| Literature DB >> 24904651 |
András Komócsi1, Dániel Aradi1, Dániel Kehl2, Imre Ungi3, Attila Thury3, Tünde Pintér1, James J Di Nicolantonio4, Adrienn Tornyos1, András Vorobcsuk1.
Abstract
INTRODUCTION: Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI.Entities:
Keywords: ST-segment elevation myocardial infarction; death; transfemoral; transradial
Year: 2014 PMID: 24904651 PMCID: PMC4042040 DOI: 10.5114/aoms.2014.42570
Source DB: PubMed Journal: Arch Med Sci ISSN: 1734-1922 Impact factor: 3.318
Figure 1Flowchart of trials
Study characteristics of the included trials
| Study name/first author (publication year) | Period of study | Design | Number of patients | Screen failure | Follow-up [month] | Time frame | MACE | Exclusion criteria | TRA expert |
|---|---|---|---|---|---|---|---|---|---|
| TEMPURA (2003) | 1999.07–2001.02 | Randomized single center | 149 | 64 (30%) | 9 | < 12 | Death, repeat MI, repeat TVR | CSh, aAllen, Graft occlusion | NA |
| RADIAL-AMI (2005) | NA | Randomized multi-center | 50 | NA | 1 | < 12 | Death, repeat MI, repeat TVR | CSh, aAllen, contraindications to GP IIb/IIIa inhibitor use | Yes |
| Vazquez-Rodrigez (2007) | NA | Randomized single center | 439 | NA | 1 | < 12 | Death, severe ischemic complications | NA | NA |
| RADIAMI (2007) | 2005.04–2006.06 | Randomized single center | 100 | 81 (45%) | In hospital | < 12 | Death, repeat MI, repeat TVR, necessity for CABG | Age > 75 years, Killip III–IV, IABP, PM, height < 150 cm, post-CABG | Yes |
| Yan (2008) | 2005.06–2007.06 | Randomized single center | 103 | NA | 1 | < 12 | Death, repeat MI, repeat TVR | Age < 75 years, CSh, non-palpable RA, aAllen, CRF | Yes |
| FARMI (2007) | 2004.01–2005.09 | Randomized single center | 114 | 54 (32.2%) | In hospital | < 12 | Death, ischemic complications | CSh or Killip III–IV, aAllen, contraindications to GP IIb/IIIa inhibitor use, post-CABG | Yes |
| Gan (2009) | NA | Randomized multi-center | 195 | NA | 6 | NA | Death, repeat MI, repeat TVR, necessity for CABG | aAllen | NA |
| Hou (2010) | 2005.08–2008.09 | Randomized single center | 200 | NA | 1 | NA | Death, repeat MI, repeat TVR | CSh, non-palpable RA, aAllen, post-CABG | Yes |
| RIVAL (2011) | 2006.06–2010.11 | Randomized multi-center | 1958 | NA | 1 | NA | Death, MI, and stroke | CSh, aAllen, severe peripheral vascular disease, bilateral mammary CABG | Yes |
| RADIAMI II (2011) | 2006.11–2008.03 | Randomized single center | 108 | 48 (30.8%) | In hospital | < 12 | Death from any cause, repeated MI, need for CABG and need for repeated PCI of IRA | Killip III–IV, IABP, PM, height < 150 cm, post-CABG | Yes |
| RIFLE STEACS (2012) | 2009.01–2011.07 | Randomized multi-center | 1001 | 330 (24.8%) | 1 | NA | Cardiac death, nonfatal MI, TLR, stroke | INR > 2.0 | Yes |
| STEMI-RADIAL (2012) | 2009.10–2012.01 | Randomized multi-center | 707 | 0 | 1 | < 12 | Death, MI, and stroke | Killip IV, oral anticoagulant, non-palpable artery, aortobifemoral bypass | Yes |
Number of patients excluded according to exclusion criteria.
