Five French Versus Six French Percutaneous Coronary Intervention: A Case Control Study of Efficacy, Safety and Outcome

Advances in catheter design have allowed the use of smaller 5 French (Fr) 1.7 mm diameter guiding catheters for percutaneous coronary intervention (PCI) with several theoretical advantages including: 1) earlier hemostasis and fewer puncture site complications; 2) earlier patient ambulation expediting patient discharge; 3) reduced contrast usage; 4) reduced procedural cost; and 5) improved patient comfort. However, potential disadvantages pertain to vessel opacification, guiding catheter support or compatibility with large balloons and stents. We have previously reported the feasibility of PCI using 5 Fr and even 4 Fr diagnostic catheters with fixed wire balloon catheters.1,2 Subsequent small series have reported the feasibility of PCI using 5 Fr guiding catheters in patients undergoing elective PCI.3,4 A recent prospective study reported a procedural success rate of 88%, but with 12% of patients requiring upsizing to 6 or 7 Fr.5 We compared our experience of PCI using 5 Fr guiding catheters in a wide-ranging group of patients in a case control study with the results of PCI using 6 Fr guiding catheters. Methods Patient population. The study involved a retrospective analysis of all consecutive PCI cases performed at the Swiss Cardiovascular Center Bern from 1999 to 2001 using 5 Fr guiding catheters. This included 210 unselected elective and emergency patients over this time period. The 5 Fr group was compared with a 6 Fr cohort of consecutive patients matched for age, sex and operator over the same time period. One hundred and seventy-four patients were included in this group as one operator performed more 5 Fr procedures than 6 Fr procedures during 2001 of the study period. Clinical characteristics of the patients were recorded in detail. PCI procedure. PCI was performed from the femoral approach in all cases and ad hoc after diagnostic angiography in 95% of patients. Until May 2001, Medtronic 5 Fr ZUMA guiding catheters with an inner lumen of 0.058´´ were used. Thereafter, Cordis 5 Fr “britetip” guiding catheters with an inner lumen of 0.056´´ were used. Either AL2, JL4, JR4 or EBU4.0 5 Fr guiding catheters were used. Procedures were performed by 7 different operators. Technical success was defined as Contrast medium usage/procedure time. Data on contrast usage (ml) and fluoroscopy time, used as an indirect measure of procedure time, were collected from the patient records of each patient. Complications and follow-up. We assessed in-hospital major adverse cardiac events (MACE) in all patients and follow-up MACE in patients with a minimum of 6 months follow-up (130/210 patients in the 5 Fr group, 142/174 patients in the 6 Fr group). MACE were defined as death from cardiac cause, non-fatal myocardial infarction (MI), need for repeat target vessel PCI or coronary artery bypass grafting (CABG). Femoral complications included excess bleeding, hematoma, false aneurysm and arterio-venous (AV) fistula. In-hospital MACE and femoral complications were sought for review of the case records of patients and 6-month follow-up was done by contacting the patient or their referring physician. Statistical analysis. Patient age, ejection fraction, contrast usage and fluoroscopy time were compared between groups using the student’s unpaired t-test. Differences in sex, procedural success, femoral closure and number of vessels undergoing PCI (single or multivessel) between groups were compared using the Fischer Exact probability test. Clinical, procedural and lesion-specific characteristics were compared using a Chi-square test. A p-value Patient demographics. Demographic details of the patients are shown in Table 1. Both groups represented unselected patients in routine clinical practice with a diverse clinical profile. No statistical difference was seen in clinical characteristics between 5 Fr and 6 Fr patients. Specifically, there was no difference in number of patients presenting with acute coronary syndromes (primary or rescue PCI for acute MI, non-Q wave MI, unstable angina, both groups: 27%), triple vessel coronary disease (5 Fr versus 6 Fr: 20% versus 19%, respectively) and prior CABG (5 Fr versus 6 Fr: 12% versus 9%, respectively). All consecutive 5 Fr procedures performed by 7 different operators were included, representing 6% of their total patient load. Numbers of 5 Fr PCI procedures by operator relative to total cases are shown in Table 2. Angiographic characteristics. Angiographic and lesion-specific characteristics are shown in Table 3. Three hundred and eleven lesions were treated in the 5 Fr group (210 patients) compared with 300 lesions in the 6 Fr group (174 patients). No