Cardiac Magnetic Resonance Imaging Versus Invasive-Based Strategies in Patients With Chest Pain and Detectable to Mildly Elevated Serum Troponin: A Randomized Clinical Trial.

BACKGROUND: The optimal diagnostic strategy for patients with chest pain and detectable to mildly elevated serum troponin is not known. The objective was to compare clinical outcomes among an early decision for a noninvasive versus an invasive-based care pathway. METHODS: The CMR-IMPACT trial (Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients with Acute Chest Pain and Detectable to Elevated Troponin) was conducted at 4 United States tertiary care hospitals from September 2013 to July 2018. A convenience sample of 312 participants with acute chest pain symptoms and a contemporary troponin between detectable and 1.0 ng/mL were randomized early in their care to 1 of 2 care pathways: invasive-based (n=156) or cardiac magnetic resonance (CMR)-based (n=156) with modification allowed as the patient condition evolved. The primary outcome was a composite including death, myocardial infarction, and cardiac-related hospital readmission or emergency visits. RESULTS: Participants (N=312, mean age, 60.6 years, SD 11.3; 125 women [59.9%]), were followed over a median of 2.6 years (95% CI, 2.4-2.9). Early assigned testing was initiated in 102 out of 156 (65.3%) CMR-based and 110 out of 156 (70.5%) invasive-based participants. The primary outcome (CMR-based versus invasive-based) occurred in 59% versus 52% (hazard ratio, 1.17 [95% CI, 0.86-1.57]), acute coronary syndrome after discharge 23% versus 22% (hazard ratio, 1.07 [95% CI, 0.67-1.71]), and invasive angiography at any time 52% versus 74% (hazard ratio, 0.66 [95% CI, 0.49-0.87]). Among patients completing CMR imaging, 55 out of 95 (58%) were safely identified for discharge based on a negative CMR and did not have angiography or revascularization within 90 days. Therapeutic yield of angiography was higher in the CMR-based arm (52 interventions in 81 angiographies [64.2%] versus 46 interventions in 115 angiographies [40.0%] in the invasive-based arm [P=0.001]). CONCLUSIONS: Initial management with CMR or invasive-based care pathways resulted in no detectable difference in clinical and safety event rates. The CMR-based pathway facilitated safe discharge, enriched the therapeutic yield of angiography, and reduced invasive angiography utilization over long-term follow-up. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01931852.

The Impact of Bleeding Avoidance Strategies on Hospital-Level Variation in Bleeding Rates Following Percutaneous Coronary Intervention: Insights From the National Cardiovascular Data Registry CathPCI Registry.

OBJECTIVES: The aim of this study was to explore whether the use of bleeding avoidance strategies (BAS) explains variability in hospital-level bleeding following percutaneous coronary intervention. BACKGROUND: Prior studies have reported that bleeding rates following percutaneous coronary intervention vary markedly among hospitals, but the extent to which use of BAS explains this variation is unknown. METHODS: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, estimated hospital-level bleeding rates from 2,459,686 procedures at 1,358 sites were determined. A series of models were fit to estimate random-effect variance, adjusting for patient risk (using the validated CathPCI bleeding risk model, C statistic = 0.77) and various combinations of BAS (transradial access, bivalirudin, vascular closure device use). The rate of any BAS use was also estimated for each hospital, and the association between percentage BAS use and predicted bleeding rates was determined. RESULTS: In total, 125,361 bleeding events (5.1%) were observed; patients experiencing bleeding events had lower rates of radial access (5.0% vs. 11.2%; p < 0.001), bivalirudin therapy (43.8% vs. 59.4%), and vascular closure device use (32.9% vs. 42.4%, p < 0.001) than those without bleeding. There was significant variation in bleeding rates across hospitals (median 5.0%; interquartile range [IQR]: 2.7% to 6.6%), which persisted after incorporating patient-level risk (median 5.1%; IQR: 4.0% to 4.4%). Patient factors accounted for 20% of the overall hospital-level variation, and radial access plus bivalirudin use accounted for an additional 7.8% of the overall hospital-level variation. The median hospital rate of any BAS use was 86.6% (IQR: 72.5% to 94.1%). A significant decrease in observed hospital-level bleeding was seen in hospitals above the median in BAS use (adjusted odds ratio: 0.90; 95% confidence interval: 0.88 to 0.93). CONCLUSIONS: A modest proportion of the variation in hospitals' rates of bleeding following percutaneous coronary intervention is attributable to differential use of BAS. Further analyses are required to determine the remaining approximately 70% causes of variation in percutaneous coronary intervention bleeding seen among hospitals.

