patients undergoing PCI, and each IPTE component was associated with subsequent adverse events. Although IPST represented

Objectives We sought to identify angiographic predictors of 2-year stent thrombosis (ST) in the ADAPT-DES study. Background A strong relationship between platelet reactivity and ST after implantation of drug-eluting stents (DES) was recently confirmed in the prospective, multicenter ADAPT-DES study. Methods In a pre-specified analysis of patients enrolled in ADAPT-DES, an independent angiographic core laboratory performed detailed angiographic analyses for all cases of ST. Patients with Academic Research Consortium definite/probable target-lesion ST were matched with controls in a 1:2 ratio, and multivariable Cox regression models identified angiographic predictors of 2-year ST. Results Among 8,582 patients who had successful percutaneous coronary intervention (PCI) and were included in the ADAPT-DES study, 92 (1.1%) patients had ST at 2-year follow-up. Target lesion-related ST was identified in 77 patients (82 lesions) who were clinically matched with 153 patients (196 lesions) without ST. Patients with ST were more likely to have longer target lesions, thrombus, moderate/severe calcification, American College of Cardiology/American Heart Association (ACC/AHA) type C lesions, and saphenous vein grafts. After adjustment for clinical covariates the angiographic variables that predicted ST were lesion complexity (ACC/AHA type C lesion, adjusted HR: 1.97, 95% CI: 1.19 to 3.26, P = 0.01) and presence of thrombus on index PCI (HR: 2.25, 95% CI: 1.40 to 3.59, P

There are limited data on the predictors of death or heart failure (HF) hospitalization in patients with HF and severe functional mitral regurgitation (FMR). In the COAPT trial, 614 symptomatic patients with HF, 3+ or 4+ FMR and left ventricular ejection fraction 20-50% were randomized to maximally

Patients (pts) with prior percutaneous coronary intervention (PCI) are thought to have worse long-term outcomes; however, the magnitude of this impact remains unknown. We sought to assess the impact of prior PCI on 5-year outcomes after stent implantation. Individual pt-data (IPD) from 20

Pts undergoing PCI for ostial lesions are thought to have worse outcomes; however, the long-term impact of PCI in ostial lesions is uncertain. Individual patient-data (IPD) from 4 prospective randomized trials (ACUITY, HORIZONS-AMI, COMPARE I, and ENDEAVOR) were pooled. Pts undergoing single lesion

We examined our institutional experience with mechanical circulatory support (MCS) over nearly a decade in patients with ST-segment elevation myocardial infarction (STEMI) to identify temporal trends and the impact of “door-to-unloading” time on in-hospital mortality. Baseline characteristics

The dual antiplatelet therapy (DAPT) risk score was developed from the DAPT trial to inform the optimal duration of DAPT after percutaneous coronary intervention. We assessed the performance of the DAPT score in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with drug-eluting stents) all-comers registry and tested the utility of additional predictors of adverse events.Outcomes between 1 and 2 years were examined according to DAPT score ≥2 versus2, adjusted for DAPT continuation as a time-dependent variable. To assess the incremental utility of variables not included in the DAPT score, baseline high platelet reactivity was added to the ischemia model, and high platelet reactivity, baseline hemoglobin, and warfarin use 1 year after percutaneous coronary intervention were added to the bleeding model. Among 8582 patients enrolled in ADAPT-DES, 5397 were event-free after 1 year. Between 1 and 2 years, ischemic (myocardial infarction or stent thrombosis) and bleeding events occurred in 75 (1.5%) and 124 (2.3%) patients, respectively. Patients with higher DAPT scores (≥2 versus2) had higher rates of myocardial infarction or stent thrombosis (1.9% versus 1.1%; P=0.01) and similar rates of bleeding (2.2% versus 2.4%, respectively; P=0.79). For the prediction of myocardial infarction or stent thrombosis, bleeding and death, DAPT score ≥2 had sensitivities of 57%, 41%, and 56%, respectively; specificities of 58%, 57%, and 58%, respectively; positive predictive values of 1.9%, 2.2%, and 2.1%, respectively; and negative predictive values of 99%, 98%, and 99%, respectively. Addition of baseline high platelet reactivity to the DAPT score did not improve discrimination for ischemic events. Addition of high platelet reactivity and 2 other bleeding covariates to the DAPT score marginally improved discrimination.In ADAPT-DES, the DAPT score was predictive of ischemic events between 1 and 2 years after drug-eluting stents. Prediction of bleeding improved marginally after addition of variables not incorporated in the DAPT score.

