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The radial artery is regarded as a good access for diagnostic coronary angiography (CAG) and percutaneous coronary intervention (PCI). Currently, transradial intervention (TRI) has become a progressively widespread practice.1-3 Compared with transfemoral intervention (TFI), TRI with such advantages as fewer vascular access site bleeding complications, ambulating immediately after the procedure, and no postural limitation has been an attractive alternative to TFI,4,5 particularly in the elderly patients with acute myocardial infarction (AMI) who are at high risk of vascular complications. However, there are few reports on the safety and feasibility of transradial approach for primary PCI in elderly patients with AMI.6,7 This study aimed to compare the safety and feasibility of primary PCI via the trnansradial approach and transfemoral approach in elderly patients with AMI.
METHODS
Study population
From June 2005 to June 2007, 103 elderly patients (age ≥65 years) with AMI within 12 hours from the onset of chest pain were studied. The criteria of AMI included: chest pain for more than 30 minutes without response to nitroglycerine, and ST segment elevation ≥1 mm in 2 or more contiguous leads. All of the patients received primary PCI; they were randomly divided into TRI group and TFI group. The TRI group included 57 patients, aged on average (70.3±7.6) years, and the TFI group comprised 46 patients, aged on average (71.4±8.4) years.
The exclusion criteria were as follows: cardiaogenic shock, non-palpable radial artery, negative Allen test, and chronic renal failure. Written informed consent was obtained from the patients or their relatives before the primary PCI.
PCI procedure
The Allen test was performed routinely in the patients of the TRI group before primary PCI to evaluate the function of the palmar arch circulation between the radial and ulnar arteries. The operators were interventional cardiologists who had performed over 500 cases of TRI. Transradial PCI was performed via the right radial artery in all patients of the TRI group. The right arm was positioned beside the patient's body and the wrist hyper-extended. After local subcutaneous anesthesia with 1% lidocaine, the radial artery was punctured with a 20-gauge angiocatheter needle (Terumo Co., Japan), and a 0.635 mm (0.025") straight tip guidewire (Terumo Co.) was inserted through the needle. Upon removal of the needle, a 16 cm 6 Fr sheath (Terumo Co.) was placed over the guidewire. A total of 200 μg verapamil was administered through the sheath to prevent arterial vasospasm. Diagnostic angiography was performed using 5 Fr Multipurpose catheters (Cordis Co., USA). PCI was performed using 6 or 7 Fr guiding catheters, including Judkins, Amplatz, XB or EBU guiding catheters.
In the case of transfemoral PCI, the femoral artery was punctured with an 18-gauge arterial needle after local anesthesia with 1% lidocaine and a 0.889 mm (0.035") guidewire was advanced through the needle. Upon removal of the needle, a 6 Fr arterial sheath was placed over the guidewire. Diagnostic angiography was performed using a 5 Fr angiography catheter. PCI was performed using 6 or 7 Fr guiding catheters.
Anticoagulant and antiplatelet regimen
Before PCI, all patients received clopidogrel 600 mg and aspirin 0.3 g after the diagnosis of AMI was established. After insertion of sheath, tirofiban was administered with a 10 μg/kg bolus intravenous injection for 3 minutes followed by 0.15 μg ∙ kg-1∙ min-1 infusion for 24 hours. During PCI, these patients received a bolus of heparin (70 U/kg) through the sheath, then received another 2000–5000 U heparin every hour during the procedure. After PCI, the patients were given clopidogrel 75 mg per day for at least 1 year, aspirin 0.1–0.2 g per day for long term, and subcutaneous Fragmin 5000 U twice a day for at least 5–7 days.
Vascular access site hemostasis
In the TRI group, the arterial access sheath was removed immediately after transradial procedure, and hemostasis was achieved by radial compression with tourniquet for 6 hours. In the TFI group, the arterial access sheath was removed 4 to 6 hours after the transfemoral procedure and hemostasis was achieved by manual compression for 20 to 30 minutes followed by a pressure bandage for 8 to 12 hours. The patients were allowed to ambulate in their room immediately after radial sheath removal and 24 hours after femoral sheath removal.
Endpoints and definitions
Endpoints were recorded from the start of the procedure to one month. Several time intervals were measured in this study: puncture time, cannulation time, reperfusion time (cannulation to balloon inflation time), and total procedure time. Also assessed were the puncture success rate, the success rate of the procedure (residual diameter stenosis of <20% with TIMI grade 3 flow), the use rates of temporary pacemaker and intra-aortic balloon pumping (IABP), and the length of hospital stay.
After the procedure, vascular access site complications were assessed, including minor bleeding (hematoma), major bleeding, pseudoaneurysm, and artery occlusion. According to the TIMI classification, major vascular access site bleeding was defined as a hemoglobin loss of at least 2 mmol/L, the administration of a blood transfusion, vascular repair, or prolonged hospitalization, but minor vascular access site bleeding was defined as hemotoma formation not requiring specific therapy. Artery occlusion was regularly examined by palpation and ultrasonographic assessment after the procedure in all patients.
After the procedure, the incidence of major adverse cardiac events (MACEs) in one month was observed. MACEs were defined as death, recurrent myocardial infarction and repeat target vascular revascularization (TVR).
Statistical analysis
Statistical analysis was made with the SPSS 11.5 statistical program. Continuous variables were expressed as mean ± standard deviation. Continuous variables were compared with Student's t test and the differences between categorical variables were examined by the chi-square test. A P level of <0.05 was considered statistically significant.
