RDG README File Template --- General --- Version: 0.1 (2022-10-04) 

This README file was generated on [2023-07-25] by [Allix-Béguec Caroline].

Last updated: [2023-10-24].

# GENERAL INFORMATION

## Dataset title:

Long-term effectiveness of a stent-less strategy in patients with coronary artery disease:  3-year follow-up of a prospective all-comers observational study (SCRAP3y)

## DOI:

10.5281/zenodo.8182420

## Contact email:

recherche.clinique@ght-atlantique17.fr

# METHODOLOGICAL INFORMATION 

## Environmental/experimental conditions: 

Cohort study

## Description of sources and methods used to collect and generate data: 

Data were collected from medical records and follow-up at one and three years

## Methods for processing the data: 

*CardioReport has generated the initial database.

*A code was used for each patient consisting of the first letter of the surname and first name, followed by a number. 

*Follow-up data were collected on Excel by a study site coordinator.

## Quality -assurance procedures performed on the data: 

*Inclusion criteria, primary and secondary outcomes were monitored by clinical research assistants.

*In case of inconsistencies, queries were sent to the study site coordinator for confirmation or correction.

*Before closing the database, outliers were detected by the statistician and queries were sent to the study site coordinator for confirmation or correction.

# DATA & FILE OVERVIEW

## File naming convention:

date_file content_version.extension

# DATA-SPECIFIC INFORMATION FOR: 230203_Data_V01.csv

## Variable/Column List:

For each variable or column name :

    -- full “human readable” name of the variable, 

    -- description of the variable, 

    -- unit of measurement if applicable, 

    -- decimal separator *i.e.* comma or point if applicable

    -- allowed values : list of values or range, or domain

    -- format if applicable, e.g. date>

*       -- ID Patient

        -- Patient unique key

        -- 

        -- 

        -- 

        -- Text

*       -- Sex

        -- 

        -- 

        -- 

        -- 1:female ; 2:male

        -- Option

*       -- Age

        -- 

        -- year

        -- 

        -- 

        -- Number

*       -- BMI

        -- Body mass index

        -- kg/m2

        -- point

        -- 

        -- Number

*       -- Family history of CAD

        -- Family history of coronary artery disease

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- Diabetes

        -- 

        -- 

        -- 

        -- 0:no diabetes ; 1:diabetes

        -- Option

*       -- Hypertension

        -- Hypertension arterial

        -- 

        -- 

        -- 0:no hypertension ; 1:hypertension

        -- Option

*       -- Smoking

        -- Tobacco use

        -- 

        -- 

        -- 0:non-tobacco user ; 1:tobacco user ; 2:ex-tobacco user

        -- Option

*       -- History of revascularization

        -- History of coronary revascularization

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- Bypass

        -- History of arterial bypass operation

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- History of myocardial infarction

        -- 

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- History of stroke

        -- 

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- Peripheral arterial occlusive disease

        -- History of peripheral arterial occlusive disease

        -- 

        -- 

        -- 0:no history ; 1:history

        -- Option

*       -- LVEF

        -- Left ventricular ejection fraction

        -- 

        -- 

        -- 1:≥ 50% ; 2:35-50% ; 3:≤ 35%

        -- Option

*       -- Indication

        -- Type of cardiac disorder

        -- 

        -- 

        -- 1:STEMI ; 2: Non STEMI ; 3:chronic coronary syndrom

        -- Option

*       -- Angioplasty strategy

        -- 

        -- 

        -- 

        -- 1: conventional-DES; 2: BO-DES; 3: DCB only

        -- Option

*       -- One year follow-up

        -- Type of contact with the patients

        -- 

        -- 

        -- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased

        -- Option

*       -- Lost to follow-up reason

        -- 

        -- 

        -- 

        -- 

        -- Text

*       -- ASA

        -- acetyl salicilic acid

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- APA

        -- anti-platelet agent

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- ACO

        -- anticoagulant

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- MACE

        -- Major adverse cardiac event

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- Type of MACE

        -- 

        -- 

        -- 

        -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)

        -- Option

*       -- Comment

        -- 

        -- 

        -- 

        -- 

        -- Text

*       -- 3-year follow-up

        -- Type of contact with the patients

        -- 

        -- 

        -- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased; 5:consent withdrawal

        -- Option

*       -- MACE 3-year follow-up

        -- Major adverse cardiac event that happened between 1 and 3 years after the procedure

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- Type of MACE 1

        -- 

        -- 

        -- 

        -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)

        -- Option

*       -- Type of MACE 2

        -- 

        -- 

        -- 

        -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)

        -- Option

*       -- N MACE

        -- Number of MACE

        -- 

        -- 

        -- 

        -- Number

*       -- ISR/TLR

        --  lesion revascularization 

        -- 

        -- 

        -- 1:intra-stent revascularization; 2:target lesion revascularization after DCB; 3:ISR+TLR

        -- Option

*       -- ASA at 3-year follow-up

        -- acetyl salicilic acid

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- APA at 3-year follow-up

        -- anti-platelet agent

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- ACO at 3-year follow-up

        -- anticoagulant

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- Covid-19

        -- confirmed by PCR within the 3-year follow-up

        -- 

        -- 

        -- 0:no ; 1:yes

        -- Option

*       -- Time to 1-year MACE

        -- 

        -- months

        -- 

        -- 

        -- Number

*       -- Time to 3-year MACE 1

        -- 

        -- months

        -- 

        -- 

        -- Number

*       -- Time to 3-year MACE 2

        -- 

        -- months

        -- 

        -- 

        -- Number

*       -- Time to last follow-up

        -- 

        -- months

        -- 

        -- 

        -- Number

## Missing data codes: 

Blank for missing data

NA for non applicable