Faculty Bibliography

OBJECTIVES:This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status. BACKGROUND:Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS. METHODS:The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification. RESULTS:The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment. CONCLUSIONS:Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.

BACKGROUND AND OBJECTIVES/OBJECTIVE:We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS:PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS:Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. CONCLUSIONS:In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

Importance:Current comparative outcomes among black and white patients treated with percutaneous coronary intervention (PCI) in the Veterans Affairs (VA) health system are not known. Objective:To compare outcomes between black and white patients undergoing PCI in the VA health system. Design, Setting, and Participants:This study compared black and white patients who underwent PCI between October 1, 2007, and September 30, 2013, at 63 VA hospitals using data recorded in the VA Clinical Assessment, Reporting, and Tracking System for Cardiac Catheterization Laboratories (CART-CL) program. A generalized linear mixed model with a random intercept for site assessed the relative difference in odds of outcomes between black and white patients. The setting was integrated institutionalized hospital care. Excluded were all patients of other races or those with multiple listed races and those with missing data regarding race or the diagnostic cardiac catheterization. The dates of analysis were January 7, 2016, to April 17, 2017. Exposure:Percutaneous coronary intervention at a VA hospital. Main Outcomes and Measures:The primary outcome was 1-year mortality. Secondary outcomes were 30-day all-cause readmission rates, 30-day acute kidney injury, 30-day blood transfusion, and 1-year readmission rates for myocardial infarction. In addition, variations in procedural and postprocedural care were examined, including the use of intravascular ultrasound, optical coherence tomography, fractional flow reserve measurements, bare-metal stents, postprocedural medications, and radial access. Results:A total of 42 391 patients (13.3% black and 98.4% male; mean [SD] age, 65.2 [9.1] years) satisfied the inclusion and exclusion criteria. In unadjusted analyses, black patients had higher rates of 1-year mortality (7.1% vs 5.9%, P < .001) as well as secondary outcomes of 30-day acute kidney injury (20.8% vs 13.8%, P < .001), 30-day blood transfusion (3.4% vs 2.7%, P < .01), and 1-year readmission rates for myocardial infarction (3.3% vs 2.7%, P = .01) compared with white patients. After adjustment for demographics, comorbidities, and procedural characteristics, odds for 1-year mortality (odds ratio, 1.04; 95% CI, 0.90-1.19) were not different between black and white patients. There were also no differences in secondary outcomes with the exception of a higher rate of adjusted 30-day acute kidney injury (odds ratio, 1.22; 95% CI, 1.10-1.36). Conclusions and Relevance:While black patients had a higher rate of mortality than white patients in unadjusted analyses, race was not independently associated with 1-year mortality among patients undergoing PCI in VA hospitals.

OBJECTIVES:The aim of this study was to compare bivalirudin with heparin as anticoagulant agents in patients with ST-segment elevation myocardial infarction treated with radial primary percutaneous coronary intervention (PCI). BACKGROUND:Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin. METHODS:Outcomes were compared in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015 who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin. RESULTS:The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The 2 groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval: 1.73 to 2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different. CONCLUSIONS:In patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, myocardial infarction, or stroke.

Treatment with P2Y12 inhibitors is an integral part of the standard of care for patients undergoing percutaneous coronary intervention. However, the most appropriate timing for P2Y12 inhibitor administration remains unclear, and the value of "preloading" with P2Y12 inhibitors prior to cardiac catheterization is controversial. While pre-catheterization treatment with P2Y12 inhibitors is performed with the goal of decreasing adverse cardiovascular events, this potential benefit must be weighed against the increased risk of bleeding complications and operative delay if coronary artery bypass graft surgery is indicated. A number of studies have been conducted to evaluate the utility of preloading with P2Y12 inhibitors prior to cardiac catheterization for varying indications including stable angina and acute coronary syndrome (ACS). In this article, we review the literature and discuss the advantages and disadvantages of the preloading strategy. Several individual studies offer inconclusive and even conflicting findings. However, when taken in sum, these studies allow for several conclusions about the utility of P2Y12 inhibitor pretreatment. The existing literature demonstrate that preloading is associated with some degree of reduction in adverse ischemic events, although this benefit comes with an increased risk of bleeding complications. The appropriateness of preloading therefore varies based on the indication for catheterization, likely justified in patients with ACS but unlikely to benefit patients with stable angina.

OBJECTIVES:This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case volume standards and identify differences in case mix and practice patterns that may account for RSMR variability. BACKGROUND:RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown. METHODS:The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean [analogous to 2 SD], respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year. RESULTS:Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period. CONCLUSIONS:There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality.

BACKGROUND:Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown. OBJECTIVES/OBJECTIVE:The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample. METHODS:Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality. RESULTS:The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding. CONCLUSIONS:Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.

BACKGROUND:Transcatheter aortic valve replacement (TAVR) is a viable alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (SAS) who are at high risk for surgery. We sought to evaluate the outcomes of TAVR vs SAVR in low-intermediate risk patients with SAS. METHODS AND RESULTS/RESULTS:We performed random-effects meta-analysis of randomized controlled trials (RCTs) and propensity-matched observational studies comparing TAVR vs SAVR for low-intermediate risk patients. Five RCTs and 5 observational studies with a total of 6891 patients (3489 TAVR patients; 3402 SAVR patients) were included. Pooled data from RCTs showed no significant differences in all-cause mortality between TAVR and SAVR at 30 days (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.73-1.47) and intermediate-term follow-up (RR, 0.86; 95% CI, 0.67-1.10). A trend toward decreased mortality was found with TAVR using the self-expandable vs balloon-expandable valves (RR, 0.77; 95% CI, 0.52-1.15 and RR, 1.91; 95% CI, 0.25-14.53, respectively) and transfemoral vs transthoracic approach (RR, 0.74; 95% CI, 0.55-1.01 and RR, 2.09; 95% CI, 0.40-11.03, respectively). Compared to SAVR, TAVR was associated with similar risks of stroke (RR, 0.91; 95% CI, 0.74-1.11) and myocardial infarction (RR, 1.00; 95% CI, 0.71-1.41). Furthermore, risks of major vascular complications, moderate-severe paravalvular regurgitation, and new permanent pacemaker implantation were higher with TAVR, whereas SAVR was associated with higher rates of acute kidney injury, atrial fibrillation, and major or life-threatening bleed. Finally, the above results from RCTs were consistent with pooled analyses of observational studies. CONCLUSION/CONCLUSIONS:TAVR appears to be a suitable alternative for patients with SAS who are at low-intermediate risk for SAVR.

Dual antiplatelet therapy (DAPT) is prescribed to millions of patients worldwide following coronary stenting. DAPT is indicated to lower the risk of ischemic events, such as myocardial infarction, including stent thrombosis, ischemic stroke, or death from cardiovascular causes. A significant number of these patients undergo noncardiac surgery and may require DAPT interruption. This poses a significant clinical dilemma because DAPT interruption exposes patients to the potential risk of stent thrombosis, perioperative myocardial infarction, or both. Conversely, continuing DAPT may be associated with excess bleeding complications. Observational data in this area are conflicting, and there are no randomized clinical trials to guide practitioner decision making. On the basis of predominantly consensus recommendations, various strategies for managing DAPT during the perioperative period have been proposed. This review presents 3 commonly encountered clinical scenarios that lead into an evidence-based discussion of practical strategies for managing perioperative antiplatelet therapy in patients following percutaneous coronary intervention.