The radial approach in primary percutaneous coronary intervention (PCI) has been recently assessed in both randomized and observational studies. However, observational studies have several biases that favor the radial approach. We conducted a meta-analysis of randomized controlled trials to compare the clinical outcomes of radial and femoral approach in primary PCI for ST-segment elevation myocardial infarction. The outcomes of interest included death, major bleeding, vascular complications/hematoma, and procedure time. The data were pooled using random-effects models. Ten randomized controlled trials involving 3,347 patients met our inclusion criteria. The radial approach was associated with improved survival (odds ratio 0.53, 95% confidence interval 0.33–0.84) and reduced vascular complications/hematoma (odds ratio 0.35, 95% confidence interval 0.24–0.53). A nonsignificant trend was found toward reduced major bleeding with the radial approach (odds ratio 0.63, 95% confidence interval 0.35–1.12). The procedural time with the radial approach was longer by <2 minutes (mean difference 1.76 minutes, 95% confidence interval 0.59–2.92). In conclusion, in patients undergoing primary PCI, the radial approach is associated with lower short-term mortality. When feasible, the radial approach should be the favored route in primary PCI.
The radial approach permits early ambulation, shortens the hospital stay, and reduces the bleeding risk. It is, however, more technically challenging than the femoral approach and requires a definitive learning curve. Although it is the default route of access in several countries, it is not commonly used in the United States, mainly because of the lack of demonstrated benefit in terms of hard end points compared to the standard femoral approach. Several studies have demonstrated a reduction in bleeding with the radial approach in both diagnostic and interventional settings. A meta-analysis of those studies confirmed the reduction in bleeding but found only a trend for reduction in ischemic events compared to the femoral approach. In primary percutaneous coronary intervention (PCI), however, it is thought that the bleeding reduction with the radial approach might be accentuated. Thus, the purpose of the present study was to perform a meta-analysis of randomized controlled trials to assess the effectiveness of the radial approach in primary PCI exclusively.
Methods
We performed a systematic review and meta-analysis in accordance with the standards set forth by the Quality of Reporting of Meta-Analyses statement. We searched PubMed, EMBASE, Web of Science, and the Cochrane Library (from inception through June 2011). We used the following keywords: “radial,” “transradial,” “percutaneous coronary intervention,” “primary PCI,” and “acute myocardial infarction.” We limited our search to the English language. In addition, we hand-searched the references of the retrieved reports and used PubMed’s related articles feature to identify studies not captured by our primary search strategy. In addition, we searched the relevant abstracts from the annual meetings of the American College of Cardiology, American Heart Association, European Society of Cardiology and Transcatheter Cardiovascular Therapeutics. Studies were considered if a publication was found. Data from unpublished sources were not searched or included.
The inclusion criteria were (1) randomized study design, (2) a patient population with documented ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI, (3) a control group undergoing femoral access, and (4) ≥1 of the following clinical outcomes reported: death, major bleeding, vascular complications/hematoma, and procedure time. The exclusion criteria were (1) case reports, case series, or any observational design of a prospective or retrospective nature, (2) unspecified myocardial infarction type, and (3) a lack of outcomes data.
The clinical outcomes investigated were death, major bleeding, vascular complications/hematoma, and procedure time. Death was defined as either in-hospital death or at 30 days. Major bleeding was defined as in each of the individual studies. Vascular complications/hematomas were defined as pseudoaneurysms, arteriovenous fistula, ischemic limb or significant hematoma (not meeting the major bleeding criteria), as adjudicated by investigators of the individual studies. The definition of procedure time could vary among studies. When it was not specifically reported, we calculated it as the time of local anesthesia to guide catheter removal.
For data extraction and analysis, our method was as follows. We extracted the absolute numbers of events in both groups for the outcomes of interest. The studies were examined independently by 2 investigators, and disagreements were resolved by consensus. The numbers of events for every outcome in every study were then pooled and entered into a statistical software package (Cochrane Collaboration Review Manager, version 5.0.20). Differences in the study characteristics introduced an additional source of heterogeneity in the estimated treatment effects among the studies. These differences would not be adequately managed in a fixed-effects model. We, therefore, used a random-effects model to better account for the differences among the trials. Dichotomous outcomes were reported as odds ratio (OR) and continuous outcomes as the mean difference. Heterogeneity was assessed using the I 2 test. An I 2 value of ≤25% was considered low heterogeneity, and a value of ≥50% was considered significant heterogeneity. All dichotomous outcomes were measured and reported as ORs, with their 95% confidence intervals (CIs).
