Effects And Cost-effectiveness Analysis Of Naoxintong Capsule Combined With Dual Antiplatelet Therapy In Patients With CYP2C19 Loss-of-function Gene Mutant After Percutaneous Coronary Intervention

Objective: Analysis on the effect and cost-effectiveness of Naoxintong capsule combined with standard dual antiplatelet therapy on the patients with CYP2C19 loss-of-function gene mutant after PCI.Methods: the study population included consecutive 991 patients who accepted selective PCI successfully from March 2012 to March 2014 in the Department of Cardiovascular Diseases of Fujian Provincial Hospital. CYP2C19 Genotypes(*1/*2/*3)were determined with a Taq Man assay.529 cases of the patients was included in the study,divided into two groups by different antiplatelet therapies:(1)Dual antiplatelet group(n=271 cases): patients at least carry one of CYP2C19 *2 or *3(loss-of- function, LOF) gene mutant,received the standard dual antiplatelet therapy( clopidogrel 300 mg or 600 mg before PCI, asprin 100 mg and clopidogrel 75 mg per day after PCI for 12 months.(2) Additional Naoxintong group(n=258 cases):patients at least carry one of CYP2C19 LOF gene mutant and recieved the standard dual antiplatelet therapy( as dual antiplatelet group) in concomitant with Buchang Naoxintong capsule(3.2 gram once before PCI and 1.6 gram TID, at least insisting 6 months) after signing up informed consent. We collected the clinical datas of all the patients.The mojor adverse cardiovascular events(MACE) scheduled in advance(include cardiac death, myocardial infarction, readmission because of unstable angina or progressive angina) and major bleeding events after PCI were followed up for 1 year between the two groups.In addition, analyse the cost(the sum of antiplatelet drugs cost,hospitalization expense caused by MACE and bleeding events) and cost-effectiveness of the two groups according to the principles of pharmacoeconomic. one-way sensitivity analysis were performed.Results:1.Following up 1 year, incidence of major adverse cardiovascular events( readmission because of unstable angine or progressive angina, myocardial infarction, cardiac death in Dual antiplatelet group was 22.5%(61/271), {18.5%(50/271), 4.1%(11/271), 0.36%(1/271)} respectively. Incidence of major adverse cardiovascular events( readmission because of unstable angine or progressive angina, myocardial infarction,cardiac death) in Additional Naoxintong group was 11.2%(29/258),{7.6%(20/258), 3.5%(9/258), 1.2%(3/258) respectively}. The incidence of major adverse cardiovascular events of Triple antiplatelet group is higher than that Dual antiplatelet group(P=0.001).2.Incidence of major bleeding events between two groups was not different.3.Cost-effectiveness analysis: cost of dual antiplatelet group and Triple antiplatelet group was 9585.1 yuan and 10216.5 yuan. Effects mean the cases of adverse cardiovascular events can be protected per 100 cases patients. Cost effectiveness ratio of dual antiplatelet group was 12448.2(yuan per case), That of Additional Naoxintong group was 11609.7(yuan per case). The incremental cost-effectiveness ratio(ΔC/ΔE) was 5740.0(yuan per case). One way sensitivity analyses outcomes suggested that Triple antiplatelet group also has the lower of cost effectiveness ratio.Conclusion:Naoxintong in addition with the standard antiplatelet therapy could lower the recurrence of adverse cardiovascular events in one year after PCI without increasing the risk of bleeding events. From the perspective of the paitients carrying CYP2C19 LOF allele after PCI, Naoxintong capsule adding to the standard double antithombotic therapy is a cost-effective strategy.