The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry.

BACKGROUND: Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. METHODS AND RESULTS: We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. CONCLUSIONS: As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases.

Comparison of percutaneous coronary intervention for previously treated versus de novo culprit lesions in acute myocardial infarction patients: insights from the National Cardiovascular Data Registry.

BACKGROUND: Little is known about percutaneous coronary intervention (PCI) outcomes among patients presenting with an acute myocardial infarction (MI) with a history of prior PCI. Outcomes may differ depending on whether PCI is performed on a previously treated or de novo culprit lesion. METHODS: We examined ST-segment elevation myocardial infarction (STEMI) and non-STEMI patients who underwent PCI in the CathPCI Registry from 2009 to 2012. We used multivariable logistic regression to compare adjusted in-hospital mortality between groups. RESULTS: Among 675,587 MI patients, 147,841 (22%) had a history of prior PCI; these patients were older and more frequently had co-morbid conditions yet had lower adjusted mortality compared with patients undergoing their first intervention (OR = 0.73, 95% CI = 0.70-0.76). Among patients with prior PCI, 50,744 (34%) received intervention to a culprit lesion in a previously treated segment. Compared with patients with de novo culprit lesions, those with previously treated culprits were more likely to present with STEMI, but had lower mortality risk (OR = 0.88, 95% CI = 0.82-0.95) regardless of STEMI or non-STEMI presentation. Among previously treated patients, in-hospital mortality was not significantly different between those with prior drug-eluting versus bare metal stent-treated culprit lesions (OR = 0.95, 95% CI = 0.81-1.12). CONCLUSION: Despite greater co-morbidity burden, MI patients with prior PCI had lower mortality compared with patients undergoing their first intervention. Among patients with prior PCI, patients undergoing PCI to a previously treated culprit lesion were associated with lower mortality than those being intervened for a de novo culprit. A better understanding of these differences will help improve procedural strategies and outcomes of patients undergoing PCI of a previously treated lesion.

Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

OBJECTIVE: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

Guidelines-based treatment of anaemic STEMI patients: practice patterns and effects on in-hospital mortality: a retrospective analysis from the NCDR.

BACKGROUND: Anaemia is associated with an increased risk for morbidity and mortality in ST-elevation myocardial infarction (STEMI) patients. While several physiological mechanisms have been proposed to explain this association, decreased receipt of guidelines-based care may also contribute. We examined the relationship between admission haemoglobin (Hgb) level, receipt of ACC/AHA guidelines-based treatments, and in-hospital outcomes among STEMI patients. We also evaluated whether administration of these treatments modified the association between anaemia and in-hospital mortality in this group. METHODS AND RESULTS: We analysed data from 92,686 patients diagnosed with STEMI included in the NCDR ACTION Registry-GWTG database from January 2007 to March 2011. Patients were stratified by initial Hgb value: 83.1% (n=77,035) were classified as non-anaemic (Hgb >13.0 g/dl for men, >12.0 g/dl for women), 11.6% (n=10,710) as mildly anaemic (11.1-13.0 g/dl for men, 11.1-12.0 g/dl for women), 4.4% (n=4059) as moderately anaemic (9.1-11.0 g/dl), and 1.0% (n=882) as severely anaemic (<9.0 g/dl). Anaemia was associated with a significantly increased prevalence of other baseline comorbidities and decreased odds of receiving several class I recommended pharmacological treatments (heparin, beta-blockers, and angiotensin-converting enzyme inhibitors, p<0.01). The overall use of reperfusion therapy (fibrinolytic therapy and/or percutaneous coronary intervention) was also lower in anaemic vs. non-anaemic patients (p<0.01). Anaemia was associated higher in-hospital mortality risk, which remained significant after adjustment for use of guidelines-recommended therapies and interventions (p<0.01). CONCLUSIONS: In a national sample of STEMI patients, anaemia on presentation was associated with decreased receipt of ACC/AHA guidelines-based care and higher in-hospital mortality. However, the higher mortality rates could not be fully explained by differences in in-hospital treatment.

Diagnostic time course, treatment, and in-hospital outcomes for patients with ST-segment elevation myocardial infarction presenting with nondiagnostic initial electrocardiogram: a report from the American Heart Association Mission: Lifeline program.

