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Transradial coronary stenting: comparison with femoral access closed with an arterial suture device |
Mann T, Cowper P A, Peterson E D, Cubeddu G, Bowen J, Giron L, Cantor W J, Newman W N, Schneider J E, Jobe R L, Zellinger M J, Rose G C |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Transradial and femoral coronary stenting
Type of intervention Treatment and secondary prevention.
Economic study type Cost-effectiveness analysis.
Study population Patients undergoing coronary stenting.
Setting The setting of the study was a hospital in the USA.
Dates to which data relate Effectiveness data were collected between May and July 1998. Resource use and cost information were obtained partly from the clinical literature published between 1993 and 1995, and partly from the study itself. No price details were stated.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data Collection of resource use data for the two procedures was undertaken prospectively on the same sample as that used in the effectiveness study. Complications' rate estimates were based on the study results and augmented by published evidence in the literature.
Study sample The study sample was drawn from patients admitted to the hospital in which the authors conducted the study. Patients were equally distributed by means of a call schedule. The allocation of the patients to the two procedures was dependent on which clinician admitted them. Two operators were always associated with transradial and three others always performed femoral access. One clinician alternated access site using radial access on even days and femoral access on odd days. No evidence of sample size calculation using power calculations was reported in the study. The sample size was 218 patients(109 femoral, 109 radial). Seventy patients in the femoral group and fifty-one in the radial group had ad hoc procedures, in which diagnostic catheterisation and coronary intervention were performed as part of the same procedure. Of the 115 patients allocated to the radial group 6 crossed over to the femoral group.
Study design This was a single centre non-randomised trial with concurrent control.
Analysis of effectiveness The authors did not state whether the analysis of the clinical study was based on intention to treat or treatment completers only. The main primary health outcomes of the analysis were:
(1) number of procedure complications;
(2) number of primary successes (defined as a reduction of the target lesion to less than 25% diameter);
3) total procedure time (divided into procedure time and Perclose time); and
(4) number of access site bleeding complications.
The analysis groups were shown to be comparable in terms of age, sex, proportion of stable/unstable angina, and other factors. The differences in the clinical characteristics of the patients in the two arms were not statistically significant.
Effectiveness results Radial and femoral access had a primary success rate of 100% and 99%, respectively. The same number of procedure complications were experienced in the two arms. Procedure time was also similar in the two groups: 49 (+/- 21) minutes for femoral versus 44 (+/- 22) minutes for radial. Femoral access required additional time to perform Perclose procedure (9.7 +/- 4.6 minutes). The total procedure time was therefore higher for the femoral approach: 57 (+/- 22) minutes. Finally, no access site bleeding complications were recorded in the radial arm, while 4 patients experienced this in the femoral group. Statistically significant differences in the health outcomes between the two groups were found in the total procedure time, and the access site bleeding complications, (P<0.01).
Clinical conclusions Although the Perclose device allows early ambulation after femoral intervention, it is important to stress that:
(1) not all patients are suitable for femoral coronary stenting;
(2) there is a considerable incidence of device failure;
(3) there is a non-ignorable risk of access site complications in the use of the femoral approach; and finally
(4) compared to radial access, femoral access has a longer procedure time and length of stay in ambulatory care.
The authors concluded that the transradial approach offers better outcomes for coronary stenting compared to the femoral approach.
Modelling A deterministic decision analytic model was used to assess the relative cost of the femoral and radial procedures, and to estimate the expected cost of the two strategies.
Measure of benefits used in the economic analysis Although a number of outcome measures were produced in the study, a summary measure of benefits for the economic study was not reported. As such a cost-consequences analysis was performed.
Direct costs Because radial and femoral approaches had several common costs that did not vary with approach, the authors restricted their analysis to resources related to the access sites. These included the supplies required to gain access and close the access site, access site complications, and overnight stay for uncomplicated cases. Unlike quantities, unit costs were reported. A list of resources used (i.e. consumables, anticoagulation drug treatment, post-operation management, and sheath management) was reported. Discounting was not relevant due to the short period of cost analysis (less than 1 year). The perspective for the analysis was not explicitly stated. No price year was given.
