Journal Wrap
Procedural Complications, Mortality and More Increased with Large-bore Catheters

Patients who undergo a transcatheter intervention with a large-bore catheter were more likely to have bleeding complications and this was associated with an increase in-hospital mortality, hospital stay and health care costs, according to a study published in JAMA: Cardiology and simultaneously presented at ACC.17.

The retrospective cohort study analyzed data in 17,672 patients in the National Inpatient Sample database of the Healthcare Cost and Utilization Project who underwent a transcatheter aortic valve replacement (n = 3,223), endovascular aneurysm repair (EVAR; n = 12,633) or percutaneous left ventricular assist device (PVAD) implant (n = 1,816). The study period was January 1, 2012 to December 31, 2013.

In what the authors state is the largest study of the effect of bleeding complications in this setting, overall, bleeding occurred in 17.7 percent of patients (mean age 75.6 years), and 80.7 percent of these patients had at least one transfusion. The rate of bleeding was highest with TAVR at 30.2 percent, and it was 25.8 percent with PVAD implant and 13.4 percent with EVAR. Bleeding was defined as need for transfusion, any hemorrhage or hematoma, or need for surgical or transcatheter intervention for bleeding.

The overall rate of in-hospital mortality was 5.6 percent, and this was significantly higher in patients with bleeding at 12.9 percent versus those without bleeding at 4.1 percent (p < 0.001). Patients who experienced bleeding complications, compared with those who did not, had a longer hospitalization (median of seven days vs. two days) and higher health care costs (median $48,663 vs. $29,968; p < 0.001 for both comparisons). As the number of transfusions increased, so did the rate of mortality, hospital stay and costs.

The authors stated that the more than two-fold adjusted increased risk of in-hospital mortality found in this study is consistent with previous reports. “Better preventive and bleeding avoidance strategies are needed if the full benefits of these new techniques are to be achieved,” stated lead author Bjorn Redfors, MD, PhD, et al.

Redfors B, Watson BM, McAndrew T, et al. JAMA Cardiol 2017;March 18:[Epub ahead of print].

Journal Wrap
Early Invasive Strategy Beneficial in Patients With Diabetes and ACS

Survival while in the hospital is higher in patients with diabetes who present with an acute coronary syndrome (NSTEMI or unstable angina [UA]) and are managed with an early invasive strategy of coronary angiography with or without revascularization within 48 hours, according to a study published in the Journal of the American Heart Association and simultaneously presented at ACC.17.

Ahmed N. Mahmoud, MD, et al., examined the effect of an early invasive strategy, compared with an initial conservative strategy, because of the scare data on its merits in this patient population. They identified 363,500 patients in the National Inpatient Sample database with a primary diagnosis of NSTEMI and a secondary diagnosis of diabetes. Their mean age was 68 years, 42.9 percent were women, and 64.5 percent were white; most had hypertension (82.8 percent) and coronary artery disease (77.9 percent).

An early invasive strategy was used in 45.3 percent of patients. Revascularization was more frequent in the early invasive arm than in the initial conservative arm for both PCI (96.9 and 30.1 percent) and CABG (15.6 and 5.9 percent).

The researchers also conducted a large propensity-score matched analysis, including more than 50 baseline characteristics and hospital presentations, with 21,681 patients in each treatment arm.

Overall, the incidence of in-hospital mortality was 3.9 percent, and this was lower in the early invasive arm than in the initial conservative arm for both the unadjusted (2.0 vs. 4.8 percent; odds ratio [OR], 0.41) and adjusted (2.2 vs. 3.8 percent; OR, 0.57) analyses (p < 0.001 for both analyses).

The authors noted the early invasive strategy was more commonly used in patients who were younger, less frequently female and had fewer co-morbidities, and was more frequently used in larger hospitals and urban teaching hospitals. Patients with UA, compared with NSTEMI, were less likely to undergo early invasive treatment. The duration of the hospital stay was shorter and total hospital charges were lower with the early invasive strategy.

“These results support the 2014 ACCF/AHA guideline recommendations for an early invasive strategy in diabetics, especially those with high-risk features (e.g., NSTEMI and cardiogenic shock,” write the authors. They also noted that registry data worldwide demonstrate this strategy is underutilized, and their results show the early strategy was more commonly used in younger patients with fewer comorbidities, which is a less common presentation for diabetics with NSTE-ACS.

Journal Wrap
Healthiest Arteries of Any Studied Population Found in Indigenous South American Population

The Tsimane, a forager-horticulturalist population indigenous to the Bolivian Amazon, have the lowest reported levels of vascular ageing for any population studied, with rates of coronary atherosclerosis five times lower than in the U.S., according to a study presented at ACC.17 and simultaneously published in The Lancet.

