Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial.
OBJECTIVE
The purpose of this study was to evaluate the use of distal protection during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) in native coronary vessels.


BACKGROUND
Embolization of material from the infarct-related lesion during PCI may result in impaired myocardial perfusion and worsen the prognosis. Previous attempts to protect the microcirculation during primary PCI have had conflicting results.


METHODS
We randomly assigned 626 patients with STEMI referred within 12 h to have PCI performed with (n = 312) or without (n = 314) distal protection. The primary end point was complete (>or=70%) ST-segment resolution detected by continuous ST-segment monitoring. Blood levels of troponin-T and creatine kinase-MB were monitored before and after the procedure, and echocardiographic determination of the left ventricular wall motion index (WMI) was performed before discharge.


RESULTS
Patients were well matched in terms of demographic and angiographic baseline characteristics. There was no significant difference in the occurrence of the primary end point (76% vs. 72%, p = 0.29), no difference in maximum troponin-T (4.8 microg/l and 5.0 microg/l, p = 0.87) or maximum creatine kinase-MB (185 microg/l and 184 microg/l, p = 0.99), and no difference in median WMI (1.70 vs. 1.70, p = 0.35). The rate of major adverse cardiac and cerebral events (MACCE) 1 month after PCI was 5.4% with distal protection and 3.2% with conventional treatment (p = 0.17).


CONCLUSIONS
The routine use of distal protection by a filterwire system during primary PCI does not seem to improve microvascular perfusion, limit infarct size, or reduce the occurrence of MACCE.
Kelbaek
Henning
H
Department of Cardiology and Cardiac Catheterization Laboratory, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Terkelsen
Christian J
CJ
Helqvist
Steffen
S
Lassen
Jens F
JF
Clemmensen
Peter
P
Kløvgaard
Lene
L
Kaltoft
Anne
A
Engstrøm
Thomas
T
Bøtker
Hans E
HE
Saunamäki
Kari
K
Krusell
Lars R
LR
Jørgensen
Erik
E
Hansen
Hans-Henrik T
HH
Christiansen
Evald H
EH
Ravkilde
Jan
J
Køber
Lars
L
Kofoed
Klaus F
KF
Thuesen
Leif
L
D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017225:Atherectomy, Coronary / Q000295:instrumentation*; D003328:Coronary Thrombosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000628:therapy*; D016896:Treatment Outcome