Perbandingan Mortalitas Kardiak, Reinfark Dan Stroke Serta Efek Perdarahan Antara Heparin, Enoxaparin Dan Fondaparinux Pada Infark Miokard Akut ST Elevasi Tanpa Reperfusi Dini
ABSTRAK
Penurunan angka mortalitas IMA STE dalam 2 dekade terakhir
berhubungan dengan kemajuan tindakan reperfusi dini, baik secara mekanik (IKP
primer) maupun farmakologis, menggunakan regimen fibrinolitik, serta obat-obat
pendukung lainnya. Meskipun begitu, sekitar 25-33% penderita IMA STE pada
studi sebelumnya tidak mendapat terapi reperfusi dini.
Tujuan dari penelitian ini adalah untuk membandingkan efektifitas
(kejadian cardiac death dan MACCE) selama perawatan di rumah sakit dan 30
hari paska infark serta kejadian efek perdarahan antara antikoagulan unfraction
heparin (UFH), enoxaparin serta fondaparinux pada penderita IMA STE yang
tidak dilakukan reperfusi dini
Penelitian ini bersifat kohort prospektif. Sebanyak 38 orang (34,2%)
menggunakan UFH, 34 orang (30,6%) menggunakan enoxaparin serta 39 orang
(35,1%) menggunakan fondaparinux. Kelompok UFH diberikan dosis bolus 60
UI/kgbb dilanjutkan dengan dosis perdrip 12 UI/jam dalam rentang waktu
pemberian 48 sampai 72 jam. Kelompok enoxaparin diberikan dosis loading
pertama 30 mg iv bolus yang dilanjutkan 15 menit kemudian dengan 60 mg
subkutan setiap 12 jam selama 5 hari. Kelompok fondaparinux diberikan dosis
pertama 2,5 mg iv bolus yang dilanjutkan dengan 2,5 mg subkutan per 24 jam
selama 5 hari.
Tidak ada perbedaan kejadian cardiac death di rumah sakit antara
enoxaparin dengan UFH (P = 0,66, RR = 0,60, 95% IK : 0,10-3,36), antara
fondaparinux dengan UFH (P = 1,00, RR = 0,68, 95% IK : 0,12-3,87) serta antara
fondaparinux dengan enoxaparin (P = 1,00, RR = 1,15 ( 95% IK: 0,25-5,31). Hasil
perbandingan MACCE di rumah sakit adalah tidak dijumpai perbedaan antara
enoxaparin dengan UFH (P = 0,66, RR = 0,59 (95% IK : 0,10-3,36), antara
fondaparinux dengan UFH (P = 0,43, RR = 0,41 (95% IK : 0,08-1,99), serta antara
fondaparinux dengan enoxaparin (P = 0,72 RR = 0,69 dan 95% IK: 0,17-2,67).
Hanya dijumpai perdarahan ringan berupa gross hematuria. Kejadian gross
hematuria hanya berbeda secara bermakna antara fondaparinux dengan UFH
(P = 0,03, RR = 0,84, 95% IK : 0,71-0,98). Tidak dijumpai perbedaan kejadian
cardiac death dan MACCE selama 30 hari paska infark pada ketiga kelompok
obat.
Penelitian ini menunjukkan bahwa tidak ada perbedaan efektifitas antara
ketiga kelompok antikoagulan pada IMA STE yang tidak dilakukan reperfusi
dini. Hanya dijumpai kejadian perdarahan ringan pada studi ini yang secara
bermakna lebih banyak dijumpai pada mereka yang menggunakan UFH.
Kata kunci : IMA STE, antikoagulan, cardiac death, MACCE, perdarahan
Universitas Sumatera Utara
ABSTRACT
The decrease of mortality rate in STEMI for the last two decades was
related to the advent of early reperfusion strategy. However, previous studies
showed that approximately 25-33% of those with STEMI were not reperfused
early after the onset.
This study aimed to compare the effectivity (cardiac death and MACCE)
and safety due to bleeding event within hospitalization and 30 days after the onset
of the infarction in those with STEMI who were not performed early reperfusion
therapy.