differences were seen in the anatomical location or complexity of lesions between groups. Specifically, the number of treated complex lesions was not different between the 5 Fr and 6 Fr groups. Complex lesions included (5 Fr versus 6 Fr): ostial, 2% versus 4%; 16 bifurcations, 5% versus 2%; recent total occlusions, 9% versus 9%; and chronic total occlusions greater than 3 months old, 1% versus 4%. However, a greater number of multivessel PCI procedures was performed in the 6 Fr group (5 Fr versus 6 Fr, 18% versus 26%, respectively; p = 0.046). In one patient, the native vessel was tackled using a 5 Fr guiding catheter, but the operator had to use a 6 Fr guide to tackle a separate vein graft stenosis for lack of a suitable 5 Fr curve. Technical success. Procedural details are shown in Table 4. For 5 Fr and 6 Fr PCI, Judkins guiding catheters were used in the majority of cases followed by Amplatz guiding catheters. Technical success was achieved in 99% with 5 Fr and in 95% with 6 Fr catheters (p = 0.03). No differences were seen in the choice of balloons or stents between the 5 Fr and 6 Fr groups. Of the 4 patients in the 5 Fr group in whom PCI was unsuccessful, there was no reflow in the context of a recent MI in 2 patients; a third involved PCI of a vein graft where upsizing to 8 Fr was required to use an Angioguard® distal protection device to remove thrombotic debris; the fourth involved wire-induced dissection of the lesion which could not be subsequently crossed. Stenting was used in 50% of lesions in the 5 Fr group and 51% in the 6 Fr group. The 5 Fr system did not prohibit the use of large or long stents (mean length, 13 mm; range, 8–38 mm; mean width, 3 mm; range, 2.5–4.0 mm) or balloons (up to 4.0 mm used). A total of 11 lesions in the 5 Fr group were treated with primary stenting. No differences were seen between choice of femoral closure (compression or Angioseal) between groups. Contrast medium/fluoroscopy time. Both mean procedure time (minutes of fluoroscopy) and mean contrast medium usage were significantly reduced in the 5 Fr group compared to the 6 Fr group (Table 5). MACE. It was quite common to have to deeply intubate the 5 Fr guiding catheter to obtain optimal support, but this was not associated with adverse complications. No in-hospital MACE were recorded in the 5 Fr group. In the 6 Fr cohort, in-hospital MACE occurred as follows: three repeat target vessel PCI and 2 in-hospital myocardial infarctions. Follow-up MACE data were available for 130 5 Fr patients who had a minimum follow-up of >= 6 months (mean, 13 ± 7 months). At follow-up, no cardiac deaths were reported. Non-fatal MI occurred in 1%. Repeat target vessel PCI was required in 15% of patients for recurrent anginal symptoms due to restenosis. No patients required CABG. MACE follow-up data greater than 6 months were available in 142 of the 6 Fr patients (mean, 21 ± 11 months). There were no cardiac deaths, 1% non-fatal MI and 9% repeat target vessel PCI. There was no statistical significance between 5 Fr and 6 Fr groups. Peripheral complications. Femoral closure was performed by compression (manual or FemoStop) in the majority of cases (83% of the 5 Fr group; 79% of the 6 Fr group) (Table 6). Other cases were closed by 6 Fr Angioseal devices (17% of the 5 Fr group; 21% of the 6 Fr group). We experienced no hemostatic problems using the 6 Fr Angioseal device for 5 Fr PCI. Information about femoral complications was available in 160 of the 5 Fr patients and 142 of the 6 Fr patients. On the whole, femoral complications were rare (Table 6). There were no cases of excess bleeding in the 5 Fr group. Two patients (0.6%) developed false aneurysms, one of which required surgical repair. There were no cases of AV fistula. Small hematomas were reported in 10 patients (6%). Two of these patients had femoral closure using an Angioseal device. There was no significant difference in the incidence of excess bleeding, hematoma or false aneurysm between the 5 Fr and 6 Fr groups. The use of the Angioseal device did not reduce the incidence of complications in either group. Discussion The evolution of balloon and stent technology, together with improvements in fluoroscopic image quality, afforded a gradual shift toward the use of lower profile, smaller equipment for PCI. The current 5 Fr guiding catheters reported in this study have an external shaft diameter of 1.7 mm, compared with 2.7 mm for the 9 Fr catheters used in the 1980s. Preliminary feasibility studies with 5 Fr diagnostic and guiding catheters for PCI have suggested that the 5 Fr approach is safe and effective, but should be reserved for selected patients without complex coronary artery stenoses. The theoretical drawbacks of the 5 Fr approach include lack