Results
Ten studies were found to meet our inclusion criteria. Figure 1 shows the flow diagram leading to our study selection. The selected studies encompassed 3,347 patients, randomized from 2,003 and 2,011. The baseline characteristics of the studied population are summarized in Table 1 . Nine studies exclusively enrolled patients with STEMI. One study (radial versus femoral access for coronary intervention [RIVAL]) enrolled patients with acute coronary syndrome, of whom only those with STEMI were included in our analysis.
| Characteristic | Study | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TEMPURA, 2003 | RADIAL-AMI, 2004 | Li et al, 2007 | FARMI, 2007 | Yan et al, 2008 | RADIAMI, 2009 | Gan et al, 2009 | Hou et al, 2010 | RADIAMI II, 2011 | RIVAL 2011 | |
| Patients (n) | ||||||||||
| Radial | 77 | 25 | 184 | 57 | 57 | 50 | 90 | 100 | 49 | 955 |
| Femoral | 72 | 25 | 186 | 57 | 46 | 50 | 105 | 100 | 59 | 1,003 |
| Age (years) | ||||||||||
| Radial | 66 ± 12 | 52 | 57 ± 11 | 60 | 70 ± 8 | 60 ± 9 | 54 ± 13 | 65 ± 8 | 62 ± 9 | NR |
| Femoral | 67 ± 10 | 58 | 55 ± 13 | 58 | 71 ± 8 | 59 ± 9 | 52 ± 12 | 66 ± 8 | 58 ± 10 | NR |
| Men | ||||||||||
| Radial | 81% | 76% | 67% | 86% | 75% | 52% | 81% | 72% | 65% | NR |
| Femoral | 82% | 100% | 65% | 83% | 74% | 49% | 80% | 69% | 63% | NR |
| Previous myocardial infarction | ||||||||||
| Radial | 7% | NR | NR | NR | NR | 16% | 9% | NR | 8% | NR |
| Femoral | 8% | NR | NR | NR | NR | 6% | 11% | NR | 14% | NR |
| Diabetes | ||||||||||
| Radial | 25% | 32% | 20% | 21% | 23% | 16% | 28% | 22% | 21% | NR |
| Femoral | 26% | 16% | 18% | 16% | 24% | 14% | 30% | 15% | 17% | NR |
| Ejection fraction (%) | ||||||||||
| Radial | NR | NR | 48 ± 9 | 46 ± 9 | NR | NR | NR | NR | NR | NR |
| Femoral | NR | NR | 51 ± 9 | 49 ± 11 | NR | NR | NR | NR | NR | NR |
| Right occlusion | ||||||||||
| Radial | 37% | 44% | 40% | 35% | NR | 39% | 31% | 44% | 49% | NR |
| Femoral | 38% | 44% | 41% | 40% | NR | 48% | 28% | 37% | 53% | NR |
| Left anterior descending occlusion | ||||||||||
| Radial | 48% | 48% | 45% | 51% | NR | 43% | 52% | 48% | 43% | NR |
| Femoral | 51% | 52% | 43% | 46% | NR | 46% | 54% | 50% | 29% | NR |
| Left circumflex occlusion | ||||||||||
| Radial | 11% | 8% | 14% | 14% | NR | 18% | 17% | 8% | 8% | NR |
| Femoral | 8% | 4% | 16% | 14% | NR | 6% | 18% | 13% | 17% | NR |
| Intra-arterial blood pump | ||||||||||
| Radial | 9% | NR | NR | NR | 0% | NR | NR | NR | NR | NR |
| Femoral | 10% | NR | NR | NR | 2% | NR | NR | NR | NR | NR |
| Glycoprotein IIb/IIIa inhibitor | ||||||||||
| Radial | 0 | 96% | 0 | 100% | 100% | 44% | 31% | 28% | 51% | NR |
| Femoral | 0 | 92% | 0 | 100% | 100% | 42% | 34% | 20% | 54% | NR |
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