Bleeding is one of the most common serious complications after percutaneous intervention (PCI). Objective: To study the peri-procedural major adverse cardiac event (MACE) and safety associated with same-day PCI on transferred patients from a satellite to a tertiary care hospital with three different arterial access strategies: re-using the same femoral arterial access (Group 1) vs crossover from a radial to a femoral access (Group 2), vs re-puncture of the same radial artery (Group 3). Materials and methods: We screened two tertiary care hospitals’ National Cardiovascular Data Registry for any patient that was transferred for a same-day PCI procedure from the (satellite) hospital to the catheterization lab at the second hospital over a 3-year period. 185 patients were studied. The primary endpoints were: (1) peri-procedural MACE; (2) all-cause mortality; and (3) major bleeding. Results: There were no statistically significant differences in the rates of peri-PCI primary endpoints between the 3 groups. Although statistically not significant, there was an obvious trend in the femoral-to-femoral approach group to have more access-related hematoma. The mean total PCI procedure and fluoroscopy times in Group 2 and Group 3 were longer than Group 1, but these differences were not statistically significant. Finally, the mean total contrast volume used in Groups 2 and 3 was greater than the volume used in Group 1. Conclusion: In this retrospective cohort analysis, we found that re-puncturing the radial artery is a currently employed strategy that may be feasible and safe strategy for urgently or emergently transferred patients undergoing same-day PCI.
Bleeding is one of the most common, serious complications after percutaneous transluminal intervention (PCI) performed on patients diagnosed with an acute coronary syndrome. This increased risk of bleeding associated with PCI is attributed to the invasive nature of the procedure, and the use of antiplatelet and antithrombotic agents before, during, and after PCI.1,2 Peri-procedural bleeding is associated with major adverse cardiovascular events (MACE), including 30-day mortality post-PCI, re-infarction, and cerebrovascular accidents.2-8 Data from the REPLACE II trial showed that peri-procedural major bleeding was a stronger predictor of post-PCI mortality than other MACE such as peri-procedural myocardial infarction (MI).9 The strong association between peri-procedural bleeding and post-procedural MACE led to several actions aimed at minimizing bleeding risk, including the introduction of new pharmacological agents10-12 and the encouragement of procedural techniques such as radial arterial access as an alternative approach to conventional femoral arterial access. Bleeding complications related to the puncture site represent the majority of the peri-procedural bleeding complications in the setting of PCI.13
Radial access was introduced in 194814, and its popularity with both operators and patients has steadily increased. Radial artery access is an alternative option for both elective coronary angiography and PCI, and has become the default strategy in many centers.15-17 Recently, the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study18 demonstrated that use of radial access in patients with ST-segment elevation MI (STEMI) is associated with both lower morbidity (hospital stay and bleeding) and cardiac mortality. The authors of RIFLE-STEACS went so far as to recommend radial artery access as a primary approach in STEMI patients, provided that adequate operator and center expertise are present.
As operators and cardiac centers gain more transradial expertise, procedure and fluoroscopy times can be significantly reduced. In our hospital, not unlike many other hospitals, this technique was adopted early for both diagnostic and therapeutic purposes. At our center, many of our patients are transferred from satellite centers after a diagnostic catheterization to the tertiary hospital for semi-elective or urgent PCI. In many cases, a radial approach is employed, but the feasibility and safety of a radial re-puncture has never been fully evaluated. In this study, we present the early peri-procedural MACE and other safety results obtained when performing PCI for transferred patients from another facility. Our patients were divided into three groups: re-using the femoral arterial primary access vs crossover from the primary radial access to a femoral access, vs re-puncturing the same radial artery.
This is an observational, retrospective study utilizing the National Cardiovascular Data Registry (NCDR), developed in 1997 by the American College of Cardiology (ACC)21 for the purpose of collecting and implementing clinical data to improve cardiovascular care. Located 20 miles apart in Michigan, Providence Hospital and Medical Center (PMHC) is a tertiary medical center and Providence Park Hospital (PPH) is a satellite hospital. Both centers are active participants in the NCDR.