of guiding catheter support, potential difficulties with the use of large-caliber balloons or stents and inadequate vessel opacification. The use of a power injector for contrast medium has been proposed to solve the latter problem.3 We report our recent experience of ad hoc PCI with 5 Fr guiding catheters in 210 unselected patients (311 lesions). They represent a clinically heterogeneous group including both elective and emergency patients and those with more complex coronary disease. We found that 5 Fr PCI in this unselected patient group was technically highly successful (99% of cases) and safe. This feasibility in “all-comers” suggests that 5 Fr PCI need no longer be relegated to a niche role, but may instead be the choice in routine interventional practice. Indeed, one of our operators has since adopted 5 Fr catheters as default equipment for all cases. An important aspect of the study was to compare our experience with 5 Fr PCI to a control arm of 6 Fr procedures. This group was matched for age, sex and operators and all consecutive cases were selected over the same time period. There appeared to be no differences in terms of clinical, lesion-specific and procedural characteristics. The principal difference was the greater number of multivessel procedures attempted in the 6 Fr cohort. We experienced few problems with guiding catheter support. Since the guides were smaller, they could be safely, intubated deeply into the target coronary ostium with minimal risk of dissection. With modern digital imaging, visualization did not appear to be a problem since procedure times were shorter compared with 6 Fr PCI. The shorter procedure time could be partly explained by fewer multivessel procedures in the 5 Fr group compared to the 6 Fr group. However, the difference remained significant when we compared fluoroscopy times for single vessel PCI procedures between groups, suggesting a real advantage (15 ± 9 minutes of fluoroscopy for the 5 Fr group versus 18 ± 12 minutes for the 6 Fr group; p = 0.01). The 5 Fr guiding catheter did not limit balloon or stent size. In 9 patients, 4.0 mm stents were deployed successfully through the 5 Fr approach (the longest was 38 mm). The significantly reduced contrast usage is attractive and consistent with our previous findings.1 The reduced contrast is directly related to the reduced luminal diameter of the 5 Fr guiding catheter. This should perhaps influence guiding catheter selection in patients with pre-existing renal impairment who are undergoing planned PCI procedures. The theoretic advantage of a smaller sheath size regarding peripheral bleeding complications could not be proven in this limited cohort. Our 5 Fr femoral complication rate of 6% compares to an overall incidence of 1.5–9% in a previously published review.7 No in-hospital MACE occurred in the 5 Fr group. MACE were rare and similar between the 5 Fr and 6 Fr groups after long-term follow-up. The main limitation of this study is that it is a retrospective case-control rather than a prospective randomized trial; nevertheless, we believe it provides a realistic view of 5 Fr PCI in routine clinical practice compared with an operator-matched 6 Fr reference group. In addition, a significant number of patients were lost to follow-up because of the nature of follow-up practices in Switzerland. As Bern provides a tertiary supra-regional service in Switzerland, many patients who underwent intervention in Bern were subsequently followed in their own referral centers. Finally, we are unable to exclude the possibility of operator selection and experience bias in choosing the 5 Fr approach over the 6 Fr approach. In summary, we report our experience with 5 Fr PCI in an unselected group of patients. We conclude that this approach is both feasible and safe with an acceptable outcome at follow-up. In no instance was the procedure abandoned because of inadequate guiding catheter support or inability to use or deploy large-caliber balloons or stents. Although there do not appear to be clear advantages in terms of vascular complications, there is a clear advantage in terms of reduced contrast medium usage. The only obvious limitation of 5 Fr PCI is when a more complex PCI procedure necessitates the use of a larger guiding catheter for access. For example, 5 Fr guiding catheters would not be suitable in the following circumstances: use of a cutting balloon for restenosis; use of kissing balloons for bifurcation lesions; use of 5 mm balloons; use of large rotablator burrs; and the use of distal protection devices. However, with current balloon and stent technology, we believe the 5 Fr approach can effectively be applied to routine interventional practice.

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