The design of the study was prospective cohort. Thirty eight patients
(34,2%) were enrolled in the UFH group, while those who used enoxaparin and
fondaparinux were each 34 patients (30,6%) and 38 patients (35,1%). Those in the
UFH arm were given bolus dose of 60 IU/kg bodyweight and then started
continuous infusion dose of 12 IU/hour in the range of 48 up to 72 hours. Those in
the enoxaparin arm were given bolus dose 30 mg intravenously and then
followed by dose of subcutaneus injection 60 mg fifteen minutes later, and every
twelve hours thereafter up to 5 days. Those in the fondaparinux arm were given
first dose 2,5 mg intravenously and then followed by subcutaneous dose 2,5 mg
every 24 hours for 5 days.
There was neither difference on inhospital cardiac death between
enoxaparin and UFH (P = 0,66, RR = 0,60, 95% CI : 0,10-3,36), nor between
fondaparinux and UFH (P = 1,00, RR = 0,68, 95% CI : 0,12-3,87). There was no
difference between fondaparinux and enoxaparin, either (P = 1,00, RR = 1,15,
95% CI : 0,25-5,31). The comparison of inhospital MACCE among the three were
; no difference between enoxaparin and UFH (P = 0,66, RR = 0,59, 95% CI :
0,10-3,36), between fondaparinux and UFH with P = 0,43, RR = 0,41, 95% CI :
0,08-1,99, and between fondaparinux versus enoxaparin , either (P = 0,72, RR =
0,69, 95% CI : 0,17-2,67). Only mild bleeding (gross hematuria) was noted in this
study. The event rate of gross hematuria was only noted to be significantly
different between fondaparinux and UFH (P = 0,03, RR = 0,84, 95% CI : 0,710,98). There were no difference in the event of cardiac death and MACCE 30 days
after the onset of the infarction among the anticoagulants.
The conclusion of the study was that there were no difference of cardiac
death event and MACCE within hospitalization and 30 days after the onset of the
infarction among the three anticoagulan in those with STEMI who were not
performed early reperfusion. The bleeding events were rare among the
anticoagulant with the highest rate of mild bleeding was found in those who used
UFH.
Keywords : STEMI, anticoagulant, cardiac death, MACCE, bleeding
Universitas Sumatera Utara
Penurunan angka mortalitas IMA STE dalam 2 dekade terakhir
berhubungan dengan kemajuan tindakan reperfusi dini, baik secara mekanik (IKP
primer) maupun farmakologis, menggunakan regimen fibrinolitik, serta obat-obat
pendukung lainnya. Meskipun begitu, sekitar 25-33% penderita IMA STE pada
studi sebelumnya tidak mendapat terapi reperfusi dini.
Tujuan dari penelitian ini adalah untuk membandingkan efektifitas
(kejadian cardiac death dan MACCE) selama perawatan di rumah sakit dan 30
hari paska infark serta kejadian efek perdarahan antara antikoagulan unfraction
heparin (UFH), enoxaparin serta fondaparinux pada penderita IMA STE yang
tidak dilakukan reperfusi dini
Penelitian ini bersifat kohort prospektif. Sebanyak 38 orang (34,2%)
menggunakan UFH, 34 orang (30,6%) menggunakan enoxaparin serta 39 orang
(35,1%) menggunakan fondaparinux. Kelompok UFH diberikan dosis bolus 60
UI/kgbb dilanjutkan dengan dosis perdrip 12 UI/jam dalam rentang waktu
pemberian 48 sampai 72 jam. Kelompok enoxaparin diberikan dosis loading
pertama 30 mg iv bolus yang dilanjutkan 15 menit kemudian dengan 60 mg
subkutan setiap 12 jam selama 5 hari. Kelompok fondaparinux diberikan dosis
pertama 2,5 mg iv bolus yang dilanjutkan dengan 2,5 mg subkutan per 24 jam
selama 5 hari.
