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Clinical Efficacy and Safety of Tirofiban Combined with Conventional Dual www.nature.com/scientificreports OPEN Clinical efcacy and safety of tirofban combined with conventional dual antiplatelet therapy in ACS patients undergoing PCI Yong‑zhe Guo, Zi‑wen Zhao, Shu‑mei Li & Liang‑long Chen* Challenges remain for clinicians over balancing the efcacy of active antithrombotic therapy and simultaneous bleeding reduction in patients. The clinical data of 347 patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) were retrospectively analyzed. On the basis of the given tirofban, the patients were assigned into three diferent dose groups: high dose group (group H), medium dose group (group M), and low dose group (group L). The tirofban efcacy was evaluated in terms of major adverse cardiovascular event (MACE) parameters and lab endpoints, including platelet count and function. The tirofban safety was assessed by the occurrence of bleeding events. The patients were followed up for 1 month after the PCI. No signifcant diference in MACE events was evident among these groups (p > 0.05). Groups H and M reported an obvious reduction in platelet count (p < 0.05 for both) and an increased platelet inhibition rate (p < 0.05 for both). Group H showed a higher rate of total bleeding events than the other groups (Group H vs. Group M: 34.4% vs. 16.5%; Group H vs. Group L: 34.4% vs. 10.3%; p < 0.05 for both). A proper administration of a low dose of tirofban may be a superior alternative in treating ACS patients, which can produce a similar favorable clinical outcome and a decrease in bleeding complication. Acute coronary syndrome (ACS) is an increasingly prevalent condition in the elderly population worldwide 1. As secondary changes to unstable atheromatous plaque, it is ofen characterized by superfcial platelet aggregation, platelet shedding, and other phenomena, which trigger the serial events of a sharp decrease in regional myocar- dial blood fow perfusion, an aggravation of myocardial ischemia, and the formation of platelet thrombus 2. Te activation of platelets and the coagulation system can directly infuence the clinical results3,4, such as patient’s cardiac function and long-term prognosis5. Platelet agglutination not only impacts coronary thrombus but also induces microcirculatory dysfunction and vascular infammation6–8. Terefore, anti-platelet aggregation is the basis for the ACS treatment of and a primary strategy for a successful operation. Although clinical practice guidelines in both the United States and Europe favor more potent, next-generation P2Y12 inhibitors, such as ticagrelor and prasugrel 9, other alternative approaches such as clopidogrel are recommended for exceptions, including urgent operation needs, antico- agulation for atrial fbrillation, fbrinolytic therapy or the high bleeding risks such as thrombocytopenia, liver disease, or renal disease. Given this background, traditional antiplatelet strategies (aspirin combination with clopidogrel) will be our choice, which has proven benefcial for patients presenting with acute coronary syn- dromes in the CURE trial10. As one of the most powerful intravenous antiplatelet drugs, GP IIb/IIIa inhibitor (GPI) plays a pivotal role in inhibiting the fnal pathway of platelet aggregation. Facing high thrombus load or any other situations necessary for strengthening antiplatelet during operation, conventional double-antiplatelet therapy does not provide a satisfactory anti-platelet efect. Te application of tirofban may reduce peri-operative complications and quickly increase blood drug level and tissue perfusion 11. Available research documents that the administration of tirofban may improve the efcacy of clinical treatments with a lower all-cause mortality and a decreased risk of serious bleeding during peri-operative intervention 12. Tirofban has also been recom- mended as a bail-out treatment for coronary intervention therapy according to the established professional expert Department of Cardiology, Fujian Medical University Union Hospital, 29 Xin-Quan Road, Fuzhou 350001, Fujian, China. *email: [email protected] Scientifc Reports | (2021) 11:17144 | https://doi.org/10.1038/s41598-021-96606-y 1 Vol.:(0123456789) www.nature.com/scientificreports/ consensus13–15. However, challenges remain over balancing adequate antiplatelet therapy and bleeding control. To our best knowledge, little literature is available to shed light on the efective dose of Tirofban in large-scale medical records16,17. Methods A short-term, single-center, retrospective study was designed to evaluate the efcacy and safety of a multi-dose tirofban treatment for 3,871 consecutive ACS patients from July 2015 to September 2019. Te patients were examined for acute ST-segment elevation myocardial