A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease

Fischman, David L.; Leon, Martin B.; Baim, Donald S.; Schatz, Richard; Savage, Michael P.; Penn, I; Detre, Katherine; Veltri, Lisa; Ricci, Donald R.; Nobuyoshi, Masakiyo; Cleman, Michael; Heuser, Richard R.; Almond, David; Teirstein, Paul S.; Fish, R. David; Colombo, Antonio; Brinker, Jeffrey; Moses, Jeffrey J.; Shaknovich, Alexander; Hirshfeld, John; Bailey, Stephen R.; Ellis, Stephen; Rake, Randal; Goldberg, Sheldon

doi:10.1056/nejm199408253310802

Cited by 3,937 publications

(1,854 citation statements)

References 22 publications

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“…Recently, in an attempt to improve long-term patency, coronary drug-eluting stents have also been placed below the knee [13][14][15]. Because continued patency of infrapopliteal vessels correlates with improved clinical outcomes in patients undergoing peripheral bypass surgery [16] and coronary drug-eluting stents markedly reduce restenosis compared to bare metal stents [17][18][19], strategies that maximize stent patency would be expected to yield improved clinical outcomes. On the basis of the surgical literature cited earlier, one may reasonably conclude that, for patients with lower limb ischemia treated with below-knee interventions, an open artery is better than a closed artery, and innovations that reduce restenosis are likely to improve and maintain limb salvage and functional recovery.…”

Section: Discussionmentioning

confidence: 99%

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Grant

White

Collins

et al. 2007

Cathet Cardio Intervent

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Objective: We report our experience with the elective placement of below-knee, drugeluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3-year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug-eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug-eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n 5 1) or limb-threatening ischemia (n 5 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug-eluting stents were electively placed in 12 below-knee arteries in 10 patients, resulting in an average of 1.7 6 0.7 stents per patient. The mean lesion length was 24.8 6 10.9 mm, the mean total stent length was 38.3 6 19.1 mm, and the mean nominal stent diameter was 2.8 6 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 6 6.5 months of follow-up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug-eluting stent patency in each case. Conclusions: The use of below-knee drug-eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. '

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Section: Discussionmentioning

confidence: 99%

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Grant

White

Collins

et al. 2007

Cathet Cardio Intervent

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“…Intra-arterial stent implantations have become a common revascularization procedure 1 since they frequently result in superior angiographic results 2,3 and reduce the need for repeated revascularization procedures. However, the stent implant itself can act as a stimulus for intimal hyperplasia, particularly if the stent becomes imbedded in the vessel wall, leading to inflammation.…”

Section: Introductionmentioning

confidence: 99%

Transgene delivery of plasmid DNA to smooth muscle cells and macrophages from a biostable polymer-coated stent

Takahashi

Palmer-Opolski²,

Smith

et al. 2003

Gene Ther

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Metallic stents coated with a polyurethane emulsion containing plasmid DNA were implanted in rabbit iliac arteries to evaluate transgene delivery and expression in the vessel wall. The expression of the plasmid-encoded marker genes, b-galactosidase, luciferase and green fluorescence protein (GFP), were evaluated at 7 days after implantation. In all cases, plasmid transfer was confined to the vessel wall at the site of stent implantation, plasmid DNA was not observed in vessel segments immediately proximal or distal to the stent and dissemination of plasmid DNA to lung, liver or spleen was not observed. Expression of transgenes occurred only in vessel segments in contact with the stent and analysis of the GFP expression pattern revealed a high frequency of marker protein-positive cells occurring at or near the luminal surface. The extent of transgene expression was dependent upon the quantity of DNA loaded onto the stent and no signal was detected in vessel segments that received polymer-coated stents lacking plasmid DNA. Of significance, colocalization studies identified transgene expression not only in vascular smooth muscle cells but also in macrophages. Hence, polymer-coated stents provide a new capability for transgene delivery to immune cells that are believed to contribute to the development of in-stent restenosis.

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“…Although percutaneous transluminal coronary angioplasty stenting has greatly improved the outcome of patients with coronary artery disease,1–3 there have been reports of restenosis in as many as half the cases 4,5. Many prophylactic pharmacological interventions have been proposed to prevent restenosis after coronary artery stenting 6–8.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of intramuscular methyl prednisolone in preventing restenosis after coronary artery stenting with bare-metal stainless steel stent : a double-blind, randomised, controlled clinical trial

Namdari¹,

Ghafarzadeh²,

Nikoo³

2011

CardioVascular Journal of Africa

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The aim of this study was to compare the mid-term outcome of patients receiving intramuscular methyl prednisolone before and after the procedure of coronary artery stenting. The study was conducted during 2007 and 2008 and compared the two arms of the study for the rate of restenosis six months after stenting. The control arm (100 patients) received only the usual preventive measures but the glucocorticoid arm (100 patients) received two doses of intramuscular methyl prednisolone (40 mg) at two-week intervals, the first at the time of the procedure. They also received the usual preventive measuresThere was no statistically significant difference between the two arms for the rate of restenosis. When separately analysing for three vessels and for gender, there was no statistically significant difference either.Lowering the dose of corticosteroid would greatly reduce the efficacy for preventing restenosis after coronary artery stenting. Therefore, if we are to achieve acceptable effectiveness with intramuscular prednisolone, we should administer increased doses at shorter intervals, which could be the target of further studies. However, there would be more chance of side effects with increased frequency of dosing.

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A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease

Cited by 3,937 publications

References 22 publications

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Transgene delivery of plasmid DNA to smooth muscle cells and macrophages from a biostable polymer-coated stent

Efficacy of intramuscular methyl prednisolone in preventing restenosis after coronary artery stenting with bare-metal stainless steel stent : a double-blind, randomised, controlled clinical trial

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