Intervention from pain onset in hours
PCI – percutaneous coronary intervention, TRI – transradial intervention, TFI – transfemoral intervention, CABG – coronary artery bypass graft surgery, IABP – need for intra-aortic balloon pump, PM – need for pacemaker, CRF – chronic renal failure, MI – myocardial infarction, IRA – infarction-related artery, TLR – target lesion revascularization, TVR – target vessel revascularization, MACE – major adverse cardiovascular events, MVD – multi-vessel disease, CSh – cardiogenic shock, aAllen – abnormal Allen test, RA – radial artery, LM – left main coronary, INR – international normalized ratio, NA – not available, TRA – transradial approach
Patient and procedural characteristics of the included trials
| Study name/ first author (publication year) | Mean age [year] | Female (%) | Rescue/primary PCI (%) | GPI use TRI/TFI (%) | Bivalirudin use TRI/TFI (%) | Cross-over TRI/TFI (%) | Failed PCI TRI/TFI (%) | Closure device TFI (%) | Culprit artery LAD/Cx/RCA (%) TRI/TFI | Contrast volume [ml] TRI/TFI | Door to balloon time [min] TRI/TFI | Procedural time [min] TRI/TFI | Fluoroscopic time [min] TRI/TFI | Vascular complications TRI/TFI (%) | Hospital stay [day] | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TEMPURA (2003) | 67 | 18.8 | 0/100 | 0/0 | NA | 0/1.5 | 3.9/2.9 | 0 | 48.1 | 51.4 | 180/186 | NA | 44’/51’ | 15.1’/16.1’ | 0/2.7 | 5.7/7.4 |
| RADIAL-AMI (2005) | 55 | 12 | 66/34 | 96/92 | NA | 4/0 | 8/4 | 8 | 48 | 52 | 210/180 | 32’/26’ | 49’/47’ | 11.3’/7.2’ | 9 RA occlusion, pseudoaneurysm 4/4, hematoma 9/20 | NA |
| Vazquez-Rodrigez (2007) | 61 | 15 | NA | NA | NA | NA | 8.5/6.8 | 95.54 | NA | NA | 21’/18’ | NA | NA | 0.5/2.3 | 8/9 | |
| RADIAMI (2007) | 59.5 | 32 | 0/100 | 44/42 | NA | 8/2 | 2/4 | NA | 42.9 | 45.8 | 198.7/197.7 | 76.9’/64.6’ | 98.7’/88.7’ | 10.9’/11.2’ | 2 RA occlusion, hematoma 10/16 | 6.26/6.75 |
| Yan (2008) | 70.8 | 25.2 | 0/100 | 100/100 | NA | 1.7/0 | 3.5/4.3 | 0 | 38.6 | 41.3 | NA | 16.2’/15.4’ | 44.2’/41.1’ | NA | 0.17 RA occlusion, TFI: 8.7 hematoma, 2.2 pseudoaneurysm | 7.2/10.1 |
| FARMI (2007) | 59 | 17.6 | 42.1/50.8 5.3/8.8* | NA | NA | 12.3/1.8 | NA | 0 | 50.9 | 45.6 | 78/73 | NA | NA | 13’/8’ | Hematoma 3.5/19.3 | 7.2/7.5 |
| Gan (2009) | 52.9 | 19.5 | 0/100 | 31.1/34.3 | NA | 1.1/0 | 2.2/11.4 | NA | 52.2 | 54.3 | NA | NA | 29’/27’ | NA | NA | 10.6/13.8 |
| Hou (2010) | 65.55 | 29.5 | NA | 28/20 | NA | 4/0 | 4/5 | NA | 48 | 50 | NA | 16.4’/16.2’ | 37.2’/35.7’ | 11.8’/11.4’ | 1 RA occlusion, hematoma 2/6, pseudoaneurysm 0/2 | 8.6/12.7 |
| RIVAL (2011) | 59.49 | 20.9 | 11.9/74.1 3.2/3.1 | 34.5/31.1 | 2.2/3.1 | 5.3/1.6 | 4.3/4.2 | NA | NA | 180/180 | NA | 128’/120’ | 9.3’/8’ | 1.3/3.5 | NA | |
