jurnal makassar 1

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Introduction Contemporary techniques of primary percutaneous coronary intervention (pPCI) enable therestoration of normal epicardial flow in the infarct-related artery in the majority of patients, asevaluated by Thrombolysis in Myocardial Infarction (TIMI) flow and the corrected TIMI framecount (cTFC) (1). However, vessel patency does not always translate into microvascular reperfusion. Impaired microvascular perfusion, measured by the TIMI myocardial perfusiongrade (TMPG), is associated with increased infarct size and worse clinical outcomes (2). ST- segment resolution (STR) has also been shown to correlate with microvascular reperfusion after revascularization for ST-segment elevation myocardial infarction (STEMI) (3, 4). Distalembolization of thrombotic material has been hypothesized as a mechanism of microvascular obstruction and injury and provides the rationale (Class IIa recommendation) for employing thrombus aspiration (TA) during pPCI (5)

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Page 1: Jurnal Makassar 1

Introduction

Contemporary techniques of primary percutaneous coronary intervention (pPCI)

enable therestoration of normal epicardial flow in the infarct-related artery in the

majority of patients, asevaluated by Thrombolysis in Myocardial Infarction (TIMI)

flow and the corrected TIMI framecount (cTFC) (1). However, vessel patency does

not always translate into microvascular reperfusion. Impaired microvascular

perfusion, measured by the TIMI myocardial perfusiongrade (TMPG), is

associated with increased infarct size and worse clinical outcomes (2). ST-segment

resolution (STR) has also been shown to correlate with microvascular reperfusion

after revascularization for ST-segment elevation myocardial infarction (STEMI)

(3, 4). Distalembolization of thrombotic material has been hypothesized as a

mechanism of microvascular obstruction and injury and provides the rationale

(Class IIa recommendation) for employing thrombus aspiration (TA) during pPCI

(5)

The results of previous studies of TA during pPCI for STEMI have been

conflicting, andcomparisons have been complicated by the variety of devices used.

Early randomized trials of rheolytic thrombectomy showed no benefit and a

possible increase in infarct size and major adverse cardiac events (MACE), while

prospective cohort studies and the recent multicenter randomized Thrombectomy

Before Direct Infarct Artery Stenting to Direct Stenting Alone inPatients with

Acute Myocardial Infarction (JETSTENT) trial in patients with high

gradethrombus burden reported improved surrogate and clinical outcomes (6, 7, 8,

9, 10, 11, 12, 13).Prospective cohort studies and randomized trials of manual TA

have fairly consistently reportedimproved STR, TIMI flow, cTFC, and TMBG, and

reductions in distal embolization and the no-reflow phenomenon (14, 15, 16, 17,

Page 2: Jurnal Makassar 1

18, 19, 20). The more recent randomized Thrombectomywith Export Catheter in

Infarct Related Artery during Primary Percutaneous Coronary Intervention

(EXPIRA) and Thrombus Aspiration during Percutaneous Coronary Intervention

inAcute Myocardial Infarction Study (TAPAS) trials both reported improved

clinical outcomeswith manual TA, although neither was powered for these

endpoints, whereas the IntracoronaryAbciximab and Aspiration Thrombectomy in

Patients With Large Anterior Myocardial Infarction(The INFUSE-AMI) Trial

showed no improvement in reperfusion parameters, infarct size oncardiac magnetic

resonance imaging, or in 30-day MACE (18, 19, 20, 21). In this sub-analysis from

the Harmonizing Outcomes with Revascularization and Stentsin Acute Myocardial

Infarction (HORIZONS-AMI) Trial (22), we evaluated whether there might be an

association between the use of manual TA and changes in

angiographic,electrocardiographic and clinical outcomes of patients with STEMI

undergoing contemporary pPCI.

