MO514CARDIORENAL OUTCOMES AND MORTALITY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A MULTINATIONAL PROSPECTIVE COHORT STUDY (PROVALID)
Authors: Thöni Stefanie , Keller Felix , Denicolo Sara , Eder Susanne , Rosivall Laszlo , Wiecek Andrzej Jan , Mark Patrick , Rossing Peter , Lambers Heerspink Hiddo , Mayer Gert 
Published: May 2021

Abstract

Background and Aims
PROVALID is a prospective, observational, multinational cohort study in 4000 patients with type 2 diabetes mellitus. Our aim was to determine the incidence rate of renal and cardiovascular endpoints, as well as all-cause-mortality in different European countries and to identify risk factors associated with the investigated outcomes.

Method
Potential risk factors associated with the investigated outcomes were identified by calculation of the incidence rate ratio. Crude and adjusted incidence rates for every country were estimated using generalized linear (poisson) regression models and corresponding 95 % confidence intervals were computed. Incidence rates were adjusted for different risk factors including age, sex, estimated GFR, albuminuria, HbA1c, LDL, HDL, total cholesterol, systolic blood pressure, BMI and cardiovascular and renal comorbidities; among these several show significant impact on outcomes.
The renal outcome was a composite of a sustained decline in the estimated GFR of at least 40%, a sustained increase in albuminuria of at least 30 % including the progression from normo- to micro- or macroalbuminuria, end-stage kidney disease, or death from renal causes. The cardiovascular composite endpoint was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

Results
3461 participants of four European countries (Austria 18 %, Hungary 41 %, Netherlands 26 % and Scotland 15 %) with a mean follow up time of 3.9 years were included into this study. Participants from Poland were excluded due to missing follow-up data. In total, 9.2 % and 6.4 % participants reached the renal and cardiovascular composite endpoint, respectively. 7.0 % of the participants died within this timeframe.
The adjusted incidence rate for the renal endpoint ranged from 14.5 to 25.3 (per 1000 patient-years) with no significant differences between countries. On average, the incidence rate was lower in Scotland (IR, 14.5; 95 % CI, 8.7 to 22.5) and in the Netherlands (IR, 15.7; 95 % CI, 10.9 to 21.8) compared to Hungary (IR, 25.3; 95 % CI, 20.7 to 30.6) and Austria (IR 21.3; 95 % CI, 16.2 to 27.5).
The adjusted incidence rate for the cardiovascular endpoint ranged from 7.0 to 20.3 and was significantly lower in Hungary (IR, 7.0; 95 % CI, 5.1 to 9.3) and the Netherlands (IR, 7.6; 95 % CI, 4.4 to 12.2) compared to Austria (IR, 16.7; 95 % CI, 12.4 to 22.1) and Scotland (IR, 20.3; 95 % CI, 13.8 to 28.9).
The adjusted incidence rate for all-cause-mortality ranged from 4.2 to 15.9 and was significantly lower in the Netherlands (IR, 4.2; 95 % CI, 2.2 to 7.6) compared to Scotland (IR, 15.9; 95 % CI, 10.9 to 22.6). No significant difference in the incidence rates between Austria (IR, 9.8; 95 % CI, 7.0 to 13.4) and Hungary (IR, 9.3; 95 % CI, 6.8 to 12.4) was found.

Conclusion
After adjustment for known risk factors, incidence rates of cardiovascular endpoints, as well as all-cause-mortality still vary significantly between four European countries. This may be due to manifold reasons. Further analysis of the national therapeutic practice pattern within the PROVALID cohort may provide additional information.