Statistical analysis of costs Differences between groups in procedure times and length of stay were compared using unpaired T and Wilcoxon tests as appropriate. Differences in the rates of procedural success and complications were compared using chi-square tests. Resources used were not treated stochastically.
Sensitivity analysis Given that Perclose was the primary expense in the femoral group, the authors performed a sensitivity analysis on its cost and rate of use. They found a threshold of 14% reduction in the cost of the Perclose device was necessary in order for the two procedures to cost the same. The authors also carried out sensitivity analyses on the cost of access site complications and its rate of occurrence.
Estimated benefits used in the economic analysis The reader is referred to the effectiveness results reported above.
Cost results The authors estimated the expected cost of the femoral and radial strategies to be $1,590 and $1,314, respectively. Sixty percent of the cost difference was due to complications and delayed discharge. The remaining forty percent was related to resources use.
Synthesis of costs and benefits Costs and benefits were not combined due to the cost-consequences approach adopted.
Authors' conclusions The authors concluded that transradial coronary stenting was a dominant strategy compared to femoral approach in that it produced better outcomes at lower cost.
CRD COMMENTARY - Selection of comparators Selection of the comparator was justified by the view that radial artery access was the procedure with lower complications rate and length of stay in hospital, as well as being preferred to the femoral access by the majority of the patients. Both procedures were accepted practices within the study's setting.
Validity of estimate of measure of benefit The analysis of effectiveness was based on a non-randomised study, which is prone to selection bias and open to potential confounding variables such as, for example, different surgeons' levels of experience. Having been enrolled in a single hospital, during a short period of time, the study sample may not be representative of the study population although groups were shown to be comparable at baseline. No appropriate statistical analysis was carried out to account for potential selection bias. The intervention seems to have important morbidity implications, affecting the health-related quality of life of patients. It seems therefore that a direct measure of the patients' quality of life could have improved the relevance of the study for the decision-makers. The study implicitly assumed therapeutic equivalence of the two strategies, and focussed on other clinical outcomes around access site choice.
Validity of estimate of costs Given that the authors did not state from which perspective the analysis was conduced, it is not possible to say whether all the relevant categories of cost were included. Procedural supply and equipment use were determined from itemised bills and were valued using acquisition cost. The lack of a price year limits the generalisability of the cost data but a good feature was that sensitivity analysis undertaken on key variables.
Other issues It is important to note that the overall cost analysis was based on a literature-derived complication rate after Perclose use with an estimation of the associated costs. Another positive feature of the study is that the authors compared their results with those obtained by other authors. In terms of device failure, a 10% crossover to standard compression was observed and found similar to previous studies. In addition previously published analysis reported similar rate of access site bleeding in the femoral patients (i.e. 3.7%) and radial patients (i.e. none) to those observed by the authors.
Implications of the study In order to overcome some of the study's design limitations a large randomised multicentre trial fully comparing the two techniques would be informative. To enhance the decision-making process, it should be added that the comparison should be based on the simultaneous analysis of costs, health benefits, and risk associated with the two interventions.
Bibliographic details Mann T, Cowper P A, Peterson E D, Cubeddu G, Bowen J, Giron L, Cantor W J, Newman W N, Schneider J E, Jobe R L, Zellinger M J, Rose G C. Transradial coronary stenting: comparison with femoral access closed with an arterial suture device. Catheterization and Cardiovascular Interventions 2000; 49(2): 150-156 Other publications of related interest Comment in: Catheterization and Cardiovascular Interventions 2000;49(2):157-9.
Indexing Status Subject indexing assigned by NLM MeSH Aged; Angioplasty, Balloon, Coronary; Catheters, Indwelling /adverse effects /economics; Coronary Disease /therapy; Cost-Benefit Analysis; Female; Femoral Artery /surgery /ultrasonography; Hemostasis, Surgical /economics /methods; Hospital Costs; Humans; Length of Stay; Male; Middle Aged; Postoperative Hemorrhage /surgery /ultrasonography; Prospective Studies; Radial Artery /surgery /ultrasonography; Stents; Suture Techniques /economics /instrumentation; Treatment Outcome; Ultrasonography, Doppler AccessionNumber 22000000320 Date bibliographic record published 28/02/2001 Date abstract record published 28/02/2001 |
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