Materials and Methods

The HORIZONS-AMI study has been previously reported in detail (22). Briefly,

the studyrandomized 3602 patients with STEMI, presenting within 12 hours after

the onset of symptoms,who were undergoing pPCI, to receive bivalirudin alone

(n=1800) or heparin plus a glycoproteinIIb/IIIa inhibitor (n=1802). A second

randomization allocated patients to a paclitaxel-eluting or an otherwise identical

bare-metal stent.Manual thrombus aspiration with a catheter such as Export

(Medtronic, Minneapolis,MN), Diver CE (Invatec, Roncadelle, Italy), Pronto

(Vascular Solutions, Maple Grove, MN), or QuickCat (Spectranetics, Colorado

Springs, CO) was allowed by the protocol and was used atthe discretion of the

operator

Page 3: Jurnal Makassar 1

The primary study endpoint was net adverse clinical events (NACE), which

includeddeath, re-infarction, ischemic target vessel revascularization (TVR),

stroke, or major bleeding.Other outcomes of interest were MACE (including death,

re-infarction, ischemic TVR, andstroke), components of MACE, major bleeding

not related to CABG, and definite or probablestent thrombosis according to ARC

criteria. Angiographically, reperfusion was assessed by thefinal TIMI flow in the

infarct artery and the TMPG (16, 18). STR was measured by continuousdigital 12-

lead Holter monitoring (3, 4, 23, 24).An independent clinical events committee

blinded to treatment assignments adjudicatedall primary end-point events by

reviewing original source documents and procedural angiograms.Angiographic and

ST-segment analysis were performed at a dedicated core laboratory with theuse of

validated methods by technicians who were unaware of the treatment assignments

andclinical outcomes (25). ST-segment elevation measurements were performed

manually, usingcalibrated/scaled magnifying glasses with a precision of 0.1 mm at

baseline, 60 minutes post- procedure, and at discharge. STR was calculated by the

angiographic core laboratory as the sumof the ST-segment elevation at the time

point of interest as a percentage of the sum of the ST-segment elevation at

baseline. Complete STR was considered STR ≥70%. Stent thrombosis wasdefined

as definite or probable, using the Academic Research Consortium classification

(26).

Statistical Analysis.

Categorical outcomes were compared using the chi-square or Fisher's exacttest.

Continuous variables were compared using the Wilcoxon rank-sum test. The

primary eventanalyses were performed with the use of time-to-event data (with

Page 4: Jurnal Makassar 1

data censored at the time of a patient's withdrawal from the study or at the last

follow-up examination). The results of theseanalyses are shown using Kaplan-

Meier methods and were compared using the log-rank test. As a secondary

analysis, we performed a time-updated Cox proportional-hazards regression

withadjustment for TA vs. none, randomization to bivalirudin vs. heparin plus GPI,

age, gender,history of hypertension, diabetes, MI, creatinine clearance <60, Killip

Class 2-4 vs.1, anemia, baseline and final TIMI flow, baseline and final TMBG,

and symptom to first balloon inflationtime (hours), to adjust for baseline

imbalances between the two groups.

Results

Study Population.

The study flow chart is shown in Figure 1. Among 3340 patients treated with pPCI,

3298 (98.7%) had information concerning the use of manual TA. We excluded 63

patients(1.9%) in whom TA was used for bail-out indications (eg, slow or no

flow). The final study population included 3235 patients, 318 patients (9.8%) who

underwent pPCI with upfront use of TA and 2917 patients (90.2%) who underwent

PCI alone. The most commonly used TA deviceswere the Export and Diver CE

catheters (Figure 2).

Patient and Procedural Characteristics.

Baseline demographics are shown in Table I. Patientstreated with versus without

TA were younger and had a lower prevalence of hypertension, but ahigher

Page 5: Jurnal Makassar 1

prevalence of smoking and prior PCI. Patients treated with TA had shorter

symptom-onsetto balloon time, a higher prevalence of single vessel disease,

angiographic evidence of thrombus,and baseline TIMI flow <3. Direct stenting and

post-stent dilatation were used more frequentlyin patients treated with TA (Table

II).

ST-segment Resolution.

At the end of the procedure, there was no difference between the twogroups in the

rates of final TIMI 3 flow and TMPG grade 2-3 (Table III). At 60 minutes post-

procedure, a similar proportion of patients treated with and without TA

hadcomplete STR (48.2% vs. 50.3%, p=0.51). However, significantly more

patients in the TA grouphad complete STR at discharge (71.8% vs. 64.6%,

p=0.02).

Clinical Outcomes.

