Safety and efficacy of short-term dual antiplatelet therapy combined with intensive rosuvastatin in acute ischemic stroke

Deng, Ting; He, Wei; Yao, Xiaohua; Chen, Jingmian; Liu, Xiaomeng; Liu, Lushan; Zhang, Tong; Lu, Haitao

doi:10.1016/j.clinsp.2023.100171

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Original articles • Clinics 78 • 2023 • https://doi.org/10.1016/j.clinsp.2023.100171 copy

Safety and efficacy of short-term dual antiplatelet therapy combined with intensive rosuvastatin in acute ischemic stroke

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objective:

To investigate the safety and efficacy of short-term (7-day) Dual Antiplatelet Therapy (DAPT) with intensive rosuvastatin in Acute Ischemic Stroke (AIS).

Methods:

In this study, patients with AIS in the emergency department of the hospital from October 2016 to December 2019 were registered and divided into the control group (Single Antiplatelet Therapy [SAPT] + rosuvastatin) and the study group (7-day DAPT + intensive rosuvastatin) according to the therapy regimens. The generalized linear model was used to compare the National Institute of Health Stroke Scale (NIHSS) scores between the two groups during the 21-day treatment. A Cox regression model was used to compare recurrent ischemic stroke, bleeding events, Statin-Induced Liver Injury (SILI), and Statin-Associated Myopathy (SAM) between the two groups during the 90-day follow-up.

Results:

Comparison of NIHSS scores after 21-day treatment: NIHSS scores in the study group decreased significantly, 0.273-times as much as that in the control group (Odds Ratio [OR] 0.273; 95% Confidence Interval [95% CI] 0.208–0.359; p < 0.001). Comparison of recurrent ischemic stroke during the 90-day follow-up: The therapy of the study group reduced the risk of recurrent stroke by 65% (7.76% vs. 22.82%, Hazard Ratio [HR] 0.350; 95% CI 0.167–0.730; p = 0.005). Comparison of bleeding events: There was no statistical difference between the two groups (7.79% vs. 6.71%, HR = 1.076; 95% CI 0.424–2.732; p = 0.878). No cases of SILI and SAM were found.

Conclusions:

Short-term DAPT with intensive rosuvastatin effectively relieved the clinical symptoms and significantly reduced the recurrent stroke for patients with mild-to-moderate AIS within 90 days, without increasing bleeding events, SILI and SAM.

Keywords:
Short-Term Dual Antiplatelet Therapy; Single Antiplatelet Therapy; Intensive Rosuvastatin; Recurrent Ischemic Stroke

HIGHLIGHTS

What Is New?

Short-term (7-day) DAPT with intensive rosuvastatin can quickly and effectively relieve the clinical symptoms for patients with mild-to-moderate AIS within 21-day.

Short-term (7-day) DAPT with intensive rosuvastatin significantly can reduce recurrent ischemic stroke for patients with mild-to-moderate AIS within 90-day.

Short-term (7-day) DAPT with intensive rosuvastatin rarely increased bleeding events, statin-induced liver injury, or statin-associated myopathy in patients with mild-to-moderate AIS.

What are the clinical implications?

Short-term (7-day) DAPT with intensive rosuvastatin might be a good alternative therapy regimen for mild-to-moderate AIS.