RESULTS
Baseline patient characteristics
The baseline clinical and angiographic characteristics of the patients are shown in Table 1. Mean age, male gender, and risk factors were similar in both groups. There were no statistical differences in cardiac function Killips classification, left ventricular ejection fraction (LVEF), infarction location, and three-vessel coronary disease between the TFI and TRI groups (P >0.05). TIMI 0 grade flow before the procedure was observed in a large majority of patients with no significant difference between the two groups (P >0.05).
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Table 1. Baseline clinical and angiographic characteristics |
Procedural results
One patient in the TRI group required crossover to the femoral artery due to radial artery puncture failure. There were no statistical differences in the success rate of puncture, puncture time, cannulation time, reperfusion time, success of PCI, total procedure time, use rates of temporary pacemaker and IABP between the TRI and TFI groups (P>0.05); but the length of hospital stay in the TFI group was longer than that in the TRI group because of higher vascular access site complications, and there was statistical difference (P <0.01) (Table 2).
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Table 2. Procedural results of the TRI and TFI groups |
Vascular complications and MACE in one month
No hematoma, pseudoaneurysm, and major bleeding were found in the TRI group, but one patient had radial occlusion without ischemia. In the TFI group, however, 4 patients had hematoma, 1 had pseudoaneurysm, and 1 had major bleeding. Statistical difference in vascular access site complications was observed between the two groups (P<0.05). In one month, 3 patients died in the two groups respectively, but neither reinfarction nor TVR was found. There was no statistical difference in the incidence of MACE between the two groups (P>0.05) (Table 3).
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Table 3. Vascular access site complications and MACE in one month |
DISCUSSION
In the initiation of TRI, primary PCI of AMI was mainly carried out via transfemoral approach, and many interventional cardiologists are reluctant to use the radial artery because of its relatively small caliber and a longer vascular access time, which results in the delay of reperfusion time. TRI in elderly patients may be more difficult because tortuosity or stenosis of the upper limb artery in these patients are common, so radial artery puncture is the technical trouble of TRI in elderly patients with AMI. In fact, radial artery puncture requires a learning period to achieve competence. Once operators master the skills of radial artery puncture, the technical obstacle of primary PCI for AMI via the radial artery will be overcome.8,9 The operators of this study were all experienced interventional cardiologists who had already done TRI for over 500 patients. The results of this study also demonstrated that all radial artery punctures were successful except for one case crossover to the TFI group because of the failure of radial artery puncture in the TRI group. But there was no statistical significance between the two groups (P >0.05). Though the puncture time in the TRI group was a little bit longer than that in the TFI group, no statistical significance was noted between the two groups (P >0.05).
In this study, no statistically significant difference was found in cannulation time, reperfusion time, the success rate of PCI, total time for the procedure between the TRI and TFI groups (P >0.05). For experienced cardiologist of TRI, the successful rate and the time for transradial access in primary PCI for elderly patients with AMI were the same as in the femoral group. So this study testified the feasibility of primary PCI for elderly patients with AMI via radial access, and the results were consistent with those of few current studies on primary PCI of AMI via radial access.10-12
Initially, primary PCI of AMI was not conducted by transradial access because patients with AMI were unlikely to use IABP and temporary pacemaker. Kim et al7 reported that the use rate of IABP and temporary pacemaker in the femoral group was higher than that of the radial group in primary PCI of AMI. But the present study did not show any statistical difference in the use rates of IABP and temporary pacemaker between the two groups (P >0.05).
According to the current guidelines, patients with AMI are treated with aggressive antithrombotic therapy, especially the use of platelet membrane glycoprotein IIb/IIIa receptor antagonist, commonly increasing the incidence of vascular access site bleeding in TFI, especially in elderly patients.13-15 Many studies have demonstrated that the transfemoral approach for PCI was associated with a higher incidence of vascular access site complications in elderly patients compared with younger patients.16-18 In a EPIC trial, advanced age was an independent risk factor for vascular access site bleeding or vascular access site surgery after TFI.19 Although several strategies are being used,20-22 i.e. closure device, early sheath removal with temporary discontinuation of anticoagulants, compression device and sutures for local hemostasis, vascular access site complications remain a problem in primary PCI via the femoral artery.
In this study, the elderly patients of the two groups were treated with potent antithrombotic agents, especially platelet membrane glycoprotein IIb/IIIa receptor antagonist (tirofiban) that was given during and after the procedure. As a result, vascular access site complications were significantly lower in the TRI group than in the TFI group (P <0.05). Thus, the shorter hospital stay in the TRI group than in the TFI group (P <0.01) indicated the reduced incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE) in elderly patients. In one month, no statistically significant difference was observed in the incidence of MACE in the two groups (P >0.05). Obviously, primary PCI via radial approach is safe and feasible for elderly patients with AMI .
The limitation of this study is lack of randomization between the radial and femoral groups, which affected the results by selecting arterial access route based on the operators' subjective criteria.
In summary, transradial primary PCI for elderly patients with AMI has the same procedural results and fewer vascular access site bleeding complications compared with transfemoral primary PCI when performed by an experienced interventional cardiologist of TRI. The radial artery might be a potential vascular access for primary PCI in elderly patients with AMI, but this needs experienced cardiologists and a team of TRI.
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