Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction

Conditions

Coronary Artery Disease

Keywords

primary PCI, distal protection, drug eluting stent, restenosis

Brief summary

The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.

Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Kløvgaard L, Engstrøm T, Bøtker HE, Saunamäki K, Krusell LR, Jørgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Køber L, Kofoed KF, Terkelsen CJ, Helqvist S.

2010-08-0154 citations

10.1016/j.jacc.2010.05.009

Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial.

Kaltoft A, Kelbaek H, Kløvgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L.

2010-03-0122 citations

10.1016/j.jacc.2009.09.052

Interventions

PROCEDUREDistal protection and drug eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Acute onset typical chest pain of \< 12 hours' duration * ST-elevation of \> 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram * High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire * Possibility to perform distal protection of the infarct-related artery

Exclusion criteria

* History of previous myocardial infarction * Use of fibrinolytic agents for the index infarction * Left main stenosis * Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route * Known renal failure * Other significant cardiac disease * Other severe disease with an expected survival \< 1 year * Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication * Linguistic difficulties needing an interpreter * Gastrointestinal bleeding within 1 month * Childbearing potential or pregnancy * Participation in another study

Design outcomes

Primary

Measure	Time frame
ST segment resolution	90 min
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).	immediately after and at 8 month follow up

Secondary

Measure	Time frame
Restenosis	8 months
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T	Post procedure
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.	8 months
Minimal lumen diameter	8 months
wall motion index	During hospitalisation: day 3-5
Occurrence of stent thrombosis and MACE.	12 months

Countries

Denmark

Outcome results

None listed