Background-We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year. Methods and Results-Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (nϭ30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the Ն50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2Ϯ5% obstruction volume, GIII) and at 12 months (GIϭ2Ϯ5% and GIIϭ2Ϯ3%). Key Words: angiography Ⅲ drugs Ⅲ stents Ⅲ restenosis Ⅲ ultrasonics D espite major technological advances in the past decades, of which the coronary stent is one of the most important, the percutaneous treatment of coronary artery disease is still hampered by a 20% to 30% incidence of restenosis. The list of candidate therapies and devices for prevention of restenosis after angioplasty is long and ever expanding. However, few if any have substantially improved the result of stenting for the treatment of de novo lesions. Intracoronary radiation has so far proven to be effective for the treatment of in-stent restenosis but not for the treatment of de novo lesions. 1 As a result of their ability to deliver prolonged and sufficient intramural drug concentrations to the target coronary segment, drug-eluting stents have emerged as a potential solution for restenosis. Our group has recently reported an almost complete absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting Bx VELOCITY stents. 2 The local release of sirolimus (rapamycin, Rapamune), a natural macrocyclic lactone with potent immunosuppressive action, 3 resulted in elimination of restenosis in this first series of patients. Comparable results have only been observed after the implantation of high-activity -emitting stents (9 mm 3 of neointimal hyperplasia at 6-month follow-up). 4 However, a worrying late progression of in-stent neointimal hyperplasia was observed between 6 months and 1 year after implantation of radioactive stents. 5 Conclusions-This See p 1996The aim of the present investigation was to determine whether sirolimus-eluting stents produce a sustained suppression of the neointimal proliferation over a period of 1 year or merely delay the restenosis process. Methods Study PopulationForty-five patients with nati...
Background-We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis. Methods and Results-Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07Ϯ0.2 mm in-stent and Ϫ0.05Ϯ0.3 mm in-lesion at 4 months, and 0.36Ϯ0.46 mm in-stent and 0.16Ϯ0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92Ϯ1.9 mm 3 at 4 months and 2.55Ϯ4.9 mm
Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007). Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.
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