Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system

Sketch, Michael H.; Ball, Michael; Rutherford, Barry D.; Popma, Jeffrey J.; Russell, Catherine; Kereiakes, Dean J.

doi:10.1016/j.amjcard.2004.08.055

Cited by 114 publications

(85 citation statements)

References 17 publications

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“…Hyponatremia is associated with activation of vasoactive neurohormonal systems such as the sympathetic nervous system, renin‐angiotensin‐aldosterone system, and arginine vasopressin 24. Activation of the sympathetic nervous system leads to systemic vasoconstriction and an increase in heart rate and cardiac contractility, whereas activation of the renin‐angiotensin‐aldosterone system leads to direct systemic vasoconstriction and activation of secretion of aldosterone and arginine vasopressin 25. Arginine vasopressin activation leads to an increase in free‐water reabsorption in the renal collecting duct, thereby increasing the blood volume 25.…”

Section: Discussionmentioning

confidence: 99%

“…Activation of the sympathetic nervous system leads to systemic vasoconstriction and an increase in heart rate and cardiac contractility, whereas activation of the renin‐angiotensin‐aldosterone system leads to direct systemic vasoconstriction and activation of secretion of aldosterone and arginine vasopressin 25. Arginine vasopressin activation leads to an increase in free‐water reabsorption in the renal collecting duct, thereby increasing the blood volume 25. These defense mechanisms are important compensatory mechanisms in emergent conditions including blood loss and low cardiac output; however, sustained activation of these systems can lead to worsening HF by multiple biologic mechanisms, including adverse effects on afterload and myocardial oxygen consumption, as well as promotion of myocyte loss and fibrosis 26, 27…”

Section: Discussionmentioning

confidence: 99%

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Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction

Patel

Kurgansky

Imran

et al. 2018

JAHA

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BackgroundThe purpose of this study was to evaluate the relationship between serum sodium at the time of diagnosis and long term clinical outcomes in a large national cohort of patients with heart failure with preserved ejection fraction.Methods and ResultsWe studied 25 440 patients with heart failure with preserved ejection fraction treated at Veterans Affairs medical centers across the United States between 2002 and 2012. Serum sodium at the time of heart failure diagnosis was analyzed as a continuous variable and in categories as follows: low (115.00–134.99 mmol/L), low‐normal (135.00–137.99 mmol/L), referent group (138.00–140.99 mmol/L), high normal (141.00–143.99 mmol/L), and high (144.00–160.00 mmol/L). Multivariable Cox regression and negative binomial regression were performed to estimate hazard ratios (95% confidence interval [CI]) and incidence density ratios (95% CI) for the associations of serum sodium with mortality and hospitalizations (heart failure and all‐cause), respectively. The average age of patients was 70.8 years, 96.2% were male, and 14% were black. Compared with the referent group, low, low‐normal, and high sodium values were associated with 36% (95% CI, 28%–44%), 6% (95% CI, 1%–12%), and 9% (95% CI, 1%–17%) higher risk of all‐cause mortality, respectively. Low and low‐normal serum sodium were associated with 48% (95% CI, 10%–100%) and 38% (95% CI, 8%–77%) higher risk of number of days of heart failure hospitalizations per year, and with 44% (95% CI, 32%–56%) and 18% (95% CI, 10%–27%) higher risk of number of days of all‐cause hospitalizations per year, respectively.ConclusionsBoth elevated and reduced serum sodium, including values currently considered within normal range, are associated with adverse outcomes in patients with heart failure with preserved ejection fraction.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction

Patel

Kurgansky

Imran

et al. 2018

JAHA

View full text Add to dashboard Cite

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“…When tested across broad ranges of risk, the same stent may be observed to have restenosis rates that vary by as much as 4-fold. 3,6 Clinical restenosis rates therefore do not allow objective comparison of the restenosis propensity across randomized or observational studies.…”

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confidence: 99%

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials

Mauri¹,

Orav²,

Candia³

et al. 2005

Circulation

117

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Background-Binary angiographic and clinical restenosis rates can vary widely between clinical studies, even for the same stent, influenced heavily by case-mix covariates that differ among observational and randomized trials intended to assess a given stent system. We hypothesized that mean in-stent late loss might be a more stable estimator of restenosis propensity across such studies. Methods and Results-In 46 trials of drug-eluting and bare-metal stenting, increasing mean late loss was associated with higher target lesion revascularization (TLR) rates (PϽ0.001). When the class of bare-metal stents was compared with the class of effective drug-eluting stents, late loss was more discriminating than TLR as measured by the high intraclass correlation coefficient () (late loss, ϭ0.71 versus TLR, ϭ0.22; 95% CI of differenceϭ0.33, 0.65). When the individual drug-eluting stents and bare-metal stents were compared, late loss was a better discriminator than TLR (0.68 versus 0.19; 95% CI of differenceϭ0.24, 0.60). Greater adjustments of study covariates are needed to stabilize assessments of TLR compared with late loss because of greater influence of reference vessel diameter on TLR than on in-stent late loss. Optimization of late loss with the use of a novel method of standardization according to diabetes prevalence and mean lesion length resulted in minor adjustments in late loss (Ͻ0.08 mm for 90% of reported trials) and an ordered array of mean late loss values for the stent systems studied. Conclusions-Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug-eluting stent platforms across studies and might be the optimum end point for evaluating drug-eluting stents in early, nonrandomized studies.

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“…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). The results observed in the present study are comparable to those obtained from the Guidant Vision Multi-Link stent registry.…”

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

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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...

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Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system

Cited by 114 publications

References 17 publications

Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction

Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials

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

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