Abstract
Objective
The authors aimed to conduct first systematic review and meta-analysis in STEMI patients evaluating vascular access site failure rate, fluoroscopy time, door to balloon time and contrast volume used with transradial vs transfemoral approach (TRA vs TFA) for PCI.
Methods
The PubMed, CINAHL, clinicaltrials.gov , Embase and CENTRAL databases were searched for randomized trials comparing TRA versus TFA. Random effect models were used to conduct this meta-analysis.
Results
Fourteen randomized trials comprising 3758 patients met inclusion criteria. The access site failure rate was significantly higher TRA compared to TFA (RR 3.30, CI 2.16–5.03; P = 0.000). Random effect inverse variance weighted prevalence rate meta-analysis showed that access site failure rate was predicted to be 4% (95% CI 3.0–6.0%) with TRA versus 1% (95% CI 0.0–1.0 %) with TFA. Door to balloon time (Standardized mean difference [SMD] 0.30 min, 95% CI 0.23–0.37 min; P = 0.000) and fluoroscopy time (Standardized mean difference 0.14 min, 95% CI 0.06–0.23 min; P = 0.001) were also significantly higher in TRA. There was no difference in the amount of contrast volume used with TRA versus TFA (SMD − 0.05 ml, 95% CI − 0.14 to 0.04 ml; P = 0.275). Statistical heterogeneity was low in cross-over rate and contrast volume use, moderate in fluoroscopy time but high in the door to balloon time comparison.
Conclusion
Operators need to consider higher cross-over rate with TRA compared to TFA in STEMI patients while attempting PCI. Fluoroscopy and door to balloon times are negligibly higher with TRA but there is no difference in terms of contrast volume use.
Highlights
- •
Cross-over rate is significantly higher with TRA compared to TFA.
- •
Cross-over rate predicted to be 3–6% with TRA versus 0–1% with TFA.
- •
Fluoroscopy & door to balloon times are negligibly higher with TRA.
- •
There is no difference in contrast volume use with TRA vs TFA.
1
Background
The role of early primary percutaneous coronary intervention (PCI) within 90 min of hospital contact is well recognized in ST-segment elevation myocardial infarction (STEMI) . Transfemoral approach (TFA) has been the method of choice for performing PCI in the United States for all indications. However, in recent years transradial approach (TRA) has gained significant momentum mainly due to lower risk of access site bleeding and other complications . Previous studies also indicate lower mortality risk with TRA compared to TFA . Notwithstanding its advantages, adoption of TRA in STEMI patients has been slow in the United States compared to other indications for PCI .
There are several reasons for slow adoption of TRA in STEMI patients. It is technically challenging and has a steep learning curve . It takes longer to perform PCI using TRA especially during the learning curve. The RIVAL trial showed that benefit of TRA was mainly seen in high volume centers or with experienced operators . According to the national cardiovascular data registry report in 2012, 49% of participating PCI centers in the United States performed 400 or fewer and 26% 200 or fewer PCIs annually. Additionally, there is high cross-over rate with TRA compared to TRA according to some studies . However, cross-over rate in primary PCI, where it matters the most, is largely undefined. The individual trials have shown conflicting results. The national cardiovascular data registry and other major observational databases do not record access site cross-over and instead report data linked to the final or successful vascular access site . The outcome data in such registries could be biased towards TRA because cases where door to balloon time (DTB) delay occurred due to access site failure associated with TRA will actually be reported as TFA cases. Additionally, individual clinical trials had low power to detect differences in door to balloon to time, fluoroscopy time and contrast volume use in STEMI patients. The observational data comparing two approaches tend to be highly skewed due to selection bias as complex and high bleeding risk patients are likely to be selected for TFA . Furthermore, vast majority of randomized trial have not reported stratified outcome data for the STEMI patients who require access site cross-over due to TRA failure making it more difficult to assess the actual impact of this problem.
Accordingly, the authors undertook first comprehensive meta-analysis of randomized trials to evaluate vascular access site failure requiring cross-over to alternate access site, DTB time, fluoroscopy time and contrast volume use associated with TRA versus TFA in STEMI patients. It is important to appropriately define the problems facing TRA adoption in STEMI patients in order to design future randomized trials to answer such questions.
