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 |
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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 |