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].

<<< Return to top

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].

<<< Return to top

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].

<<< Return to top

“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.

<<< Return to top