At 30-day, 1-year, and 3-year follow-up, the TA and no TA groups hadsimilar

rates of MACE, NACE, death, MI, ischemic TVR, and stent thrombosis (Table

IV).There were more strokes and major bleeding events in the TA group at 30

days, but by 3 yearsthe difference was no longer apparent. The cumulative

incidence of definite or probable stentthrombosis was similar between the two

groups; however, late stent thrombosis occurredsignificantly more frequently in the

TA group.After multivariate adjustment, the use of manual TA was not associated

with anydifferences in long-term outcomes (Table V).

Page 6: Jurnal Makassar 1

Discussion

In this sub-analysis of the HORIZONS-AMI trial we found that the quality of

reperfusion attained was similar between the two groups with no significant

differences in the rates of final TIMI 3 flow, TMPG 2-3, or complete STR at 60

minutes despite worse initial angiographic presentation among patients in the TA

group, who were more likely to have visible thrombus,TIMI 0/1 flow and TMPG

0/1 at baseline. Furthermore, there was a higher rate of complete STR in the TA

group at hospital discharge. With respect to clinical outcomes, there were

nosignificant differences in the rates of MACE, NACE, death, MI, ischemic TVR,

or stentthrombosis at 30 days, 1 year, or 3 years in patients treated with or without

TA. There was,however, a higher incidence of late stent thrombosis in patients

treated with TA, as well as anearly association with increased stroke and major

bleeding with TA which was no longer present at 3-year follow-up. Finally, after

adjusting for differences in the two groups, we found that theuse of manual TA

was not associated with rates of short- or long-term MACE.Unfortunately no

clinical benefit has been demonstrated from the use of distal protectiondevices (27,

28, 29, 30, 31). Analysis of the results of previous thrombectomy trials

iscomplicated by the variety of devices studied, which can be broadly categorized

into mechanicalthrombectomy (eg, Angiojet [Medrad, Warrendale, PA], X-sizer

[eV3, White Bear Lake, MN])and manual aspiration catheters (eg, Export, Diver

CE).Rheolytic thrombectomy using the Angiojet device had until recently been

reported inrandomized trials to be of no benefit and to possibly be associated with

increased infarct size,MACE, and reduced TIMI flow (6, 7). Prospective cohort

studies and registry data specifically in patients with high-grade thrombus burden

Page 7: Jurnal Makassar 1

have reported improved angiographic and clinicaloutcomes (8, 9, 10, 32, 33). The

recently published JETSTENT multicenter randomized trial of rheolytic

thrombectomy and direct stenting versus direct stenting alone during pPCI with

highgrade thrombus burden reported improved STR, but no improvement in the

other primaryendpoints including infarct size (11). There was a significant

reduction in the secondary endpointof MACE at 1, 6, and 12 months (11).

Randomized trials of the X-sizer device demonstratedimproved STR, corrected

TIMI frame count (cTMC), and reduced distal embolization, butreported no

difference in TIMI 3 flow, TMBG, or MACE (12, 13).Randomized and

prospective cohort studies of manual TA, as used in this study, havereported

improvements in electrocardiographic and angiographic endpoints, including

STR,TIMI flow, cTFC, and TMPG (14, 15, 21, 16, 17, 18, 19, 20). In our study

there was noimprovement in post-procedural TIMI 3 flow and TMPG, or in 60-

minute complete STR withthe use of TA devices, while STR was significantly

improved in the TA group at discharge. This may indicate a delayed improvement

in microvascular reperfusion following TA in our study population. It should be

noted that the TA patients had more visible thrombus and a higher  proportion of

TIMI 0/1 flow pre-procedure at baseline, from which they then achieved

similar rates of TIMI 3 flow as the no TA patients.While the majority of studies

report an improvement in surrogate markers with the use of manual TA, it remains

uncertain whether this translates into an improvement in clinicaloutcomes. One

early study suggesting a possible mortality benefit (34) was recently supported

bythe randomized EXPIRA and TAPAS trials (18, 19, 20). Both studies used the

Export catheter.Importantly, inclusion in EXPIRA required TIMI 0-1 flow and

high grade visible thrombus, andthe PCI strategy was direct stenting in both arms

of the trial. Manual TA was associated withimprovement in the co-primary

endpoints of TMPG and STR. Cardiac death, MACE and infarctsize on MRI were

Page 8: Jurnal Makassar 1

also noted to be reduced, although the study was not powered to detect

theseendpoints (20). Similarly, in TAPAS, manual TA was associated with

improved TMPG, STR,cardiac death, and non-fatal MI, but again was not powered

for the clinical endpoints (18, 19).Although TAPAS was a large study, it was a

single center trial and, importantly, mandated pre-dilatation in the no TA group,

raising the issue of whether the benefits observed in the TA groupwere due to the

