Randomizovana studija o fiziološkoj proceni aspiracije tromba kod bolesnika sa akutnim infarktom miokarda sa elevacijom ST segmenta lečenih primarnom perkutanom koronarnom intervencijom
The randomized Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction patients treated with primary percutaneous intervention (PATA STEMI) study
Author
Orlić, Dejan N.Mentor
Ostojić, MiodragCommittee members
Beleslin, BrankoAšanin, Milika
Savić, Sava
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Cilj. Primarni cilj doktorske teze je bio da se odredi srednja vrednost indeksa mikrocirkulatorne
rezistencije (IMR) kod bolesnika sa infarktom miokarda sa elevacijom ST segmenta (STEMI)
koji su lečeni primarnom perkutanom koronarnom intervencijom (pPCI) i kojima je
randomizovano dodeljen jedan oblik lečenja- manuelna aspiracija tromba ili drugi oblik lečenjastandardna
pPCI bez aspiracije tromba. Na ovaj način poređene su dve grupe bolesnika, jedna
grupa sa rutinskom manuelnom aspiracijom tromba u infarktnoj arteriji i druga grupa, bez
aspiracije tromba. Obzirom na potencijalni uticaj kolateralne cirkulacije na vrednost srednjeg
IMR, određen je i korigovani IMR (IMR corr) koji uzima u obzir koronarni „wedge“ pritisak u
infarktnoj arteriji. Obzirom da se ne zna da li je IMR u infarktnoj arteriji povišen, IMR je određen
i u susednoj i kontralateralnoj neinfarktnoj arteriji. Pored primarnog cilja određeni su i
sekundarni ciljevi koji ukazuju na stepen miokardne perfuzije (angiog...rafski,
elektrokardiografski), veličinu infarkta (enzimski, EKG, jednofotonska kompjuterizovana
tomografija-SPECT), remodelovanje leve komore (ehokardiografski indeksi, SPECT) i klinički
ishod bolesnika tokom perioda praćenja od 12 meseci (glavni neželjeni srčani i cerebralni
događaji, MACCE: smrt, reinfarkt miokarda, šlog, hospitalizacija zbog srčane insuficijencije i
revaskularizacija infarktne arterije-TVR).
Metod. IMR je određivan kao proizvod distalnog pritiska merenog u distalnog trećini infarktne
ili neinfarktne arterije (susedna i kontralateralna neinfarktna arterija sa dijametrom stenoze
<70%) i srednjeg vremena prolaska fiziološkog rastvora na sobnoj temperaturi merenog između
proksimalnog šafta žice i distalnog termistora za merenje pritiska i temperature. Koronarni
„wedge“ pritisak je meren tokom okluzije stentiranog segmenta infarktne arterije semikomplijanntnim balonom na 2 atm pomoću koronarne žice za merenje pritiska i temperature
(Certus, St Jude)...
Aim. Primary end point of doctoral thesis was an assessment of mean value of index of
microcirculatory resistance (IMR) in patients with ST-segment elevation myocardial infarction
(STEMI) treated with primary percutaneous coronary intervention (pPCI) randomly alocated to
either one teatment modality – manual thrombus aspiration or the other treatment modality -
standard pPCI without thrombus aspiration. In this way two groups of patients were compared,
one group with routine manual thrombus aspiration in infarct related artery and the other group,
without thrombus aspiration. Corrected IMR (IMRcorr) was calculated because it accounted for
the potential influence of collateral circulation on the value of IMR: Its calculation is based on
the mean value of capillary wedge pressure. Secondary end points which indicated the magnitude
of myocardial reperfusion (angiographic and electrovardiographic indices), the final infarct size
(enzyme release, ECG, SPECT), remodeling rate of le...ft ventricle (echocardiographic indices,
SPECT) at 4months and clinical outcome (MACCE: death, myocardial reinfarction, stroke,
hospitalization due to congestive heart failure and target vessel revascularization) at 12 months of
follow-up, were also determined.
Method. IMR was assessed as a product of distal pressure measured in the distal third of infarct
related artery or non-infarct related artery (both adjacent and contralateral with diameter stenosis
of <70%) and mean transit time of saline at room temperature measured between proximal shaft
of pressure-termistor tipped coronary wire. Coronary wedge pressure was measured during
occlusion of stented segment of infarct related artery by a semicompliant balloon inflated at 2
atmospheres by means of pressure-termistor tipped coronary wire (Certus, St Jude,MN).
Results. Primary end point was achieved. „Intention to treat analysis“ and „per protocol analysis“
were both done. The main difference between these two analysis is 10 (15,9%) patients who were transfered from the standard pPCI group into thrombus aspiration group, according to the study
protocol. In the „intention to treat“ analysis mean IMR was decreased in the thrombus aspiration
group as compared with the standard pPCI group (RR 28,7%; 31,2±18,18 vs. 43,79±33,77 U,
P=0.0505)...