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document
XS0601 reduces the incidence of restenosis : a prospective study of 335 patients undergoing percutaneous coronary intervention in China . BACKGROUND XS0601 , consisting of active ingredients ( Chuangxiongol and paeoniflorin ) , has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies . The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention ( PCI ) . METHODS A multi-center , randomized , double-blind , placebo-controlled trial was conducted . A total of 335 patients were randomized into treatment with the oral administration of XS0601 , or a placebo for 6 months after successful PCI . Angiographic follow-up was scheduled at 6 months , and clinical follow-ups performed at 1 , 3 and 6 months after PCI . The primary end point was angiographic restenosis . The secondary end points were the combined incidence of death , target lesion nonfatal myocardial infarction , repeat angioplasty , and coronary artery bypass graft surgery . RESULTS A total of 308 patients ( 91.9 % ) completed the study and 145 cases ( 47.1 % ) received angiographic follow-up . The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group ( 26.0 % vs. 47.2 % , P < 0.05 ) , and the minimum lumen diameter ( MLD ) was greater [ ( 2.08 +/- 0.89 ) mm for XS0601 vs. ( 1.73 +/- 0.94 ) mm for placebo , P < 0.05 ] . XS0601 also significantly reduced the combined incidence of major adverse cardiac event ( 10.4 % in the XS0601 group vs. 22.7 % in the placebo group , P < 0.05 ) . The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group ( 7.1 % and 11.0 % ) as compared with those in placebo group ( 19.5 % and 42.9 % ) ( P < 0.05 ) . No significant side effects occurred within the 6-month follow-up period in the XS0601 group . CONCLUSION Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients .
25365
Intervention_Pharmacological
XS0601
25366
Intervention_Pharmacological
XS0601
25367
Intervention_Pharmacological
XS0601
25368
Intervention_Surgical
percutaneous coronary intervention
25369
Intervention_Pharmacological
XS0601
25370
Intervention_Control
placebo
25371
Intervention_Surgical
coronary artery bypass graft surgery
25372
Intervention_Pharmacological
XS0601
25373
Intervention_Control
placebo
25374
Intervention_Pharmacological
XS0601
25375
Intervention_Control
placebo
25376
Intervention_Pharmacological
XS0601
25377
Intervention_Control
placebo
25378
Intervention_Pharmacological
XS0601
25379
Intervention_Control
placebo
25380
Intervention_Pharmacological
XS0601
25381
Intervention_Pharmacological
XS0601
25382
Outcome_Physical
angiographic restenosis .
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Outcome_Mortality
death
25384
Outcome_Physical
, target lesion nonfatal myocardial infarction , repeat angioplasty , and coronary artery bypass graft surgery
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Outcome_Physical
restenosis rates
25386
Outcome_Physical
minimum lumen diameter ( MLD )
25387
Outcome_Physical
combined incidence of
25388
Outcome_Adverse-effects
major adverse cardiac event
25389
Outcome_Physical
incidence of recurrent angina
25390
Participant_Sample-size
335
25391
Participant_Condition
percutaneous coronary intervention
25392
Participant_Sample-size
335
25393
Participant_Sample-size
308
25394
Participant_Sample-size
145