Efficacy of the Radial Approach for the Performance of Primary PCI for STEMI

Author(s): 

Carlos Cafri, MD, Doron Zahger, MD, Miriam Merkin, MD, Jean Marc Weinstein, FRCP, Sergio Kobal, MD, Reuvem Ilia, MD

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Abstract: Background. Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) is associated with increased bleeding complications, impacting clinical outcome. Transradial PPCI could decrease the risk of bleeding, but concerns about technical difficulties and longer reperfusion times limit its adoption. Aim and Methods. This was a retrospective comparison of reperfusion times and bleeding complications in a large cohort of STEMI patients treated by PPCI through the trans-radial (TR; n = 244) or transfemoral approach (TF; n = 364) from January 2005 to December 2009. Endpoints were door-to-balloon time, access-site and non-access site bleeding, as well 1-month and 1-year mortality rates. Results. Patients treated with TR-PPCI were younger than those having TF-PPCI, (57 ± 13 years vs 62 ± 13 years, respectively; P<.01), more frequently males (84% vs 73%, respectively; P<.01), and had less renal failure (9% vs 16%, respectively; P<.01) or hemodynamic compromise, ie, pulmonary edema or cardiogenic shock (1% vs 4%, respectively; P=.01). Angiographic and angioplasty characteristics, including the angiographic success rate, were similar, with the exception of a higher use of aspiration devices in the TR-PPCI group (31% vs 15%, respectively; P<.01). The door-to-balloon time was similar in both groups (76 ± 40 minutes vs 74 ± 41 minutes; P=NS). Significant lower rates of overall bleeding (6% vs 31%; P<.01), access-site bleeding (4% vs 27%; P<.01), non-access site bleeding (1% vs 3%; P=.01) and need for blood transfusion (0% vs 3%; P=.01) were observed in the TR-PPCI group. One-month (3% vs 7%; P<.05) and 1-year mortality rates (4% vs 11%; P<.05) were lower in the TR-PPCI group. Radial PCI was an independent predictor of 1-year mortality. Conclusion. TR-PPCI is feasible in STEMI patients and can be performed efficiently within the time limits recommended. This approach provides advantages in terms of reduction of bleeding that could translate into an improved clinical outcome.

J INVASIVE CARDIOL 2013;25(3):150-153

Key words: transradial primary PCI, transfemoral primary PCI, primary percutaneous coronary intervention

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Primary percutaneous coronary intervention (PPCI) is the best existing reperfusion strategy for patients with ST elevation myocardial infarction (STEMI).1,2 Bleeding complications are frequent in the setting of PPCI due to the intensive antithrombotic treatment used in this group of patients. Recently, bleeding after coronary interventions has been associated with an increased mortality rate in multiple trials. Therefore, strategies to reduce the risk of bleeding are needed.3,4 Access-site bleeding is the most frequent bleeding complication of transfemoral (TF) PPCI.5,6 In contrast, transradial percutaneous coronary intervention (TR-PCI) has been demonstrated in multiple trials to be safer than the femoral approach due to the lower risk of significant bleeding. Implementation of the TR approach for PPCI (TR-PPCI) might lead to improved outcomes through reduced bleeding, but concerns remain regarding potential prolongation of reperfusion times with this more challenging technique. Our aim was to assess the efficacy and safety of the transradial approach in an unselected group of patients who had PPCI for STEMI.

Methods

Study populations. All consecutive patients admitted to Soroka University Medical Center with STEMI between October 2004 to October 2008 and treated with PPCI who belonged to Clalit Health Services were retrospectively identified from our computerized database. Patients were compared according to the access site used during the procedure. Seven operators were involved in the performance of PPCI (6 of them with a high degree of expertise in the use of the TR approach). The choice of arterial access was at the discretion of the operating physician. Patients’ data were prospectively recorded in a computerized database and included demographic and clinical variables, risk factors, hemodynamic status and left ventricular function during admission, door-to-balloon time, angiographic and procedural characteristics, bleeding complication at the access site and other sites, as well as mortality up to 1 year of follow-up.

Vascular access. In patients selected for TR-PCI, Allen’s test was performed. A delay of more than 10 seconds before the return of color to the blanched hand was considered abnormal and a contraindication to the use of the radial approach. Diagnostic angiography was performed using 6 Fr left and right Judkins catheters and the intervention was performed in 97% of cases with 6 Fr Extra back-up 3 or 3.5 (for left coronary interventions) or right Judkins guiding catheters (for right coronary interventions).

In patients selected for the femoral approach, diagnostic and interventional angiography were performed with conventional 6 Fr diagnostic or guiding catheters.

Anticoagulation and antiplatelet regimen. All patients were pretreated before arrival at the catheterization laboratory with 300 to 600 mg of clopidogrel and 5000 units of heparin intravenously. Immediately prior to performing PCI, activated clotting time (ACT) was measured and additional heparin was administered, if necessary, to maintain an ACT >300 seconds. The use of glycoprotein IIb/IIIa antagonists was left to the operator’s discretion.

Definitions. Procedural success was defined as a residual stenosis in the culprit lesion of <30% with Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow. Door-to-balloon time was calculated as the time from the patient’s arrival in the emergency room or the coronary care unit (in patients admitted directly to the coronary care unit) to the moment of first balloon inflation or first aspiration with a manual aspiration device. Major hematoma was determined by a minimal diameter of 6 cm.

Endpoints. Efficacy endpoints were procedural success, door-to-balloon time, fluoroscopy time, and contrast volume administered during the procedure. Safety endpoints were the rate of access-site and non-access site bleeding complications after the procedure as well as the need for blood transfusion. One-year mortality was obtained from the Interior Ministry of the State of Israel.

Statistical analysis. Continuous variables are expressed as mean ± standard deviation and are compared using the unpaired t-test. Categorical variables are expressed as absolute or relative frequencies and are compared using chi-square analysis. To examine the independent association between TR-PPCI and the 1-year survival, a multivariate analysis was performed using a logistic regression model. Probability values of <.05 were considered statistically significant. The adjusted risk of mortality is expressed as odds ratios (ORs) and their 95% confidence intervals (CIs).

Results

Baseline characteristics. A total of 608 patients with STEMI treated with PPCI were included in the study. TR-PCI was performed in 244 patients (40%) and TF-PPCI was performed in 364 patients. The baseline characteristics are summarized in Table 1.

In the TR-PPCI group, patients were younger and more often males and smokers. The frequency of peripheral vascular disease was similar in both groups, The frequency of pulmonary edema or cardiogenic shock on admission was higher in the TF-PPCI group (8% vs 3%; P<.01), as was the frequency of moderate-to-severe left ventricular dysfunction (59% vs 50%; P<.01).

Angiographic and procedural characteristics. Angiographic and procedural characteristics are summarized in Table 2. No differences were observed in the number of vessels with significant disease, the culprit artery, or the complexity of the lesions. The use of intraortic balloon counterpulsation was most frequent in the TF-PPCI group (14% vs 5%; P<.01). The PCI technique applied was similar in both groups, with the exception of a higher frequency of direct stenting in the TR-PPCI group (48% vs 36%; P<.05). Importantly, angiographic success was similar in both groups.

The door-to-balloon time (76 ± 40 minutes vs 75 ± 41 minutes; P=.1), fluoroscopy time (11 ± 7 minutes vs 13 ± 11 minutes; P=.1), and the amount of contrast used (146 ± 70 cc vs 149 ± 67 cc; P=.1) were similar in both groups. 

Bleeding. Bleeding complications are displayed in Figure 1. A higher frequency of access-site small hematomas (19% vs 4%; P<.01), access-site large hematomas (8% vs 2%; P<.01), and bleeding complications (31% vs 6%; P<.01) was observed in the TF-PPCI group. No differences were observed in the frequency of non-access site bleeding.

Survival. The 1-month and 1-year cumulative survival rates are presented in Figure 2. Better survival was observed up to 1 month (97% vs 93%; P<.05) as well at 1 year (96% vs 89%; P<.05) in the radial group.

Multivariate analysis showed that the femoral approach was associated with an increased 1-year mortality (OR, 1.9; 95% CI, 1.2-3.3). In addition, 1-year survival was influenced by age, Killip class, the presence of three-vessel disease, and moderate-to-severe left ventricular dysfunction (Table 3).

Discussion

In this observational study, we demonstrated that PPCI can be performed safely and effectively, with reperfusion times and procedural success rates that parallel those obtained via the femoral approach. The radial approach was safer than the femoral approach due to a significant reduction of access-site bleeding and was associated with a reduction in the 1-year mortality rate.


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