Clinical trials of restenosis after coronary angioplasty.

Popma, Jeffrey J.; Califf, R.M.; Topol, Eric J.

doi:10.1161/01.cir.84.3.1426

Cited by 324 publications

(113 citation statements)

References 59 publications

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“…This rate is also acceptable when compared with the rate of first TLR after ␥-brachytherapy (23% to 24%) or that in patients treated with percutaneous intervention without brachytherapy for in-stent restenosis (41% to 63%). 11,12 Major adverse cardiac events (excluding TLR) in the irradiated group were also comparable to those seen in both brachytherapy/restenosis series and de novo PTCA/ stenting trials, 6,[21][22][23][24] especially when the long follow-up period of the present patient population is taken into account.…”

Section: Discussionsupporting

confidence: 72%

Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of γ-Brachytherapy for the Treatment of In-Stent Restenosis

et al. 2002

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Background-Although 192 Ir intracoronary brachytherapy has been demonstrated to dramatically reduce the recurrence of in-stent restenosis, up to 24% of these patients will still require repeat target-vessel revascularization. The short-and long-term outcomes of repeat percutaneous intervention in this population have not been characterized. Methods and Results-Analysis was performed of all patients enrolled in the GAMMA-I and GAMMA-II brachytherapy trials who underwent repeat percutaneous target lesion revascularization (TLR) because of restenosis. Subjects were divided into 2 cohorts: those who had received 192 Ir brachytherapy and those randomized to placebo. Forty-five (17.6%) of a total of 256 patients whose index treatment was intracoronary radiation therapy and 36 (29.8%) of 121 patients whose index treatment was placebo required repeat percutaneous TLR. The mean time to this first TLR was 295Ϯ206 days in the irradiated group and 202Ϯ167 days in the placebo group (Pϭ0.03). Acute procedural success occurred in 100% of irradiated patients and 94% of placebo controls (Pϭ0.19). After the first TLR, a subsequent TLR was required in 15 (33.3%) of 45 brachytherapy patients versus 17 (47.2%) of 36 placebo failure patients (Pϭ0.26). There was no significant difference in time to second TLR between the 2 groups. Other long-term major adverse event rates in both groups were comparable to those of other contemporary angioplasty/stenting series. Conclusions-In those patients who "fail"192 Ir intracoronary brachytherapy for in-stent restenosis, treatment with 192 Ir delays the time to first TLR. Additionally, repeat percutaneous intervention in these patients is safe and efficacious in the short term, with acceptable long-term results.

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Section: Discussionsupporting

confidence: 72%

Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of γ-Brachytherapy for the Treatment of In-Stent Restenosis

et al. 2002

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“…1 Coronary stents reduce restenosis by limiting the extent of elastic recoil and late vascular remodeling. 2 Despite these improvements, the incidence of restenosis remains high because of neointimal hyperplasia, which is induced by all forms of dilating mechanical injury and is aggravated by the presence of the stent ("in-stent restenosis").…”

mentioning

confidence: 99%

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

et al. 2001

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Background-Despite limiting elastic recoil and late vascular remodeling after angioplasty, coronary stents remain vulnerable to restenosis, caused primarily by neointimal hyperplasia. Paclitaxel, a microtubule-stabilizing drug, has been shown to inhibit vascular smooth muscle cell migration and proliferation contributing to neointimal hyperplasia. We tested whether paclitaxel-coated coronary stents are effective at preventing neointimal proliferation in a porcine model of restenosis. Methods and Results-Palmaz-Schatz stents were dip-coated with paclitaxel (0, 0.2, 15, or 187 g/stent) by immersion in ethanolic paclitaxel and evaporation of the solvent. Stents were deployed with mild oversizing in the left anterior descending coronary artery (LAD) of 41 minipigs. The treatment effect was assessed 4 weeks after stent implantation.

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“…The two studies [92,94] added in the present paper do not basically alter such a recommendation. Moreover, two large scale trials, EMPAR and FORT are currently recruiting patients [97] and we can hopefully draw final conclusions after the results of these studies have been published.…”

Section: Restenosis After Percutaneous Transluminal Coronary Angioplamentioning

confidence: 99%

Fish oil and the prevention and regression of atherosclerosis

Sassen

Lamers

Verdouw

1994

Cardiovasc Drug Ther

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Summary. Epidemiological studies in the seventies have put forward that dietary rather than genetic factors are responsible for the lower incidence of ischemic heart disease in Greenland Inuit and have generated a large body of both in vitro and in vivo experimental studies, exploring the putative favorable effects of fish (oil) on atherogenesis and its risk factors. The first part of this report reviews the in vivo animal studies, concentrating on the hypercholesterolemic models and the arterialized vein graft model. In the hypercholesterolemic animal studies, the results are inconclusive as the studies reporting a protective effect are matched by the number of studies showing no effect or an adverse effect. The diversity in species, dose of fish oil, duration of study, type of vessel studied and type of fish oil preparation (content of n-3 fatty acids, unesterified n-3 fatty acids, ethylesters or triglyceridcs) could all contribute. Furthermore, the definitions and criteria used in the literature to evaluate atherogenesis are diverse and it appears that while one parameter is affected, another is not necessarily modified in the same direction, stressing the importance of extending the analysis of the effects on atherogenesis to more than one parameter. We also believe that it is time to reach a consensus as to which animal model mimicks most closely a particular human situation. Only in appropriate models, investigating more than one atherosclerosis variable, can the effects of a putative anti-atherogenic drug or diet be verified. In the veno-arterial autograft model, mimicking the patient after coronary bypass grafting, dietary fish oil has been consistently effective in preventing accelerated graft intima proliferation. It could therefore be of interest to evaluate the effects of fish oil on graft patency in patients after coronary bypass surgery after a period of years.The results from studies on restenosis after percutaneous transluminal angioplasty are also reviewed and it is concluded that the two large scale trials, that are currently underway, might reliably answer the question whether fish oil is effective as a non-pharmacological adjuvants in the prevention of restenosis.Lastly, the studies on the effects of fish oil on the regression of experimental atherosclerosis are reviewed. In view of the small number of studies (i.e., four) investigating the effects of fish oil on the regression of atherosclerosis, it is premature to draw any conclusion, and therefore further experimental work is required.

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Clinical trials of restenosis after coronary angioplasty.

Cited by 324 publications

References 59 publications

Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of γ-Brachytherapy for the Treatment of In-Stent Restenosis

Long-Term Outcome of Patients Treated With Repeat Percutaneous Coronary Intervention After Failure of γ-Brachytherapy for the Treatment of In-Stent Restenosis

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

Fish oil and the prevention and regression of atherosclerosis

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