Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stentswith paclitaxel-eluting TAXUS Liberté stents in de novo native coronaryartery lesions

Background—The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimusrelease from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of thisstudy was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus thesurface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte´ PES) in human native coronary lesions usingintravascular ultrasound (IVUS).Methods and Results—The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition tostandard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions bycomputing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along thestented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5 11.0%versus 11.5 9.7%, P 0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thicknesswithin each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte´PES(0.04 0.04 mm versus 0.10 0.07 mm, P 0.0001). TAXUS Liberte´ PES showed significantly greater positivevessel remodeling than the NEVO SES ( vessel volume index: 1.30 1.36 mm3/mm versus 0.36 0.63 mm3/mm,respectively, P 0.003).Conclusions—The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and moreconsistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte´ PES. This was associated withless positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at thestent margins.

Six-month results of the NEVO RES-ELUTION I (NEVO RES-I) trial: randomized, multicenter comparison of the NEVO Sirolimus-Eluting coronary stent vith the TAXUS libert paclitaxel-eluting stent in de novo native coronary artery lesions

Background—Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis,which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs withbioabsorbable polymer to reduce spatial and temporal polymer exposure.Methods and Results—NEVO ResElution-I was a prospective randomized study in 394 patients with coronary arterydisease comparing the NEVO SES with the TAXUS Liberte´ paclitaxel-eluting coronary stent (TAXUS Liberte´ PES)stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronaryintervention (PCI), the primary end point favored NEVO SES (0.13 0.31 mm versus 0.36 0.48 mm, P 0.001 fornoninferiority and superiority). The study was not powered for clinical end points and showed no significant differencefor NEVO SES versus TAXUS Liberte´ PES: death: 0.5 versus 1.6%, P 0.36; myocardial infarction: 2.0 versus 2.6%,P 0.75; target lesion revascularization: 1.5 versus 3.2%, P 0.33; major adverse cardiac events: 4.0 versus 7.4%, P 0.19.No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberte´ PES. Intravascularultrasound showed lower percent volume obstruction for NEVO SES (5.5 11% versus 11.5 9.7%, P 0.016).Conclusions—This trial proved the superiority of NEVO SES over TAXUS Liberte´ PES for the primary angiographic endpoint of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.

Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the triMaxx trial

Background: The TriMaxxTM coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. Objectives: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. Methods: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 3 15 or 3 3 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. Results: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 6 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 6 0.57 mm. Conclusions: These results demonstrate that the Tri-Maxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.

Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents

Background—Despite the proven superiority of sirolimus-eluting stents (SES) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation.Methods and Results—The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; n 15] and fast release [FR; n 15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2- and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the totalpopulation (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group(0.41 0.49 mm) than the SR group (0.09 0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FR 9.1% and SR 5.7%).Conclusions—This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimuseluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation).

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries

Background- Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor) coated BX velocity stents. Methdo and Results- Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analized angiographic and 3D volumetric intravascular ultrasound data (immediatlly after procedure and at 4-month follow-up). Eigth month clinical follow-up was obtained for all patients...

Sustained suppression of neointimal proliferation by sirolimus-eluting stents

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 (n530, 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 $50% 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 (265% obstruction volume, GIII) and at 12 months (GI5265% and GII5263%). Conclusions—This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.

Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions

The aim of this study is to compare the efficacy of sirolimus-eluting stents (SES) on neointimal growth and vessel remodelling for in-stent restenosis versus de novo coronary artery lesions using serial intravascular ultrasound (IVUS). METHODS AND RESULTS: The study population consisted of 86 patients with in-stent restenosis (ISR) (n=41) or de novo lesions (n=45) treated with SES and evaluated by IVUS post-procedure and at follow-up. One 18-mm SES was used for de novo lesions while 16 patients with ISR received >1SES (total stented length 17.9 mm vs 22.0 mm espectively; P=0.004). At follow-up, no differences were observed between the ISR and de novo groups with respect to changes in the mean external elastic membrane (1.7% vs 1.3%; 0.53),plaque behind the stent (1.2% vs 3.4%; P=0.49), and lumen areas (0.7% vs 1.9%; P=0.58). No positive remodelling or edge effect was observed. A gap between stents was observed in two patients with ISR, where more prominent, though non-obstructive, neointimal proliferation was noted. CONCLUSION: Sirolimus-eluting stenting is equally effective at inhibiting neointimal proliferation in de novo and ISR lesions without inducing edge restenosis or positive vascular remodelling...

Clinical and angiographic outcome in the laser angioplasty for restenotic stents (LARS) multicenter registry

In-stent restenosis (ISR) when treated with balloon angioplasty (PTCA) alone, has a angiogrphic recurrence rate of 30%-85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, yet the late outcomes of such treatment have not been fully determined. This multicenter case control study assessed the angiographic and clinical outcomes of 157 consecutive procedures in 146 patients with ISR at nine institutions treated with either the PTCA alone (n=64)o excrimer laser assisted coronary angioplasty (ELCA, n=93) for ISR. Demographics were similar except more unstable angina at presentation in ELCA-treated patients (74.5% vs 63.5$; P=0.141). Lesions selected for ELCA were longer (16.8 +_ 11.2mm vs. 11.2+_ 8.6 mm;P < 0.001), more complex (ACC/AHA type C:35.1% vs. 13.6%;P<0.00001)...