BACKGROUND: Prior studies indicate that a subset of patients diagnosed as having ST-segment elevation myocardial infarction (STEMI) will have an initial non-diagnostic electrocardiogram (ECG) during evaluation. However, the timing of diagnostic ECG changes in this group is unknown. Our primary aim was to describe the timing of ECG diagnosis of STEMI in patients whose initial ECG was non-diagnostic. Secondarily, we sought to compare the delivery of American College of Cardiology/American Heart Association guidelines-based care and in-hospital outcomes in this group compared with patients diagnosed as having STEMI on initial ECG. METHODS: We analyzed data from 41,560 patients diagnosed as having STEMI included in the National Cardiovascular Data Registry ACTION Registry-GWTG from January 2007 to December 2010. We divided this study population into 2 groups: those diagnosed on initial ECG (N = 36,994) and those with an initial non-diagnostic ECG that were diagnosed on a follow-up ECG (N = 4,566). RESULTS: In general, baseline characteristics and clinical presentations were similar between the 2 groups. For patients with an initial non-diagnostic ECG, 72.4% (n = 3,305) had an ECG diagnostic for STEMI within 90 minutes of their initial ECG. There did not appear to be significant differences in the administration of guideline-recommended treatments for STEMI, in-hospital major bleeding (P = .926), or death (P = .475) between these groups. CONCLUSIONS: In a national sample of patients diagnosed as having STEMI, 11.0% had an initial non-diagnostic ECG. Of those patients, 72.4% had a follow-up diagnostic ECG within 90 minutes of their initial ECG. There did not appear to be clinically meaningful differences in guidelines-based treatment or major inhospital outcomes between patients diagnosed as having STEMI on an initial ECG and those diagnosed on a follow-up ECG.

Trends and predictors of length of stay after primary percutaneous coronary intervention: a report from the CathPCI registry.

BACKGROUND: Post hoc analyses of clinical trials suggest that certain patients are eligible for early discharge after ST-segment elevation myocardial infarction. The extent to which ST-segment elevation myocardial infarction patients are discharged early after primary percutaneous coronary intervention (PPCI) in current practice is unknown. METHODS: We examined 115,113 patients in the CathPCI Registry to assess temporal trends in length of stay (LOS) after PPCI. Baseline characteristics were compared between patients with LOS ≤2 and >2 days. Predictors of LOS >2 days were determined by logistic regression and adjusted for clustering among centers. Patterns of discharge within 2 days for low-risk patients with no inhospital complications were examined. RESULTS: From January 2005 through March 2009, mean LOS (4.0 ± 3.0 to 3.6 ± 2.7 days) (P for trend <.001) and the proportion of patients discharged after 2 days decreased (72.0%-65.9%), while predicted inhospital mortality risk remained unchanged. Patients with LOS >2 days (n = 77,471; 67.3%) were older and more likely to have had an intra-aortic balloon pump, cardiogenic shock, transfusions, and post-PPCI complications. Of 958 hospitals, 437 (45.6%) discharged at least half of their low-risk patients with no inhospital complications within 2 days. CONCLUSIONS: While the predicted risk profile has remained stable, there has been a significant decrease in LOS after PPCI. Nevertheless, hospitals vary in discharging low-risk and uncomplicated patients early. Discharge within 2 days was associated with specific patient, procedure, and hospital factors. Further study is needed to determine the safety of early discharge among patients undergoing PPCI.

Percutaneous coronary intervention at centers with and without on-site surgery: a meta-analysis.

