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. 2001 Oct 23;2001(4):CD002133. doi: 10.1002/14651858.CD002133

STARS.

Methods Multicenter study 
 Randomization method: unclear 
 Stratification: according to clinical site and diabetes mellitus 
 No double blinding 
 Blinded outcome assessment of all outcomes 
 Loss to follow‐up: no but not specified 
 Intention‐to‐treat: yes 
 compliance evaluated: 
 no
Participants Patients after successful stenting of 1‐2 target lesions > 60% stenosis in 3‐4 
 mm native coronary artery 
 not involving left coronary artery or a major coronary bifurcation 
 Characteristics of patients at baseline: similar 
 Age: mean 61, 
 Men: 70% 
 Previous AMI: 35% 
 previous PTCA: 16% 
 previous CABG: 7.5% 
 angina of grade III or IV: 60% 
 Comorbidity: 
 Diabetes mellitus: 19% 
 Hypertension: 52% 
 Current smokers: 29% 
 Dyslipidemia: 33% 
 Exclusion criteria: 
 additional stenoses in the target vessel, recent AMI in the previous 7 days, contraindication to ASA, ticlopidine or warfarin, history of bleeding diathesis, current treatment with abciximab, planned angioplasty of another lesion within 30 days after enrolment.
Interventions Pre‐procedural: not specified 
 Peri‐procedural: 
 generic non‐enteric coated ASA 325 mg + 
 heparin infusion 10,000‐15,000 titrated to maintain an activated clotting time of 250‐300 seconds. No further heparin was given after the procedure except among patients assigned to receive warfarin. 
 Type of stent: 
 Palmaz‐Schatz 
 inflation pressure: >16 atm 
 Post‐procedural 
 Anticoagulation group: ASA 325 mg od + warfarin with INR 2.0‐2.5 for 4 weeks. First dose of warfarin at conclusion of stenting procedure + heparin 
 with the dose titrated to achieve an activated partial thromboplastin time of 40‐60 seconds. Heparin infusion lasted for several days (5‐10 days) and discontinued until an INR of 2.0.2.5 was obtained.
Antiplatelet therapy group 1: 
 non enteric coated ASA 325 mg daily for 4 weeks. 
 Antiplatelet therapy group 2: 
 ticlopidine 250 mg bid +ASA 325 mg od for 4 weeks 
 First dose of ticlopidine at conclusion of stenting procedure.
Outcomes Total mortality 
 non fatal myocardial infarction, revascularization within 30 days, stent thrombosis on angiography, 
 cerebrovascular accidents, vascular site surgical complications, 
 bleeding, leukopenia 
 Criteria for bleeding: 
 a major bleeding complication was defined as any procedure‐related bleeding episode that required transfusion. 
 Vascular surgical complications included any retroperitoneal haematoma, vascular access haematoma of more than 4 cm, pseudoaneurysm or arteriovenous fistula requiring surgery of ultrasonographic compression. 
 Schedule and assessment criteria for haematological side‐effects: 
 two complete blood counts were perfomed two and four weeks after the stenting procedure , with neutropenia defined as absolute white‐cell count less than 1200 per cubic millimeter and thrombocytopenia as a reduction in the platelet count to below 80,000 per cubic millimeter. 
 No criteria given for treatment interruption in case of cytopenia.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear

AMI: acute myocardial infarction 
 PTCA: percutaneous coronary angioplasty 
 CABG: coronary artery bypass graft 
 INR: International Normalized Ratio 
 ASA: acetil salicylic acid (aspirin) 
 GP IIb/IIIa antagonists: platelet glycoprotein GPIIb/IIIa antagonists 
 OAC: oral anticoagulants