Faculty Bibliography

Recent meta-analyses investigating dual antithrombotic therapy (DAT) versus triple antithrombotic therapy (TAT) among patients who require oral anticoagulants especially with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) raised the concern of stent thrombosis (ST) and myocardial infarction (MI), however, these meta-analyses did not include all randomized trials who require oral anticoagulants. We aimed to investigate the efficacy of DAT versus TAT in these patients undergoing PCI. Our data showed the risk of ST was not significantly different in DAT vs. TAT (HR [95%CI]: 1.50 [0.97-2.34], p = .07; I

BACKGROUND:The initial wave of the coronavirus disease 2019 (COVID-19) pandemic resulted in an influx of patients with acute viral illness and profound changes in healthcare delivery in New York City. The impact of this pandemic on the presentation and invasive management of acute myocardial infarction (MI) is not well described. METHODS:This single-center retrospective study compared patients with MI who underwent invasive coronary angiography at New York University from March-April 2020, during the peak of the first wave of the pandemic, with those presenting in March-April 2019. RESULTS:Only 35 patients with MI underwent angiography during the study period in 2020 vs 109 patients in 2019. No differences in comorbidities or baseline medications were identified. The proportion of patients with ST-segment elevation MI (STEMI) was higher in 2020 than in 2019 (48.6% vs 24.8%, respectively; P=.01). Median peak troponin concentration was higher (14.5 ng/mL vs 2.9 ng/mL; P<.01) and left ventricular ejection fraction was lower (43.34% vs 51.1%; P=.02) during the pandemic. Among patients with non-STEMI, time from symptom onset to presentation was delayed in 2020 compared with 2019 (median, 24 hours vs 10 hours; P=.04). CONCLUSION/CONCLUSIONS:There was a dramatic decrease in the number of patients with MI undergoing coronary angiography during the first wave of the COVID-19 pandemic. Of those who presented, patients tended to seek care later after symptom onset and had excess myocardial injury. These data indicate a need for improved patient education to ensure timely cardiovascular care during public health emergencies.

Background: Alport syndrome is a rare and serious inherited form of CKD affecting as many as 60,000 persons in the US with no specific therapies approved for its treatment.
Method(s): An international, multicenter, double-blind, placebo-controlled, randomized Phase 3 trial (CARDINAL; NCT03019185) evaluated the safety and efficacy of bardoxolone methyl (Bard) in patients with Alport syndrome 12 to 70 years of age with baseline eGFR 30-90 mL/min/1.73 m² and UACR<= 3500mg/g. As an exploratory endpoint, the trial assessed patient global impression of change (PGIC), a non-disease specific 7-point scale that asks patients to rate how much their illness has changed as very much/much/minimally improved (1, 2, and 3 pts), no change (4 pts), or minimally/much/ very much worse (5, 6, and 7 pts) after 48 and 100 weeks of treatment.
Result(s): A total of 157 patients were randomized to Bard (n=77) or placebo (n=80). In addition to significant on-treatment and off-treatment increases in mean eGFR relative to placebo (between-group differences of 7.7 +/- 2.1 [p=0.0005] at Week 100 and 4.3 +/- 1.9 mL/min/1.73 m² [p=0.023] at Week 104, respectively), Bard improved PGIC scores relative to placebo (lower values) after 48 and 100 weeks. Categorical summaries also showed more patients randomized to bardoxolone (34%) reported their condition had improved compared to those on placebo (19%) after 100 weeks of treatment.
Conclusion(s): In CARDINAL, Bard significantly preserved eGFR in patients with Alport syndrome and also resulted in improvements in how patients evaluated their wellbeing. (Figure Presented)

