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Journal Wrap
The hottest research from various peer-reviewed journals – handpicked weekly by the ACC.org Editorial Board led by Kim Eagle, MD, MACC.
Clinical Trials of ULM PCI May Not Reflect Contemporary Practice: NCDR Study
Randomized clinical trials demonstrating safety and efficacy of unprotected left main (ULM) PCI may not reflect its use in clinical practice, according to a study published in JAMA Cardiology.Using ACC's CathPCI Registry, Javier A. Valle, MD, MSc, FACC,et al., analyzed data from 33,128 patients undergoing ULM PCI and 3,309,034 undergoing all other PCI to define current ULM PCIpractice and compare outcomes to those reported in clinical trials. Theprimary outcome was in-hospital major adverse clinical events, whichincluded death, myocardial infarction(MI), stroke or emergent CABG.Each outcome also was measured individually. The researchers also compared patient and procedural characteristics between ULM PCI and all other PCI.
The results found that patients undergoing ULM PCI had significantly higher rates of major adverse clinical events (9 percent), compared with other PCI (2.6 percent). In addition, ULM PCI was associated with higher rates for each individual outcome, including death (5.0 vs. 0.6 percent), MI (3.9 vs. 1.8 percent), stroke (0.5 vs. 0.2 percent) and emergent CABG (0.7 vs. 0.1 percent).
However, composite rates of in-hospital death, MI, stroke or emergent CABG decreased over time (9.3 percent for 2009-2011 vs. 7.8 percent for 2015-2016). In addition, individual MI rates went down over time, but individual rates of death, stroke and emergent CABG did not change significantly. Operators and institutions performing ULM PCI had higher annual PCI volume, compared with operators and institutions performing all other PCI. In addition, ULM PCI was more likely to be performed at institutions in urban areas with private or community designations.
The study's findings suggest "significantly worse outcomes" for ULM PCI in the study cohort vs. in clinical trials, although the researchers suggest the difference "likely is attributable to patient and procedural factors." They conclude that clinical trials for ULM PCI likely do not reflect clinical practice and "suggest an opportunity to refine patient selection and increase operator and institutional experience" to improve outcomes.
Valle JA, Tamez H, Abbott JD. JAMA Cardiol 2019;4:100-9.
NCDR Study Looks at Medicare Advantage vs. Medicare FFS in CAD
Medicare Advantage patients with coronary artery disease (CAD) may be more likely to receive secondary prevention treatments than Medicare Fee-for-Service (FFS) beneficiaries with CAD, but these treatments may not improve outcomes, according to a study published in JAMA Cardiology.
Jose F. Figueroa, MD, MPH, et al., used data from ACC's PINNACLE Registry to assess differences in delivery of evidencebased treatments and outcomes in 35,563 patients with CAD enrolled in Medicare Advantage plans vs. 172,732 CAD patients in Medicare FFS plans. The primary outcomes were prescriptions patterns among eligible patients and intermediate outcomes including blood pressure and LDL-C.
Results showed that Medicare Advantage beneficiaries received secondary prevention treatments more often than those in FFS plans – including beta blockers (80.6 vs. 78.8 percent); angiotensinconverting enzyme inhibitors or angiotensin II receptor blockers (70.7 vs. 65.1 percent); and statins (68.4 vs. 64.5 percent). Medicare Advantage patients were also more likely than FFS patients to receive all three medications when eligible (48.9 vs. 40.4 percent).
Those enrolled in Medicare Advantage plans also had greater odds of receiving guideline-recommended therapy for each medication individually and for all three medications combined than FFS beneficiaries. The study did not report significant differences in intermediate outcomes, such as systolic and diastolic blood pressure and LDL-C.
The researchers suggest that Medicare Advantage plans may encourage greater uptake of process-based quality measures but that these may have a limited effect in improving patient outcomes. As more patients enroll in Medicare Advantage plans, continued monitoring of quality and outcomes will be necessary "to determine whether these patterns ultimately lead to better outcomes in Medicare," the authors conclude.
In an invited commentary, Paul A. Heidenreich, MD, MS, FACC, writes that the lack of improved outcomes among Medicare Advantage patients should not "supersede a benefit in a process of care that is shown to improve outcomes in randomized clinical trials," adding that research that combines process and outcomes metrics" will be more accurate and helpful to health system users."
Figueroa JF, Blumenthal DM, Feyman Y, et al. JAMA Cardiol 2019;Feb 20:[Epub ahead of print].
DIAL Model Predicts CVD-Free Life Expectancy in T2D
Readily available clinical characteristics can be used to estimate cardiovascular disease-free life expectancy in patients with type 2 diabetes (T2D), as well as the effects of lifelong prevention on life-years gained free of cardiovascular disease.
The research was published in the European Heart Journal. The researchers developed and validated the Diabetes Lifetime-perspective prediction (DIAL) model, consisting of two complementary competing risk-adjusted Cox propor-tional hazards functions using data from people with T2D registered in the Swedish National Diabetes Registry (n=389,366).
Competing outcomes were cardiovascular disease events (vascular mortality, myocardial infarction or stroke) and nonvascular mortality. Predictors were age, sex, smoking, systolic blood pressure, body mass index, hemoglobin A1c, estimated glomerular filtration rate, non-HDL-C, albuminuria, T2D duration, insulin treatment and history of cardiovascular disease.
