TY - JOUR
T1 - Nurse-led vs. usual-care for atrial fibrillation
AU - Wijtvliet, E. P. J. Petra
AU - Tieleman, Robert G.
AU - van Gelder, Isabelle C.
AU - Pluymaekers, Nikki A. H. A.
AU - Rienstra, Michiel
AU - Folkeringa, Richard J.
AU - Bronzwaer, Patrick
AU - Elvan, Arif
AU - Elders, Jan
AU - Tukkie, Raymond
AU - Luermans, Justin G. L. M.
AU - Van Asselt, A. D. I. Thea
AU - Van Kuijk, Sander M. J.
AU - Tijssen, Jan G.
AU - Crijns, Harry J. G. M.
AU - RACE 4 Investigators
N1 - Funding Information:
Conflict of interest: E.P.J.W., I.C.V.G., R.J.F., P.B., A.E., J.E., R.T., A.D.I.A., S.M.J.K., and J.G.P.T. declare no competing interests. R.G.T. reports grants and personal fees from Boehringer Ingelheim, Bristol-Meyers Squibb, Pfizer, and Daiichi-Sankyo and grants from Bayer during the conduct of the study. N.A.H.A.P. reports grants from Boehringer Ingelheim, Medtronic, Bayer, Pfizer, Bristol-Myers Squibb, Daiichi-Sankyo, and grants from Netherlands Health Insurance companies DSW, ACHMEA, and CZ, during the conduct of the study, all to the institution. M.R. reports grants from Netherlands Cardiovascular Research Initiative funded by Dutch Heart Foundation, outside the submitted work. J.G.L.M.L. reports grants from the Netherlands Cardiovascular Research Initiative funded by the Dutch Heart Foundation, grants from Boehringer Ingelheim,
Publisher Copyright:
© The Author(s) 2019.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Background Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist.Methods and results We randomized 1375 patients with atrial fibrillation (6410 years, 44% women, 57% had CHA(2)DS(2)-VASc >= 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P=0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interactionConclusion Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037).
AB - Background Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist.Methods and results We randomized 1375 patients with atrial fibrillation (6410 years, 44% women, 57% had CHA(2)DS(2)-VASc >= 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P=0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interactionConclusion Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037).
KW - Atrial fibrillation
KW - Cardiovascular mortality and morbidity
KW - Nurse-led care
KW - Stroke
KW - Heart failure
KW - Usual-care
KW - Randomized clinical trial
KW - MANAGEMENT
KW - RISK
U2 - 10.1093/eurheartj/ehz666
DO - 10.1093/eurheartj/ehz666
M3 - Article
C2 - 31544925
SN - 0195-668X
VL - 41
SP - 634
EP - 641
JO - European Heart Journal
JF - European Heart Journal
IS - 5
ER -