Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Figures & data

Table 1 Baseline Demographic and Clinical Characteristics of Non-Valvular Atrial Fibrillation Group of Patients from Colombia

Clinical Characteristic	Total		Warfarin		DOACs		Rivaroxaban		Apixaban		Dabigatran
	n=2076	%	n=459	%	n=1617	%	n=950	%	n=405	%	n=262	%
Female gender (%)	1184	57	258	56.2	926	57.3	518	54.5	247	61	161	61.5
BMI – kg/m^2, mean (SD)	27.3 ± 4.9		27.1 ± 4.9		27.3 ± 5.0		27.3 ± 5.0		26.9 ± 4.6		27.8 ± 5.1
Age - years, mean (SD)	73.3 ± 10.5		71.6 ± 10.0		73.7 ± 10.0		73.9 ± 10.3		73.3 ± 10.9		72.3 ± 10.6
<50	32	1.5	9	2	23	1.4	9	0.9	6	1.5	8	3.1
50–59	177	8.5	39	8.5	138	8.5	75	7.9	42	10.4	21	8
60–69	533	25.7	147	32	386	23.9	241	25.4	83	20.5	62	23.7
70–79	672	32.4	161	35.1	511	31.6	298	31.4	116	28.6	97	37
80–89	593	28.6	90	19.6	503	31.1	293	30.8	142	35.1	68	26
> 90	69	3.3	13	2.8	56	3.5	34	3.6	16	4.0	6	2.3
Geographic region
Bogota/center	672	32.4	175	38.1	497	30.7	311	32.7	103	25.4	83	31.7
Atlantic Coast	521	25.1	35	7.6	486	30.1	196	20.6	194	47.9	96	36.6
Coffee belt	324	15.6	122	26.6	202	12.5	145	15.3	26	6.4	31	11.8
Santander	194	9.3	48	10.5	146	9	103	10.8	24	5.9	19	7.3
Antioquia	188	9.1	60	13.1	128	7.9	87	9.2	33	8.1	8	3.1
Center-West	149	7.2	16	3.5	133	8.2	90	9.5	24	5.9	19	73.3
Eastern plains	28	1.3	3	0.07	25	1.5	18	1.9	1	0.2	6	2.3
Comorbid conditions
Charlson comorbidity index, mean (SD)	4.95 ± 2.4		4.65 ± 2.2		5.03 ± 2.5		5.02 ± 2.5		5.15 ± 2.5		4.90 ± 2.6
CHA2DS2-VASc score, mean (SD)	3.6 ± 1.5		3.4 ± 1.4		3.6 ± 1.5		3.6 ± 1.5		3.7 ± 1.5		3.7 ± 1.5
HASBLED, mean (SD)	2.2 ± 0.9		2.3 ± 0.9		2.2 ± 1.0		2.2 ± 0.9		2.3 ± 0.9		2.3 ± 0.9
Hypertension	1816	87.5	386	84.1	1430	88.4	839	88.3	356	87.9	235	89.7
Chronic kidney disease	931	44.9	196	42.7	735	45.5	426	44.8	197	48.6	112	42.7
Severe renal failure	107	5.1	33	7.2	74	4.6	43	4.5	26	6.4	5	1.9
Glomerular filtration rate, mean (SD)	64.3 ± 25.5		64.6 ± 25.6		64.2 ± 25.5		63.5 ± 24.9		63.2 ± 26.1		67.7 ± 26.6
Diabetes mellitus	470	22.6	100	21.8	370	22.9	216	22.7	90	22.2	64	24.4
Acute myocardial infarction	378	18.2	70	15.3	308	19	189	19.9	75	18.5	44	16.8
Chronic obstructive pulmonary disease	360	17.3	84	18.3	276	17.1	171	18	59	14.6	46	17.6
Stroke	319	15.4	56	12.2	263	16.3	144	15.2	69	17	50	19.1
Congestive heart failure	317	15.3	86	18.7	231	14.3	135	14.2	66	16.3	30	11.5
Peripheral vascular disease	103	5.0	30	6.5	73	4.5	40	4.2	24	5.9	9	3.4
Rheumatic disease	81	3.9	23	5	58	3.6	35	3.7	16	4	7	2.7
Dementia	59	2.8	11	2.4	48	3	29	3.1	15	3.7	4	1.5
Liver disease	30	1.5	5	1.1	25	1.6	10	1	9	2.2	6	2.2
Solid cancer	21	1	0	0	21	1.3	12	1.3	4	1	5	1.9
Leukemia/lymphoma	11	0.5	2	0.4	9	0.6	5	0.5	3	0.7	1	0.4
Medical history
Anemia	279	13.4	62	13.5	217	13.4	115	12.1	73	18	29	11.1
Tobacco use	66	3.2	21	4.6	45	2.8	27	2.8	11	2.7	7	2.7
Gastrointestinal bleeding	25	1.2	5	1.1	20	1.2	12	1.3	4	1	4	1.5
Alcohol consumption	15	0.7	5	1.1	10	0.6	5	0.5	2	0.5	3	1.1
Other bleeding	13	0.6	1	0.2	12	0.7	9	0.9	3	0.7	0	0
Intracranial bleeding	6	0.3	0	0	6	0.4	3	0.3	2	0.5	1	0.4

Abbreviations: DOACS, direct oral anticoagulants; BMI, body mass index; SD, standard deviation.