| RADIAMI II (2011) | 59.6 | 36.11 | 0/100 | 51/54 | NA | 4.1/1.7 | 0 | 93.2 | 43 | 29 | 165/162 | 67.4’/57.5’ | 89.6’/76.8’ | 7.5’/6.9’ | Hematoma 16.3/20.3, pseudoaneurysm 0/3.3 | 4.2/4.4 |
| RIFLE STEACS (2012) | 65 | 26.7 | 7.6/92.4 | 67.4/69.9 | 8/7.2 | 47/14 | 1.4/4.7 | NA | 47 | 46.7 | NA | 60’/53’ | NA | NA | NA | 5/6 |
| STEMI-RADIAL (2012) | 62 | 23 | 0/100 | 45/45 | NA | 3.7/0.6 | 9/9 | NA | 40 | 42 | 170/182 | NA | 49’/49’ | 7.9’/8’ | 0.3/0.8 | NA |
PCI – percutaneous coronary intervention, GPI – platelet glycoprotein IIb/IIIa inhibitor, TRI – transradial intervention, TFI – transfemoral intervention, RA – radial artery, NA – not available, LAD – left anterior descending coronary artery, Cx – ramus circumflexus, RCA – right coronary artery
Figure 2Risk of major bleeding
CI – confidence interval, TRI – transradial intervention, TFI – transfemoral intervention
Figure 3Risk of death
CI – confidence interval, TRI – transradial intervention, TFI – transfemoral intervention
Figure 4Risk of major adverse events (MACE)
CI – confidence interval, TRI – transradial intervention, TFI – transfemoral intervention
Sensitivity and subgroup analyses
| Subgroup analysis | Number of studies (number of patients) | Odds ratio (95% CI) | |||
|---|---|---|---|---|---|
| MACE | Mortality | Major bleeding | |||
| Overall effect | Fixed effect model | 12 (5124) | 0.66 (0.52, 0.85) | 0.57 (0.42, 0.78) | 0.49 (0.36, 0.66) |
| Publication |
| 10 (3978) | 0.62 (0.47, 0.81) | 0.53 (0.37, 0.75) | 0.59 (0.42, 0.82) |
| Abstract or conference | 2 (1146) | 0.94 (0.53, 1.69) | 0.82 (0.42, 1.60) | 0.19 (0.08, 0.46) | |
| Design | Single center | 7 (1213) | 0.85 (0.51, 1.42) | 0.79 (0.43, 1.45) | 0.43 (0.22, 0.86) |
| Multi-center | 5 (3911) | 0.62 (0.46, 0.82) | 0.52 (0.36, 0.74) | 0.50 (0.36, 0.71) | |
| Number of patients | < 200 | 7 (819) | 0.65 (0.34, 1.24) | 0.67 (0.29, 1.53) | 0.47 (0.23, 0.94) |
| ≥ 200 | 5 (4305) | 0.67 (0.51, 0.88) | 0.56 (0.41, 0.79) | 0.49 (0.35, 0.69) | |
| Rescue PCI | Yes | 4 (3123) | 0.62 (0.45, 0.83) | 0.50 (0.34, 0.73) | 0.64 (0.45, 0.93) |
| No | 6 (1362) | 0.68 (0.39, 1.18) | 0.68 (0.34, 1.35) | 0.29 (0.16, 0.54) | |
| GP IIb/IIIa use | < 45% | 5 (2602) | 0.58 (0.39, 0.86) | 0.48 (0.29, 0.81) | 0.52 (0.26, 1.03) |
| ≥ 45% | 5 (1969) | 0.66 (0.46, 0.95) | 0.58 (0.37, 0.89) | 0.19 (0.08, 0.46) | |
p < 0.05
p ≤ 0.01
p ≤ 0.001.
MACE – major adverse cardiovascular events
Figure 5Funnel plots for visualizing potential publication bias. A – A funnel plot for overall mortality. B – The plot for major adverse events. No skewed distribution could be observed