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

MATTIS.

Methods Multicenter study 
 Randomization method: stated 
 Randomization after successful stenting 
 Stratification: 
 according to stent categories (n.4) 
 No double blinding 
 Blinded outcome assessment of all outcomes 
 Losses to follow‐up : no 
 Intention‐to‐treat: yes 
 compliance evaluated: yes
Participants High risk patients after implantation procedure e.g. 1 or more of the following conditions: bail‐out stenting, suboptimal results with residual stenosis > 20%, 
 multiple stent implantations, nominal diameter of largest ballon inflated<2.5mm 
 Characteristics of patients at baseline: similar 
 Age: mean 60 
 Men: 80% 
 previous AMI: 49.1%; 
 previos CABG: 9%; 
 previous PTCA: 23%; 
 Comorbidity: 
 Diabetes mellitus: 15% 
 Hypertension: 37% 
 Current smokers: 20% 
 Dyslipidemia: 47% 
 Indication for stenting: 
 post‐AMI: 19% 
 unstable angina: 39% 
 stable angina: 37% 
 silent ischemia: 5% 
 Exclusion criteria: 
 recent AMI, persistent ischemia, age < 18 , pregnancy, administration of GP IIb/IIIa antagonists, ongoing OAC treatment, coronary reintervention planned within 30 days of follow‐up, previous participation in any study within 30 days
Interventions Pre‐ procedural: not stated 
 Peri‐procedural: 
 heparin dose not specified. In pt assigned to antiplatelet regimen duration of heparin infusion was a maximum of 36 hours and discontinued 6 hours before sheath removal. 
 type of stent: Palmaz‐Schatz (19%), Wiktor (4.5%), Gianturco‐Robin (4.5%), other stents (72%, Microstents, NIR, Multilink, Pura, Wallstent); inflation pressure: not specified 
 bail‐out stenting: in 32.5% (114/350) of patients
Post‐procedural 
 Anticoagulation group: ASA 250 mg od + heparin+ warfarin started on day of randomization with target INR 2.5‐3.0 for 30 days. Heparin infusion was discontinued when INR was documented > 2.5 for two consecutive days. 
 Antiplatelet therapy group: ticlopidine 250 mg bid ( first daily dose 500 mg given on one intake in the first day of randomization+ 
 ASA 250 mg od for 30 days
Outcomes Total mortality (cardiovascular) 
 non fatal myocardial infarction, revascularization within 30 days, 
 stent thrombosis on angiography, bleeding complications were one or more of the following: vascular access site requiring surgical repair, any bleeding leading to a decrease of haemoglobin > 4 gr/dL and/or requiring transfusion of > 2 U of blood, documented intracranial or retroperitoneal bleeding, leukopenia 
 hepatitis, sk,in reactions . 
 Schedule and assessment criteria for haematological side‐effects: 
 blood cell counts on day 15, 30 and 5 and 6 weeks after the procedure. 
 No criteria given to evaluate degree of cytopenia.No rules given for treatment interruption in case of cytopenia.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate