Transradial vs Femoral Percutaneous Coronary Intervention for
Left Main Disease in Octogenarians
Olivier F. Bertrand, Rodrigo Bagur, Olivier Costerousse, Josep Rodés-Cabau,
Quebec Heart-Lung Institute, Quebec, Canada
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Introduction
High-risk patients are increasingly referred for percutaneous coronary intervention (PCI). Most of the time significant co-morbidities preclude consideration for standard coronary artery bypass graft surgery. Among these, older patients and especially octogenarians represent a growing number of patients presenting with severe coronary artery disease and associated com-morbidities. Several reports have described the use of transradial approach in elderly patients (1-3). A few experiences have also been published in patients older than 80 years using a transradial approach (4-6). However, limited data are available to compare transradial and femoral acute and long-term results in patients referred for left main PCI (7-9).
Furthermore, most reports originate from centers using transradial PCI when there are technical limitations of using femoral approach. Accordingly, some groups have reported longer fluoroscopic time and larger volume of contrast with transradial approach compared to femoral approach in high-risk patients or more complex lesions (4). In our center, transradial PCI has been the preferred technique since 1994, and today virtually all procedures are performed by a transradial or transulnar approach unless it is technically not feasible(10-12). Our objective is to report our experience in left main PCI in octogenarians using the transradial and femoral techniques.
Methods
Study Population and Study Design
This study included all patients > 80 years old who underwent left main PCI using either transradial or femoral approach from January 2002 to January 2008. Patients were treated by PCI either due to patient’s preference, treating physician’s choice or refusal from the surgical team(13). The choice of transradial or femoral routes, the use of antithrombotic agents, pre-dilatation or direct stenting and the use of intravascular ultrasound as per the operators discretion. Angiographic success was defined as a residual lesion <30% with coronary Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow. Serial cardiac biomarkers measurements were performed after intervention during the first 24 hours or longer if clinically indicated. All patients were pretreated with aspirin and clopidogrel prior to PCI and clopidogrel was prescribed after PCI for at least 1 month in case of bare metal stent or at least 6 months in case of drug-eluting stent use. Patients were followed up by clinical visits or phone contacts. Control angiography during follow-up was not mandated. If an event occurred during follow-up, medical files were retrieved and the primary care physician or referring cardiologist were consulted if required. The study protocol was conducted in accordance with institutional ethics committee, and all patients provided a written informed consent prior to PCI procedures.
E-mail: olivier.bertrand@crhl.ulaval.ca
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Study Outcomes
All cardiac and non-cardiac complications occurring within 30 days of the procedures were captured. Major cardiac and cerebrovascular events (MACCE) including death, myocardial infarction (MI), repeat revascularization and any cerebrovascular event (stroke or transient ischemic attack) were analyzed 30 days post-PCI and at last follow-up. All deaths were considered of cardiac origin unless proven otherwise. Periprocedural MI was defined as a rise of creatine kinase-MB (CK-MB) isoenzyme 3 times the upper limit of normal, that is greater than 30 µg/ml in our laboratory. In case of elevated CK-MB at baseline, MI was defined as an increase in 50% over baseline values after PCI. Beyond the peri-procedural period, MI was defined as any typical rise above the upper limit of normal and fall of cardiac biomarkers either troponins or CK-MB with at least one of the following: cardiac symptoms, new Q-waves on the ECG, or ECG changes compatible with ischemia.
Statistical Analysis
Categorical variables are expressed as numbers and percentages and continuous variables as mean ± SD unless stated otherwise. Baseline and procedural characteristics were compared between transradial and femoral groups using Fischer’s exact test or χ2 test for categorical variables and Student’s t test or Wilcoxon rank-sum test for continuous variables. MACCE-free survival curves were constructed according to Kaplan-Meier techniques and comparison between transradial and femoral groups was performed using log rank test. A probability value < 0.05 was considered significant. Statistical tests were performed using JMP 7.0 software (SAS institute, Cary, NC).
Results
patients, 85 ± 3 vs 82 ± 3 years (p = 0.0067) (Table I). In this population, 40% of patients were females with a mean weight of 67 ± 13 kgs in the radial group compared to 66 ± 13 kgs in the femoral group (p= 0.90). Indication for PCI was an acute coronary syndrome in majority of patients, 90% in the radial group and 85% in the femoral group. Patients received heparin in 90% of the cases in the radial group and 85% in the femoral group (0.63). There was no difference in weight-adjusted heparin dose in the 2 groups, 92 ± 22 U/kg in the radial group compared to 86 ± 21 U/kg in the femoral group (p = 0.44). Bivalirudin was rarely used and glycoprotein IIb-IIIa receptor inhibitors were used in 33% of radial cases and 23% of femoral cases (p = 0.54). A mean of 3 ± 2 stents was implanted in each patient with drug eluting stents used in 44% in the radial group and 69% in the femoral group (p = 0.14). Hemodynamic support with intraaortic balloon pump was used more often in the femoral group compared to the transradial group (23% vs 4%, p = 0.042) (Table II). The types of left main lesions were similar in the both groups. Majority of the patients underwent PCI of other coronary lesions during the same session. Procedures were performed in 5-6Fr in 93% of transradial cases and 85% of femoral cases (p = 0.14) with use of similar guiding catheter shapes. Angiographic success was obtained in 98% in the radial group and 92% in the femoral group (p = 0.34). There was no difference between the 2 groups in fluoroscopic time, procedure duration and contrast volume used. Furthermore, hospitalization duration was also similar in the transradial group and femoral group, 4 days (interquartile range 1-7) vs 4 days (interquartile 2-8) respectively (p = 0.68).
