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Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

ABSTRACT: Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH (n=30) or standard peri-procedural UFH (n=16). Blood samples for markers of thrombin generation and coagulation activation were drawn prior to and at 0, 0.5, 2, 6-8 and 48 hours (h) after start of PCI. In patients treated with rivaroxaban (10 or 20 mg) and patients treated with rivaroxaban plus heparin, the levels of prothrombin fragment 1 + 2 at 2 h post-PCI were 0.16 [0.1] nmol/l (median) [interquartile range, IQR] and 0.17 [0.2] nmol/l, respectively. Thrombin-antithrombin complex values at 2 h post-PCI were 3.90 [6.8]µg/l and 3.90 [10.1] µg/l, respectively, remaining below the upper reference limit (URL) after PCI and stenting. This was comparable to the control group of UFH treatment alone. However, median values for thrombin-antithrombin complex passed above the URL with increasing tendency, starting at 2 h post-PCI in the UFH-alone arm but not in rivaroxaban-treated patients. In this exploratory trial, rivaroxaban effectively suppressed coagulation activation after elective PCI and stenting.

SUBMITTER: Vranckx P

PROVIDER: S-EPMC6374984 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

Vranckx P P Leebeek F W G FW Tijssen J G P JG Koolen J J Stammen F F Herman J-P R JP de Winter R J RJ van T Hof A W J AW Backx B B Lindeboom W W Kim S-Y SY Kirsch B B van Eickels M M Misselwitz F F Verheugt F W A FW

Thrombosis and haemostasis 20150430 2

Patients on rivaroxaban requiring percutaneous coronary intervention (PCI) represent a clinical conundrum. We aimed to investigate whether rivaroxaban, with or without an additional bolus of unfractionated heparin (UFH), effectively inhibits coagulation activation during PCI. Stable patients (n=108) undergoing elective PCI and on stable dual antiplatelet therapy were randomised (2:2:2:1) to a short treatment course of rivaroxaban 10 mg (n=30), rivaroxaban 20 mg (n=32), rivaroxaban 10 mg plus UFH ...[more]

PMID: 25925992

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Project description:ObjectivesTo assess the perceptions of patients with stable coronary artery disease of the urgency and benefits of elective percutaneous coronary intervention and to examine how they vary across centers and by providers.DesignCross sectional study.Setting10 US academic and community hospitals performing percutaneous coronary interventions between 2009 and 2011.Participants991 patients with stable coronary artery disease undergoing elective percutaneous coronary intervention.Main outcome measuresPatients' perceptions of the urgency and benefits of percutaneous coronary intervention, assessed by interview. Multilevel hierarchical logistic regression models examined the variation in patients' understanding across centers and operators after adjusting for patient characteristics, using median odds ratios.ResultsThe most common reported benefits from percutaneous coronary intervention were to extend life (90%, n=892; site range 80-97%) and to prevent future heart attacks (88%, n=872; site range 79-97%). Although nearly two thirds of patients (n=661) reported improvement of symptoms as a benefit of percutaneous coronary intervention (site range 52-87%), only 1% (n=9) identified this as the only benefit. Substantial variability was noted in the ways informed consent was obtained at each site. After adjusting for patient and operator characteristics, the median odds ratios showed significant variation in patients' perceptions of percutaneous coronary intervention across sites (range 1.4-3.1) but not across operators within a site.ConclusionPatients have a poor understanding of the benefits of elective percutaneous coronary intervention, with significant variation across sites. No sites had a high proportion of patients accurately understanding the benefits. Coupled with the wide variability in the ways in which hospitals obtain informed consent, these findings suggest that hospital level interventions into the structure and processes of obtaining informed consent for percutaneous coronary intervention might improve patient comprehension and understanding.

Project description:BackgroundTwenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches to treatment.MethodsTwo hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life-5 dimension-5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was performed to compare clinical and procedural characteristics among patients with and without post-PCI angina (defined by follow-up SAQ-angina frequency score <100).ResultsEighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, P<0.001) and EQ-5D-5L health index scores (0.84±0.15 versus 0.69±0.22, P<0.001). Pre-PCI fractional flow reserve (FFR) was lower among patients who had no post-PCI angina (0.56±0.15 versus 0.62±0.13, P=0.003). Percentage change in FFR after PCI had a moderate correlation with angina frequency score at follow-up (r=0.36, P<0.0001). Patients with post-PCI angina had less improvement in FFR (43.1±33.5% versus 67.0±50.7%, P<0.001). There were no between-group differences in post-PCI FFR, coronary flow reserve, or corrected index of microcirculatory resistance. Patients with post-PCI angina had lower SAQ-summary scores (64.01±22 versus 95.16±8.72, P≤0.001) and EQ-5D-5L index scores (0.69±0.26 versus 0.91±0.17, P≤0.001) at follow-up.ConclusionsLarger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriateness of PCI.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT03259815.

Dataset Information

Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

Publications

Peri-procedural use of rivaroxaban in elective percutaneous coronary intervention to treat stable coronary artery disease. The X-PLORER trial.

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