Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System (the PREDICT trial)

Baim, Donald S.; Flatley, M.; Caputo, Ronald P.; O’Shaughnessy, Charles; Low, Reginald I.; Fanelli, Claude; Popma, Jeffery J.; Fitzgerald, Peter J.; Kuntz, Richard

doi:10.1016/s0002-9149(01)02114-2

Cited by 62 publications

(44 citation statements)

References 8 publications

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“…Several observational [6,14 -16] and randomized studies [4,5,7,9,17] have been conducted on the value of the DS strategy in the treatment of coronary artery disease. Different aspects of this technique such as feasibility, safety, duration of procedure, costs of consumables, clinical adverse events, and restenosis have been evaluated.…”

Section: Discussionmentioning

confidence: 99%

“…Different aspects of this technique such as feasibility, safety, duration of procedure, costs of consumables, clinical adverse events, and restenosis have been evaluated. The direct stenting strategy has been proven to be a feasible and safe procedure, but without a significant benefit in the clinical outcome as compared to the CS strategy [4,5,7,9,17]. Based on previous studies, an accurate assessment of the value of the DS strategy is difficult due to inclusion of highly selected lesions and insufficient power for the assessment of restenosis (maximal number of patients included in a randomized trial Ͻ 420).…”

Section: Discussionmentioning

confidence: 99%

“…Animal data have demonstrated a lower degree of injury with direct stent implantation than with conventional stenting, which is expected to lead to diminished intimal hyperplasia of the vessel wall [3]. Recent clinical trials have shown equivalent [4,5] or a trend toward better results [6 -9] with direct stenting as compared to stenting with predilation. A definitive conclusion about the potential benefit of direct stenting as a preventive strategy for restenosis is difficult on the basis of the available data.…”

Section: Introductionmentioning

confidence: 99%

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Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR‐DIRECT trial)

Mehilli

Kastrati

Dirschinger

et al. 2004

Cathet Cardio Intervent

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The objective of this randomized study was to assess whether direct stenting leads to less restenosis than does conventional stenting (CS) with predilation in clinical practice. We included 910 patients who were randomly assigned to undergo either direct stenting (DS; n = 456) or CS (n = 454). No significant difference was observed in the incidence of angiographic restenosis (primary endpoint): 23.6% for DS and 21.0% for CS (P = 0.41; relative risk = 1.1; 95% CI = 0.8-1.5). The incidence of target vessel revascularization was 17.3% among DS and 14.8% among CS patients (P = 0.29; relative risk = 1.2; 95% CI = 0.8-1.6). The combined incidence of death or myocardial infarction at one year was 9.0% in the DS group and 7.0% in the CS group (P = 0.28). In conclusion, direct stenting is not associated with any reduction of thrombotic and restenotic complications as compared to the conventional stenting.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR‐DIRECT trial)

Mehilli

Kastrati

Dirschinger

et al. 2004

Cathet Cardio Intervent

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“…Balloon-expandable endovascular stents provide a luminal scaffolding with minimal direct contact between the balloon and the endothelium. Even a correlation between the severity of the endothelial injury and the intimal lesion [20, 21, 22], had no clearly demonstrated consequences in clinical practice: there is no proof that direct stenting decreases the incidence of in-stent restenosis [23, 24]as described in animal studies [19]. In experimental studies, limited deleterious effects of direct stenting on endothelial cells were observed in nonstenotic arteries which are not representative of stenotic arteries in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Neointimal Hyperplasia after Stenting in a Human Mammary Artery Organ Culture

Guérin

Rondeau²,

Grimandi³

et al. 2004

J Vasc Res

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Although the use of stents has limited the incidence of restenosis, in-stent restenosis remains an important problem. In-stent restenosis is the result of a healing process that induced neointimal hyperplasia through mechanisms that are still not understood. The aim of this study was to analyze the histological consequences of the healing process following stent implantation. Internal mammary arteries from atheroslerotic patients undergoing coronary artery bypass surgery were stented and maintained in culture for 0–28 days. Stent implantation after predilatation induced an extensive loss of endothelial cells whereas direct stenting preserved endothelium between the struts. Morphometric analysis shows that stent placement induced neointimal thickening. Smooth muscle α-actin labeling indicates that neo-intimal formation was mainly due to proliferation and migration of smooth muscle cells. Smooth muscle cell proliferation, assessed by MIB-1 staining, was maximal at day 14 after stent insertion. Human mammary artery organ culture thus provides valuable information on histological consequences of stent implantation with or without predilatation regarding endothelial cell disappearance and neointimal hyperplasia. These data also demonstrate that neointimal thickening induced by stent implantation comprises an intrinsic component resulting from the vessel wall response to stent insertion and suggest that blood factors could play an amplifying but not necessary role.

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“…The plaque was generalized as parabolic profile with length of 13 mm along longitudinal direction and circular profile with an edge ratio of 2:1 at its narrowest lumen for all cases. This asymmetric plaque could lead to a remaining lumen diameter of 30% of the reference lumen, which is referred to as 70% stenosis, as in the case of PS stent [13], or 50% for all other cases [14][15][16][17][18]. The material behaviors of artery and plaque were described using hyperelastic constitutive models with the non-zero material coefficients as C 10 =0.019513 MPa, C 03 =0.02976 MPa for the artery; and C 10 =0.04 MPa, C 02 =0.003 MPa, C 03 =0.02976 MPa for the plaque [19].…”

Section: Methodsmentioning

confidence: 99%

Effects of arterial strain and stress in the prediction of restenosis risk: Computer modeling of stent trials

Zhao

Froemming

2012

Biomed. Eng. Lett.

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Purpose -In-stenting restenosis is one of the major complications after stenting. Clinical trials of various stent designs have reported different restenosis rates. However, quantitative correlation between stent features and restenosis statistics is scant. In this work, it is hypothesized that stress concentrations on arterial wall caused artery injury, which initiates restenosis. The goal is to assess the correlation between stent-induced arterial stress and strain and the documented restenosis rates. Methods -Six commercially available stents, including balloon-expandable stents and self-expanding stents, were virtually implanted into the arteries through finite element method. The resulted peak Von Mises stress, principal stress, principal logarithm strain, as well as percentage of intimal area with abnormal higher stress were monitored. Results -Positive correlation between arterial stress and strain after stent implantations and the documented restenosis rates from the corresponding clinical trials was found regardless of stent types. No statistical significant difference was observed for various stress or strain parameters serving as indicators of artery injury. Conclusions -In-stent restenosis are less likely to occur as arterial mechanics are least altered by stent implantations. Optimization of stent designs to minimize the stent-induced arterial stresses and strains can reduce the arterial injury, and thus reduce the occurrence of restenosis. This work improved our understanding of the stent-lesion interactions that regulate arterial mechanics and demonstrated that arterial stress and strain could predict the risk of instent restenosis.

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Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System (the PREDICT trial)

Cited by 62 publications

References 8 publications

Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR‐DIRECT trial)

Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR‐DIRECT trial)

Neointimal Hyperplasia after Stenting in a Human Mammary Artery Organ Culture

Effects of arterial strain and stress in the prediction of restenosis risk: Computer modeling of stent trials

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