Abstract
Background
The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population.
Methods
We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes.
Results
From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p = 0.008) and had a higher left ventricular ejection fraction (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p = 0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p = 0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p = 0.48). At a follow-up of 32 ± 13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p = 0.28).
Conclusions
The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.
1
Introduction
Transradial access (TRA) has become an interesting approach for percutaneous coronary intervention (PCI), mainly because of reduced rates of bleeding complications compared to the transfemoral approach (TFA) . However, although most coronary lesions can now be successfully treated via the TRA, PCI for unprotected left main coronary artery (ULMCA) disease is usually performed via transfemoral access (TFA) using 7 or 8 French (Fr) guiding catheters because of the high rate of distal bifurcation lesion and the large diameter of the vessel . In this retrospective study we evaluated in an unselected population undergoing PCI for ULMCA stenosis the feasibility and the efficacy of TRA compared to TFA, in terms of success of procedure and in-hospital and long-term outcomes.
2
Methods
2.1
Study population and procedural details
We reviewed the data of patients undergoing PCI for significant ULMCA stenosis from January 2008 and December 2011 at our hospital. Our catheterization laboratory is a high-volume PCI center (> 800 PCI and > 150 primary PCI per year) with 3 skilled operators, one of whom is dedicated to TRA procedures. The operator using TRA had similar experience with TFA procedures and no experience with TRA at the onset of the study but, at the end of it, its activity in PCI via TRA rose up to 81% ( Fig. 1 ). In order to avoid confounding factors, only the procedures performed by this operator dedicated to TRA were considered. PCI was chosen as a therapeutic option in case of clinical and/or hemodynamic instability or when cardiac surgery was considered at high risk because of the presence of either old age or severe comorbidities. All patients were categorized into the TRA group (n = 27) or the TFA group (n = 22). Demographic, clinical and procedural data were prospectively collected in a dedicated database (Cardioplanet V.3.0.8, Ebit Aet S.p.A., Genoa, Italy) and, after the coronary angiography, the complexity of the coronary disease was classified using the SYNTAX Score calculation . The study protocol was reviewed and approved by the Ethics Committee of our Institution (ASL 103, Piemonte Region, Italy). The vascular access method and the PCI technique were performed according to the operator’s discretion. Intra-aortic balloon pump (IABP) was used as much as possible, also in stable patients. Intravascular ultrasounds (IVUS) were used, if possible, to achieve optimal stent expansion and lesion coverage. At the end of the procedure the radial hemostasis was accomplished by compressing folded gauze wrapped by an elastic bandage, whereas closure devices (Angioseal, St Jude Medical, St. Paul, Minnesota; Perclose or Star Close, Abbott Vascular, Santa Clara, California) were used for femoral hemostasis if the access site was suitable. All patients were routinely treated with aspirin (325 mg upon arrival, and then 100 mg daily), clopidogrel (loading dose of 300 or 600 mg, and then 75 mg daily) and with an intravenous bolus of unfractionated heparin (100 U/kg body weight, or 60 U/kg body weight if also glycoprotein IIb-IIIa inhibitors were given). Heparin therapy was stopped after the procedure, but, in case of IABP use, it was continued until its removal. Abciximab and eptifibatide were the glycoprotein IIb-IIIa inhibitors used. Bivalirudin was not used in these patients. Beta-adrenergic blockers, ACE inhibitors and statins were used as in-hospital standard therapy, if not contraindicated.
2.2
Study end point
The end point of the study was the feasibility of the TRA procedure without need of access crossover, defined as failure to successfully complete the procedure by the TRA, and its efficacy, defined as achievement of final residual stenosis of < 30% and of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 . We assessed also the rate of the in-hospital and long-term major adverse cardiac events (MACE) including death; myocardial infarction (MI), defined as of typical chest pain with new ECG abnormalities and elevation of creatine kinase to twice the basal level; stroke, defined as defined as any focal and nonconvulsive neurological deficit lasting more than 24 hours; target vessel revascularization (TVR), defined as repeated PCI or CABG due to restenosis or progression of the disease in the treated vessels; major bleeding complications, defined according to the Bleeding Academic Research Consortium classification ; stent thrombosis (ST), defined as definite and probable according to the Academic Research Consortium classification and contrast-induced nephropathy (CIN) defined as absolute increase in serum creatinine of 0.5 mg/dL (44 μ mol/L), or a relative 25% increase from the baseline value, assessed 48–72 hours following intravascular administration of the contrast medium .
