Stenting in Diabetic Patients With De Novo Coronary Lesions
Stenting in Diabetic Patients With De Novo Coronary Lesions
Background Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES).
Methods The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non–insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year.
Results Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; Psuperiority = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11).
Conclusion In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
Cardiovascular disease is the leading cause of death in diabetic patients. These patients not only have an increased risk for developing cardiovascular disease but have a more diffuse and advanced pattern of the disease. Those undergoing percutaneous coronary intervention (PCI) have smaller vessels and longer lesions, requiring treatment with multiple stents, which might explain their less favorable response to treatment and poorer long-term outcomes.
First-generation drug-eluting stents (DESs) reduced the need for repeat revascularization with a similar safety profile when compared with bare-metal stents. Deployment of DES is considered the preferred treatment strategy for diabetic patients who are at a substantially higher risk for restenosis after bare-metal stenting. Furthermore, PCI, using the second-generation everolimus-eluting stent (EES), has been shown to result in better long-term outcomes than when first-generation DES are used in all-comer populations, However, a post hoc pooled analysis of 4 randomized trials showed a marked attenuation of this beneficial effect in subsets of diabetic patients. This may be due to suppression of the antiproliferative effect of everolimus, a phenomenon reflected in attenuation, in a small subset of patients with diabetes, of the marked reduction in late loss (LL) observed with EES in nondiabetic patients in an angiographic subset of the SPIRIT III study. However, although SPIRIT III enrolled 300 diabetic patients, only 96 lesions in the EES arm and 31 lesions in the paclitaxel-eluting stent (PES) arm were available for assessment of 8-month angiographic LL, with the resulting lack of power limiting the robustness of the subgroup observation. Furthermore, post hoc linear regression analysis revealed no significant interaction between treatment assignment and angiographic outcome in the diabetic subset. The angiographic analysis of SPIRIT II was even more limited with respect to sample size and rate of follow-up. An angiographic comparison powered to address the mechanistic questions that may impact on clinical outcomes is, thus, needed.
The SPIRIT V Diabetic Study was a prospective, single-blind, multicenter, randomized trial designed to compare outcomes after stenting with the XIENCE V EES compared with the Taxus Liberte PES, specifically in diabetic patients undergoing nonemergent PCI. The primary aim was to compare 9-month angiographic outcomes. Secondary aims included comparisons between the groups of clinical events and stent thrombosis at 1 year, although the study was not powered for these events.
Abstract and Introduction
Abstract
Background Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES).
Methods The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non–insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year.
Results Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; Psuperiority = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11).
Conclusion In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
Introduction
Cardiovascular disease is the leading cause of death in diabetic patients. These patients not only have an increased risk for developing cardiovascular disease but have a more diffuse and advanced pattern of the disease. Those undergoing percutaneous coronary intervention (PCI) have smaller vessels and longer lesions, requiring treatment with multiple stents, which might explain their less favorable response to treatment and poorer long-term outcomes.
First-generation drug-eluting stents (DESs) reduced the need for repeat revascularization with a similar safety profile when compared with bare-metal stents. Deployment of DES is considered the preferred treatment strategy for diabetic patients who are at a substantially higher risk for restenosis after bare-metal stenting. Furthermore, PCI, using the second-generation everolimus-eluting stent (EES), has been shown to result in better long-term outcomes than when first-generation DES are used in all-comer populations, However, a post hoc pooled analysis of 4 randomized trials showed a marked attenuation of this beneficial effect in subsets of diabetic patients. This may be due to suppression of the antiproliferative effect of everolimus, a phenomenon reflected in attenuation, in a small subset of patients with diabetes, of the marked reduction in late loss (LL) observed with EES in nondiabetic patients in an angiographic subset of the SPIRIT III study. However, although SPIRIT III enrolled 300 diabetic patients, only 96 lesions in the EES arm and 31 lesions in the paclitaxel-eluting stent (PES) arm were available for assessment of 8-month angiographic LL, with the resulting lack of power limiting the robustness of the subgroup observation. Furthermore, post hoc linear regression analysis revealed no significant interaction between treatment assignment and angiographic outcome in the diabetic subset. The angiographic analysis of SPIRIT II was even more limited with respect to sample size and rate of follow-up. An angiographic comparison powered to address the mechanistic questions that may impact on clinical outcomes is, thus, needed.
The SPIRIT V Diabetic Study was a prospective, single-blind, multicenter, randomized trial designed to compare outcomes after stenting with the XIENCE V EES compared with the Taxus Liberte PES, specifically in diabetic patients undergoing nonemergent PCI. The primary aim was to compare 9-month angiographic outcomes. Secondary aims included comparisons between the groups of clinical events and stent thrombosis at 1 year, although the study was not powered for these events.
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