Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD).

The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100.

The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.

The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD).

The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.

The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD).

CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (<60% of time within therapeutic range),Elderly (>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score & HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED.

Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP).

Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female).

Stages of kidney disease are categorized based on Cockcroft-Gault review as below:

No kidney failure (> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (< 15 ml/min).

Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.

Categories of reasons for switching from VKAs to Pradaxa® are as below:

• Hypersensitivity (Hypersensitivity to the drug)
• Intracranial haemorrhage (Patients with a history of intracranial haemorrhage (ICH) (except during the acute phase) in whom the benefits of anticoagulation were deemed to outweigh the risk of haemorrhage)
• Ischaemic stroke (Patients with ischaemic stroke who present clinical and neuroimaging criteria indicating a high risk of ICH)
• Arterial thromboembolic episodes (Patients undergoing treatment with VKAs, suffering from severe arterial thromboembolic episodes despite good INR control)
• INR not in range (Patients who have started treatment with VKAs in whom it is not possible to keep the INR in range (2-3) despite good therapeutic compliance)
• INR management (Lack of access to conventional INR management)
• Pts decision (Patient's decision)
• Others.

A single patient may have specified more than one reason

Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below:

1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason

Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below:

1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason

Reasons for no longer receiving Pradaxa® treatment categorized as below:

• Treatment change (Change of treatment (by patient or by investigator)
• Adverse event (Diarrhea, gastrointestinal discomfort, rectorrhagia, dyspepsia)
• Exitus
• Others