infarction (STEMI), non-acute ST-segment elevation myo- cardial infarction (NSTEMI), and unstable angina pectoris (UA). Te inclusion criteria were as follows: (1) an age range of 18–80 years; (2) evidence of recurrent stenocardia; (3) signs of electrocardiographic ST-T defection; and (4) a confrmed correlation of responsible lesion with clinical symptoms by coronary angiography. A total of 436 ACS patients, who had received PCI and intravenous tirofban, met the inclusion criteria, from which 89 cases were excluded due to various reasons: 15 lacking angiography-verifed pathological lesions, 37 undergoing balloon dilatation only, 19 requiring surgical bypass surgery due to lef main vessel disease or multi-segmental lesions of multiple coronary arteries, 8 without a 1-month follow-up afer the operation, and 10 presenting contraindications for the use of GPIs (active internal bleeding, known bleeding diathesis, intracerebral mass, or aneurysm, severe anemia and abnormal coagulation). Te screening procedure lef a total of 347 patients eligible for the retrospective analysis. Among the enrolled patients who had received tirofban, the majority of them (94.5%) were treated with aspirin plus clopidogrel, of who 237 patients with atrial fbrillation (68.3%) received oral anticoagulant and 91 (26.2%) were treated with fbrinolytic therapy before interventional operation. Tis is consistent with the recommendations in the guidelines 15,18 for patients who sufer atrial fbrillation and should be treated with oral anticoagulant and those receiving fbrinolytic therapy. According to the intravenous speed of tirofban (per unit time), the patients were divided into the high-dose group (Group H, 0.10–0.15ug/kg/min, N = 61), the moderate-dose group (Group M, 0.05–0.10ug/kg/min, N = 218) and the low-dose group (Group L, < 0.05ug/kg/min, N = 68). Major medications were administered to all the patients according to the current clinical practice: aspirin (loading dose of 300 mg, then 100 mg qd), clopidogrel (loading dose of 300 mg, then 75 mg qd), ACEI/ARB, β-blocker, statin, and so on. Tese patients were unable to use potent P2Y12 because advanced age, coagulopathy, recent active gastrointestinal or cerebral hemorrhage, oral anticoagulant afer atrial fbrillation or valve replacement surgery, or other factors ineligible for potent P2Y12. PCI was performed by the transradial approach, using standard 6F or 7F guiding catheters. Unfractionated heparin was initiated at 100 IU/kg bolus and followed by the 12 U/kg/h infusion for any of the clinical indications, including atrial fbrillation, lef ventricular thrombus or aneurysm, recent or recurrent venous thromboembo- lism, or deferred sheath removal. Coronary artery angiography (CAG) and PCI were performed by experienced practitioners in the center (designated as independent operation experience for more than 5 years). According to previous studies19,20, the administration of tirofban [Grandpharma (China) Co., Ltd.; GYZ Zi H20041165] was divided into the following categories and the specifc proportion was as follows: 29.7% for large, intraluminal residual thrombus, 24.2% for no (slow) refow, 21.9% for threatening or acute vessel closure, 8.9% for complex lesions, and 15.3% for thrombotic complications. Te dose recommendation was based on the judgment of the operator and was administered intravenously by continuous infusion for at least 48 h. Tromboelastography (TEG) was measured before and 48 h afer the bolus tirofban (ADP-induced turbidimetry by platelet aggrega- tion instrument). End points and defnitions. Primary clinical endpoint referred to major adverse cardiac events (MACEs), which consisted of total mortality, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven target ves- sel revascularization and stent thrombosis. Nonfatal infarction was designated as the presence of: (1) recurrent ischemic chest pain lasting for more than 20 min; (2) reoccurrence of ST-segment defection, T-wave inversion, or new pathognomonic Q waves in at least two contiguous leads; and (3) increase of cardiac troponin over the upper reference limit by at least 2 times. Stroke was defned as a new onset of focal or global neurological defcit for more than 24 h. Computed tomography was used to classify stroke as ischemic or hemorrhagic. According to the Academic Research Consortium 21, a defnite stent thrombosis was specifed as an angiography or autopsy- confrmed thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent with the presence of acute coronary syndrome within a 48-h time window. Stent thrombosis contained acute and suba- cute stent thromboses, the former defned as within frst 24 h afer the intervention and the latter as between 24 h and 30 days afer the intervention. Te revascularization of the
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