Background-The safety and efficacy of drug-eluting stents (DES) among more generalized "real-world" patients than those enrolled in pivotal randomized controlled trials (RCTs) are controversial. We sought to perform a meta-analysis of DES studies to estimate the relative impact of DES versus bare metal stents (BMS) on safety and efficacy end points, particularly for non-Food and Drug Administration-labeled indications.
Methods and Results-Comparative
Conclusions-InRCTs, no significant differences were observed in the long-term rates of death or myocardial infarction after DES or BMS use for either off-label or on-label indications. In real-world nonrandomized observational studies with greater numbers of patients but the admitted potential for selection bias and residual confounding, DES use was associated with reduced death and myocardial infarction. Both RCTs and observational studies demonstrated marked and comparable reductions in target vessel revascularization with DES compared with BMS. These data in aggregate suggest that DES are safe and efficacious in both on-label and off-label use but highlight differences between RCT and observational data comparing DES and BMS. (Circulation. 2009;119:3198-3206.)
Objective: To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Design: Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Setting: Tertiary care. Participants: 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Main outcome measures: Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Results: Four factors were identified for patients undergoing elective surgery (n = 1951) and two for nonelective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the nonelective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be £112 (US$212, J162) (sirolimus stents) or £89 (US$167, J130) (paclitaxel stents). Conclusions: At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.
Background: There is a strong inverse relationship between final vessel diameter and subsequent risk of treatment failure after coronary stent deployment. The aim of this study was to investigate the magnitude by which stent delivery balloon underexpansion and stent elastic recoil contributed to suboptimal final vessel geometry. Methods: A prospective angiographic study recruiting 499 lesions (385 patients) undergoing coronary stent implantation was performed. Quantitative coronary angiography (QCA) was used to measure the minimal lumen diameters of the delivery balloon during stent deployment (MLD1) and of the stented segment following balloon deflation (MLD2). The expected balloon diameter for the deployment pressure was determined from the manufacturer's reference chart. Delivery balloon deficit was measured by subtracting the MLD1 from the expected balloon size and stent recoil was calculated by subtracting MLD2 from MLD1. Delivery balloon deficit and stent recoil were examined as a function of reference vessel diameter (RVD) and balloon-vessel (BV) ratio. Results: The final stent MLD was a mean 27.2% (SD = 7.2) less than the predicted diameter. The mean delivery balloon deficit was 0.65 mm (SD = 0.27) and the mean stent recoil was 0.28 mm (SD = 0.17). Percentage delivery balloon deficit and stent recoil were independent of RVD. Delivery balloon deficit increased with higher BV ratios. Stent recoil was independent of BV ratio and the use of predilatation. Conclusion: Failure to achieve predicted final stent diameter is a real problem with contribution from delivery balloon underexpansion and stent recoil. On average the final stent MLD is only 73% of the expected diameter, irrespective of vessel size.
This study was performed to assess the possibility that patient age may independently affect improvements in health-related quality of life following percutaneous coronary intervention. One hundred five patients undergoing elective percutaneous coronary intervention at a single tertiary referral center between January 10, 2001 and January 6, 2002 were enrolled and prospectively evaluated. Health-related quality of life was assessed before and 1 year following percutaneous coronary intervention using Short Form-12 and the Seattle Angina Questionnaire. For the purpose of analysis, patients were divided according to age (younger than 60, 60-70, and older than 70 years). One hundred patients (95%) completed both questionnaires. Baseline characteristics among the age groups were similar in terms of gender, cardiac risk factors, and procedural details. All health-related quality-of-life indices demonstrated improvements with at least four variables in each group achieving a clinically significant increase (>20%). At least eight modalities in each group achieved statistical significance (p=0.01). With the exception of physical functioning, the improvements in health-related quality of life were not significantly different among age groups.
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