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Incidence of AFib Could Be Substantial in Older Patients With Stroke Risk Factors

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The incidence of previously undiagnosed atrial fibrillation (AFib) may be substantial in patients who have AFib and stroke risk factors, according to data from the REVEAL AF study presented at ESC Congress 2017 in Barcelona and simultaneously published in JAMA Cardiology.

Using an insertable cardiac monitor (ICM) for 18 to 30 months, researchers monitored a total of 385 patients (52.2 percent men, mean age of 71.5 years) from the United States and Europe with a CHADS2 score of three or greater (or a score of two with at least one additional risk factor) between November 2012 and January 2017. Roughly 90 percent of enrolled patients had nonspecific symptoms like fatigue, dyspnea and/or palpitations that could be compatible with AFib. The primary endpoint was adjudicated AFib lasting six or more minutes and was assessed at 18 months. Read More >>>

Results showed a 29.3 percent detection rate of AFib lasting six or more minutes at 18 months. Additionally, incidence of AFib at 18 months was similar among patients with CHADS2 scores of two (24.7 percent), three (32.7 percent) and four or greater (31.7 percent) (p = 0.23). Researchers also noted detection rates at 30 days and six, 12, 24 and 30 months were 6.2 percent, 20.4 percent, 27.1 percent, 33.6 percent and 40.0 percent, respectively.

Median time from device insertion to the first detection of an AFib episode was 123 days. Thirteen of the patients (10.2 percent) who reached the primary endpoint had one or more episodes lasting 24 hours or longer, and oral anticoagulation therapy was prescribed for 72 patients (56.3 percent).

The researchers, led by James A. Reiffel, MD, FACC, note that AFib would have gone undetected in this specific patient population had ICM monitoring been limited to 30 days. “As the AFib incidence was still rising at 30 months, the ideal monitoring duration is unclear,” they write. “Our findings have important implications for AFib screening and stroke prevention in this population.” They suggest additional trials assessing the value of detecting subclinical AFib and of prophylactic therapies are warranted.

In a related editorial comment, Jeff S. Healey, MD, MSc, writes: “The REVEAL AF study has shown that AFib is extremely common among older individuals with stroke risk factors. Over the next three to four years, subgroup analyses, economic evaluations and randomized clinical trials will help determine if this insight can be translated into a cost-effective stroke prevention strategy for high-risk individuals.”

Reiffel JA, Verma A, Kowey PR, et al. JAMA Cardiol 2017;August 26:[Epub ahead of print].

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VALIDATE-SWEDEHEART: Bivalirudin vs. Heparin in STEMI, NSTEMI Patients Undergoing PCI

At 180 days, no significant difference in the rate of death, myocardial infarction (MI) or major bleeding was seen among patients with STEMI or NSTEMI who were undergoing PCI and who received either bivalirudin or heparin treatment, according to data from VALIDATE-SWEDEHEART presented at ESC Congress 2017 in Barcelona and simultaneously published in the New England Journal of Medicine. Read More >>>

The study compared bivalirudin with heparin monotherapy among 6,006 STEMI and NTEMI patients who were undergoing PCI in Sweden. PCI was predominantly performed using a radial approach and the majority of patients were receiving treatment with high-intensity platelet inhibitors. The primary endpoint was a composite of death from any cause, MI or major bleeding during a 180-day follow-up period.

Results showed that at 180 days a primary endpoint event had occurred in 12.3 percent of patients in the bivalirudin group (369 of 3,004 patients), compared with 12.8 percent in the heparin group (383 of 3,002 patients) (p = 0.54). These results were consistent across patients with STEMI and NSTEMI, as well as other major subgroups. Broken down by event, MI occurred in 2.0 percent of patients in the bivalirudin group, compared with 2.4 percent in the heparin group (p = 0.33); major bleeding occurred in 8.6 percent of patients in both groups (p = 0.98); definite stent thrombosis occurred in 0.4 percent of patients in the bivalirudin group vs. 0.7 percent of patients in the heparin group (p = 0.09); and death occurred in 2.9 percent of the bivalirudin group vs. 2.8 percent of the heparin group.

“In this investigator-initiated, registry-based, randomized clinical trial, we enrolled patients with acute coronary syndromes who were undergoing PCI and receiving treatment with aspirin and potent P2Y12 inhibitors, without the planned use of glycoprotein IIb/IIIa inhibitors,” researchers said. “The low rates of ischemic events overall and the absence of a significant between-group difference in event rates may have been influenced by the robust antithrombotic regimen used in the trial.”

In an accompanying editorial, Gregg W. Stone, MD, FACC, highlights several limitations to the study that make it difficult to definitively answer the question of whether to use bivalirudin or heparin during PCI. He notes that the principal investigators from each of the large-scale randomized trials comparing bivalirudin and heparin for MI, including VALIDATE-SWEDEHEART, have agreed to combine individual patient data from their respective studies into a single database, which “should provide robust evidence to guide decisions.”

Erlinge D, Omerovic E, Fröbert O, et al. New Engl J Med; 2017:August 27:[Epub ahead of print].

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Outcomes of Clopidogrel Reloading for MI Patients on Pre-Admissions Clopidogrel Therapy

Clopidogrel reloading occurs most frequently in patients with acute myocardial infarction (MI) who are already taking clopidogrel, particularly for STEMI. Results from a recent study published in the European Heart Journal show clopidogrol reloading does not cause an increased risk of in-hospital major bleeding or mortality.

