Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings

Brito, Fábio Sândoli de; Caixeta, Adriano; Perin, Marco Antônio; Rati, M; Arruda, Jose A.; Cantarelli, Marcelo José de Carvalho; Castello, Hélio José; Machado, Bruno Martins; Silva, Lélio A; Ribeiro, Expedito E.; Luz, Protásio Lemos da

doi:10.1016/s0002-9149(01)02185-3

Cited by 50 publications

(45 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…These results are in accordance to previous studies reporting that DS fails to reduce the rate of restenosis [4,22,23] as it had been initially postulated by preclinical and observational studies [6,14,24]. Our findings regarding other late clinical outcomes, such as MACE and ST, are also supported by the existing literature [3][4][5]25]. In reference to early clinical events, the incidence of PPMI was specifically evaluated in this study given a proposed reduction with the use of DS and an established association with worsened in-hospital and longterm outcomes [26][27][28].…”

Section: Discussionsupporting

confidence: 93%

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention

Sardi

Laynez-Carnicero

Torguson

et al. 2013

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

Section: Discussionsupporting

confidence: 93%

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention

Sardi

Laynez-Carnicero

Torguson

et al. 2013

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

“…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%

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

View full text Add to dashboard Cite

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.

show abstract

“…The Driver stent was deployed with a high degree of procedural and angiographic success, similar to results obtained from studies using stents manufactured from stainless steel (87% to 100%). [5][6][7][8][9][10] The primary safety outcome, the cumulative incidence of major adverse cardiac events at 6 months, also compared favorably with that in studies using stainless steel stents. 7,8,10 Furthermore, the procedural and angiographic success rates we observed were consistent with those obtained from the recently completed Driver Registry, which evaluated the Driver stent in patients with symptomatic ischemic heart disease.…”

mentioning

confidence: 99%

“…[5][6][7][8][9][10] The primary safety outcome, the cumulative incidence of major adverse cardiac events at 6 months, also compared favorably with that in studies using stainless steel stents. 7,8,10 Furthermore, the procedural and angiographic success rates we observed were consistent with those obtained from the recently completed Driver Registry, which evaluated the Driver stent in patients with symptomatic ischemic heart disease. 11 The only other cobalt-chromium alloy stent to be evaluated in a clinical trial is the thin-strut (0.0032 in) Guidant Vision Multi-Link stent (Guidant Corporation, Indianapolis, Indiana).…”

mentioning

confidence: 99%

Clinical and Angiographic Analysis With a Cobalt Alloy Coronary Stent (Driver) in Stable and Unstable Angina Pectoris

Legrand

Kelbæk

Hauptmann

et al. 2006

The American Journal of Cardiology

View full text Add to dashboard Cite

The Clinical and Angiographic analysis with a Cobalt Alloy Coronary Stent (Driver) (CLASS) study was a prospective, nonrandomized, multicenter study designed to assess the safety and efficacy of a cobalt-chromium alloy-based stent in patients with stable or unstable angina pectoris. A total of 203 lesions were treated in 202 enrolled patients. The percentage of major adverse cardiac event-free patients was 87.6% (177 of 202) at 6 months (primary safety end point; major adverse cardiac events were defined as death, myocardial infarction, emergency bypass surgery, or target lesion revascularization [percutaneous transluminal coronary angioplasty or coronary artery bypass grafting]). The angiographic success rate (primary efficacy end point) was 100%, and the procedural success rate was 98%. The binary in-stent restenosis rate at 6 months was 12.6%. Our results have demonstrated that the Driver cobalt-chromium alloy stent can be used with a low 6-month incidence of major adverse cardiac events, a low 6-month binary restenosis rate, and high angiographic and procedural success rates. The Medtronic Driver stent (Medtronic Vascular, Santa Rosa, California) is composed of a cobalt-chromium alloy and is similar in design to the Medtronic S7 stent. The design is based on elements 1.0 mm in length with an elliptical-rectangular strut cross section and a strut thickness of 0.0036 in. (91 m). The cobalt-chromium alloy has superior mechanical properties compared with traditional 316L stainless steel, including greater strength and increased density. These properties have allowed the development of stents with thinner struts, offering increased flexibility and ease of delivery, without compromising radial strength or radiopacity. The strut thickness has been shown to be an important determinant of the long-term restenosis rate. [1][2][3][4] This prospective, nonrandomized, multicenter study was designed to assess the safety and efficacy of the Medtronic Driver stent.• • • Patients with clinical evidence of stable or unstable angina pectoris, or positive functional study findings, with a planned percutaneous transluminal coronary angioplasty procedure of a single de novo lesion in a native coronary artery were considered for inclusion. Lesions (Յ13 mm) situated in a major coronary artery or major branch with estimated stenosis of 50% to 100% and a diameter suitable for implantation of a single stent with a diameter of 3.0 to 4.0 mm were considered eligible for enrollment.Preprocedural antiplatelet therapy was administered according to local routine with the following recommendations: aspirin (minimum 75 mg/day) and ticlopidine (500 mg loading dose followed by 250 mg twice daily) or aspirin and clopidogrel (300 mg loading dose followed by 75 mg/ day). It was initiated Ն24 hours before the procedure or before the conclusion of the catheterization. Ticlopidine or clopidogrel were discontinued after 14 to 28 days, and aspirin (Ն75 mg/day) was maintained indefinitely (Ն6 months after implantation).After introduction of the arterial...

show abstract

Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings

Cited by 50 publications

References 20 publications

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention

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

Clinical and Angiographic Analysis With a Cobalt Alloy Coronary Stent (Driver) in Stable and Unstable Angina Pectoris

Contact Info

Product

Resources

About