A randomized controlled trial of adjunctive Bunchang Naoxintong Capsule (步长脑心通胶囊) versus maintenance dose clopidogrel in patients with CYP2C19*2 polymorphism.

OBJECTIVE

To determine the impact of adjunctive Buchang Naoxintong Capsule (, NXT) on dual antiplatelet therapy in patients with cytochrome P450 2C192 (CYP2C192) polymorphism undergoing percutaneous coronary intervention (PCI).

METHODS

Ninety patients with CYP2C19*2 polymorphism were enrolled, and their genotypes were confirmed by polymerase chain reaction (PCR). The patients were randomly assigned to receive either adjunctive NXT (triple group, 45 cases) or dual antiplatelet therapy (dual group, 45 cases) using a computer-generated randomization sequence and sealed envelopes. Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry. Subsequent major adverse cardiovascular events (MACE, including sudden cardiac arrest and acute coronary syndrome) were recorded during a 12-month follow-up.

RESULTS

Baseline platelet function measurements were similar in both groups. After 7 days, percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group (42.3%±16.0% vs. 20.8%±15.2%, P<0.01, and 54.7%±18.3% vs. 21.5%±29.2%, P<0.01, respectively). During the 12-month follow-up, the rate of subsequent MACE (6/45) was significantly lower in the triple group compared with the dual group (14/45; P<0.05).

CONCLUSION

Adjunctive NXT to maintenance dose clopidogrel (75 g) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19*2 polymorphism undergoing PCI.