Faculty Bibliography

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.

OBJECTIVE:To describe from a non-interventional registry the short-term ischemic and hemorrhagic outcomes in patients with NSTEMI managed with a loading dose of a P2Y12 inhibitor (P2Y12i) given at least four hours prior to diagnostic angiography and delineation of coronary anatomy. Prior data on the effects of such "upstream loading" have been inconsistent. METHODS:In 53 US hospitals, we evaluated the in-hospital care and outcomes of patients with confirmed NSTEMI managed with an interventional strategy and loaded upstream (at least four hours before diagnostic angiography) with P2Y12 inhibitor therapy. Patients entered into the database were grouped into one of four cohorts for analysis: (1) overall cohort, (2) thienopyridine (clopidogrel or prasugrel) load, (3) ticagrelor load, and (4) ticagrelor-consistent. The fourth cohort is a subset of cohort 3 that received ticagrelor throughout the index hospital stay and at discharge. We evaluated in-hospital clinical course and ischemic and bleeding outcomes in all patients, and also 30-d outcomes in the ticagrelor-consistent cohort. RESULTS:A total of 3,355 patients were enrolled, of whom 1,087 had 30-day follow-up. The mean (+/-SD) age was 63.3+/-12.5 y and 62.6% were male. TIMI and GRACE scores placed these patients in the intermediate risk range and CRUSADE scores were in the moderate risk range. The loading dose in UPSTREAM was clopidogrel in 45.6%, ticagrelor in 53.6%, and prasugrel in 0.8%. The median upstream interval (loading dose to angiography) was 17:27 hours and did not change appreciably over the course of the data collection period (2/15 - 10/19). Access was radial in 48.6% and femoral in 51.4%. Post-angiography management was medical only in 32.3%, PCI in 59.4%, and CABG in 8.3%. Median LOS was 2.7d, and median time from angiography to CABG was 3.6d. In-hospital mortality was 0.51% and major bleeding (TIMI) was 0.24%; the in-hospital MACE rate was 0.7% and stent thrombosis occurred in 0.18%. No significant differences were seen between the ticagrelor and clopidogrel cohorts in hospital, but 16% received more than one P2Y12i in-hospital. On follow-up (93.2% response), 86.7% of patients reported taking ticagrelor as directed. CONCLUSION/CONCLUSIONS:Upstream loading of P2Y12 inhibitors was associated with very low rates of bleeding and short LOS in a large cohort of NSTEMI patients managed invasively.

We aimed to investigate long-term (≥5 years) outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) using a meta-analysis from updated published randomized trials. Our data showed that the risk of all-cause death as well as cardiovascular death, myocardial infarction, and stroke was similar between PCI and CABG, whereas PCI had significantly higher rates of repeat revascularization compared to CABG. Decisions for PCI versus CABG for LMCAD should be based on weighing the upfront morbidity and mortality risk of CABG with late risk of repeat revascularization with PCI and taking into consideration patient preference.

Cardiogenic shock (CS) complicating acute myocardial infarction (MI) is associated with high mortality. In the absence of data to support coronary revascularization beyond the infarct artery and selection of circulatory support devices or medications, clinical practice may vary substantially.

The Centers for Medicare and Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed. This article is protected by copyright. All rights reserved.

BACKGROUND:Patients with atrial fibrillation on oral anticoagulation (OAC) undergoing cardiac catheterization face risks for embolic and bleeding events, yet information on strategies to mitigate these risks in contemporary practice is lacking. METHODS:We aimed to describe the clinical/procedural characteristics of a contemporary cohort of patients with atrial fibrillation on OAC who underwent cardiac catheterization. Use of bleeding avoidance strategies and bridging therapy were described and outcomes including death, stroke, and major bleeding at 30 days and 1 year were compared by OAC type. RESULTS:Of 13 404 patients in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II Registry from 2013 to 2016, 741 underwent cardiac catheterization (139 with percutaneous coronary intervention) in the setting of OAC. The patients' median age was 71, 61.8% were male, white (87.2%), had hypertension (83.7%), hyperlipidemia (72.1%), diabetes mellitus (31.6%), and chronic kidney disease (28.2%); 20.2% received warfarin while 79.8% received direct acting oral anticoagulant. One third of patients underwent radial artery access, and bivalirudin was used in 4.6%. Bridging therapy was used more often in patients on warfarin versus direct acting oral anticoagulant (16.7% versus10.0%). OAC was interrupted in 93.8% of patients. Patients on warfarin versus direct acting oral anticoagulant were equally likely to restart OAC (58.0% versus 60.7%), had similar use of antiplatelet therapy (44.0% versus 41.3%) after catheterization, and had similar rates of myocardial infarction and death at 1 year, but higher rates of major bleeding (43.3 versus 12.9 events/100 patient years) and stroke (4.9 versus 1.9 events/100 patient years). CONCLUSIONS:In a real-world registry of patients with atrial fibrillation undergoing cardiac catheterization, most cases are elective, performed by femoral access, with interruption of OAC. Bleeding avoidance strategies such as radial artery access and bivalirudin were used infrequently and use of bridging therapy was uncommon. Nearly 40% of patients did not restart OAC postprocedure, exposing patients to risk for stroke. Further research is necessary to optimize the management of patients with atrial fibrillation undergoing cardiac catheterization.