2
Methods
2.1
Search strategy and data synthesis
Two reviewers (SS and MS) independently searched PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), clinicaltrials.gov and Excerpta Medica (Embase) for studies published until March, 2015 ( Appendix Table 1 ). No language restriction was imposed. Reference lists of included studies were scanned to retrieve additional relevant studies. Authors of included studies were systematically contacted to obtain additional information and unpublished data if available.
The following eligibility criteria were set in the protocol; 1) Trials in adult STEMI patients; 2) Randomized clinical trials comparing TRA versus TFA for primary or rescue PCI; 3) Trials reporting at least one outcome of interest. Disagreements regarding inclusion or exclusion criteria were resolved with consensus or input from third reviewer (SK).
2.2
End points
Primary end point was relative and individual access site cross-over rate with TRA and TFA. Secondary end points included DTB time, fluoroscopy time and contrast volume use.
2.3
Statistical analysis
These systematic review and meta-analysis were conducted in accordance with Cochrane Handbook and PRISMA statement . The authors assessed statistical heterogeneity using the I 2 statistic. It describes the percentage variation across studies which can be attributed to heterogeneity rather than chance. As a guide, I 2 values, 25% indicated low, 25–50% indicated moderate, and > 50% indicated high heterogeneity . The authors compared outcomes between groups using both DerSimonian & Laird random effect and Mantel–Haenszel fixed effect models. Pooled access site cross-over rates were also calculated separately for TRA and TFA using inverse variance weighted random effect meta-analysis. This technique assigns statistical weight to the cross-over rates derived from each trial based on sample size and precision of the trial. Only cross-over rates derived from the randomized trials could be reliable due to high selection bias in observational data. Pooled risk ratios (RRs), standardized mean differences (SMDs) and their 95% confidence were used as summary statistics. Statistical analysis was conducted with Stata 13 SE (StataCorp LP, College Station, Texas, USA). A sensitivity analysis was conducted by excluding one trial at a time.
2.4
Assessment of study quality and publication bias
Quality of the randomized trials was assessed using Cochrane’s risk of bias assessment tool . The publication bias was assessed with visual inspection of the funnel plot. The Egger’s statistical test for publication bias assessment was also used .
2
Methods
2.1
Search strategy and data synthesis
Two reviewers (SS and MS) independently searched PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), clinicaltrials.gov and Excerpta Medica (Embase) for studies published until March, 2015 ( Appendix Table 1 ). No language restriction was imposed. Reference lists of included studies were scanned to retrieve additional relevant studies. Authors of included studies were systematically contacted to obtain additional information and unpublished data if available.
The following eligibility criteria were set in the protocol; 1) Trials in adult STEMI patients; 2) Randomized clinical trials comparing TRA versus TFA for primary or rescue PCI; 3) Trials reporting at least one outcome of interest. Disagreements regarding inclusion or exclusion criteria were resolved with consensus or input from third reviewer (SK).
2.2
End points
Primary end point was relative and individual access site cross-over rate with TRA and TFA. Secondary end points included DTB time, fluoroscopy time and contrast volume use.
2.3
Statistical analysis
These systematic review and meta-analysis were conducted in accordance with Cochrane Handbook and PRISMA statement . The authors assessed statistical heterogeneity using the I 2 statistic. It describes the percentage variation across studies which can be attributed to heterogeneity rather than chance. As a guide, I 2 values, 25% indicated low, 25–50% indicated moderate, and > 50% indicated high heterogeneity . The authors compared outcomes between groups using both DerSimonian & Laird random effect and Mantel–Haenszel fixed effect models. Pooled access site cross-over rates were also calculated separately for TRA and TFA using inverse variance weighted random effect meta-analysis. This technique assigns statistical weight to the cross-over rates derived from each trial based on sample size and precision of the trial. Only cross-over rates derived from the randomized trials could be reliable due to high selection bias in observational data. Pooled risk ratios (RRs), standardized mean differences (SMDs) and their 95% confidence were used as summary statistics. Statistical analysis was conducted with Stata 13 SE (StataCorp LP, College Station, Texas, USA). A sensitivity analysis was conducted by excluding one trial at a time.