External validation was performed using data from the ADVANCE, ACCORD, ASCOT and ALLHAT-LLT-trials; the SMART and EPIC-NL cohorts; and the Scottish diabetes register (total n=197,785).
Predicted one-year risk for cardiovascular disease and all-cause mortality showed good agreement with 10-year observed risk in the development dataset.
Predicted and observed survival free of cardiovascular disease showed good agreement in all validation sets. C-statistics for prediction of cardio-vascular disease were 0.83 (95 percent confidence interval, 0.83-0.84) and 0.64-0.65 for internal and external validation, respectively. An interactive calculator is available at www.U-Prevent.com, which combines model predictions with relative treatment effects from trials to predict individual benefit from preventive treatments.
The DIAL model has the potential to support medical decision-making for cardiovascular disease prevention in people with T2D in diverse populations, because it was validated in populations from different continents.
According to the authors, the DIAL model may be used to estimate lifetime benefits of preventive treatment when combined with trial findings. Therefore, the model may help clinicians translate group-level trial findings to individual patients. This also may lead to greater cost-effectiveness of treatment on a group level.
Berkelmans GF, Gudbjörnsdottir S, Visseren FL, et al. Eur Heart J 2019;Jan 9:[Epub ahead of print].
Good Oral Hygiene Reduces CV Risk
A study of healthy adults found that good oral health reduced the risk of future cardiovascular events.
Researchers in Korea examined 247,696 healthy adults ≥40 years old without a history of major cardio-vascular events who underwent an oral health screening. Periodontal disease was found in about 30 percent; 20 percent had ≥ one dental caries and 25 percent had lost ≥ one tooth.
After a median follow-up of 9.5 years, 14,893 major cardiovascular events occurred for a 10-year event rate of 6.84 percent. The risk of cardio-vascular events was higher for persons with periodontal disease, more dental caries and more lost teeth.
One additional daily brushing of teeth was associated with a 9 percent lower risk of cardiovascular events (p<0.001). A 14 percent reduction was seen with regular professional cleaning, independent of potential confounding factors or oral health problems (p<0.001).
Mechanisms that may explain this relationship include: chronic inflammation caused by periodontal disease; oral microbiota altered by oral hygiene; modification of risk factors such as diabetes and dyslip-idemia by oral hygiene.
Park SY, Kim SH, Kang SH, et al. Eur Heart J 2018;Dec 18:[Epub ahead of print].
Review Examines Mechanisms of Angina After PCI
Persistence or recurrence of angina after a PCI may affect about 20-40 percent of patients during short- to medium-term follow-up. A review paper published in the European Heart Journal examined the potential mechanisms for this phenomenon.
According to authors Filippo Crea, MD, et al., potential mechanisms include recurrent ischemic lesion due to stent thrombosis, in-stent restenosis, residual diffuse disease and myocardial bridging. With newer-generation stents, rates of stent thrombosis are <1 percent and rates of recurrent stenosis are about 5 percent at one year, but can vary based on clinical risk.
Persistent angina due to coronary vasomotor disorders should also be considered. Significant constriction of epicardial coronary arteries post PCI may be related to increased activation of rho-kinase pathways, which can increase vascular smooth muscle constriction. Coronary microvascular dysfunction due to microvascular spasm and impaired microvascular dilation may also mediate recurrent angina.
Noninvasive testing such as exercise stress testing with imaging should be the first step to further diagnose and/or risk stratify.
Invasive testing strategies include physiologic and anatomic assessment using pressure wire or intravascular ultrasound or optical coherence tomography when there is concern for obstructive epicardial disease.
In the absence of obstructive lesions, functional assessment using acetylcholine or ergonovine to diagnose epicardial or microvascular spasm can be considered.
For patients who are on optimal tolerated medical therapy and with persistent post-PCI angina, further diagnostic testing should be considered. Presence of angina and/or ischemia on a noninvasive functional test should prompt coronary angiography. Additional invasive testing of moderate epicardial stenosis or coronary vasomotor disorders may be needed.
Significant knowledge gaps remain when symptoms are due to coronary vasomotor dysfunction.
Crea F, Bairey Merz CN, Beltrame JF, et al. Eur Heart J 2019;Jan 4:[Epub ahead of print].
Keywords: ACC Publications, Cardiology Magazine, Acetylcholine, Albuminuria, Angina Pectoris, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Body Mass Index, Cohort Studies, Blood Pressure, Confidence Intervals, Constriction, Constriction, Pathologic, Coronary Angiography, Coronary Artery Disease, Coronary Disease, Cost-Benefit Analysis, Dental Caries, Diabetes Mellitus, Type 2, Dilatation, Fee-for-Service Plans, Ergonovine, Follow-Up Studies, Glomerular Filtration Rate, Hospital Mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Inflammation, Life Expectancy, Insulin, Medicare Part C, Microbiota, Muscle, Smooth, Vascular, Myocardial Infarction, Oral Health, Oral Hygiene, Myocardial Bridging, Percutaneous Coronary Intervention, Patient Selection, Registries, Periodontal Diseases, rho-Associated Kinases, Secondary Prevention, Smoking, Risk Factors, Spasm, Stents, Stroke, Systole, Tomography, Optical Coherence, Thrombosis
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