Characteristics	Control group (n = 149)	Study group (n = 116)	p-value
Median age (IQR), years	65.00 (58.50–77.00)	65.00 (58.25–74.50)	0.843
Female, n (%)	48 (32.2)	26 (22.4)	0.097
Median SBP (IQR), mm/Hg	154.00 (138.00–174.00)	153.00 (142.25–172.00)	0.887
Median DBP (IQR), mm/Hg	89.00 (78.00–103.00)	90.00 (81.00–103.00)	0.221
Medical history, n (%)
Hypertension	129 (86.6)	95 (81.9)	0.309
Diabetes	64 (43.0)	46 (39.7)	0.617
Known atrial fibrillation	23 (15.4)	11(9.5)	0.195
Ischemic stroke	66 (44.3)	42 (36.2)	0.208
Antiplatelet	37 (24.8)	31 (26.7)	0.777
Median OMT (IQR) – hours	12.00 (5.00–25.00)	18.00 (5.00–36.00)	0.612
Median bNIHSS (IQR)	4.00 (2.00–5.00)	4.00 (3.00–5.00)	0.151
Median various enzymology before medication (IQR), U/L
ALT	17.00 (12.20–22.00)	18.35 (13.83–24.53)	0.171
AST	16.40 (12.25–22.10)	16.55 (13.00–21.60)	0.751
LDH	176.00 (158.00–200.50)	178.50 (150.50–202.50)	0.980
CK	81.00 (55.50–127.00)	70.00 (53.25–109.25)	0.103
Median of various enzymology in 2 weeks after medication (IQR), U/L
ALT	17.60 (12.05–25.10)	17.20 (12.65–25.58)	0.785
AST	17.00 (13.20–21.65)	17.70 (14.10–21.85)	0.569
LDH	181.00 (156.00–210.00)	171.50 (151.00–202.25)	0.056
CK	71.00 (49.00–101.50)	68.00 (46.50–101.50)	0.409

	Coefficient	p-value	OR	95% Confidence Interval
	Coefficient	p-value	OR	Lower	Upper
(Intercept)	3.857	0.000	47.330	39.527	56.673
[study group] * [time = 0]^a a Comparison of the bNIHSS between the two groups	0.171	0.631	1.186	0.592	2.377
[control group] * [time = 0]	0		1
[study group] * [time = 6]^b b Comparison of NIHSS scores between the two groups after 21 days of treatment.	-1.298	0.000	0.273	0.208	0.359
[control group] * [time = 6]	0		1

	Coefficient	p-value	OR	95% Confidence Interval
	Coefficient	p-value	OR	Lower	Upper
(Intercept)	1.000	0.000	2.718	1.614	4.578
[study group] * [time = 6]	-3.103	0.000	0.045	0.025	0.081
[study group] * [time = 5]	-2.793	0.000	0.061	0.034	0.110
[study group] * [time = 4]	-2.138	0.000	0.118	0.066	0.211
[study group] * [time = 3]	-1.172	0.000	0.310	0.173	0.555
[study group] * [time = 2]	-0.966	0.001	0.381	0.212	0.683
[study group] * [time = 1]	-0.638	0.032^a a Indicates the NIHSS score of patients after 12h of treatment (T1) in the study group decreased significantly, which was statistically significant compared with bNIHSS (p = 0.032).	0.528	0.295	0.948
[study group] * [time = 0]	0		1
[control group] * [time = 6]	-0.906	0.016^b b Indicates that the NIHSS score of the control group decreased significantly after 3 weeks of treatment (T6), which was statistically significant compared with bNIHSS (p = 0.016).	0.404	0.193	0.846
[control group] * [time = 5]	-0.537	0.154	0.585	0.279	1.223
[control group] * [time = 4]	0.060	0.873	1.062	0.508	2.223
[control group] * [time = 3]	0.376	0.319	1.456	0.696	3.048
[control group] * [time = 2]	0.262	0.487	1.299	0.621	2.719
[control group] * [time = 1]	0.215	0.569	1.240	0.592	2.594
[control group] * [time = 0]	0		1

	Control group (n = 149)		Study group (n = 116)		HR and 95% CI	p-value
	Cases (no)	%	Cases (no)	%	HR and 95% CI	p-value
Recurrent ischemic stroke	34	22.82	9	7.76	0.350 (0.167–0.730)	0.005
Bleeding events ^a a According to the GUSTO criteria, they were all minor gastrointestinal mucosal bleeding events.	10	6.71	9	7.76	1.076 (0.424–2.732)	0.878

		ALT (U/L)	AST (U/L)	LDH (U/L)	CK (U/L)
Before	25%	13.830	13.00	150.50	53.25
	Median	18.35	16.55	178.50	70.00
	75%	24.53	21.60	202.50	109.25
After	25%	12.65	14.10	151.00	46.50
	Median	17.20	17.70	171.50	68.00
	75%	25.58	21.85	202.25	101.50
p (2-tailed)		0.251	0.483	0.114	0.086

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E-mail: clinics@hc.fm.usp.br

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[1] *Corresponding author. E-mail addresses:tommzhang@163.com (T. Zhang), 13051760807@163.com (H. Lu).