2.4
Assessment of study quality and publication bias
Quality of the randomized trials was assessed using Cochrane’s risk of bias assessment tool . The publication bias was assessed with visual inspection of the funnel plot. The Egger’s statistical test for publication bias assessment was also used .
3
Results
Out of total 3672 records, 14 randomized trials meeting inclusion criteria were selected for this meta-analysis ( Appendix Fig. 1 ). Trials provided data on 3758 patients. The data were extracted and analyzed in intention to treat basis. Majority of trials recruited patients going for primary PCI except two trials in which most patients underwent rescue PCI ( Table 1 ). Mean age of trials participants was below 65 in most trials ( Table 1 ). Seven trials followed up participant during the index hospitalization alone and the remaining trials reported outcomes up to 30 days or longer follow up period. There was low overall risk of bias in majority of the trials ( Table 2 ). Blinding of patients and operators was not possible in any trial because both had to know the site of procedure due to anatomically different locations of the procedures. Lack of blinding was not considered a major limitation when overall quality of the trials was assessed although it was rated as high risk on the risk of bias table as per Cochrane Handbook’s guidelines ( Table 2 ).
| Trial | Period of enrollment | Multi-center | Patients number | Mean age (years) | Male (%) | Rescue PCI % | Follow-up | TRA expert definition (minimum number of TRA PCIs by the operator required prior to participation in the study) | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TFA | TRA | TFA | TRA | TFA | TRA | TFA | TRA | |||||
| FARMI 2007 | 2004–05 | No | 57 | 57 | 60 | 58 | 86 | 82.5 | 49.1 | 35.1 | In-hospital | > 100 |
| Gan et al. 2009 | 2004–07 | Yes | 105 | 90 | 52.3 | 53.6 | 80 | 81.1 | 0 | 0 | In-hospital | NA |
| Hou et al. 2010 | 2005–08 | No | 100 | 100 | 66.2 | 64.9 | 69 | 72 | 0 a | 0 a | 30 days | > 200 |
| RADIAL-AMI 2005 | NA | Yes | 25 | 25 | 58 | 52 | 0 | 76 | 68 | 64 | 30 days | > 100 |
| RADIAMI 2009 | 2005–06 | No | 50 | 50 | 59.1 | 59.9 | 48.5 | 51.5 | 0 | 0 | In-hospital | > 100 |
| RADIAMI II 2011 | 2006–08 | No | 59 | 49 | 57.6 | 62.1 | 63 | 65 | 0 a | 0 a | In-hospital | NR |
| RIFLE-STEACS 2012 | 2009–11 | Yes | 501 | 500 | 65 | 65 | 71.9 | 74.8 | 7 | 8.2 | 30 days | Annual vol > 200 with 80% TRA PCIs |
| RIVAL 2011 | 2006–10 | Yes | 3,514 | 3,507 | 62 | 62 | 72.9 | 74.1 | 11.1 | 10.6 | 30 days | Defintion NR but mean TRA volume 352 (180–599) |
| Li 2007 | NR | No | 186 | 184 | 56 | 56 | 66 | 66 | NR | NR | In-hospital | NR |
| Vasquez-Rodriguez 2009 | 2004–05 | Yes | 222 | 217 | 62 | 60 | 84.8 | 83.8 | 72.5 | 67.5 | 30 days | NA |
| TEMPURA 2003 | 1999–2001 | No | 72 | 77 | 67 | 66 | 81.9 | 80.5 | 0 a | 0 a | In-hospital | NA |
| OCEAN RACE 2014 | 2010–12 | No | 51 | 52 | 62.8 | 61 | 77 | 77 | NR | NR | In-hospital & 12 months | > 200 |
| Yan 2008 | NR | No | 46 | 57 | 70.8 | 70.8 | 74.8 | 74.8 | 0 | 0 | 30 days | NR |
| Wang et al. 2012 | 2008–10 | No | 59 | 60 | 60.2 | 59.8 | 83.1 | 86.7 | NR | NR | In-hospital | > 500 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