In the cross-sectional cohort study, researchers visited 85 Tsimane villages between 2014 and 2015 and took non-contrast CT scans of the hearts of roughly 700 adults between the ages of 40 and 94, among other metrics. Based on the CT scans, 85 percent of the Tsimane people had no coronary artery calcium (CAC), 13 percent were at low risk with CAC scores between 1-100 and only 3 percent had moderate or high risk (CAC scores >100). Their mean LDL level was 91 mg/dL and HDL was 39.5 mg/dL.

These findings continued into old age, where nearly two-thirds of those over 75 years old had almost no risk of heart disease and only 8 percent had moderate or high risk. By comparison, in a population of 6,814 people aged 45 to 84 in the Multi-Ethnic Study of Atherosclerosis (MESA), only 14 percent of Americans had no CAC and 50 percent had a moderate or high risk of coronary artery disease.

“These findings are very significant,” says Randall Thompson, MD, FACC, who presented the results of the study. “Put another way, the arteries of the Tsimane are 25-30 years younger than the arteries of sedentary urbanites. The data also show that the Tsimane arteries are aging at a much slower rate.”

Journal Wrap
Low-Dose Rivaroxaban Reduces Recurrent VTE in EINSTEIN CHOICE

Extended treatment with low-dose rivaroxaban provided nearly a three-fold greater reduction in recurrent venous thromboembolism (VTE) than aspirin with a similar rate of bleeding in patients who had completed six to 12 months of anticoagulation, according to results presented at ACC.17 and simultaneously published in the New England Journal of Medicine.

EINSTEIN CHOICE is the first study to directly compare low-dose rivaroxaban and aspirin in this population in whom there is equipoise regarding the benefit of continued therapy. The international multicenter study enrolled 3,396 patients. After a median follow-up of 351 days, compared with aspirin (4.4 percent), there was a significant reduction in symptomatic fatal or non-fatal recurrent VTE, with rivaroxaban 10 mg and 20 mg (1.2 percent and 1.5 percent, respectively; p < 0.001).

There was no statistically significant difference in the rates of bleeding between the three treatment groups, which occurred in 0.4 percent of the rivaroxaban 10 mg group, 0.5 percent of the rivaroxaban 20 mg group, and 0.3 percent of the aspirin group. There were no differences between groups for any of the secondary efficacy or safety endpoints.

In patients who suffered a provoked VTE, the rate of a recurrent VTE was lower with both doses of rivaroxaban (0.9 percent and 1.4 percent for the 10 and 20 mg doses) versus aspirin (3.6 percent). The number needed to treat to prevent one VTE was 30 with the 10 mg dose of rivaroxaban and 33 with the 20 mg dose of rivaroxaban.

A follow-up study is planned to explore whether low-dose rivaroxaban is equally effective in other patient populations. “The results of this trial cannot be extended to patients who have an unequivocal indication for long-term anticoagulation therapy and who thus were ineligible to participate in the trial,” write Mark A.Crowther, MD, and Adam Cuker, MD, in an accompanying editorial.

Weitz JI, Lensing A WA, Prins MH, et al. N Engl J Med 2017;376:1211-22.

Journal Wrap
GEMINI-ACS-1: Low-dose Rivaroxaban Yields Similar Bleeding Rate Versus DAPT

In patients with an acute coronary syndrome (ACS), substituting aspirin with low-dose rivaroxaban combined with a P2Y12 inhibitor resulted in a similar rate of clinically significant bleeding, according to results from the GEMIN-ACS-1 study presented at ACC.17 and simultaneously published in The Lancet.

The phase II study randomized 3,037 patients within ten days of an ACS event 1:1 to low-dose rivaroxaban (2.5 mg twice daily) or aspirin (100 mg daily); 56 percent received ticagrelor and 44 percent clopidogrel, as selected by the investigator. The study was conducted at 371 sites in 21 countries (with 77 percent of patients enrolled in Europe) between April 2015 and October 2016.

The presenting event was STEMI for 49 percent, NSTEMI for 40 percent, and unstable angina for 11 percent. Before randomization, most patients had cardiac catheterization (94 percent) and PCI (87 percent).

In each treatment arm, 5 percent of patients experienced the primary endpoint of TIMI non-CABG clinically significant bleeding (p = 0.58). The median duration of treatment was 291 days. TIMI bleeding requiring medical attention was the most common type of bleeding that occurred in the study, at 4 percent in each group.

The rate of major bleeding was low using the TIMI definition, but with the ISTH definition it was 2 percent with rivaroxaban versus 1 percent with aspirin. Using the GUSTO or BARC bleeding definitions, no differences were seen between the groups. Stent thrombosis was low at 1 percent of each group.

E. Magnus Ohman, MD, et al., write that the trial was not powered to evaluate the effect of this treatment strategy on ischemic events, and that “in view of the risk of recurrent events in this patient population, additional study of this approach seems warranted.”

Ohman EM, Roe MT, Steg PG, et al. Lancet 2017;March 18:[Epub ahead of print].