Background: The dual antiplatelet therapy (DAPT) risk score was developed from the DAPT trial to inform the optimal duration of DAPT after percutaneous coronary intervention. We assessed the performance of the DAPT score in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with drug-eluting stents) all-comers registry and tested the utility of additional predictors of adverse events. Methods and Results: Outcomes between 1 and 2 years were examined according to DAPT score ≥2 versus P =0.01) and similar rates of bleeding (2.2% versus 2.4%, respectively; P =0.79). For the prediction of myocardial infarction or stent thrombosis, bleeding and death, DAPT score ≥2 had sensitivities of 57%, 41%, and 56%, respectively; specificities of 58%, 57%, and 58%, respectively; positive predictive values of 1.9%, 2.2%, and 2.1%, respectively; and negative predictive values of 99%, 98%, and 99%, respectively. Addition of baseline high platelet reactivity to the DAPT score did not improve discrimination for ischemic events. Addition of high platelet reactivity and 2 other bleeding covariates to the DAPT score marginally improved discrimination. Conclusions: In ADAPT-DES, the DAPT score was predictive of ischemic events between 1 and 2 years after drug-eluting stents. Prediction of bleeding improved marginally after addition of variables not incorporated in the DAPT score.

Short-term outcome after percutaneous coronary intervention (PCI) has improved dramatically, but the association between clinical or angiographic characteristics and long-term outcome remains less well described. The SYNTAX (Synergy Between PCI With TAXUS and Cardiac Surgery) II score has been designed to overcome the limitations of the purely angiographic SYNTAX I score by including clinical parameters and comorbidities. It has not been tested extensively in "real-world" PCI patients, outside of randomized clinical studies.We identified unique patients undergoing PCI between January 1, 2011 and January 24, 2013 and followed for at least 60 days. We calculated the SYNTAX I and II scores for each patient and collected data at longest follow-up available for vital status, recurrent PCI, systolic heart failure, stroke, or Q-wave myocardial infarction. Cox proportional hazards regression was used to assess independent predictors of mortality. There were 831 patients followed for a mean of 4 years. The average age was 66 ± 10 years. Nearly 40% were women and 50% had diabetes mellitus. The mean follow-up interval was 4 years, during which 42 patients died (Kaplan-Meier rate, 4.3% [IQR, 3.0-6.2%]). The PCI-SYNTAX II score was significantly higher in patients who died than in survivors (43 ± 12 vs 32 ± 12, respectively; P.001). The SYNTAX II score was the only variable associated with death at a mean follow-up of 4 years (hazard ratio per 1 point, 1.05 [95% confidence interval, 1.03-1.08]; P.001).The SYNTAX II score, incorporating angiographic and clinical parameters, is a useful tool for risk stratification and prediction of 4-year mortality in "real-world" patients.

Background: Despite advances in technology and technique, a substantial proportion of patients still die within several years after percutaneous coronary intervention (PCI). The relative rates of cardiovascular and noncardiovascular death after PCI remain uncertain. Methods and Results: We pooled individual patient-level data from 21 randomized clinical trials of PCI performed in 32 882 patients. All studies had independent adjudication of clinical events. We calculated the relative ratio of cardiovascular to noncardiovascular death in each trial up to 5 years and identified predictors of all-cause, cardiovascular, and noncardiovascular death. At the end of the follow-up period, 1980 patients had died (Kaplan-Meier estimated mortality rate, 9.19%). The rates of cardiovascular and noncardiovascular mortality at 5 years were 4.23% (945) and 5.17% (1035), respectively. The rate of cardiovascular death was higher than noncardiovascular death in the first 30 days after PCI (relative ratio, 6.99; 95% confidence interval, 3.16–15.42; P P =0.0005). Any adverse cardiac event (definite stent thrombosis, spontaneous myocardial infarction, or repeat revascularization) preceded cardiovascular and noncardiovascular mortality in 292 (30.9%) and 151 (14.6%) patients, respectively. In a multivariable model with adverse events entered as time-adjusted covariates, myocardial infarction and definite ST were associated with early and late all-cause and cardiovascular mortality but not noncardiovascular mortality. Conclusions: In this large-scale study of patients undergoing PCI, the 5-year rates of cardiovascular and noncardiovascular mortality were similar, but their relative timing was different.