J. Eduardo Sousa

Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease.

BACKGROUND The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were

Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice One-Year Follow-Up of the e-Cypher Registry

4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be

Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights from the Arterial Revascularization Therapy Study (ARTS) trial.

2,973 per patient. CONCLUSION As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.

New Frontiers in Cardiology Drug-Eluting Stents: Part I

Background— The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results— Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of ≥1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7±11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions— This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries

Background—Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. Methods and Results—Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient’s use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P <0.001) and nondiabetic patients treated with stents (76.2%, P =0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents Three-Year Results of the RAVEL Trial

12 855 and

Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis. A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study

16 585 (P <0.001) and in the nondiabetic groups,

Clinical and Economic Impact of Diabetes Mellitus on Percutaneous and Surgical Treatment of Multivessel Coronary Disease Patients

10 164 for stenting and

Four-Year Angiographic and Intravascular Ultrasound Follow-Up of Patients Treated With Sirolimus-Eluting Stents

13 082 for surgery. Conclusions—Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status.

New Frontiers in Cardiology

Stents represent a major advance in the treatment of obstructive coronary artery disease since the advent of balloon angioplasty. The number of percutaneous coronary interventions performed each year has expanded considerably since the early days. Angioplasty procedures doubled in Europe between 1992 and 1996,1 while an estimated 601 000 percutaneous coronary revascularizations were performed in the United States in 1997.2 Unfortunately, many of these patients develop an exaggerated vascular neointimal proliferation after stenting—namely, in-stent restenosis. Much research has been devoted to the pathophysiology and treatment of in-stent restenosis. As a result of many relentless “trial-and-error” endeavors, drug-eluting stents have emerged as a potential solution for restenosis. Drug-eluting stents are coated stents capable of releasing single or multiple bioactive agents into the bloodstream and surrounding tissues. We have been commissioned to present an overview on drug-eluting stents. Acknowledging the challenge of examining such a dynamic and flourishing field, our goals in this 2-part article were to provide a broad perspective of the development of drug-eluting stent technology, to summarize the available clinical data, and to introduce emerging concepts for the understanding and application of this new device in clinical practice. In 1991, stent use was still facing skepticism because of an unacceptably high (20% to 25%) incidence of thrombotic complications.3 Systemic anticoagulation proved disappointing in reducing the catastrophic consequences of stent thrombosis, such as myocardial infarction and sudden death. Consequently, antithrombotic stent coatings were developed to decrease the inherent thrombogenicity of coronary metallic stents. Some heparin-coated stents have become available for clinical use: BX-Velocity Carmeda-coated stent (Johnson & Johnson), Wiktor Hepamed-coated stent (Medtronic, Inc), and the Jostent Corline-coated stent (Jomed International AB). Heparin-coated stents differ from drug-eluting stents because the medication is covalently bonded to the device and hence may remain attached long after deployment. However, these stents …