Table 2 Treatment Patterns of Non-Valvular Atrial Fibrillation Group of Patients from Colombia

Clinical and Pharmacologic Characteristic	Warfarin			Rivaroxaban				Apixaban				Dabigatran
	n=459	%		n=950		%		n=405		%		n=262		%
Mean dose - mg, day (SD)	4.5 ± 2.6			17.9 ± 2.7				7.8 ± 2.5				239 ± 48.5
Dose, median (IQR)	5 (2.5–5)			20 (15–20)				10 (5–10)				220 (220–300)
Most used presentation	5 mg			20 mg				5 mg				110 mg
Ratio of DDD	0.60			0.90				0.78				0.80
Dose range (mg/day)	(1.25–10)			(5–40)				(2.5–10)				(75–300)
Persistence in days, median (IQR)	440 (158–805)			491 (181–985)				364 (202–627)				608 (279–1176)
Reduced doses	NA			375		39.5		173		42.7		159		60.7
Days between diagnosis of NVAF and start of anticoagulant, mean (SD)	71 ± 230.8			324 ± 712.2				218 ± 541.2				406 ± 676.0
Weight- kg, (mean ± SD)	70.0 ± 14.0			70.5 ± 14.7				70.1 ± 13.8				71.9 ± 14.3
Creatinine- mg/dL (mean ± SD)	1.1 ± 0.7			1.0 ± 0.3				1.0 ± 0.3				1.0 ± 0.7
Hemoglobin – g/L (mean ± SD)	13.6 ± 1.8			13.5 ± 1.8				13.3 ± 1.9				13.5 ± 1.7
Naïve	459	100.0		825		86.8		391		96.5		220		84.0
Previous medication
Acetylsalicylic acid	191	41.6		376		39.6		176		43.5		108		41.2
Acetylsalicylic acid withdrawal at baseline	79	17.2		184		19.4		113		27.9		65		24.8
P2Y12 inhibitors	37	8.1		62		6.5		40		9.9		31		11.8
P2Y12 inhibitor withdrawal at baseline	8	1.7		37		3.9		26		6.4		26		9.9
Nonsteroidal anti-inflammatory drugs	18	3.9		21		2.2		17		4.2		12		4.6
Number of medications, mean (SD)	6.1 ± 2.7			6.4 ± 3.8				6.1 ± 2.4				6.0 ± 2.5
Polypharmacy (≥5 medications)	321	69.9		718		75.6		303		74.8		187		71.4
Medication use
β-blockers	305	66.4		641		67.5		270		66.6		186		71.0
Statins	266	58.0		598		62.9		266		65.7		164		62.6
Angiotensin II receptor blockers	232	50.5		543		57.2		247		61.0		164		62.6
Furosemide	126	27.5		275		28.9		98		24.2		61		23.3
Angiotensin converting enzyme inhibitor	119	25.9		182		19.2		71		17.5		50		19.1
Proton pump inhibitor	116	25.3		242		25.5		105		25.9		63		24.0
Calcium channel blockers	112	24.4		260		27.4		129		31.9		89		34.0
Levothyroxine	96	20.9		224		23.6		81		20.0		52		19.8
Thiazide diuretics	85	18.5		189		19.9		82		20.2		59		22.5
Bronchodilators	76	16.6		144		15.2		45		11.1		33		12.6
Aldosterone antagonists	75	16.3		155		16.3		55		13.6		24		9.2
Antiarrhythmics	75	16.3		206		21.7		65		16.0		55		21.0
Oral antidiabetics	72	15.7		159		16.7		72		17.8		42		16.0
Acetaminophen	54	11.8		105		11.1		44		10.9		27		10.3
Digoxin	34	7.4		73		7.7		14		3.5		18		6.9
Antidepressants	34	7.4		82		8.6		31		7.7		17		6.5
Insulins	34	7.4		63		6.6		31		7.7		22		8.4
Alpha-blockers	30	6.5		62		6.5		18		4.4		6		2.3
Opioids	23	5.0		46		4.8		15		3.7		10		3.8
Fibrates	8	1.7		8		0.8		6		1.5		6		2.3
Disease-modifying antirheumatic drugs	8	1.7		12		1.2		6		1.5		5		1.9
Systemic corticosteroids	3	0.7		10		1.1		5		1.2		2		0.8
Benzodiazepines	2	0.4		17		1.8		7		1.7		4		1.5
Z-drugs	0	0.0		1		0.1		1		0.2		1		0.4

Abbreviations: SD, standard deviation; IQR, interquartile range; Ratio of DDD, relationship between mean dose and defined daily dose; NVAF, non-valvular atrial fibrillation.

Table 3 Effectiveness and Safety Outcomes of Non-Valvular Atrial Fibrillation Group of Patients from Colombia

Effectiveness and Safety Outcomes	Warfarin		DOACs
	n=459	%	n=1617	%
Follow-up days (until clinical event or end of follow-up)	645 ± 575		897 ± 568
General composite outcome (Total events)	326	71.0	397	24.6
Effectiveness outcome
Ischemic cerebrovascular event	11	2.4	45	2.8
Pulmonary embolism	1	0.2	5	0.3
Safety outcomes
Gastrointestinal bleeding	19	4.1	23	1.4
Another major bleeding	17	3.7	19	1.2
Hemorrhagic cerebrovascular event	5	1.1	2	0.1
Death associated with adverse event	1	0.2	5	0.3
Persistence outcome
Switch of oral anticoagulant	194	42.3	151	9.3
Discontinuation	78	17.0	147	9.1

Abbreviation: DOACS, direct oral anticoagulants.

Figure 1 Kaplan Meier of non-valvular atrial fibrillation group of patients from Colombia by treatment type.