Tidak ada perbedaan kejadian cardiac death di rumah sakit antara
enoxaparin dengan UFH (P = 0,66, RR = 0,60, 95% IK : 0,10-3,36), antara
fondaparinux dengan UFH (P = 1,00, RR = 0,68, 95% IK : 0,12-3,87) serta antara
fondaparinux dengan enoxaparin (P = 1,00, RR = 1,15 ( 95% IK: 0,25-5,31). Hasil
perbandingan MACCE di rumah sakit adalah tidak dijumpai perbedaan antara
enoxaparin dengan UFH (P = 0,66, RR = 0,59 (95% IK : 0,10-3,36), antara
fondaparinux dengan UFH (P = 0,43, RR = 0,41 (95% IK : 0,08-1,99), serta antara
fondaparinux dengan enoxaparin (P = 0,72 RR = 0,69 dan 95% IK: 0,17-2,67).
Hanya dijumpai perdarahan ringan berupa gross hematuria. Kejadian gross
hematuria hanya berbeda secara bermakna antara fondaparinux dengan UFH
(P = 0,03, RR = 0,84, 95% IK : 0,71-0,98). Tidak dijumpai perbedaan kejadian
cardiac death dan MACCE selama 30 hari paska infark pada ketiga kelompok
obat.
Penelitian ini menunjukkan bahwa tidak ada perbedaan efektifitas antara
ketiga kelompok antikoagulan pada IMA STE yang tidak dilakukan reperfusi
dini. Hanya dijumpai kejadian perdarahan ringan pada studi ini yang secara
bermakna lebih banyak dijumpai pada mereka yang menggunakan UFH.
Kata kunci : IMA STE, antikoagulan, cardiac death, MACCE, perdarahan
Universitas Sumatera Utara
ABSTRACT
The decrease of mortality rate in STEMI for the last two decades was
related to the advent of early reperfusion strategy. However, previous studies
showed that approximately 25-33% of those with STEMI were not reperfused
early after the onset.
This study aimed to compare the effectivity (cardiac death and MACCE)
and safety due to bleeding event within hospitalization and 30 days after the onset
of the infarction in those with STEMI who were not performed early reperfusion
therapy.
The design of the study was prospective cohort. Thirty eight patients
(34,2%) were enrolled in the UFH group, while those who used enoxaparin and
fondaparinux were each 34 patients (30,6%) and 38 patients (35,1%). Those in the
UFH arm were given bolus dose of 60 IU/kg bodyweight and then started
continuous infusion dose of 12 IU/hour in the range of 48 up to 72 hours. Those in
the enoxaparin arm were given bolus dose 30 mg intravenously and then
followed by dose of subcutaneus injection 60 mg fifteen minutes later, and every
twelve hours thereafter up to 5 days. Those in the fondaparinux arm were given
first dose 2,5 mg intravenously and then followed by subcutaneous dose 2,5 mg
every 24 hours for 5 days.
There was neither difference on inhospital cardiac death between
enoxaparin and UFH (P = 0,66, RR = 0,60, 95% CI : 0,10-3,36), nor between
fondaparinux and UFH (P = 1,00, RR = 0,68, 95% CI : 0,12-3,87). There was no
difference between fondaparinux and enoxaparin, either (P = 1,00, RR = 1,15,
95% CI : 0,25-5,31). The comparison of inhospital MACCE among the three were
; no difference between enoxaparin and UFH (P = 0,66, RR = 0,59, 95% CI :
0,10-3,36), between fondaparinux and UFH with P = 0,43, RR = 0,41, 95% CI :
0,08-1,99, and between fondaparinux versus enoxaparin , either (P = 0,72, RR =
0,69, 95% CI : 0,17-2,67). Only mild bleeding (gross hematuria) was noted in this
study. The event rate of gross hematuria was only noted to be significantly
different between fondaparinux and UFH (P = 0,03, RR = 0,84, 95% CI : 0,710,98). There were no difference in the event of cardiac death and MACCE 30 days
after the onset of the infarction among the anticoagulants.
The conclusion of the study was that there were no difference of cardiac
death event and MACCE within hospitalization and 30 days after the onset of the
infarction among the three anticoagulan in those with STEMI who were not
performed early reperfusion. The bleeding events were rare among the
anticoagulant with the highest rate of mild bleeding was found in those who used
UFH.
Keywords : STEMI, anticoagulant, cardiac death, MACCE, bleeding
Universitas Sumatera Utara