We screened our local NCDR registry and the electronic medical database at PHMC for any patient >18 years of age that was transferred within 24 hours from PPH to the catheterization laboratory at PMHC. Transferred patients underwent diagnostic catheterization for different indications at PPH. We screened all patients with the above criteria transferred to PHMC between March 1, 2011 and December 30, 2014. The Institutional Review Board at PHMC approved the study. A total of 185 consecutive transferred patients were found to meet the specified criteria and were suitable for analysis. These 185 patients were divided into 3 groups based on the second access approach at PHMC. Group 1 included 104 patients with femoral access at PPH which was also used for access after transfer to PHMC (femoral to femoral); Group 2 included 28 patients with radial access at PPH that was closed and a new femoral access at PHMC was established (radial to femoral), and Group 3 included 53 patients with radial access at PPH that was closed and a new secondary access at PHMC was established by re-puncturing the same radial artery (radial to radial).
The primary endpoints of this retrospective study were (1) MACE (major adverse cardiac events) including cardiac death, recurrent myocardial infarction (MI), emergency PCI, or coronary artery bypass graft (CABG) surgery, and stroke; (2) all-cause mortality, and; (3) major bleeding. Secondary endpoints included access-related bleeding, fluoroscopy time, procedure time, total amount of contrast used, and serum creatinine change. Death was defined as in-hospital death, and divided into death from any cause or cardiac death. Major bleeding was defined as one of the following: fatal bleeding, intracranial hemorrhage, bleeding associated with a ≥3 g/dL hemoglobin drop, or requiring transfusion, prolonged hospitalization, or surgery.
Vascular access-related complications were site-related bleeding, arteriovenous fistula, vascular site infection or abscess, compartment syndrome, nerve damage, hematoma, vascular occlusion with or without ischemia, pseudoaneurysm, retroperitoneal bleeding, and radial artery thrombosis. For non-CABG related bleeding, we used the TIMI (Thrombolysis in Myocardial Infarction) classification (see Appendix A).19-21
For the following definitions, please refer to the diagnostic cardiac catheterizations and percutaneous coronary interventions of the NCDR CathPCI registry v 4.4 and coder’s data dictionary22: hypertension, dyslipidemia, heart failure, prior MI, post-procedure MI, PCI, CABG definition and status, cerebrovascular disease, peripheral arterial disease, contrast dose, fluoroscopy time, procedure time, vascular complication, and other outcome definitions.
Patients were divided into three groups: Group 1 included patients with femoral-to-femoral access, Group 2 included patients with radial-to-femoral access, and Group 3 included patients with a radial re-puncture access approach. Quantitative variables were analyzed using t-test, and the categorical variables were analyzed using either Fisher-exact test or Pearson chi-square test. For this study, a P-value <0.05 was considered statistically significant. Patient characteristics and medical treatments were compared using either the Mann-Whitney non-parametric test (for non-normal) or students’ T-test (for normal) continuous variables.
The following baseline characteristics were studied: socio-demographic (gender, age and race), medical conditions (history of hypertension, dyslipidemia, cerebrovascular accident, peripheral vascular disease, chronic kidney disease requiring hemodialysis, smoking, myocardial infarction, coronary intervention or cardiac bypass surgery), current medications and laboratory values (hemoglobin and serum creatinine levels before and after PCI, and INR). These covariates were compared between the three groups and their effect was examined statistically (Table 1).
There were no significant differences (especially for diabetes, chronic kidney disease, history of prior PCI or cerebrovascular accident) between the groups, except for the following: there was a greater number of smokers, obese, hypertensive patients, and patients taking aspirin of any dose at baseline in Group 1 compared with the other two groups (P<0.001). Patients in Group 2 were older than the patients in the other groups (P<0.001). As expected, the TR Band (Terumo) for hemostasis and a smaller catheter size for access were used more frequently in Group 3, and manual compression methods for hemostasis and a larger-size catheter were used more frequently for Group 1 patients (P values for both closure methods and catheter size were <0.001).
