Drug-eluting Stents In Diabetic Patients Research Articles

Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus: Pooled Analysis From 5 Randomized Trials

We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials. Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM. Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin. In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.

Issue Highlights

HomeCirculationVol. 112, No. 14Issue Highlights Free AccessIn BriefPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessIn BriefPDF/EPUBIssue Highlights Originally published4 Oct 2005https://doi.org/10.1161/circ.112.14.2077Circulation. 2005;112:2077–2078PROGNOSTIC VALUE OF N-TERMINAL PRO–BRAIN NATRIURETIC PEPTIDE IN PATIENTS WITH CHRONIC STABLE ANGINA, by Ndrepepa et al.The heart has become an endocrine organ, and its hormones today are used for diagnostic and prognostic purposes. Brain natriuretic peptide is predictive for cardiac events and death in patients with heart failure, but its role in chronic stable angina is less clear. In their study, Gjin Ndrepepa et al report on plasma levels of NT-proBNP in more than a thousand patients with chronic stable angina with mortality as a primary end point. In their cohort, NT-proBNP levels were highly predictive for total and cardiovascular mortality. Interestingly, patients in the upper quartile of NT-proBNP had lower left ventricular ejection fraction and higher left ventricular end-diastolic pressure as well as more advanced coronary artery disease angiographically. In a multivaried analysis, NT-proBNP was the strongest of all analyzed parameters to predict mortality in these patients. Although patients with impaired left ventricular function do have higher levels of NT-proBNP, the cardiac hormone appears to provide prognostic information beyond hemodynamics. Although the mechanisms underlying this prognostic information are not yet clear, NT-proBNP has become an important prognostic marker for clinical practice, apparently in the entire spectrum of cardiovascular disease. See p 2102.POSTCONDITIONING THE HUMAN HEART, by Staat et al.The existence of serious reperfusion-induced injury, resulting in significant cell death as opposed to temporary impairment of mechanical function (stunning), has long remained controversial. And if it were to exist, what could be done to lessen this added burden? Experimentalists have established that preconditioning the heart by repetitive brief episodes of reversible ischemia before the onset of a prolonged ischemic assault lessens cardiomyocyte death at reperfusion. Thus, the ultimate infarct size is decreased. But preconditioning must be applied in advance and is relatively short lived. The group of Michel Ovize now provides a landmark human study that answers two major questions. First, how to do it—by postconditioning, a relatively simple procedure involving a few short sharp bursts of reocclusion and full reperfusion started just after angioplastic revascularization for acute myocardial infarction. Second, what is the benefit? Postconditioning reduced enzyme release by about one third, thus saving dying cells. Both the simplicity and the strength of this observation challenge current views on optimal revascularization for acute myocardial infarction. See p 2143.RANDOMIZED COMPARISON OF SIROLIMUS-ELUTING STENT VERSUS STANDARD STENT FOR PERCUTANEOUS CORONARY REVASCULARIZATION IN DIABETIC PATIENTS: THE DIABETES TRIAL, by Sabaté et al.Patients with diabetes mellitus are recognized to have an elevated risk of cardiovascular disease. This patient population presents a significant challenge with respect to percutaneous revascularization procedures owing to the presence of diffuse coronary artery disease as well as the aggressive nature of the disease process. After bare metal stent placement, diabetic patients demonstrate an increased rate of restenosis as compared with nondiabetic patients, suggesting the need for more efficacious treatment strategies. Recent studies, by subset analysis, have shown that drug-eluting stents have improved restenosis rates in diabetic patients. In this issue of Circulation, Sabaté et al present definitive findings from a multicenter, prospective, randomized study that evaluates the efficacy of sirolimus drug-eluting stents in diabetic patients. The results from this trial will help to guide interventional therapies for diabetic patients that require percutaneous coronary revascularization procedures in the future. See p 2175.Visit http://www.circ.ahajournals.org:Images in Cardiovascular MedicineCardiac Transplantation for Giant Sarcoma of the Left Ventricle. See p e247. Download figureDownload PowerPointTamponade From Acute Left Atrium Compression. See p e250.Right-Sided Heart Failure Due to Compression of the Right Atrium by Remarkable Ascending Aortic Elongation. See p e252.CorrespondenceSee p e253. Previous Back to top Next FiguresReferencesRelatedDetails October 4, 2005Vol 112, Issue 14 Advertisement Article InformationMetrics https://doi.org/10.1161/circ.112.14.2077 Originally publishedOctober 4, 2005 PDF download Advertisement

Diabetes and Coronary Revascularization

Patients with diabetes mellitus account for approximately 25% of the nearly 1.5 million coronary revascularization procedures performed each year in the United States and experience worse outcomes compared with nondiabetic patients. To summarize the current state of evidence comparing the effectiveness and safety of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) in diabetic patients and to examine developments that may affect future outcomes in this high-risk group. Using the key terms diabetes mellitus, revascularization, coronary artery bypass, angioplasty, and coronary intervention, we searched MEDLINE from 1985 to 2004 for all randomized controlled trials (RCTs) comparing CABG surgery and PCI that reported outcomes in diabetic patients. Bibliographies and the Web sites of cardiology conferences were also reviewed. Studies comparing drug-eluting stents and bare-metal stents were identified in a similar fashion. The literature was reviewed to identify clinical measures that may impact revascularization outcomes in diabetic patients. We identified 6 RCTs comparing CABG surgery and PCI in a total of 950 diabetic patients. A mortality benefit for CABG over balloon-only PCI has been demonstrated in diabetic patients with multivessel coronary artery disease but has not been clearly established against stent-assisted PCI or in high-risk CABG patients. Use of glycoprotein IIb/IIIa receptor inhibitors has improved survival in diabetic patients undergoing PCI. Restenosis after PCI in diabetic patients has led to substantially higher repeat revascularization rates than after CABG. The use of drug-eluting stents has led to dramatic reductions in restenosis in diabetic patients. Ongoing RCTs comparing CABG and PCI using drug-eluting stents in diabetic patients will clarify the impact of these advances on outcomes. There is a relative lack of data from RCTs specifically comparing CABG surgery and PCI as currently practiced in diabetic patients. The mortality advantage and decreased rates of revascularization seen with CABG in subgroups from early trials may not be applicable in the era of drug-eluting stents, glycoprotein IIb/IIIa inhibitors, and the latest medical therapies.