Radial versus femoral approach comparison in percutaneous coronary intervention with intraaortic balloon pump support: The RADIAL PUMP UP Registry

doi:10.1016/j.ahj.2013.09.009

American Heart Journal

Volume 166, Issue 6, December 2013, Pages 1019-1026

https://doi.org/10.1016/j.ahj.2013.09.009 Get rights and content

Background

The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome.

Methods

We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points.

Results

Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site–related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups.

Conclusions

In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.

Section snippets

Study design and data collection

The Radial versus femoral approach in percutaneous coronary intervention with intra-aortic balloon pump support (RADIAL PUMP UP) was a multicenter, observational, investigator-initiated clinical study. Data were retrospectively collected from 4 high-volume Italian independent centers using radial artery as primary approach both for diagnostic and interventional procedures (>70% of all cases). All centers had a procedural electronic database enabling automatic data capture and had H24 PCI

Population and procedural characteristics

Between 2007 and 2011, a total of 321 patients undergoing urgent or emergent PCI received periprocedural IABP support. Each center provided data on a minimum of 50 patients, and the recruitment was competitive among the hospital involved. Counterpulsation was normally started at the beginning of the procedure, but in 29% of cases, bailout IABP use was conditioned by an acute clinical status worsening or a procedure-related complication.

The main clinical and procedural characteristics are

Discussion

This retrospective registry evaluated the 30-day outcome of transradial versus transfemoral approach in 321 consecutive patients undergoing urgent or emergent PCI and requiring periprocedural IABP support. Cardiogenic shock or unexpected intraprocedural hypotension in the context of ACS diagnosis (93%) or acute heart failure (2%) were the common indications for IABP support, whereas it was used to prevent hemodynamic instability during high-risk PCI (eg, last remaining vessel) only in a

Conclusion

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Cited by (34)

Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial: Arterial access for PCI in cardiogenic shock
2020, American Heart Journal
The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.
This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.
Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).
In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.
New insights into cardiogenic shock and coronary revascularization after acute myocardial infarction
2020, Archives of Cardiovascular Diseases
Citation Excerpt :
Although there is no dedicated study using ultrasound in patients with CS, we strongly encourage interventional cardiologists to include the use of this technique for arterial access. Transfemoral artery access may be more comfortable and faster for the operator during primary PCI in the setting of haemodynamic support, although there was an increased risk of access site-related bleeding in patients who underwent bilateral femoral access compared with in those who underwent one radial and one femoral access [24]. Beyond haemodynamic instability and severe heart failure, up to 80% of patients with CS have a severe and complex coronary artery disease, with a higher mortality rate associated with multivessel coronary artery disease [25,26].
Cardiogenic shock complicating acute myocardial infarction is challenging, and continues to be associated with high rates of in-hospital and long-term mortality. Coronary revascularization is critical for improving prognosis in CS. Thus, a systematic protocol-driven approach to cardiogenic shock, the development of specialized cardiac care centres, technical advances in interventional cardiology enabling treatment of more complex and severe lesions, the availability of recent antithrombotic therapies and the evolution of new haemodynamic support devices are important considerations in current management of cardiogenic shock complicating acute ischaemic heart disease. Despite these potentially meaningful developments, several substantial gaps in knowledge still exist regarding optimal coronary revascularization of patients with cardiogenic shock. This review will describe current principles in the revascularization of these patients, with a focus on: the time to transfer and revascularize; the choice of vascular access site; the need for complete revascularization or only a culprit lesion strategy; the optimal antithrombotic therapy; the type, place and timing of haemodynamic support; and the medical care system network.
La survenue d’un choc cardiogénique après un infarctus du myocarde aigu reste une situation clinique fréquente et grave dont le pronostic est associé à une morbi-mortalité élevée. La revascularisation coronaire peut en théorie permettre d’améliorer le devenir de ces patients mais la rapidité du transfert, la précocité du geste, les modalités ainsi que le choix et le moment d’une éventuelle assistance restent des points essentiels. En conséquence, il paraît indispensable de construire une organisation en réseau avec des protocoles de prise en charge des patients présentant un choc cardiogénique constitué ou un infarctus du myocarde avec risque évolutif rapide vers le choc. L’organisation de soins doit tendre vers le développement de centres spécialisés comportant un environnement optimal de réanimation cardiologique, de support hémodynamique, pharmacologique et chirurgical. Dans cette revue de la littérature récente, nous discuterons des principes actuels de la revascularisation, en insistant particulièrement sur: (1) les délais de mise en œuvre; (2) la voie d’abord vasculaire; (3) le caractère ciblé de la revascularisation; (4) l’environnement anti-thrombotique; (5) la place de l’assistance et notamment le type d’assistance, le moment idéal du support hémodynamique; et (6) l’organisation du réseau de soins critique.
RadialFirst in CHIP and Cardiogenic Shock
2020, Interventional Cardiology Clinics
Citation Excerpt :
Other clinical scenarios in which TRA access may be preferred include patients on therapeutic anticoagulation, bleeding diatheses, an inability to receive transfusion or lay flat, and extremes of body mass index (BMI).4,6,7 In the RADIAL PUMP UP Registry, there was a significantly higher event-free survival for cardiac death, MI, target lesion revascularization, stroke, and bleeding in the population of patients who underwent single TFA access with accompanying TRA access when compared with patients who underwent bilateral TFA access.8 Patients who undergo TRA access are also able to ambulate sooner and ultimately leads to an earlier discharge, resulting in both a reduced hospital course and shorter length of stay.2,9,10
In-Hospital Outcomes After Percutaneous Coronary Intervention for Acute Coronary Syndrome With Cardiogenic Shock (from a Japanese Nationwide Registry [J-PCI Registry])
2019, American Journal of Cardiology
In-hospital complications and their predictors in acute coronary syndrome (ACS) patients with cardiogenic shock (CS) have not been fully investigated, particularly in those who underwent invasive revascularization procedures. This study investigated the in-hospital outcomes, along with the volume-outcome relationship of ACS patients with CS, using a contemporary large-scale nationwide percutaneous coronary intervention (PCI) registry in Japan. We analyzed PCI procedural data on ACS patients treated between 2014 and 2016 in a nationwide Japanese PCI registry. Predictors of in-hospital death and major bleeding complications requiring transfusion were identified via multivariable logistic regression analysis. The association of bleeding complications with in-hospital death was also analyzed. This study enrolled 253,355 patients who underwent PCI for ACS, of whom 17,549 (6.9%) were with CS. The rates of in-hospital mortality and access/nonaccess site bleeding complications in CS patients were 13.2%, 1.2%, and 1.3%, respectively. Age, gender, and baseline kidney condition, along with presentation status (e.g., cardiopulmonary arrest and/or acute heart failure) or the number and location of diseased vessels (e.g., left main lesion), were associated with in-hospital mortality and bleeding complications. Of note, the in-hospital mortalities decreased in parallel with the increasing institutional PCI volumes. In-hospital mortality also differed by the presence of concomitant bleeding complications (43.1% and 48.3% with access or nonaccess site bleeding, and 12.9% and 12.7% without, respectively). In conclusion, in-hospital mortality was 13.2% in ACS patients with CS who underwent contemporary PCI. Other than traditional predictors of PCI complications, lower institutional PCI volumes, and concurrent bleeding were associated with higher in-hospital mortality.
The Radial Artery for Percutaneous Coronary Procedures or Surgery?
2018, Journal of the American College of Cardiology
Influence of access site choice for cardiac catheterization on risk of adverse neurological events: A systematic review and meta-analysis
2016, American Heart Journal
Stroke is a rare but potentially catastrophic complication of cardiac catheterization. Although some procedural aspects are known to influence stroke risk, the impact of radial versus femoral access site use is unclear. Early observational studies and limited randomized trial data suggested more frequent embolic events with radial access. Subsequently, larger pooled analyses have shown no clear differences in stroke risk but were limited by low event rates. Recent publication of relevant new data prompted our reevaluation of this concern. Therefore, we conducted a systematic review and meta-analysis to evaluate stroke complicating cardiac catheterization with use of transradial versus transfemoral access.
A search of MEDLINE and EMBASE was undertaken using OVID SP with appropriate search terms. RevMan 5.3.5 was used to conduct a random-effects meta-analysis using the inverse variance method for pooling risk ratios (RRs) or the Mantel-Haenszel method for pooling dichotomous data. Pooled data from >24,000 patients in randomized controlled trials and >475,000 patients from observational studies were used. The risk ratio (RR) for (any) stroke, using randomized controlled trial data, was not significant (RR 0.87, 95% CI 0.58-1.29). Using observational data, a significant difference favoring radial access was seen (RR 0.71, 95% CI 0.52-0.98).
Radial access site utilization for cardiac catheterization is not associated with an increased risk of stroke events. These data provide reassurance and should remove another potential barrier to conversion to a “default” radial practice among those who are currently predominantly femoral operators.

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: Deepak L. Bhatt, MD, MPH, MB, ChB, DPhil, served as guest editor for this article.

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Clinical InvestigationInterventional CardiologyRadial versus femoral approach comparison in percutaneous coronary intervention with intraaortic balloon pump support: The RADIAL PUMP UP Registry

Background

Methods

Results

Conclusions

Section snippets

Study design and data collection

Population and procedural characteristics

Discussion

Conclusion

J Thorac Cardiovasc Surg

J Am Coll Cardiol

Am J Cardiol

Lancet

J Am Coll Cardiol

JACC Cardiovasc Interv

Int J Cardiol

Am J Cardiol

JACC Cardiovasc Interv

Effects of intra-aortic balloon pumping on coronary flow and metabolism in man

Circulation

Intraaortic balloon assistance in intractable cardiogenic shock

Eur Heart J

Clinical Investigation
Interventional Cardiology
Radial versus femoral approach comparison in percutaneous coronary intervention with intraaortic balloon pump support: The RADIAL PUMP UP Registry