Using data from ACC’s ACTION Registry, Jacob A. Doll, MD, et al., analyzed 51,524 patients who were admitted to 735 PCI-capable hospitals between July 2009 and Dec. 2014. Approximately 39 percent of the study population presented with STEMI, while 61 percent presented with NSTEMI. Only 9 percent of STEMI patients used pre-admission P2Y12 inhibitors, whereas 19 percent of NSTEMI patients did. Read More >>>

The authors note that “clopidogrel was the most common agent (91.9 percent), though rates of clopidogrel use declined slightly in later years in concert with increasing use of prasugrel and ticagrelor.” In fact, they excluded 4,803 patients for switching to one of these two P2Y12 inhibitors during the study period.

Of those taking clopidogrel, 38 percent were reloaded with a dose ≥300 mg upon presentation. Majority of STEMI patients (76 percent) received a loading dose, while only a quarter of NSTEMI patients were reloaded. Across both subgroup populations, reloaded patients “were more likely to be younger, male and had lower rates of prior cardiovascular disease, diabetes, renal disease, and other comorbidities compared with patients not receiving a loading dose.” Researchers also found no association between clopidogrel reloading and an increased risk of major bleeding.

However, there were a few minor differences among the two subgroups. For example, reloaded STEMI patients were more likely to be treated with PCI, whereas NSTEMI patients had an early angiography (<24 hours) and PCI. Additionally, reloaded STEMI patients had lower rates of in-hospital death (odds ratio [OR], 0.80; 95 percent confidence interval [CI], 0.66-0.96); however, researchers observed no significant difference in mortality in reloaded NSTEMI patients (OR, 1.13; 95 percent CI, 0.93-1.37).

“Clinicians may be selectively reloading patients with more acute disease but also greater likelihood of survival and recovery,” state the study authors. “Patients already taking clopidogrel at the time of MI are a large and understudied population.” As such, they suggest further investigation with a prospective randomized study to “determine if this should be the preferred treatment strategy for this common clinical scenario.”

Doll JA, Li S, Chiswell K, et al. Eur Heart J 2017;May 25:[Epub ahead of print].

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Association Between BMI and Long-Term Outcomes Among Older STEMI Patients

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Older STEMI patients who fit into the World Health Organization’s normal weight or extreme obesity body mass index (BMI) categories are more likely to have worse long-term outcomes than those who are mildly obese. The results of a study recently published in the European Heart Journal: Quality of Care & Clinical Outcomes address a knowledge gap in the obesity paradox and highlight the risks of an increasing aging population.

After matching Centers for Medicare and Medicaid Services longitudinal administrative data to patient data in ACC’s ACTION Registry, Ian J. Neeland, MD, et al., analyzed the long-term outcomes of 19,499 patients (mean age of 74.8 years) who had an acute STEMI between January 2007 and December 2011. The majority of the patients were white (90 percent) and more than half were men (62 percent). When stratified by BMI, 30 percent were normal weight, 41 percent overweight, 19 percent mildly obese, 6 percent moderately obese and 3 percent extremely obese. Read More >>>

“As BMI increased, there was a significant trend towards younger age, female sex, black race, and less smoking (p < 0.001),” write the study authors. “Higher mean [socioeconomic status] SES and lower comorbidity were seen among those with normal weight/overweight whereas obese patients had lower mean SES and greater comorbidity, with a widening gap seen as BMI increases.”

Results also showed an association between increasing BMI, higher left ventricular ejection fraction at presentation and less in-hospital cardiogenic shock (p < 0.001). In regard to in-hospital major bleeding, the authors noted a U-shaped relationship, with rates highest at the extreme BMI categories (p < 0.001). However, the study authors did not find significant differences based on BMI for cardiac arrest, provision of antiplatelet, anticoagulation, statin or reperfusion therapy, door to balloon time or cardiac rehabilitation referral.

Within the three-year follow-up period, 15.3 percent of the total study population died and 27.3 percent experienced a major adverse cardiac event. Patients who were normal weight or extremely obese had lower odds of days alive and out of hospital (odds ratio [OR], 0.79; 95 percent confidence interval [CI], 0.68-0.90 vs. OR, 0.73; 95 percent CI, 0.54-0.99, respectively). A U-shaped association was also observed between BMI categories and mortality.

“The clinical implications of these findings are increasingly relevant given the static prevalence of obesity despite substantial clinical and policy efforts.” The authors underline how the results “have economic and patient-centered implications since increased rates of readmission and longer time in the hospital lead to higher costs and decreased quality of life.”

They conclude by emphasizing the “need for aggressive prevention and treatment for this high risk group,” and recommend further study “to discern the sociobiological mechanisms underpinning these observations.”

Neeland IJ, Das SR, Simon DN, et al. Eur Heart J Quality Care Clinical Outcomes 2017;3:183-191.

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Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Arrhythmias and Clinical EP, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Anticoagulation Management and ACS, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Nonstatins, Novel Agents, Statins, Acute Heart Failure, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging, Smoking

Keywords: ACC Publications, Cardiology Magazine, Acute Coronary Syndrome, Acute Disease, Adenosine, Angiography, Aspirin, Atrial Fibrillation, Antithrombins, Body Mass Index, Body Weight, Cardiac Rehabilitation, Centers for Medicare and Medicaid Services (U.S.), Comorbidity, Confidence Intervals, Cost-Benefit Analysis, Diabetes Mellitus, Dyspnea, Follow-Up Studies, Heart Arrest, Heparin, Hirudins, Hospital Mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Incidence, Obesity, Odds Ratio, Overweight, Patient Readmission, Peptide Fragments, Platelet Aggregation Inhibitors, Platelet Glycoprotein GPIIb-IIIa Complex, Prevalence, Prospective Studies, Quality of Life, Registries, Research Personnel, Risk Factors, Shock, Cardiogenic, Smoking, Social Class, Myocardial Infarction, Stents, Stroke, Stroke Volume, Thrombosis, Ticlopidine

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