2.3
Patient follow-up
In-hospital events were derived from clinical records. An angiographic control was scheduled between 6 and 12 months if not contraindicated. Clinical follow-up was performed by ambulatory clinical visits or telephone calls. In case of events, clinical records were checked when available or detailed history was acquired from patients or (in case of death) from patients’ relatives or physicians.
2.4
Statistical analysis
Data are reported as means (with standard deviations) or proportions. Continuous variables were compared by t test, whereas categorical variables were compared by chi-square test. A p value < 0.05 was always required for statistical significance. Analyses were performed using the statistical software SAS System, Version 9.1 (SAS Institute Inc., Cary, NC).
2
Methods
2.1
Study population and procedural details
We reviewed the data of patients undergoing PCI for significant ULMCA stenosis from January 2008 and December 2011 at our hospital. Our catheterization laboratory is a high-volume PCI center (> 800 PCI and > 150 primary PCI per year) with 3 skilled operators, one of whom is dedicated to TRA procedures. The operator using TRA had similar experience with TFA procedures and no experience with TRA at the onset of the study but, at the end of it, its activity in PCI via TRA rose up to 81% ( Fig. 1 ). In order to avoid confounding factors, only the procedures performed by this operator dedicated to TRA were considered. PCI was chosen as a therapeutic option in case of clinical and/or hemodynamic instability or when cardiac surgery was considered at high risk because of the presence of either old age or severe comorbidities. All patients were categorized into the TRA group (n = 27) or the TFA group (n = 22). Demographic, clinical and procedural data were prospectively collected in a dedicated database (Cardioplanet V.3.0.8, Ebit Aet S.p.A., Genoa, Italy) and, after the coronary angiography, the complexity of the coronary disease was classified using the SYNTAX Score calculation . The study protocol was reviewed and approved by the Ethics Committee of our Institution (ASL 103, Piemonte Region, Italy). The vascular access method and the PCI technique were performed according to the operator’s discretion. Intra-aortic balloon pump (IABP) was used as much as possible, also in stable patients. Intravascular ultrasounds (IVUS) were used, if possible, to achieve optimal stent expansion and lesion coverage. At the end of the procedure the radial hemostasis was accomplished by compressing folded gauze wrapped by an elastic bandage, whereas closure devices (Angioseal, St Jude Medical, St. Paul, Minnesota; Perclose or Star Close, Abbott Vascular, Santa Clara, California) were used for femoral hemostasis if the access site was suitable. All patients were routinely treated with aspirin (325 mg upon arrival, and then 100 mg daily), clopidogrel (loading dose of 300 or 600 mg, and then 75 mg daily) and with an intravenous bolus of unfractionated heparin (100 U/kg body weight, or 60 U/kg body weight if also glycoprotein IIb-IIIa inhibitors were given). Heparin therapy was stopped after the procedure, but, in case of IABP use, it was continued until its removal. Abciximab and eptifibatide were the glycoprotein IIb-IIIa inhibitors used. Bivalirudin was not used in these patients. Beta-adrenergic blockers, ACE inhibitors and statins were used as in-hospital standard therapy, if not contraindicated.
2.2
Study end point
The end point of the study was the feasibility of the TRA procedure without need of access crossover, defined as failure to successfully complete the procedure by the TRA, and its efficacy, defined as achievement of final residual stenosis of < 30% and of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 . We assessed also the rate of the in-hospital and long-term major adverse cardiac events (MACE) including death; myocardial infarction (MI), defined as of typical chest pain with new ECG abnormalities and elevation of creatine kinase to twice the basal level; stroke, defined as defined as any focal and nonconvulsive neurological deficit lasting more than 24 hours; target vessel revascularization (TVR), defined as repeated PCI or CABG due to restenosis or progression of the disease in the treated vessels; major bleeding complications, defined according to the Bleeding Academic Research Consortium classification ; stent thrombosis (ST), defined as definite and probable according to the Academic Research Consortium classification and contrast-induced nephropathy (CIN) defined as absolute increase in serum creatinine of 0.5 mg/dL (44 μ mol/L), or a relative 25% increase from the baseline value, assessed 48–72 hours following intravascular administration of the contrast medium .
