A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications

Abstract

Background-Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. Methods-We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. Results-Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. Conclusions-Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications. IN 2003, THE FOOD AND DRUG ADMINISTRAtion (FDA) approved drug-eluting stents for the treatment of coronary artery disease. This decision was based on the results of clinical trials that compared a baremetal stent with a drug-eluting stent in highly selected patients. 1-10 Because of the magnitude of the treatment effect of drug-eluting stents in suppressing the recurrence of lesions, consistent

Clinical Evaluation of Different Revascularization Strategies: Unlabelled Use

“…Our results show the implementation of a higher number of drug-coated stents among the diabetic population and a 56% of unlabelled use indications, which is accompanied by a lower restenosis rate. These results are generally consistent with the recorded results of the authors mentioned above [18][19][20][21][22][23][24][25] . Related to the restenosis rate and the emergence of new ischemic episodes, those were higher in the non-diabetic group.…”

Cobalt Chromium Coronary Stents and Drug-Eluting Stents in Real Practice

“…Several studies support the superiority of DES over BMS in reducing revascularization. [19][20][21][22] This study supports the effectiveness of DES for reducing TLR compared with CCS. There was an imbalance of baseline clinical and procedural factors that could potentially influence the likelihood of repeat revascularization, however, the superiority of DES in reducing the TLR was confirmed after statistical adjustment.…”

Intravascular Ultrasound Guidance vs. Angiographic Guidance in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction – Long-Term Clinical Outcomes From the CREDO-Kyoto AMI Registry –

“…Definite ST was defined as thrombosis at culprit lesions, confirmed on angiography or pathology in accordance with the criteria of the Academic Research Consortium. 17 Death was regarded as cardiac in origin unless obvious non-cardiac causes could be identified. MI was defined according to the definition in the Arterial Revascularization Therapy Study.…”