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NOACs safe, effective in octogenarians

Audrey Abella
17 Dec 2018
Dr Jan Beyer-Westendorf

Low rates of cardiovascular (CV) or major bleeding complications were observed among octogenarians who were receiving active NOAC* therapy, suggesting that long-term anticoagulation with NOACs may result in a good risk-benefit ratio in this patient subgroup, according to data presented at ASH 2018.

To evaluate the potential of NOACs among elderly patients, researchers evaluated participants from the DRESDEN NOAC registry who were aged ≥80 years (n=935, mean age 84.2 years, 43.4 percent male) and receiving NOAC therapy (rivaroxaban [52.1 percent], apixaban [21.2 percent], edoxaban [17.6 percent], and dabigatran [9.1 percent]). Atrial fibrillation (AF) was the primary indication for anticoagulant therapy (80.4 percent) followed by venous thromboembolism (VTE, 19.1 percent). [ASH 2018, abstract 422]

After a mean follow-up of 2.5 years, an event rate of 1.0/100 patient-years (PY) was observed for the composite endpoint of stroke, transient ischaemic attack (TIA), systemic embolism, or VTE in the intention-to-treat cohort.

In patients with AF, the rate for stroke, TIA, and systemic embolism was 1.0/100 PY. For those with VTE, the rate for recurrent deep venous thrombosis or pulmonary embolism was 0.4/100 PY.

On-treatment analysis revealed event rates of 0.7/100 PY for the composite endpoint, 0.7/100 PY for stroke, TIA, and systemic embolism in AF patients, and 0.1/100 PY for recurrent VTE in VTE patients.

In terms of safety, the overall rate of ISTH** major bleeding was 1.0/100 PY (p<0.0001), while for clinically relevant non-major bleeding, the rate was 6.0/100 PY (p=0.0002).

Nearly 27 percent of patients discontinued their NOAC regimen. Although bleeding was the primary reason (28 percent), the other reasons for NOAC discontinuation should also be considered, pointed out study author Dr Jan Beyer-Westendorf from King’s College London in London, UK. “There [was no] single driver of discontinuation … Bleeding [was only one reason],” he said, noting other factors such as inconvenience in taking medications, scheduled end of treatment, nonbleeding side effects, worsening of renal function, and physicians’ decision to discontinue therapy. Other infrequent reasons were vascular events, contraindication to anticoagulation, and frequent falls.

A total of 255 deaths (27.3 percent) were reported, with almost half (n=120) occurring within 3 days after the last NOAC intake. The leading cause of death was fatal cardiovascular event (n=86, ie, non-thromboembolic causes, acute coronary syndrome, ischaemic stroke/systemic embolism, VTE), which occurred mostly after anticoagulant discontinuation. Other causes of death were age-related mortality (n=79), sepsis/infection (n=40), terminal malignant disease (n=26), and fatal bleeding (n=11).

According to Beyer-Westendorf, the mortality rate was unsurprising in this population as the deaths were primarily due to ‘natural causes’ and not major thromboembolism or bleeding.

“[Among those who died within 3 days of last NOAC intake,] only 21 fatalities occurred which were not prevented or, in the case of bleeding, might have been caused, by NOAC therapy,” highlighted Beyer-Westendorf. “From a clinician’s point of view … [these are] acceptably low rates of CV or major bleeding events … [As] these patients are at high risk of bleeding [given] their comedication, comorbidities, and renal impairment, it is impressive that … overall, we only had a total of eleven fatal bleeding events.”

Taken together, the results address the challenges associated with this patient subgroup given their high thromboembolic and bleeding risks, noted Beyer-Westendorf. The findings may help streamline treatment decisions for very old patients who require anticoagulant therapy, he added. “[Moreover,] the use of warfarin in elderly patients is quite rare … NOACs might be [a favourable] alternative.”

 

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Most Read Articles
Pearl Toh, Yesterday
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Audrey Abella, 4 days ago
Extremes of sleep duration (≤5 or ≥10 hours/day), which is a known mortality risk factor in the general population, may increase absolute mortality in adults with type 2 diabetes (T2D), a prospective study has shown.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 12 Oct 2020

Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.