CONTEXT: Percutaneous coronary interventions are performed at centers without onsite surgery, despite current guidelines discouraging this. OBJECTIVE: To assess literature comparing rates of in-hospital mortality and emergency coronary artery bypass grafting surgery at centers with and without on-site surgery. DATA SOURCES: A systematic search of studies published between January 1990 and May 2010 was conducted using MEDLINE, EMBASE, and Cochrane Review databases. STUDY SELECTION: English-language studies of percutaneous coronary intervention performed at centers with and without on-site surgery providing data on in-hospital mortality and emergency bypass were identified. Two study authors independently reviewed the 1029 articles originally identified and selected 40 for analysis. DATA EXTRACTION: Study title, time period, indication for angioplasty, and outcomes were extracted manually from all selected studies, and quality of each study was assessed using the strengthening the reporting of observational studies in epidemiology (STROBE) checklist. DATA SYNTHESIS: High-quality studies of percutaneous coronary interventions performed at centers with and without on-site surgery were included. Pooled-effect estimates were calculated with random-effects models. Analyses of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction of 124,074 patients demonstrated no increase in in-hospital mortality (no on-site surgery vs on-site surgery: observed risk, 4.6% vs 7.2%; odds ratio [OR], 0.96; 95% CI, 0.88-1.05; I(2) = 0%) or emergency bypass (observed risk, 0.22% vs 1.03%; OR, 0.53; 95% CI, 0.35-0.79; I(2) = 20%) at centers without on-site surgery. For nonprimary percutaneous coronary interventions (elective and urgent, n = 914,288), the rates of in-hospital mortality (observed risk, 1.4% vs 2.1%; OR, 1.15; 95% CI, 0.93-1.41; I(2) = 46%) and emergency bypass (observed risk, 0.17% vs 0.29%; OR, 1.21; 95% CI, 0.52-2.85; I(2) = 5%) were not significantly different at centers without or with on-site surgery. CONCLUSION: Percutaneous coronary interventions performed at centers without on-site surgery, compared with centers with on-site surgery, were not associated with a higher incidence of in-hospital mortality or emergency bypass surgery.

Cost-effectiveness of drug-eluting stents versus bare metal stents in clinical practice.

BACKGROUND: Drug-eluting stents (DES) reduce the need for repeat target revascularization (TVR) compared with bare metal stents (BMS) but are more costly. The objective was to evaluate the cost-effectiveness of DES versus BMS. METHODS AND RESULTS: We evaluated clinical outcomes and costs of care over 3 years in 1147 undergoing BMS before the availability of DES and 1247 DES patients at Wake Forest University Baptist Medical Center from 2002 to 2005. Costs for index stenting, TVR, and clopidogrel use were assessed. The 2 groups were well matched for baseline characteristics. Index stenting costs were $1846 higher per patient for DES versus BMS ($1737 more to $1950 more). At 3 years, absolute TVR rates were 15.2 per 100 DES patients and 24.1 per 100 BMS patients, and as a result, cumulative TVR-related costs were $2065 less per patient for DES versus BMS ($3001 less to $1134 less). Including the cost of clopidogrel, the incremental cost-effectiveness ratio per TVR avoided with DES was $4731 through 1 year, $4703 through 2 years, and $6379 through 3 years. CONCLUSIONS: At 3 years, the higher index cost of DES versus BMS was completely offset by lower TVR-related costs. However, because of extended clopidogrel use for DES, the incremental cost-effectiveness ratio per TVR avoided ranged from $4703 to $6379 over 3 years. These unadjusted observational findings provide support for the continued use of DES in routine practice but highlight the important impact of prolonged dual antiplatelet use on the cost-effectiveness of this technology.

Target lesion revascularization after bare-metal or drug-eluting stents: clinical presentations and outcomes.

OBJECTIVE: We sought to examine the clinical presentations and subsequent clinical outcomes of patients undergoing target lesion revascularization (TLR) after either bare-metal stent (BMS) or drug-eluting stent (DES) placement. BACKGROUND: The widely held notion that BMS TLR is benign has recently been challenged. While DES substantially reduce TLR, little is known about the clinical syndromes accompanying DES TLR and the long-term clinical outcomes after TLR. METHODS: The clinical syndrome at the time of hospitalization when TLR was performed and subsequent clinical outcomes after TLR were assessed in 1,147 BMS patients and 1,246 DES patients who were followed for 3 years. Patients were considered to have TLR when repeat target lesion PCI was required including those with myocardial infarction (MI) and stent thrombosis. RESULTS: At 3 years, the overall incidence of TLR was higher after BMS compared to DES 98/1,147 (9.2%) vs. 56/1,246 (4.5%); p < 0.001. The clinical presentations at the time of TLR were not always benign with non-STelevation myocardial infarction (N-STEMI) or STEMI in 25% of BMS vs. 34% DES; p = 0.217. The risk of non-fatal MI or death outcomes over 3 years were significantly worse in those with TLR compared to those without TLR; hazard ratio (HR) 2.65 (2.00-3.52), independent of stent type. CONCLUSIONS: The clinical presentation at the time of TLR is not always a benign clinical event and identifies a subgroup of stent-treated patients at high risk for non-fatal MI or death in the 3 years following the index percutaneous coronary intervention, independent of stent type.