Faculty Bibliography

OBJECTIVES:The aim of this study was to examine the frequency, associations, and outcomes of native coronary artery versus bypass graft percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafting (CABG) in the Veterans Affairs (VA) integrated health care system. BACKGROUND:Patients with prior CABG surgery often undergo PCI, but the association between PCI target vessel and short- and long-term outcomes has received limited study. METHODS:A national cohort of 11,118 veterans with prior CABG who underwent PCI between October 2005 and September 2013 at 67 VA hospitals was examined, and the outcomes of patients who underwent native coronary versus bypass graft PCI were compared. Logistic regression with generalized estimating equations was used to adjust for correlation between patients within hospitals. Cox regressions were modeled for each outcome to determine the variables with significant hazard ratios (HRs). RESULTS:During the study period, patients with prior CABG represented 18.5% of all patients undergoing PCI (11,118 of 60,171). The PCI target vessel was a native coronary artery in 73.4% and a bypass graft in 26.6%: 25.0% in a saphenous vein graft and 1.5% in an arterial graft. Compared with patients undergoing native coronary artery PCI, those undergoing bypass graft PCI had higher risk characteristics and more procedure-related complications. During a median follow-up period of 3.11 years, bypass graft PCI was associated with significantly higher mortality (adjusted HR: 1.30; 95% confidence interval: 1.18 to 1.42), myocardial infarction (adjusted HR: 1.61; 95% confidence interval: 1.43 to 1.82), and repeat revascularization (adjusted HR: 1.60; 95% confidence interval: 1.50 to 1.71). CONCLUSIONS:In a national cohort of veterans, almost three-quarters of PCIs performed in patients with prior CABG involved native coronary artery lesions. Compared with native coronary PCI, bypass graft PCI was significantly associated with higher incidence of short- and long-term major adverse events, including more than double the rate of in-hospital mortality.

Vorapaxar, a novel antiplatelet thrombin PAR-1 inhibitor, has been evaluated in the successful TRA2P trial and the failed TRACER trial. The drug is currently approved for post myocardial infarction and peripheral artery disease indications with concomitant use of clopidogrel and/or aspirin. The FDA ruled that the vorapaxar safety profile is acceptable. However, both trials revealed excess diplopia (double vision) usually reversible after vorapaxar. The diplopia risk appears to be small (about 1 extra case per 1,000 treated subjects), but real. Overall, there were 10 placebo and 34 vorapaxar diplopia cases (p=0.018) consistent for TRACER (2 vs 13 cases; p=0.010) and for TRA2P (8 vs 21 cases; p=0.018). Hence, we review the FDA-confirmed evidence and discuss potential causes and implications of such a surprising adverse association, which may be related to off-target PAR receptor mismodulation in the eye.

IMPORTANCE:Many patients undergo cardiac catheterization and/or percutaneous coronary intervention (PCI) before noncardiac surgery even though these procedures are not routinely indicated. Data on this cohort of patients are limited. OBJECTIVE:To describe the characteristics, angiographic findings, and treatment patterns of clinically stable patients undergoing cardiac catheterization and/or PCI before noncardiac surgery in a large national registry. DESIGN, SETTING, AND PARTICIPANTS:This study is a retrospective, descriptive analysis of National Cardiac Data Registry CathPCI Registry diagnostic catheterization and PCI data from July 1, 2009, through December 31, 2014. Data analysis was performed from April 21, 2015, to January 4, 2016. The study included 194 444 patients from 1046 sites who underwent coronary angiography before noncardiac surgery. Patients with acute coronary syndrome, cardiogenic shock, cardiac arrest, or emergency catheterization were excluded. MAIN OUTCOMES AND MEASURES:Demographic characteristics, preprocedure noninvasive testing results, angiographic findings, and treatment recommendations are summarized. Among the 27 838 patients who underwent PCI, procedural details, inpatient outcomes, and discharge medications are reported. RESULTS:Of the 194 444 included patients, 113 590 (58.4%) were male, the median age was 65 years (interquartile range, 57-73 years), and 162 532 (83.6%) were white. Most were overweight or obese (152 849 [78.6%]), and 78 847 (40.6%) had diabetes mellitus. Most patients were asymptomatic (117 821 [60.6%]), although 112 302 (57.8%) had been taking antianginal medications within 2 weeks of the procedure. Prior noninvasive stress testing was reported in 126 766 (65.2%), and results were positive in 109 458 (86.3%) of those with stress data. Obstructive disease was present in 93 447 (48.1%). After diagnostic angiography, revascularization with PCI or bypass surgery was recommended in 46 380 patients (23.8%) in the overall cohort, 27 191 asymptomatic patients (23.1%), and 45 083 patients with obstructive disease (48.3%). In the 27 191 patients undergoing PCI, 367 treated lesions (1.3%) were in the left main artery and 3831 (13.8%) in the proximal left anterior descending artery. A total of 11 366 patients (40.8%) received drug-eluting stents. Complications occurred in a few patients, with a catheterization-related mortality rate of 0.05%. CONCLUSIONS AND RELEVANCE:In the largest contemporary US cohort reported to date, most patients undergoing diagnostic catheterization before noncardiac surgery are asymptomatic. The discovery of obstructive coronary artery disease is common, and although randomized clinical trials have found no benefit in outcomes, revascularization is recommended in nearly half of these patients. The overall findings highlight management patterns in this population and the need for greater evidence-based guidelines and practices.

IMPORTANCE:The evolution of percutaneous coronary intervention (PCI) has led to improved safety and efficacy, such that overnight observation can be avoided in some patients. We sought to provide a narrative review of the current literature regarding the outcomes of same-day discharge (SDD) PCI and to describe a framework for the development of an SDD program. OBSERVATIONS:A literature search of PubMed was performed for human studies on SDD PCI published in English from January 1, 1995, to July 31, 2015. We reviewed the studies between June and September 2015. After literature review, we included reports of randomized clinical trials, observational studies, meta-analyses guidelines, and consensus statements in a narrative review. Compared with overnight observation, there was no increase in adverse events (bleeding, repeat coronary procedures, death, or rehospitalization) among patients in these studies who were discharged on the same day of their PCI procedure. Same-day discharge was associated with significant cost savings and was preferred by patients. CONCLUSIONS AND RELEVANCE:The available evidence supports the safety of SDD in selected patients after PCI. Specific programmatic features are important to the successful implementation of SDD after PCI. Greater adoption of SDD programs after PCI has the potential to improve patient satisfaction, increase bed availability, and reduce hospital costs without increasing adverse patient outcomes.

OBJECTIVES/OBJECTIVE: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.

Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.

Platelets play a key role in mediating stent thrombosis, which is the major cause of ischemic events immediately after percutaneous coronary intervention (PCI). Antiplatelet therapy is therefore the cornerstone of antithrombotic therapy after PCI. However, the use of antiplatelet agents increases bleeding risk, with more potent antiplatelet agents further increasing bleeding risk. In the past 5 years, potent and fast-acting ^P2Y12 inhibitors have augmented the antiplatelet armamentarium available to interventional cardiologists. This article reviews the preclinical and clinical data surrounding these new agents, and discusses the significant questions and controversies that still exist regarding the optimal antiplatelet strategy.

BACKGROUND:Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. METHODS AND RESULTS/RESULTS:Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. CONCLUSIONS:Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care.