Background: The role of invasive management compared with medical management in patients with non-ST-segment elevated myocardial infarction (NSTEMI) and advanced chronic kidney disease (CKD) is uncertain, given the increased risk of procedural complications in patients with CKD. We examined the efficacy and safety of invasive management in patients with NSTEMI-CKD compared with medical management.
Method(s): We identified NSTEMI and CKD stages 3, 4, 5, end-stage renal disease (ESRD) admissions using administrative codes from the Nationwide Readmission Database 2016 to 2018. Invasive approach was defined as coronary angiography with or without revascularization procedure, and other patients were categorized into medical management. Major adverse cardiovascular events (MACE) outcome was a composite of myocardial infarction (MI), heart failure, stroke, or death at 6 months. The safety outcome was a composite of acute kidney injury (AKI), vascular complication, major bleeding, or stroke at 6 months. We matched 2 groups using propensity score and applied Cox-proportional hazard regression to compute hazard ratio (HR) and 95% confidence interval (CI).
Result(s): Of 133,642 patients with NSTEMI and CKD, 62.3% were treated with the invasive management, whereas 37.7% patients were managed medically. Invasive management was associated with a lower hazard of MACE (CKD 3: HR: 0.73 [95% CI: 0.69-0.76, P < 0.001]; CKD 4: HR: 0.75 [95% CI: 0.70-0.81, P < 0.001]; CKD 5: HR: 0.67 [95% CI: 0.54-0.84, P < 0.001]; ESRD: HR: 0.80 [95% CI: 0.75-0.86, P < 0.001]) without increasing safety outcomes (CKD 3: HR: 0.99 [95% CI: 0.89-1.10, P = 0.822]; CKD 4: HR: 1.07 [95% CI: 0.91-1.26, P = 0.406]; CKD 5: HR: 0.91 [95% CI: 0.55-1.49, P = 0.698]; ESRD: HR: 1.14 [95% CI: 0.93-1.41, P = 0.213]) at 6 months in all CKD groups compared with medical management. Similarly, invasive management was associated with reduced hazard of mortality across all the CKD groups compared with medical management (Figures 1A and 1B). [Formula presented]
Conclusion(s): The benefits of invasive management remained significantly higher in patients with NSTEMI and CKD compared with medical management, without any difference in safety. Categories: CORONARY: Acute Myocardial Infarction
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An acute coronary syndrome (ACS) event is associated with a high risk of recurrent ACS, stroke, and death. To ameliorate the risk of subsequent events, current guidelines for ST-segment elevation myocardial infarction and non-ST-segment elevation ACS recommend long-term management strategies for secondary prevention including risk factor modification and anti-ischemic and antiplatelet therapies. Dual antiplatelet therapy (DAPT), comprising aspirin plus a P2Y₁₂ inhibitor, is a critical component of secondary prevention therapy following ACS. However, despite the importance of DAPT for secondary prevention after ACS, questions remain over the optimal duration of therapy. Clinical evidence is emerging that maintenance DAPT >12 months lowers the risk of recurrent ACS events; however, this benefit must be considered against any potential risks of prolonged DAPT such as bleeding. Several tools for bleeding risk assessment have shown promise; however, their limited accuracy and discriminative power necessitates further development. Assessment of patient ischemic risk should consider the complexity of the percutaneous coronary intervention (PCI) procedure, anatomic burden of coronary artery disease, and additional underlying risk factors. Consequently, identifying patients in whom the risk:benefit ratio favors prolonged DAPT may prove invaluable for clinicians in deciding which patients should continue or stop taking DAPT at 12 months after PCI, or consider P2Y₁₂ inhibitor monotherapy as an option. This article reviews the most recent information about the risks and benefits of DAPT continued for >12 months after ACS and provides critical guidance to assist physicians in identifying patients most likely to benefit from a secondary prevention strategy with DAPT.

BACKGROUND:Among patients with diabetes and chronic coronary disease, it is unclear if invasive management improves outcomes when added to medical therapy. METHODS:The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trials (ie, ISCHEMIA and ISCHEMIA-Chronic Kidney Disease) randomized chronic coronary disease patients to an invasive (medical therapy + angiography and revascularization if feasible) or a conservative approach (medical therapy alone with revascularization if medical therapy failed). Cohorts were combined after no trial-specific effects were observed. Diabetes was defined by history, hemoglobin A1c ≥6.5%, or use of glucose-lowering medication. The primary outcome was all-cause death or myocardial infarction (MI). Heterogeneity of effect of invasive management on death or MI was evaluated using a Bayesian approach to protect against random high or low estimates of treatment effect for patients with versus without diabetes and for diabetes subgroups of clinical (female sex and insulin use) and anatomic features (coronary artery disease severity or left ventricular function). RESULTS:<0.001). At median 3.1-year follow-up the adjusted event-free survival was 0.54 (95% bootstrapped CI, 0.48-0.60) and 0.66 (95% bootstrapped CI, 0.61-0.71) for patients with diabetes versus without diabetes, respectively, with a 12% (95% bootstrapped CI, 4%-20%) absolute decrease in event-free survival among participants with diabetes. Female and male patients with insulin-treated diabetes had an adjusted event-free survival of 0.52 (95% bootstrapped CI, 0.42-0.56) and 0.49 (95% bootstrapped CI, 0.42-0.56), respectively. There was no difference in death or MI between strategies for patients with diabetes versus without diabetes, or for clinical (female sex or insulin use) or anatomic features (coronary artery disease severity or left ventricular function) of patients with diabetes. CONCLUSIONS:Despite higher risk for death or MI, chronic coronary disease patients with diabetes did not derive incremental benefit from routine invasive management compared with initial medical therapy alone. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.