There was a significant catheter size difference between Groups 1 and 2 (median 6 French vs 5 French size, P<0.001), and between Groups 1 and 3 (median 6 French vs 5 French size, P<0.001), but there was no significant difference in catheter size between Groups 2 and 3 (median 5 French vs 5 French size, P=NS). There was also a significant BMI difference between Groups 1 and 2 (median 29.7 vs 24.4, P<0.001), and between Groups 2 and 3 (median 24.4 vs 29.7, P<0.001), but there was no significant BMI difference between Groups 1 and 3 (median 29.7 vs 29.7, P=NS).
A look at antiplatelet and anticoagulation medications used at baseline or prior to PCI, as well as peri-procedure medications, revealed that a greater number of patients in Group 1 were taking aspirin of any dose at baseline compared to the other 2 groups (P<0.001). More patients in Group 1 were on clopidogrel compared to Group 3 (P<0.001), but more patients in Group 3 were given intravenous bivalirudin during PCI (7 patients, 13%) compared to Group 1 (no patients were given bivalirudin, P<0.001). Otherwise, there was no significant difference in other peri-procedural antiplatelet regimens or heparin use between the three groups prior to PCI.
There were no crossover patients between groups for failed access (e.g., femoral access because of failed radial access and vice versa). There were no statistically significant differences between the 3 groups in rates of peri-PCI MACE, all-cause mortality, major or minor bleeding, procedure-related or access-related bleeding, bleeding requiring blood transfusion, and access-related vascular complications. Although statistically not significant, there was a clear trend in the femoral-to-femoral approach group of higher rates of access-related bleeding and access hematoma compared to the radial-to-femoral approach and radial re-puncture approach (Table 2). More patients underwent CABG after the index procedure since enrollment in Group 1 (2 patients, 1.8%) and Group 2 (1 patient, 3.8%) compared to Group 3, where no patients underwent CABG surgery post index procedure, though this difference was not statistically significant (Appendix B). There were no patients with radial artery thrombosis at follow-up in Groups 2 and 3.
Mean total PCI procedure times in Group 2 and Group 3 (69 minutes and 64 minutes, respectively) were longer than Group 1 (60.9 minutes), and mean total fluoroscopy time in Groups 2 and 3 (14 minutes and 11 minutes, respectively) was longer than Group 1 (10.6 minutes), but these differences were not statistically significant (Table 3). The femoral-to-femoral patients (Group 1) had a longer mean hospital stay post PCI compared to the other two groups (Group 1 = 19.6 days, Group 2 = 6.9 days, and Group 3 = 8.6 days, P<0.001). Finally, mean total contrast volume used in Groups 2 and 3 (199 cc and 173 cc, respectively) was greater than the volume used in Group 1 (121 cc) (P-values, Group 3 vs 1 = <0.001 and Group 2 vs 1 = <0.001) (Table 3).
Contemporary treatment of patients undergoing PCI includes aggressive treatment with antiplatelet and antithrombotic agents. As more potent adjunctive pharmaceutical agents are used, more bleeding complications may be anticipated and impact mortality.23 Other vascular site-related complications, including arterial venous fistulas, arterial dissection or perforation, vascular site infection, ischemic limb, pseudoaneurysms, compartment syndrome, and radial artery thrombosis, can also occur. Most of these complications are known to be more common in the femoral access approach. Previous studies have shown that transradial access is associated with lower bleeding rates at the puncture site23,24, making this approach a reasonable alternative to the femoral approach, especially with regards to patients’ preference for comfort and early ambulation.
