Fig. 12.1
(a, b) It assumes that the largest studies will be near the average, and small studies will be evenly spread on both sides of the average. Deviation from this assumption can indicate publication bias. Of note, similar to confidence interval plots, funnel plots are conventionally drawn with the treatment effect measure on the horizontal axis, so that study size appears on the vertical axis (Reprint with permission from Ref. [8])
The association between access and non-access site bleeding and mortality in people with acute coronary syndrome has been the subject of intense research over the last decade [9]. Hypothetical mechanisms link bleeding and mortality in acute coronary syndrome include the hemodynamic consequences of blood loss, complications related to blood transfusion, and the need to modify antithrombotic medication. Nevertheless, a clear causal relationship between bleeding and mortality has not been confirmed and it is possible that major bleeding simply identifies people with an underlying mortality risk. According to data analysis by The National Institute for Health and Care Excellence on Myocardial Infarction with ST segment elevation the following statement was given.
In all-cause mortality
Radial access PPCI has a clinically effective association when compared to femoral access PPCI with reduced all-cause mortality rates at ≤ 30 days [8 studies, n = 3825]. Radial access PPCI potentially has a clinically effective association when compared to femoral access PPCI with reduced all-cause mortality in the longer term, but the direction of the estimate of effect could favor either intervention [2 studies, n = 306].
Regarding reinfarction
Radial access PPCI potentially has a clinically effective association when compared to femoral access PPCI at reducing reinfarction rates at ≤ 30 days, but the direction of the estimate of the effect could favor either intervention [7 studies, n = 3661]. However, femoral access PPCI potentially has a clinically effective association when compared to radial access PPCI with reduced reinfarction rates in the longer term, but the direction of the estimate of effect could favor either intervention [2 studies, n = 306].
In major bleeding incidence and repeat revascularization rates
Radial access PPCI potentially has a clinically effective association when compared to femoral access PPCI with reduced major bleeding incidence at ≤ 30 days [10] [8 studies, n = 3825]. Evidence suggested that there may be no clinical difference between radial access PPCI and femoral access PPCI with an association with repeat revascularization rates at ≤ 30 days, but the direction of the estimate of effect could favor either intervention [5 studies, n = 1558]. Very low quality evidence also suggested that there may be no clinical difference between radial access PPCI and femoral access PPCI with repeat revascularization rates in the longer term, but the direction of the estimate of effect could favor either intervention [2 studies, n = 308].
In stroke incidence
No clinical difference between the association of radial access PPCI and femoral access PPCI with reduced stroke incidence at ≤ 30 day [3 studies, n = 3059].
In access site crossover
Low quality evidence showed that femoral access PPCI was more clinically effective when compared radial access PPCI at reducing rate of access site crossover during PPCI [9 studies, n = 4195].
In fluoroscopy time
The analysis showed that there is no clinical difference between radial access PPCI and femoral access PPCI and PPCI procedural success [9 studies, n = 3903]. Fluoroscopy time of PPCI showed that there was no clinical difference between radial access PPCI and femoral access PPCI at fluoroscopy time [5 studies, n = 671].
In total radiographic contrast media use
Total radiographic contrast media used during PPCI procedure suggested that there may be no clinical difference between radial access PPCI and femoral access PPCI at reducing total radiographic contrast media use, but the direction of the estimate of effect could favor either intervention [4 studies, n = 471].
In reducing vascular access site complications
Radial access PPCI is more clinically effective when compared to femoral access PPCI at reducing vascular access site complications at ≤ 30 days [4 studies, n = 2416].
In reducing hospital stay
Additional evidence showed that radial access PPCI was more clinically effective when compared with femoral access PPCI at reducing hospital stay [4 studies, n = 644].
In procedure length
Very low quality evidence showed that femoral access PPCI is more clinically effective when compared with radial access at reducing procedure length [7 studies, n = 1235].
In cost analysis
One original comparative cost analysis found that PPCI carried out by femoral access was more costly than PPCI carried out by radial access. There was insufficient evidence to reliably predict the size of the cost difference. This analysis was assessed as directly applicable with minor limitations.
Cardiogenic shock
Cardiogenic shock remains the leading cause of mortality in patients hospitalized with AMI. Even though TRA has become increasingly adopted as a default PCI; however, even in experienced centers that favor the radial artery as the primary access site during PCI, patients presenting in CS are often treated via the transfemoral access site (TFA); and commentators have suggested that CS remains the final frontier even for experienced radial operators. However, even in cardiogenic shock, recent studies showed that the transradial access site was independently associated with a lower 30-day mortality, in-hospital major adverse cardiac and cerebrovascular events and major bleeding [11, 12]. In addition to lower bleeding rates, transradial PCI in patients with cardiogenic shock has the advantage of preserving bilateral femoral access for hemodynamic support devices such as IABP, impeller, ECMO and others.
12.2 Strategy of Anticoagulant and Antiplatelet Therapy During Primary PCI
Recently, Lee MS et al. stated that the benefits of radial over femoral PPCI were strongly influenced by suboptimal antithrombotic regimens as well as liberal use of potent parenteral antiplatelet agents [13]. Thus, the influence of access site alone on outcomes could be accurately measured. Radial access and bivalirudin usage. In the National Cardiovascular Data Registry it was found that the combination of radial access and bivalirudin anticoagulation is associated with a significant reduction in post-PCI bleeding compared with either radial access alone or the combination of femoral access, bivalirudin, and a vascular closure device. The overall bleeding rate was 2.59 %: 2.71 % in the femoral group, 2.5 % in the radial group, and 1.8 % in radial access-bivalirudin group (P < 0.001) The authors calculated the relative risk of bleeding events for radial combination therapy to be 0.79 (0.72–0.86), as compared to 0.96 (0.88–1.05) for radial only. The numbers are given as adjusted OR (95 % CI). However, the limitation of the reported data is that they are observational. Moreover, the data of the US National Cardiovascular Data Registry are contrasted by, the report by the European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trial. This trial had been designed to test whether bivalirudin given already during transport for STEMI is superior to heparins with regards to major bleedings. The results showed that radial access was not associated with major bleedings or patients’ outcomes at 30 days. This trial, however, was not conducted and powered to show superiority or non-inferiority of one access site over the other. In addition, it should be mentioned, that in EUROMAX acute stent thrombosis was more frequent with bivalirudin (1.1 % vs. 0.2 %; p = 0.07) compared to heparin.
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