Drug-eluting stents in patients at high risk of restenosis: Assessment for France

2011 ◽  
Vol 27 (2) ◽  
pp. 108-117 ◽  
Author(s):  
Emmanuelle Schapiro-Dufour ◽  
Michel Cucherat ◽  
Elodie Velzenberger ◽  
Hubert Galmiche ◽  
Catherine Denis ◽  
...  
Keyword(s):  
Statistical Power ◽  
Meta Analysis ◽  
A Priori ◽  
Bare Metal Stents ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Patient Category ◽  
Drug Eluting

Background: In unselected patients, the incidence of restenosis is lower after placement of drug-eluting stents (DES) than bare-metal stents (BMS) without difference in safety at a time horizon of 4 years. However, DES appears less effective in “off label” patients.Objectives: The aim of the study was to assess available evidence of DES efficacy and safety by patient category to establish when DES placement may be recommended for reimbursement by the French national health insurance.Methods: Based on a systematic review by patient category (January 2002 to August 2009), two health technology assessment (HTA) reports and thirty-eight clinical studies not covered by the HTA reports (eleven meta-analysis including ours, eleven randomized trials and sixteen cohort studies) were selected. After assessment of the methodological quality, the studies mostly comparing DES with BMS were reviewed by a panel of health professionals who defined a priori the most relevant end points of safety and efficacy.Results: Seven to fourteen patients treated with DES were needed to avoid one target lesion revascularization (TLR) in patients with lesions >15 mm long, vessel diameter <3 mm, or diabetes, and with some complex lesions (total coronary occlusion, BMS in-stent restenosis multivessel disease, unprotected left main stenosis). DES appeared as safe as other alternatives over a follow-up of up to 4 years when dual antiplatelet therapy was continued for at least 1 year, but statistical power remains limited to conclude for some clinical features.Conclusions: For reimbursement, DES use should be limited to certain categories of patients. Treatment of particular cases requires a multidisciplinary approach.

Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease

2016 ◽  
Vol 23 (6) ◽  
pp. 851-863 ◽  
Author(s):  
Konstantinos Katsanos ◽  
Panagiotis Kitrou ◽  
Stavros Spiliopoulos ◽  
Athanasios Diamantopoulos ◽  
Dimitris Karnabatidis
Keyword(s):  
Wound Healing ◽  
Balloon Angioplasty ◽  
Evaluation System ◽  
Meta Analysis ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Bare Metal ◽  
Drug Eluting

Purpose: To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries. Methods: Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed. Results: There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency. Conclusion: Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound healing compared to BA and BMS. DES also significantly reduced amputations compared with PCB.

Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Rastan ◽  
Noory ◽  
Zeller
Keyword(s):  
Limb Salvage ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Target Lesion Revascularisation ◽  
Randomized Studies ◽  
Drug Eluting ◽  
The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

scholarly journals Comparison by Meta-Analysis of Drug-Eluting Stents and Bare Metal Stents for Saphenous Vein Graft Intervention

2010 ◽  
Vol 105 (8) ◽  
pp. 1076-1082 ◽  
Author(s):  
Michael S. Lee ◽  
Tae Yang ◽  
David E. Kandzari ◽  
Jonathan M. Tobis ◽  
Hsini Liao ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Vein Graft ◽  
Saphenous Vein Graft ◽  
Meta Analysis ◽  
Bare Metal Stents ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Bare Metal ◽  
Drug Eluting ◽  
Saphenous Vein Graft Intervention

scholarly journals Continuation of dual anti-platelet therapy after drug-eluting stents in primary angioplasty beyond 12 months

F1000Research ◽  
2012 ◽  
Vol 1 ◽  
pp. 53
Author(s):  
Iman Mohasseb ◽  
Christian A Gericke
Keyword(s):  
Meta Analysis ◽  
Bare Metal Stents ◽  
Primary Angioplasty ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Clinical Implications ◽  
Bare Metal ◽  
Original Publication ◽  
Anti Platelet Therapy ◽  
Drug Eluting

In this correspondence we discuss the results of the meta-analysis by De Luca et al. (2012) in the Archives of Internal Medicine which found that late myocardial reinfarction and stent thrombosis is more common in drug-eluting stents than in bare-metal stents. We discuss the clinical implications of this paper for dual anti-platelet therapy which did not receive sufficient attention in the original publication and the accompanying editorial.

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