Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs (GuLLD)

Predicted Impact on Cardiovascular and Economic Outcomes of Swedish Atherosclerotic Cardiovascular Disease Guideline 2014 With Focus on Lipid Lowering Treatment

Methods: All patients <75 years registered in the Swedish Secondary Prevention after Heart Intensive care Admission registry (SEPHIA), will be followed-up within one year post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for recurrent cardiovascular disease (CVD) events and death will be used to estimate base case, and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´ Collaboration findings.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Other: Well-controlled

Detailed Description

SWEDEHEART is a Swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. Patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all Swedish coronary care units are collected in this registry.SEPHIA is a sub registry collecting data on secondary prevention and cardiac rehabilitation. Follow-up are registered at six to ten weeks and at 12 to14 months post MI by office visits or phone. Around 80 % of all Swedish acute myocardial infarction (AMI) patients below the age of 75 years are included in this register.

In this study, a cohort of 5 904 (74% men) registered in the SEPHIA registry and who had one year follow-up during 2013, will be included. Data are aggregated and delivered from the SWEDEHEART/SEPHIA national registry. All patients were informed about their participation in the registry, the follow-up, and their right to decline participation. No written consent was obtained

• Study Type: Observational
• Enrollment (Actual): 5304

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 74 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

a cohort of 5 904 (74% men) registered in the Swedish Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry and who have had one year follow-up during 2013

Description

Inclusion Criteria: All patients with acute myocardial infarction registered in the SEPHIA registry and who had one year follow-up during 2013 -

Exclusion Criteria:none

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Well-controlled cohort (LDL-C ≤ 1.8 mmol/L); Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation with well-controlled LDL-cholesterol	Other: Well-controlled; Both groups got treatment but well-controlled reached target of LDL-C<1.8 mmol/l; Other Names: Non-controlled
Non-controlled cohort; Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation and with not well-controlled LDL-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not	Treatment gap will be analysed in well-controlled (LDL-C ≤1.8 mmol/L) and non-controlled ( LDL-C >1.8 mmol/L) cohort in men and women separately.	AMI patients with one year follow-up year 2013

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group	Number of events predicted to occur in the non-controlled group	Predicted number of events within a 10 year period
Health care costs in SEK saved, due to number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group	Health care costs predicted to be gained if the non-controlled group achieved target LDL-cholesterol	Predicted health care costs within a 10 year period

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Gunilla Journath, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Journath G, Hambraeus K, Hagstrom E, Pettersson B, Lothgren M. Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline. BMC Cardiovasc Disord. 2017 Aug 16;17(1):224. doi: 10.1186/s12872-017-0659-2.

Helpful Links

• Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Myocardial infarction; Lipids; Guidelines; Costs
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2015/4:7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO