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Table 1 Study characteristics

From: Aspiration thrombectomy prior to percutaneous coronary intervention in ST-elevation myocardial infarction: a systematic review and meta-analysis

Author, year

Location

No. patient

Mean age (SD)

No. male (%)

Inclusion criteria

Exclusion criteria

Follow-up time (months)

Outcomes evaluated

ADMIT [28]

Haifa, Israel

100

I = 57.5 (12.4)

86 (86.0)

Admission <12 hours of onset of symptoms of STEMI, regardless of the initial TIMI flow

Inability to consent; known allergy to either aspirin or clopidogrel; life expectancy <6 months; cardiogenic shock

6 months

Quality of epicardial and microcirculation perfusion; LV function; ischemic mitral regurgitation; MACE (death, recurrent MI, TVR)

C = 57.2 (12.1)

Bulum 2012 [29]

Zagreb, Croatia

60

I = 54.3 (9.7)

47 (78.3)

Symptoms suggesting acute myocardial ischemia of >20 min, time from symptom onset of <12 hours, and ST-segment elevation >0.1 mV in >2 contiguous ECG leads

Need for rescue PCI after failed thrombolysis; cardiogenic shock; triple-vessel disease; significant LMCA stenosis; previous PCI of an IRA; previous CABG; life expectancy <6 months

6 months

Referent vessel diameter; minimal lumen diameter; lesion length; percentage of diameter stenosis; MACE (death, recurrent MI, stroke, TLR)

C = 58.5 (8.6)

Chao 2008 [30]

Taipei City, Taiwan

74

I = 60 (13)

63 (85.1)

STEMI (typical chest pain >30 min with new ST-segment elevation ≥0.1 mV in >2 contiguous leads on a 12-lead ECG), <12 hours after onset, and eligible for primary PCI

Killip IV hemodynamic status; ventricular tachyarrhythmias; previous CABG or significant LMCA lesion; culprit vessel diameter <2 mm; existing TIMI 3 flow without visible thrombus in IRA

6 months

Angiographic differences in TIMI and MBG (post PCI - baseline); MACE (death, stroke, non-fatal recurrent MI, TVR)

C = 62 (11)

De Luca 2006 [31]

Rome, Italy

76

I = 66.7 (14.1)

48 (63.2)

Anterior STEMI, >18 years old, and have an identifiable thrombus on IRA at coronary angiography

Previous MI or CABG; triple-vessel disease; severe valvar disease; TIMI 2 or 3 flow at the time of initial angiography; unsuccessful PCI defined as no antegrade flow or >50 % residual stenosis in the IRA

6 months

LV remodeling; MACE (death, recurrent MI, hospitalization for HF)

C = 64.6 (12.5)

EXPIRA [32, 33]

Rome, Italy

175

I = 66.7 (14.1)

105 (60.0)

First STEMI, <9 hours from symptoms onset, IRA ≥2.5 mm in diameter, thrombus score ≥ 3, TIMI flow ≤1, and >18 years old

Previous PCI on IRA; previous CABG; cardiogenic shock; triple-vessel disease; LMCA disease; severe valvular disease; thrombolysis; contraindication to glycoprotein IIb/IIIa inhibitors

9 months

Final MBG ≥2; rate of 90-min ST-segment resolution >70 %; MACE (cardiac death, recurrent MI, TVR); stent thrombosis

C = 64.6 (12.5)

EXPORT [34]

24 centres in India and Europe

249

I = 59.2 (12.8)

202 (81.1)

>18 years old, STEMI <12 hours of symptom onset, ST-segment elevation ≥2 mm in ≥2 contiguous leads, visual reference vessel diameter >2.5 mm, and with TIMI flow of 0 or 1 before placing the wire in the IRA

Cardiogenic shock; cardiac arrest prior to intervention; pre-catheterization therapy with lytic agents, or with glycoprotein IIb/IIIa inhibitors, or with pacemakers; life expectancy <1 year; current participation in other investigations

1 month

Reperfusion (rate of ST-segment resolution >50 % at 60 minutes postprocedure or MBG 3 immediately postprocedure); magnitude of ST-segment resolution; improvement in TIMI flow; corrected TIMI frame count; MACE (death, recurrent MI, emergent CABG, TLR or TVR, stroke); rate of distal embolization; rate of required bailout techniques (rescue use of the aspiration catheter, distal protection, or glycoprotein IIb/IIIa inhibitors)

C = 61.2 (12.9)

IMPACT [35]

Cambridge, UK

56

I = 64.9 (11.2)

C = 67.2 (11.6)

31 (55.3)

>18 and <90 years old, ability to give informed consent, STEMI (ST-segment elevation ≥2 mm in ≥2 contiguous chest leads or ≥1 mm in ≥2 contiguous limb leads) or new LBBB, chest pain for <12 hours, restoration of at least TIMI 1 flow after the wire crossed the occlusion

Cardiogenic shock; previous MI in the IRA territory; unfavourable anatomy (LMCA occlusion or distal vessel occlusion); severe asthma or bradycardia precluding use of adenosine; women of childbearing age; life expectancy <3 months

6 months

Index of microcirculatory resistence; MACE (all-cause death or MI)

INFUSE-AMI [36, 37]

37 sites in 6 countries

452

I = 61 (NR)

334 (73.9)

≥18 years old, STEMI with ≥1 mm of ST-segment elevation in ≥2 contiguous leads in V1 through V4 or new LBBB with anticipated symptom onset to device time of ≤5 hours

Prior MI, CABG or LAD stenting; contraindications to study medications, contrast or CMRI; creatinine clearance <30 mL/min per 1.73 m2 or dialysis; platelet count <100,000 or >700,000 cells/mm3; hemoglobin <10 g/dL; recent major bleeding; bleeding diathesis; current warfarin use; intracranial disease, stroke or TIA within 6 months or any neurological defect; cardiogenic shock; prior fibrinolysis or glycoprotein IIb/IIIa inhibitors for the present admission; any comorbid likely to interfere with protocol compliance or associated with <1 year survival

12 months

Infarct size measured as a percentage of LV mass at 30 days. MACE (death, recurrent MI, new-onset severe HF, re-hospitalization for HF, stroke, clinically driven TVR)

C = 60 (NR)

ITTI [38]

Kaohsiung City, Yun-Lin Branch, Taiwan

100

I = 60.4 (11.9)

86 (86.0)

≥18 years old, continuous

chest pain ≥30 min, ST-segment elevation >0.1 mV in ≥2 contiguous leads on a 12-lead ECG

Cardiogenic shock (systolic BP > 80 mmHg or need for inotropic agent); history of bleeding tendency, major operation within 6 weeks; hepatic or renal insufficiency; contraindication to tirofiban use

6 months

Occurrence of MBG 3; complete ST-segment resolution; procedure time; occurrence of no-reflow; CK-MB peak and time to peak; TIMI flow and corrected TIMI frame count; MACE (death, recurrent MI, TLR, stroke)

C = 56.5 (11.9)

Kaltoft 2006 [39]

Aarhus, Denmark

215

I = 65 (11)

168 (78.1)

STEMI, symptoms lasting >30 min but <12 hours, and cumulative ST-segment elevation of ≥2 mV in ≥2 contiguous leads

LBBB; MI within the previous 30 days; fibrinolytic treatment; previous CABG; LCA stenosis; need for mechanical ventilation; severe HF treated with intra-aortic balloon pump

1 month

Myocardial salvage estimated by 99mTc-sestamibi SPECT; final infarct size; markers of effective reperfusion (TIMI flow, corrected TIMI frame count, ST-segment resolution immediately, 90 min and 6 hours after PCI); release of TnT; distal embolization visible at the end of PCI; total procedure time; MACE (death, recurrent MI, disabling stroke); LVEF after 30 days; technical success of the thrombectomy

C = 63 (13)

Liistro 2009 [40]

Arezzo, Italy

111

I = 64 (11)

86 (77.5)

STEMI with symptoms lasting >30 minutes and <12 hours, ST-segment elevation >0.1 mV in ≥2 leads on the ECG

Contraindication to the use of platelet glycoprotein IIb/IIIa inhibitors; rescue PCI after thrombolysis; previous MI; absence of optimal echocardiographic apical view; life expectancy <6 months; lack of informed consent

6 months

Rate of ST-segment resolution ≥70 %; TIMI 3 grade flow; corrected TIMI frame count; myocardial contrast echocardiography score index; absence of persistent ST-segment deviation; time course of wall-motion score index; LVEF; LV volume; death; recurrent MI; LV failure; new revascularization

C = 65 (11)

REMEDIA [41]

Rome, Italy

99

I = 61 (13)

83 (83.3)

<12 hours of onset of STEMI referred for primary or rescue PCI

No angiographic exclusion criteria were adopted

1 month

MBG ≥2; rate of ST-segment resolution ≥70 %; peak CK-MB; direct stenting rate; distal embolization rate (abrupt “cutoff” occlusion of a distal branch); composite of distal embolization, slow-flow (TIMI flow grade 2), no-reflow (TIMI flow grade 0 to 1); death; recurrent MI; stroke; TLR; any major adverse event

C = 60 (13)

Shehata 2014 [25]

Cairo, Egypt

100

I = 60.32 (9.2)

64 (64)

Diabetic patients suffering from acute STEMI, symptoms lasting >30 minutes and <12 hours before admission, and ST-segment elevation of >0.1 mV in ≥2 leads

Need for rescue PCI after thrombolysis; prior history of unstable angina or MI; prior PCI CABG; congenital heart disease or any myocardial disease apart from ischemia; limited life expectancy due to coexistent disease

8 months

In-stent restenosis (angiographic luminal diameter stenosis by >50 % in quantitative coronary angiography); MACE (death due to cardiac cause, nonfatal MI, TLR)

C = 59.4 (7.4)

Sim 2013 [42]

Gwangju, Republic of Korea

86

I = 63 (NR)

59 (71.1)

STEMI with onset of symptoms <12 hours, coronary artery lesions with visible thrombus, ability to undergo a complete CCT examination (Killip I and II) with the ability to perform a15-second breath-hold

Previous MI or CABG; cardiogenic shock; LMCA disease; severe valvular heart disease; unsuccessful PCI (post-PCI TIMI flow <2 or ≥50 % residual stenosis in IRA); rescue or facilitated PCI; contraindication to glycoprotein IIb/IIIa inhibitors

12 months

Infarct size at 2 months; markers of myocardial reperfusion (TIMI flow, MBG, ST-segment resolution rate at 90 min); LV function and volumes at 2 months; MACE (cardiac death, MI, TVR)

C = 60(NR)

TAPAS [43, 44]

Groningen, The Netherlands

1071

I = 63 (13)

755 (70.5)

STEMI, symptoms >30 minutes and <12 hours, and ST-segment elevation of ≥0.1 mV in ≥2 leads

Rescue PCI after thrombolysis; life expectancy <6 months; lack of informed consent

1 month

Rate of post-procedural MBG of 0; rate of TIMI flow grade of 3; complete resolution of ST-segment elevation; absence of persistent ST-segment deviation; TVR; recurrent MI; death

C = 63 (13)

TASTE [26, 27]

29 centers in Sweden, 1 center in Iceland and 1 in Denmark

7244

I = 66.5 (11.5)

5424 (74.9)

STEMI, chest pain for >30 minutes and <24 hours, ST-segment elevation in ≥2 contiguous leads (≥0.2 mV in lead V2 or V3 or ≥0.1 mV in other leads) or a presumably new LBBB, and a corresponding culprit-artery lesion on angiography

Need for emergency CABG; inability to provide oral informed consent; <18 years old; previously randomized in the study

12 months

MACE (all-cause mortality; rehospitalization for MI; stent thrombosis); TVR; TLR; complications of PCI, stroke or neurologic complications, HF and length of stay during index hospitalization

C = 65.9 (11.7)

TOTAL [6]

87 hospitals in 20 countries

10732

I = 61.0 (11.8)

7797 (72.6)

Symptoms of MI lasting for ≥30 min, definite ECG changes indicating STEMI, referred for PCI for presenting symptoms, randomized within 12 hours of symptoms onset and before diagnostic angiography, Informed consent

≤18 years old; prior CABG; life expectancy <6 months due to noncardiac condition; treatment with fibrinolytic therapy for qualifying index STEMI event

6 months

MACE (cardiovascular death, recurrent MI, cardiogenic shock, HF NYHA class IV); stroke

C = 65.0 (11.9)

TROFI [45, 46]

5 european centres

141

I = 61.1 (11.8)

102 (72.3)

≥18 years old, STEMI documented with ≥2 mm ST-segment elevation in ≥2 contiguous leads prior to PCI, presenting in the cath lab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographically visible stenosis (>30 %) or TIMI ≤ II in a single de novo, native, previously unstented vessel

Pregnancy; known intolerance to aspirin, clopidogrel, heparin, stainless steel, limus drugs, contrast material; diameter stenosis <30 % in the target lesion; multi-vessel CAD; unprotected LMCA stenosis >30 %; distal vessel occlusion; severe tortuous, calcified or angulated anatomy that would result in sub-optimal imaging or excessive risk of complication from insertion of catheter; fibrinolysis prior to PCI; platelet <100,000 cells/μl; coagulopathy or active bleeding or chronic anticoagulation therapy; cardiogenic shock; significant comorbidities precluding follow-up as judged by investigators; major planned surgery requiring discontinuation of antiplatelets; proximal RCA stenosis (>30 %) if the IRA is mid or distal-RCA

12 months

Minimum flow area immediately after PCI assessed by OFDI; MACE (cardiac death, recurrent MI in the territory of IRA, clinically driven TVR)

C = 60.9 (12.7)

VAMPIRE [47]

23 hospitals in Japan

355

I = 63.2 (10.6)

281 (79.1)

≥21 years old, STEMI symptom >30 min but <24 hours, ST-segment elevation ≥2 mm in ≥2 contiguous leads or with a presumably new LBBB

Primary thrombolysis prior to randomization; cardiogenic shock; history of cardiac arrest; history of CABG; chronic renal failure (Cr >2.0 mg/dl) or hemodialysis; LMCA disease; target vessel <2.5 mm or >5 mm in diameter

8 months

Incidence of slow flow or no reflow during primary PCI (TIMI flow grade <3 not attributable to dissection, occlusive thrombus, or epicardial spasm); coronary flow and myocardial perfusion immediately after PCI (assessed by TIMI flow grade, corrected TIMI frame count and MBG); magnitude of ST-segment resolution, peak CK and CK-MB; angiographic in-stent late lumen loss; LV function; brain natriuretic peptide; MACE (death, recurrence MI, TLR)

C = 63.5 (9.9)

Yin 2011 [48]

Dalian, China

164

I = 63.1 (12.9)

120 (73.2)

STEMI patients who had PCI

Not reported

12 months

Thrombus score; periprocedural no-reflow; TIMI frame count; lumen diameter; stent length; 1-week post-procedural ejection fraction; post-procedural angina; recurrent MI; death

C = 62.9 (9.5)

  1. SD standard deviation, no. number, I intervention group, C control group, STEMI ST-segment elevation myocardial infarction, TIMI thrombolysis in myocardial infarction, LV left ventricular, MACE major adverse cardiac events, MI myocardial infarction, TVR target vessel revascularization, ECG electrocardiogram, PCI percutaneous coronary intervention, LMCA left main coronary artery, IRA infarct-related artery, CABG coronary artery bypass grafting, TLR target lesion revascularization, MBG myocardial blush grade, HF heart failure, LBBB left bundle branch block, NR not reported, LAD left anterior descending, CMRI cardiac magnetic resonance imaging, TIA transient ischemic attack, SPECT single-photon emission computed tomography, TnT troponin T, LVEF left ventricular ejection fraction, CK-MB creatine kinase myocardial band, CCT cardiac computed tomography, NYHA New York Heart Association, CAD coronary artery disease, OFDI optical frequency domain imaging, RCA right coronary artery