Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial

Kim, Jin Bae; Joung, Hyun Jun; Lee, Jung Myung; Woo, Jong Shin; Kim, Woo-shik; Kim, Kwon Sam; Lee, Kyung Hye; Kim, Weon

doi:10.1186/s13063-016-1541-8

Cited by 12 publications

(9 citation statements)

References 18 publications

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“…Although the semaglutide trial showed significant beneficial effects on nonfatal stroke, the cardiovascular outcome trials were underpowered for the specific stroke endpoints. More studies using ertugliflozin (SGLT2 inhibitor) and dulaglutide (once-weekly GLP1 analogue) are currently ongoing in the hope of improving vascular outcomes and total mortality in patients with diabetes at high stroke risk [83,84]. Until the results of these studies are released, multifactorial interventions targeting individual cerebrovascular risk factors are required to improve clinical outcomes in diabetes patients after a stroke or at high risk of stroke.…”

Section: Discussionmentioning

confidence: 99%

Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke

Ahn

Lim

2019

J Stroke

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Patients with hyperglycemia are at a high risk of cardio-and cerebrovascular diseases. Diabetes patients also have poor outcomes after cerebrovascular disease development. Several classes of drugs are used for diabetes management in clinical practice. Thiazolidinedione (TZD) was introduced in the late 1990s, and new antidiabetic agents have been introduced since 2000. After issues with rosiglitazone in 2007, the U.S. Food and Drug Administration strongly recommended that trials investigating cardiovascular risk associated with new antidiabetic medications should be conducted before drug approval in the United States, to prove the safety of these new drugs and to determine their superiority to previous medications. Currently, results are available from two studies with TZD focusing on cardiovascular diseases, including stroke, and from 12 cardiovascular outcome trials focusing on major adverse cardiovascular events associated with new antidiabetic agents (four with dipeptidyl peptidase-4 inhibitors, three with sodium-glucose cotransporter-2 inhibitors, and five with glucagon-like peptide-1 analogues). These studies showed different results for primary cardiovascular outcomes and stroke prevention. It is important to determine whether prescription of TZD or new antidiabetic medications compared to conventional treatment, such as sulfonylurea or insulin, is better for stroke management. Furthermore, it is unclear whether drugs in the same class show greater safety and efficacy than other drugs for stroke management.

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Section: Discussionmentioning

confidence: 99%

Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke

Ahn

Lim

2019

J Stroke

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“…Additively, Kim et al ( 16 ) have been planning a randomized prospective study, with the aim of evaluating the effects of dabigatran and rivaroxaban on endothelial intima, medial thickness, and atheroma plaques in carotid artery in patients with atrial fibrillation. Warfarin will be administered to control group.…”

Section: Discussionmentioning

confidence: 99%

“…The ending date was determined as 2018. Within this study, same processes end-up with restenosis will be assessed in humans ( 16 ). Apparently, this trial has a great importance as it is first study in humans assessing rivaroxaban effect on intimal and medial changes.…”

Section: Discussionmentioning

confidence: 99%

Effects of rivaroxaban on intimal hyperplasia and smooth muscle cell proliferation at the carotid artery anastomosis site in rabbits

