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-The angiographic presentation of in-stent restenosis (ISR) may convey prognostic information on subsequent target vessel revascularizations (TLR). Methods and Results-We developed an angiographic classification of ISR according to the geographic distribution of intimal hyperplasia in reference to the implanted stent. Pattern I includes focal (Յ10 mm in length) lesions, pattern II is ISRϾ10 mm within the stent, pattern III includes ISRϾ10 mm extending outside the stent, and pattern IV is totally occluded ISR. We classified a total of 288 ISR lesions in 245 patients and verified the angiographic accuracy of the classification by intravascular ultrasound. Pattern I was found in 42% of patients, pattern II in 21%, pattern III in 30%, and pattern IV in 7%. Previously recurrent ISR was more frequent with increasing grades of classification (9%, 20%, 34%, and 50% for classes I to IV, respectively; Pϭ0.0001), as was diabetes (28%, 32%, 39%, and 48% in classes I to IV, respectively; PϽ0.01). Angioplasty and stenting were used predominantly in classes I and II, whereas classes III and IV were treated with atheroablation. Final diameter stenosis ranged between 21% and 28% (PϭNS among ISR patterns). TLR increased with increasing ISR class; it was 19%, 35%, 50%, and 83% in classes I to IV, respectively (PϽ0.001).Multivariate analysis showed that diabetes (odds ratio, 2.8), previously recurrent ISR (odds ratio, 2.7), and ISR class (odds ratio, 1.7) were independent predictors of TLR. Conclusions-The introduced angiographic classification is prognostically important, and it may be used for appropriate and early patient triage for clinical and investigational purposes.

We studied 954 consecutive patients with native coronary artery lesions treated with elective Palmaz-Schatz stents implantation using conventional coronary angiographic and intravascular ultrasound methodology. Procedural success, major in-hospital complications, and 1-year clinical outcome were compared according to the diabetic status. RESULTS. In-hospital mortality was 2% in IDDM, significantly higher (p <0.02) compared with non-IDDM (0%) and nondiabetics (0.3%). Stent thrombosis did not differ among groups (0.9% in IDDM vs. 0% in non-IDDM and 0% in nondiabetics, p >0.1). During follow-up, target lesion revascularization (TLR) was 28% in IDDM, significantly higher (p <0.05) compared with non-IDDM (17.6%) and nondiabetics (16.3%). Late cardiac event-free survival (including death, myocardial infarction [MI], and any coronary revascularization procedure) was significantly lower (p=0.0004) in IDDM (60%) compared with non-IDDM (70%) and nondiabetic patients (76%). By multivariate analysis, IDDM was an independent predictor for any late cardiac event (OR=2.05, p=0.0002) in general and TLR (odds ratio=2.51, p=0.0001) in particular. CONCLUSIONS. In a large consecutive series of patients treated by elective stent implantation, IDDM patients were at higher risk for in-hospital mortality and subsequent TLR and, as a result, had a significantly lower cardiac event-free survival rate. On the other hand, acute and long-term procedural outcome was found to be similar for non-IDDM compared with nondiabetic patients.

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Background-The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation. Methods and Results-This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], nϭ15, and fast release [FR], nϭ15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28Ϯ0.4 mm) than in the SR group (Ϫ0. 09Ϯ0.23 mm, Pϭ0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had Յ35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33Ϯ0.42 mm [FR] and 0.13Ϯ0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FRϭ 9.90Ϯ9 mm 3 and SRϭ10.35Ϯ9.3 mm 3 ). Conclusions-This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population. Key Words: stents Ⅲ angiography Ⅲ ultrasonics Ⅲ restenosis A new generation of drug-eluting coronary stents designed to limit restenosis has been developed recently. The clinical success of these novel technologies will depend on a complex interaction between stent, coating matrix, drug, and the vessel wall. Stents coated with sirolimus, a natural macrocyclic lactone with immunosuppressive and antiinflammatory action, represented the first successful attempt to abolish restenosis in human coronary arteries. 1-3 A virtual absence of neointimal proliferation was observed 1 year after implantation of sirolimus-eluting Bx Velocity stents in a pilot study. 2 Subsequently, the RAVEL (a RAndomized comparison of a sirolimus-eluting Bx VELocity stent with a standard stent for coronary revascularization) investigators reported an absence of both angiographic restenosis at 6 months and target-lesion revascularization 1 year after the implantation of sirolimus-eluting stents in a multicenter randomized trial. 3 Although encouraging, potential late side effects of these drug-eluting coronary stents may pose limitations. Lessons from intracoronary brachytherapy include the development of late thrombosis and neointimal proliferation that may occur beyond the first year after treatment. 4 -6 In the present study, we evaluated the clinical...