Since its introduction, radial artery access has been gaining in popularity for both diagnostic coronary angiography and PCI. However, the rate of adoption of this useful technique remains relatively low, generally understood to be because of operator resistance to learning the nuances of radial technique that affect its learning curve. Additional perceived challenges may be reports of increased procedure time, exposure to radiation, and contrast volumes, as well as higher procedure failure rates with radial artery access.4,23 Nevertheless, radial artery access holds several advantages when compared to traditional approaches, including patient comfort, early ambulation, and safer access for obese patients and for patients with severe peripheral occlusive vascular disease.5,25,26 Importantly, multiple studies have shown lower bleeding risk with the radial approach. Transradial access may also result in significant cost savings, an important factor in the current era of limited health care dollars. Nevertheless, skills and expertise in radial technique are required, along with a time investment to manage the associated learning curve. Finally, same-day re-puncture of the same radial artery has been seldom practiced, and poorly understood and reported.
In this study, we reported peri-procedural MACE and safety endpoints associated with same-day PCI on transferred patients from a satellite to a tertiary care hospital with three different arterial access strategies: re-puncture of the same femoral access (Group 1) vs crossover from a radial to a femoral access (Group 2), vs re-puncture of the same radial access (Group 3).
We believe our study is the first to describe the feasibility and safety profile (MACE and procedural-related complex outcomes) of re-puncturing the radial artery in the setting of transferred patients between different facilities for same-day PCI. All groups received similar antiplatelet and anticoagulation regimens (except for greater clopidogrel use in Group 1, other P2Y12 receptor antagonists had a higher rate of use in Groups 2 and 3, and bivalirudin was used preferentially in Group 3), with no statistical difference among the groups when MACE and all-cause mortality were compared. Bleeding and vascular complications were similar between groups, despite the slight differences in catheter sizes and BMI that favor the radial approach.
There were, however, statistical differences in some procedure-related parameters. Group 1 patients received a lower amount of contrast and had a longer hospital stay after PCI. These observations are consistent with reports from the recent literature.18 Possible explanations include greater familiarity with the conventional approaches, larger caliber of the femoral artery, fewer incidences of spasm, and generally less tortuous course that allows the operator to use less contrast to explore the anatomy of the access and the vascular anatomy.
In this retrospective cohort analysis, we found that re-puncturing the radial artery is a currently employed strategy that may be a feasible and safe strategy for urgently or emergently transferred patients undergoing same-day PCI. Compared to the femoral-to-femoral and radial-to-femoral approaches, the radial re-puncture approach showed no statistically significant differences in the rates of post-procedural MACE, all-cause mortality, major or minor bleeding, procedure-related or access-related bleeding, and vascular complications. As expected, the total contrast volume used in the radial-to-femoral and radial re-puncture groups was larger, and the total length of stay time for these same groups was shorter. In practice, the conventional period of bed rest recommended after femoral access hemostasis is achieved by either manual compression or closure device use is longer than the period recommended after the TR Band is used for a radial access approach. This can explain the longer length of stay time in Group 1 compared to Groups 2 and 3. Radial artery re-puncture may prove to be safer for higher-risk patients, especially in the presence of significant peripheral occlusive vascular disease. Larger, randomized, controlled studies are needed to confirm and expand our findings.
Some of the limitations of our study include the fact that this was a single-center, non-randomized, observational study with a relatively small sample size, and some differences in BMI, catheter sizes, clopidogrel and bivalirudin between groups that we don’t feel have a great impact on the overall results.
Our sincerest thanks go to Frances Williams, whose help in the statistical analysis of the complex data was instrumental and is greatly appreciated.
- Moscucci M, Fox KA, Cannon CP, et al. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003; 24: 1815e23.
- Budaj A, Eikelboom JW, Mehta SR, et al; OASIS 5 Investigators. Improving clinical outcomes by reducing bleeding in patients with non-ST-elevation acute coronary syndromes. Eur Heart J. 2009; 30: 655e61.
- Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coro¬nary syndromes: An analysis from the ACUITY trial. J Am Coll Cardiol. 2007; 49: 1362-1368.
- Agostoni P, Biondi-Zoccai GG, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; system¬atic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004; 44: 349-356.
- Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: A systematic review and meta-analysis of randomized trials. Am Heart J. 2009; 157: 132-140.
- Yang X, Alexander KP, Chen AY, et al. The implications of blood transfusions for patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE National Quality Improvement Initiative. J Am Coll Cardiol. 2005 Oct 18; 46(8): 1490-1495.
- Rao SV, Ou FS, Wang TY, et al. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug; 1(4): 379-386. doi: 10.1016/j.jcin.2008.05.007.
- Rao SV, Eikelboom JA, Granger CB, et al. Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007; 28: 1193e204.
- Feit F, Voeltz MD, Attubato MJ, et al. Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 Trial. Am J Cardiol. 2007; 100: 1364e9.
- Montalescot G, White HD, Gallo R, et al. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med. 2006; 355: 1006e17.
- Cannon CP, Harrington RA, James S, et al; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomized double-blind study. Lancet. 2010; 375: 283e93.
- Mehran R, Lansky AJ, Witzenbichler B, et al; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009; 374: 1149e59.
- Verheugt FW, Steinhubl SR, Hamon M, et al. Incidence, prognostic impact and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC Cardiovasc Interv. 2011; 4: 191e7.
- Radner S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new technique. Acta Radiol. 1948; 29 (2): 178-80.
- Kiemeneij F, Laarman GJ, de Melker E. Transradial artery coronary angioplasty. Am Heart J. 1995; 129: 1-7.
- Lotan C, Hasin Y, Mosseri M, Rozenman Y, Admon D, Nassar H, et al. Transradial approach for coronary angiography and angioplasty. Am J Cardiol. 1995; 76: 164-167.
- Díaz de la Llera LS, Fournier Andray JA, Gómez Moreno S, Arana Rueda E, Fernández Quero M, et al. Transradial approach for percutaneous coronary stenting in the treatment of acute myocardial infarction. Rev Esp Cardiol. 2004; 57(8): 732-736.
- Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, et al. The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome). J Am Coll Cardiol. 2012 Dec 18; 60(24): 2481-2489.
- Rao SV, O’Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, et al. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005; 96: 1200-1206.
- Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991; 115: 256-265.
- Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15; 357(20): 2001-2015.
- About NCDR. Quality Improvement for Institutions. The American College of Cardiology. Available online at https://www.ncdr.com/webncdr/home/aboutthencdr. Accessed February 18, 2016.
- Brueck M, Bandorski D, Kramer W, Wieczorek M, Holtgen R, Tillmanns H. A randomized comparison of transradial versus transfemoral approach for coronary angiography and angioplasty. JACC Cardiovasc Interv. 2009 Nov; 2(11): 1047-1054.
- Diaz de la Llera LS, Fournier Andray JA, Gomez Moreno S, et al. [Transradial approach for percutaneous coronary stenting in the treatment of acute myocardial infarction]. Rev Esp Cardiol. 2004 Aug; 57(8): 732-736.
- Waksman R, King SB 3rd, Douglas JS, Shen Y, Ewing H, Mueller L, Ghazzal ZM, Weintraub WS. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol. 1995 May 1; 75(14): 886-889.
- Saito S, Tanaka S, Hiroe Y, Miyashita Y, Takahashi S, Tanaka K, Satake S. Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the test for myocardial infarction by prospective unicenter randomization for access sites (TEMPURA) trial. Catheter Cardiovasc Interv. 2003 May; 59(1): 26-33.
This article received a double-blind peer review from members of the Cath Lab Digest Editorial Board.
Disclosure: The authors report no conflicts of interest regarding the content herein.
The authors can be contacted via Ahmad Daraghmeh, MD, at email@example.com