Faculty Bibliography

BACKGROUND:The ISCHEMIA-CKD (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches-Chronic Kidney Disease) trial found no advantage to an invasive strategy compared to conservative management in reducing all-cause death or myocardial infarction (D/MI). However, the prognostic influence of angiographic coronary artery disease (CAD) burden and ischemia severity remains unknown in this population. We compared the relative impact of CAD extent and severity of myocardial ischemia on D/MI in patients with advanced chronic kidney disease (CKD). METHODS:Participants randomized to invasive management with available data on coronary angiography and stress testing were included. Extent of CAD was defined by the number of major epicardial vessels with ≥50% diameter stenosis by quantitative coronary angiography. Ischemia severity was assessed by site investigators as moderate or severe using trial definitions. The primary endpoint was D/MI. RESULTS:Of the 388 participants, 307 (79.1%) had complete coronary angiography and stress testing data. D/MI occurred in 104/307 participants (33.9%). Extent of CAD was associated with an increased risk of D/MI (P < .001), while ischemia severity was not (P = .249). These relationships persisted following multivariable adjustment. Using 0-vessel disease (VD) as reference, the adjusted hazard ratio (HR) for 1VD was 1.86, 95% confidence interval (CI) 0.94 to 3.68, P = .073; 2VD: HR 2.13, 95% CI 1.10 to 4.12, P = .025; 3VD: HR 4.00, 95% CI 2.06 to 7.76, P < .001. Using moderate ischemia as the reference, the HR for severe ischemia was 0.84, 95% CI 0.54 to 1.30, P = .427. CONCLUSION/CONCLUSIONS:Among ISCHEMIA-CKD participants randomized to the invasive strategy, extent of CAD predicted D/MI whereas severity of ischemia did not.

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) found that there was no statistical difference in cardiovascular events with an initial invasive strategy as compared with an initial conservative strategy of guideline-directed medical therapy for patients with moderate to severe ischemia on noninvasive testing. In this study, we describe the reasons that potentially eligible patients who were screened for participation in the ISCHEMIA trial did not advance to enrollment, the step prior to randomization. Of those who preliminarily met clinical inclusion criteria on screening logs submitted during the enrollment period, over half did not participate due to physician or patient refusal, a potentially modifiable barrier. This analysis highlights the importance of physician equipoise when advising patients about participation in randomized controlled trials.

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:The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES/OBJECTIVE:The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation. METHODS:The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS:A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS:Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

OBJECTIVES/OBJECTIVE:This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. BACKGROUND:In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. METHODS:The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS:and no evidence of strut malapposition. CONCLUSIONS:The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

OBJECTIVE:To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents. BACKGROUND:Second-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications. METHODS:DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up. RESULTS:A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not. CONCLUSIONS:Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes.

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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Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged in Wuhan, China, and rapidly led to a global pandemic that affected 213 countries, more than 5.8 million cases, and 360,000 deaths worldwide as of May 28, 2020. The United States currently has the highest number of COVID-19 cases in the world and contributes to nearly a third of the global death rate. The prevalence of COVID myocarditis is unclear but generally considered rare, with estimates up to 7% of COVID-related deaths. However, these patients suffered catastrophic worsening disease with respiratory compromise requiring intubation and often death. We report the case of a patient with COVID-19-induced myocarditis who was successfully treated with dexamethasone and review the literature.