Akkaya

Bilen²,

Gencpinar³

et al. 2017

Anatol J Cardiol

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Objective:This study aimed to assess the effect of new generation oral, direct factor Xa inhibitor rivaroxaban on intimal hyperplasia and smooth muscle cell proliferation at the carotid artery anastomosis site of rabbits.Methods:In total, 14 New Zealand male rabbits weighing 3–3.5 kg were randomized into two groups. Group A (7 rabbits) served as the control group and received no medication. Rivaroxaban was perorally administered to group B (7 rabbits) mg/kg/day for 28 days. Following anesthesia induction, carotid arteries were dissected through a right neck incision. following heparinization at 100 IU/kg, vertical full thickness arteriotomy was performed, then was repaired continuously with 8-0 polypropylene. At day 28, all rabbits were sacrificed and the anastomosed carotid artery segments were analyzed using light microcopy. Hematoxylin–eosin and Masson’s trichrome stained images were analyzed using a digital image analysis program, and lumen diameter, lumen area, intimal and medial thickness, and media areas were measured and results were compared.Results:In the serial sections, the average lumen diameter of group B was higher than that of group A (p=0.001). The lumen areas of group B were also higher than those of group A (p=0.004). The intimal thickness of group B was lower than that of group A (p=0.001). When the section series were evaluated for media thickness, the thickness of group B was lesser than that of group A; the difference was statistically significant (p=0.002).Conclusion:This study may imply a potential midterm benefit of rivaroxaban following arterial anastomosis by reducing intimal proliferation and restenosis.

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“…However, these hypotheses will have to be further proved in newer randomized trials beginning with the PREFER-AF trial which should be the first randomized trial evaluating vascular protective effects of these DOACs [25]. The overall use of these DOACs will also depend on several factors such as patient satisfaction, cost, and risk profile of patients.…”

Section: Discussionmentioning

confidence: 99%

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

Bundhun

Soogund

Teeluck

et al. 2017

BMC Cardiovasc Disord

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BackgroundWarfarin is commonly used as a secondary prevention of stroke in patients with atrial fibrillation (AF). However, limitations have been observed even with the use of this medication. Recently, several newer direct oral anticoagulants (DOACs) have been approved for use by the food and drug administrations. Unfortunately, these newer drugs have seldom been compared directly with each other. Therefore, this study aimed to compare the bleeding events associated with rivaroxaban and dabigatran in patients treated for non-valvular AF.MethodsEMBASE, Medline (National Library of Medicine) and the Cochrane Central Registry of Controlled Trials were searched for studies comparing rivaroxaban with dabigatran using the terms ‘rivaroxaban, dabigatran and atrial fibrillation’. Primary endpoints were: any bleeding outcomes, intracranial bleeding and gastro-intestinal (GI) bleeding. Secondary outcomes included stroke/systemic embolism (SE)/transient ischemic attack (TIA), venous thromboembolism and mortality. Odds ratios (OR) with 95% confidence intervals (CIs) were calculated. The pooled analyses were carried out with RevMan 5.3 software. All the authors had full access to the data and approved the manuscript as written.ResultsA total number of 4895 patients were included. This analysis showed that rivaroxaban was not associated with a significantly higher bleeding event when compared to dabigatran (OR: 1.28, 95% CI: 0.95–1.72; P = 0.11). GI bleeding was similarly manifested between these two DOACs (OR: 0.98, 95% CI: 0.43–2.25; P = 0.97). Even if intracranial bleeding was higher with the use of rivaroxaban, (OR: 2.18, 95% CI: 0.51–9.25; P = 0.29), the result was not statistically significant. Moreover, stroke/SE/TIA and venous thromboembolism were also not significantly different (OR: 0.81, 95% CI: 0.53–1.23; P = 0.32) and (OR: 2.06, 95% CI: 0.73–5.82; P = 0.17) respectively. However, even if mortality favored dabigatran (OR: 1.42, 95% CI: 0.99–2.06; P = 0.06), this result only approached statistical significance.ConclusionHead to head comparison showed that rivaroxaban was not associated with significantly higher bleeding events compared to dabigatran. Intracranial bleeding, GI bleeding, stroke/SE/TIA, venous thromboembolism and mortality were also not significantly different between these two DOACs. However, due to the limited number of patients analyzed, and which were mainly obtained from observational studies, this hypothesis might only be confirmed in future randomized trials. Furthermore, the CHADS2-VASC and HAS-BLED score which might play an important role in predicting bleeding risks should also not be ignored.

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Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial

Cited by 12 publications

References 18 publications

Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke

Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke

Effects of rivaroxaban on intimal hyperplasia and smooth muscle cell proliferation at the carotid artery anastomosis site in rabbits

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

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