2.3
Patient follow-up
In-hospital events were derived from clinical records. An angiographic control was scheduled between 6 and 12 months if not contraindicated. Clinical follow-up was performed by ambulatory clinical visits or telephone calls. In case of events, clinical records were checked when available or detailed history was acquired from patients or (in case of death) from patients’ relatives or physicians.
2.4
Statistical analysis
Data are reported as means (with standard deviations) or proportions. Continuous variables were compared by t test, whereas categorical variables were compared by chi-square test. A p value < 0.05 was always required for statistical significance. Analyses were performed using the statistical software SAS System, Version 9.1 (SAS Institute Inc., Cary, NC).
3
Results
From January 2008 to December 2011, 172 patients with significant stenosis of ULMCA underwent PCI at our center. Of these, 49 (28.5%) were performed by the TRA-dedicated operator and form the population of the study.
3.1
Clinical and procedural characteristics
The clinical characteristics of the two groups are summarized in Table 1 , whereas their angiographic and procedural characteristics are shown in Table 2 . There was a total of 27 interventions (55%) in the TRA group and 22 interventions (45%) in the TFA group. In the TRA group 25 interventions (92.6%) were performed from right TRA and 2 (7.4%) from the left TRA. In the TRA group there was a crossover to the TFA in 3 patients (11.1%): in 2 of them it occurred after the coronary angiography because the operator was at the beginning of his learning curve and preferred the TFA to perform the PCI, whereas in the other patient the crossover was necessary because of the extreme tortuosity of a calcified brachiocephalic artery that did not let the catheters to get to the coronary vessels. There were no crossovers in the TFA group (p = 0.31). In the TRA group patients were more likely to be hypertensive (81.5% vs 40.9%, p = 0.008) and to present with a higher LVEF (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). In both groups the majority of the patients presented with an acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73) and the rate of the patients with ST-segment elevation myocardial infarction (STEMI) was 25.9% in the TRA group and 31.8% in the TFA group (p = 0.89). Eight patients (16.3%) presented with cardiogenic shock: 2 patients in TRA (7.4%) and 6 patients (27.2%) in the TFA group (p = 0.14). The left main bifurcation was involved in most cases in both groups (92.6% in the TRA group vs 90.1% in the TFA group, p = 0.74) and the SYNTAX Score was not significantly different between the two groups (21.8 ± 10.4 in the TRA group vs 24.8 ± 8 in the TFA group, p = 0.27). Guiding catheters larger than 6 Fr were used in the majority of the patients in the TFA group (13 out of 22, 59.1%), whereas in the TRA group only 3 out of 24 patients (12.5%, p = 0.003) were treated with guiding catheter sheathless 7.5 Fr (Asahi Intecc, Japan). Yet, the rate of the bifurcation managed with 2 stents did not significantly differ between the two groups (40% in the TRA group vs 35% in the TFA group, p = 0.97) and the final kissing balloon was performed in all cases. The use of IVUS and hemodynamic support was similar between the 2 groups as well as the procedural time, the fluoroscopic time and the contrast volume.
| All patients | TRA | TFA | p Value | |
|---|---|---|---|---|
| Number of patients | 49 | 27 (55) | 22 (45) | |
| Age | 70 ± 9 | 68 ± 9 | 72 ± 9 | 0.11 |
| Males | 36 (73.5) | 18 (66.7) | 18 (81.8) | 0.38 |
| History of CAD | 7 (14.3) | 5 (18.5) | 2 (9.1) | 0.59 |
| Diabetes | 18 (36.7) | 11 (40.7) | 7 (31.8) | 0.72 |
| Current smokers | 16 (32.6) | 10 (37) | 6 (27.3) | 0.67 |
| Renal failure ⁎ | 2 (4.1) | 1 (3.7) | 1 (4.5) | 0.56 |
| Hypertension | 31 (63.3) | 22 (81.5) | 9 (40.9) | 0.008 |
| LVEF (%) | 51 ± 12 | 54 ± 10 | 46 ± 13 | 0.01 |
| Clinical presentation | 0.73 | |||
| Acute coronary syndrome | 35 (71.4) | 18 (66.7) | 17 (77.3) | |
| Stable ischemia | 14 (28.6) | 9 (33.3) | 5 (22.7) | |
| STEMI | 14 (28.6) | 7 (25.9) | 7 (31.8) | |
| Cardiogenic shock | 8 (16.3) | 2 (7.4) | 6 (27.2) | 0.14 |
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