TA or to direct stenting (18, 19). A subsequent meta-analysis of 9

randomizedtrials, including TAPAS, concluded that manual thrombectomy was

associated with improved30-day mortality (35). A more comprehensive meta-

analysis of 30 randomized trials of alladjunctive devices used in STEMI also

reported that manual aspiration was associated withimproved mortality and

reduced MACE rates (36). Contrary to the results of TAPAS and themeta-analyses,

we did not observe any difference in MACE or mortality at 1 year with TA,

evenafter adjusting for many important covariatesAn important procedural

difference between the two groups in our study was a greater use of direct stenting

in the TA group than in the no TA group. As already discussed, there have been

concerns raised in prior TA trials, including TAPAS, that some of the benefit

observed may be due to direct stenting and not to the TA itself (18, 19, 36). There

is, however, some evidencethat the use of TA is an independent predictor of

improved angiographic outcomes even in thesetting of direct stenting (20, 37). In

our study, the use of direct stenting was more frequent in theTA group, but the net-

clinical effect of this difference in procedural approach would be difficultto assess

among a host of potential confounders. In the HORIZONS-AMI trial, median

ischemiatime of TA patients exceeded that of TAPAS by 14 minutes and the LAD

was less affected(33.4% as compared to 42.9%), differences that may reduce the

prognostic impact of TA.We reported an increased rate of stroke at 30 days and 1

year in the TA group. After adjusting for multiple covariates, patients treated with

Page 9: Jurnal Makassar 1

manual TA still had a trend towards anincreased stroke rate at 1 year, but no such

difference was apparent at 3-year follow-up, and our finding should be regarded as

an association of clinical interest. This finding is partly consistentwith results from

the meta-analysis of randomized trials of thrombectomy and embolic

protectiondevices (36). That study demonstrated a trend towards increased stroke

following manual or mechanical thrombectomy. It is hypothesized that this could

be due to dislodgement andembolization of thrombus from the coronary ostium or

aspiration catheter.While there was no difference in the incidence of cumulative

definite or probable stentthrombosis between patients treated with or without TA,

we found a higher incidence of latestent thrombosis in the TA group at 1-year

follow-up. This clearly raises concern that TA, possibly due to endothelial

disruption and impaired endothelialization, may induce a higher incidence of late

stent thrombosis. Interestingly, we also observed a trend towards less sub-acute

stent thrombosis in our TA group, raising the possibility that the use of aspiration

catheters mayaffect the time of occurrence of stent thrombosis. Another important

consideration in our study isthat patients treated with manual TA were more likely

to have visible thrombus, and there isevidence in STEMI patients that large

thrombus burden is an independent predictor of infarct-related artery stent

thrombosis (38). However, at 3-year follow-up, the rate of late cumulativestent

thrombosis did no longer differ between the two groups, suggesting that slowing

down of vascular repair by TA may be a temporary phenomenon, but this

assumption should be regardedwith caution, due to many potential confounders

that cannot be corrected for.

Limitations

Page 10: Jurnal Makassar 1

The use of manual TA was non-randomized and was left to the

operator’sdiscretion, potentially introducing confounding factors and bias into the

analysis, and as theanalysis was not pre-specified in the original study design, the

associations noted should beregarded as hypothesis generating.

Conclusions

In the HORIZONS-AMI trial, manual TA was associated with improved STR at

discharge,whereas final TIMI flow and TMPG were unaffected. There were similar

rates of NACE, death,cardiac death, re-infarction, ischemic TVR, major bleeding,

and MACE at 30 days, 1-year, and3-year follow-up. Further multicenter

randomized trials are required to clarify the safety andefficacy of routine TA in

patients with STEMI undergoing pPCI

Page 11: Jurnal Makassar 1

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