At 30 days, cardiac events were similar in both groups (Table III). Bleeding requiring transfusion was numerically lower in the transradial group (14%) compared to femoral group (23%, p = 0.42). Access site complications occurred less frequently after transradial (6%) than after femoral (31%) approach (p = 0.014). All complications were in the form of large hematomas except 1 hematoma with leg ischemia after femoral PCI. At late follow-up (Table IV), cardiac death (17% vs 15%, p = 1.00), MI (23% in both groups), and revascularisation (11% vs 0%, p = 0.35) remained similar in the radial and femoral groups (Figure 1).
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TABLE I: Baseline Characteristics
Data are mean ± SD or number (percent of total). MI: myocardial infarction; PCI: percutaneous coronary intervention; CABG: coronary artery bypass grafting; BMI: body mass index; LVEF: left ventricular ejection fraction; GPIIb/IIIa: platelet glycoprotein IIb/IIIa receptor, LMWH: low molecular weight heparin.
Discussion
In this analysis, we showed that transradial left main PCI in patients older than 80 years old is technically feasible in large majority of cases and is associated with similar angiographic success with significantly less access site complications and numerically less serious bleeding than femoral approach.
We have previously shown that in this study population, outcomes at 2 years were similar between PCI and CABG(13). Importantly, in this study we included only very high-risk patients with a EuroSCORE ≥ 6 and as such they were all evaluated prior to procedure as poor candidates or non-candidates for CABG. Similar to our experience, in-hospital mortality rates between 6% and 13% have been previously reported for left main PCI mainly with femoral approach(13-15). It is interesting to note that patients in the femoral group had on average one point higher EuroSCORE than the transradial group and early mortality in the femoral group was twice that in the transradial group. We have previously described that the Euroscore was the only independent predictor of MACCE at follow-up in this study population (HR 1.29 for each point) with a cut-off value >9 presenting the best sensitivity and specificity(13).
TABLE II: Procedural Characteristics
Data are mean ± SD or number (percent of total). IABP: intra-aortic balloon pump; LAD: left anterior descending artery; LCx: left circumflex artery; RCA: right coronary artery; PCI: percutaneous coronary intervention.
This experience is rather unique as it represents the real world practice in a high-volume center where transradial approach is the preferred technique whenever feasible. Despite the fact that using plethysmography as a screening tool for verification of dual hand circulation, it has been shown that transradial approach is feasible in > 98% of the cases, other technical considerations must be weighted for high-risk situations such as in these octogenarians with left main disease(16). In a recent randomized study in elderly patients less than 80 years of age, transradial approach was feasible in 85% of the cases(1). This rate is similar to that reported by other groups for transradial left main PCI(7). Indeed, in older patients, which includes usually a higher percentage of women, anatomical features such as smaller radial arteries, radial or brachial arteries loops, or brachiocephalic trunk tortuosities, transradial approach may remain more challenging. In the randomized OCTOPLUS study, Louvard et al. (2004) compared transradial and femoral approach for diagnostic ± PCI in octogenarians(6). Interestingly, crossovers from transradial to femoral approach occurred in 8.9% of patients but crossovers from femoral to transradial occurred in 8.1%. Overall, the rate of vascular complications was lower in the transradial group with significantly less hematoma delaying hospital discharge compared to the femoral group. Procedural success was > 95% and similar in the both groups. Also Klinke et al.(2004) reported significantly better acute outcomes and less hospitalization duration after transradial PCI in octogenarians compared to femoral approach although statistical adjustement for differences in baseline characteristics greatly minimized the observed differences(5). The
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TABLE III: 30-Day Events
TABLE IV: Major adverse cardiac and cerebrovascular events at follow-up
same group also compared their experience using transradial (n = 27) or femoral approach (n= 53) for left main PCI(9). Overall, fluoroscopy time, amount of contrast, procedural success and MACE rate were similar in the both groups but major vascular complications occurred only in the femoral group. Our results extend those findings as there was no difference in fluoroscopic time, total volume of contrast and procedural duration between the transradial and femoral groups. Therefore, it appears that in centers experienced in transradial approach, patients do not receive undue radiation exposure during PCI(17).
It is also worth noting that all devices used i.e. guiding catheters, rotablator, cutting balloons were similar in the both groups. This reinforces the facts that the armamentarium used by femoral approach for complex cases can be used by transradial approach. It is unclear why the use of IABP was more frequent with femoral approach although we cannot exclude that this simply reflects the operators confidence to the use of the transradial approach without IABP for complex procedures.This was a non-randomized and retrospective analysis, which may create bias and confounding factors. Furthermore, it was a limited sample size. However, it represents the largest series so far of real-world practice in a high volume tertiary center using transradial approach as the preferred technique for left main PCI in octogenarians.
In conclusion, left main PCI in octogenarians is technically feasible in majority of patients, it is associated with similar acute and long-term results than femoral approach but minimizes the risk of bleeding and vascular complications.
References
1.Achenbach S, Ropers D, Kallert L, Turan N, Krahner R, Wolf T, Garlichs C, Flachskampf F, Daniel WG, Ludwig J. Transradial versus transfemoral approach for coronary angiography and intervention in patients above 75 years of age. Catheter Cardiovasc Interv 2008;72(5):629-35.
2.Bagur R, Bertrand O, Rodes-Cabau J, Rinfret S, Tizon-Marcos H, Gleeton O, Nguyen C, Roy L, Costerousse O, De La Rochelliere R. Comparison of outcomes in patients > 70 years vs < 70 years after transradial coronary stenting with maximal antiplatelet therapy for acute coronary syndrome. Am J Cardiol 2009;(in press).
3.Valsecchi O, Musumeci G, Vassileva A, Tespili M, Guagliumi G, Mihalcsik L, Rossini R, Gavazzi A, Ferrazzi P. Safety and feasibility of transradial coronary angioplasty in elderly patients. Ital Heart J 2004;5(12):926-31.
4.Jaffe R, Hong T, Sharieff W, Chisholm RJ, Kutryk MJ, Charron T, Cheema AN. Comparison of radial versus femoral approach for percutaneous coronary interventions in octogenarians. Catheter Cardiovasc Interv 2007;69(6):815-20.
5.Klinke WP, Hilton JD, Warburton RN, Warburton WP, Tan RP. Comparison of treatment outcomes in patients > or =80 years undergoing transradial versus transfemoral coronary intervention. Am J Cardiol 2004;93(10):1282-5.
6.Louvard Y, Benamer H, Garot P, Hildick-Smith D, Loubeyre C, Rigattieri S, Monchi M, Lefevre T, Hamon M. Comparison of transradial and transfemoral approaches for coronary angiography and angioplasty in octogenarians (the OCTOPLUS study). Am J Cardiol 2004;94(9):1177-80.
7.Cheng CI, Wu CJ, Fang CY, Youssef AA, Chen CJ, Chen SM, Yang CH, Hsueh SK, Yip HK, Chen MC and others. Feasibility and safety of transradial stenting for unprotected left main coronary artery stenoses. Circ J 2007;71(6):855-61.
8.Minden HH, Lehmann H, Meyhofer J, Butter C. Transradial unprotected left main coronary stenting supported by percutaneous Impella Recover LP 2.5 assist device. Clin Res Cardiol 2006;95(5):301-6.
9.Ziakas A, Klinke P, Mildenberger R, Fretz E, Williams MB, Della Siega A, Kinloch RD, Hilton JD. Comparison of the radial and femoral approaches in left main PCI: a retrospective study. J Invasive Cardiol 2004;16(3):129-32.
10.Bertrand OF, De Larochelliere R, Rodes-Cabau J, Proulx G, Gleeton O, Nguyen CM, Dery JP, Barbeau G, Noel B, Larose E and others. A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Circulation 2006;114(24):2636-43.
11.Bertrand OF, Faurie B, Larose E, Nguyen CM, Gleeton O, Dery JP, Noel B, Proulx G, Roy L, Costerousse O and others. Clinical outcomes after multilesion percutaneous coronary intervention: comparison between exclusive and selective use of drug-eluting stents. J Invasive Cardiol 2008;20(3):99-104.
12.Mangin L, Bertrand OF, De La Rochelliere R, Proulx G, Lemay R, Barbeau G, Gleeton O, Rodes-Cabau J, Nguyen CM, Roy L. The transulnar approach for coronary intervention: a safe alternative to transradial approach in selected patients. J Invasive Cardiol 2005;17(2):77-9.
13.Rodes-Cabau J, Deblois J, Bertrand OF, Mohammadi S, Courtis J, Larose E, Dagenais F, Dery JP, Mathieu P, Rousseau M and others. Nonrandomized comparison of coronary artery bypass surgery and percutaneous coronary intervention for the treatment of unprotected left main coronary artery disease in octogenarians. Circulation 2008;118(23):2374-81.
14.Bottner RK, Blankenship JC, Klein LW. Current usage and attitudes among interventional cardiologists regarding the performance of percutaneous coronary intervention (PCI) in the outpatient setting. Catheter Cardiovasc Interv 2005;66(3):455-61.
15.Palmerini T, Marzocchi A, Marrozzini C, Ortolani P, Saia F, Savini C, Bacchi-Reggiani L, Gianstefani S, Virzi S, Manara F and others. Comparison between coronary angioplasty and coronary artery bypass surgery for the treatment of unprotected left main coronary artery stenosis (the Bologna Registry). Am J Cardiol 2006;98(1):54-9.
16.Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J 2004;147(3):489-93.
17.Bertrand OF, Arsenault J, Mongrain R. Operator vs. patient radiation exposure in transradial and transfemoral coronary interventions. Eur Heart J 2008;29(20):2577-8.
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