BACKGROUND:Prasugrel is a potent thienopyridine that may be preferentially used in younger patients with lower bleeding risk. OBJECTIVE:We compared prasugrel use and outcomes by age from the PROMETHEUS study. We also assessed age-related trends in treatment effects with prasugrel versus clopidogrel. METHODS:PROMETHEUS was a multicenter acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) registry. We compared patients in age tertiles (T1 < 60 years, T2 60-70 years, T3 > 70 years). Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke or unplanned revascularization. Data were adjusted using multivariable Cox regression for age-related risks and propensity score stratification for thienopyridine effects. RESULTS:The study included 19,914 patients: 7045 (35.0%) in T1, 6489 (33.0%) in T2 and 6380 (32.0%) in T3. Prasugrel use decreased from T1 to T3 (29.2% vs. 23.5% vs. 7.5%, p < 0.001). Crude 1-year MACE rates were highest in T3 (17.4% vs. 16.8% vs. 22.7%, p < 0.001), but adjusted risk was similar between the groups (p-trend 0.52). Conversely, crude incidence (2.8% vs. 3.8% vs. 6.9%, p < 0.001) and adjusted bleeding risk were highest in T3 (HR 1.24, 95% CI 0.99-1.55 in T2; HR 1.83, 95% CI 1.46-2.30 in T3; p-trend < 0.001; reference = T1). Treatment effects with prasugrel versus clopidogrel did not demonstrate age-related trends for MACE (p-trend = 0.91) or bleeding (p-trend = 0.28). CONCLUSIONS:Age is a strong determinant of clinical risk as well as prasugrel prescription in ACS PCI with much lower use among older patients. Prasugrel did not have a differential treatment effect by age for MACE or bleeding. Frequency of prasugrel use and age-related temporal risks of all-cause death and bleeding after ACS PCI.

OBJECTIVES/OBJECTIVE:Investigation of novel vertical radiation shield (VRS) in reducing operator radiation exposure. BACKGROUND:Radiation exposure to the operator remains an occupational health hazard in the cardiac catheterization laboratory (CCL). METHODS:A mannequin simulating an operator was placed near a computational phantom, simulating a patient. Measurement of dose equivalent and Air Kerma located the angle with the highest radiation, followed by a common magnification (8 in.) and comparison of horizontal radiation absorbing pads (HRAP) with or without VRS with two different: CCL, phantoms, and dosimeters. Physician exposure was subsequently measured prospectively with or without VRS during clinical procedures. RESULTS:Dose equivalent and Air Kerma to the mannequin was highest at left anterior oblique (LAO)-caudal angle (p < .005). Eight-inch magnification increased mGray by 86.5% and μSv/min by 12.2% compared to 10-in. (p < .005). Moving 40 cm from the access site lowered μSv/min by 30% (p < .005). With LAO-caudal angle and 8-in. magnification, VRS reduced μSv/min by 59%, (p < .005) in one CCL and μSv by 100% (p = .016) in second CCL in addition to HRAP. Prospective study of 177 procedures with HRAP, found VRS lowered μSv by 41.9% (μSv: 15.2 ± 13.4 vs. 26.2 ± 31.4, p = .001) with no difference in mGray. The difference was significant after multivariate adjustment for specified variables (p < .001). CONCLUSIONS:Operator radiation exposure is significantly reduced utilizing a novel VRS, HRAP, and distance from the X-ray tube, and consideration of lower magnification and avoiding LAO-caudal angles to lower radiation for both operator and patient.

BACKGROUND:Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Data on the distribution of stroke occurrence post-PCI and its impact on mortality are scarce. OBJECTIVES/OBJECTIVE:We sought to determine the incidence, predictors and impact of stroke on mortality in ACS patients undergoing PCI. METHODS:A total of 19,914 ACS patients underwent PCI in the PROMETHEUS multicenter observational study. We calculated the cumulative stroke incidence at 30 days and 1 year using the Kaplan Meier method. We also compared the distribution of stroke, myocardial infarction (MI), and bleeding across time and evaluated their overlap. Predictors of stroke were identified through multivariable Cox-regression. Stroke, MI, and bleeding were assessed as time-updated covariates to estimate how each impacts subsequent mortality. RESULTS:We found that 244 patients had a stroke within 1 year, a cumulative incidence of 1.5%. Previous cerebrovascular disease was the strongest predictor for post-PCI stroke, followed by ST-elevation MI presentation, hypertension, non-ST-elevation MI presentation, smoking, female sex, and age. Mortality risk was significantly higher among those who had a stroke versus those who did not (adjusted HR 4.84, p < .0001). However, the association attenuated over time with a much larger effect in the first 30 days of its occurrence (adjusted HR 17.7; 95% CI: 12.3-25.4, p < .0001) versus beyond 30 days (adjusted HR 1.22; 95% CI: 0.6-2.46, p = .58). CONCLUSIONS:Stroke occurrence within 1 year was not uncommon for ACS patients undergoing PCI. When compared with MI and bleeding, stroke had a substantial impact on mortality that attenuated rapidly over time.