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. |
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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