Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

First nine-month complete invasive assessment (angiography, IVUS, and OCT) of the novel NEVO sirolimus-eluting stent with biodegradable polymer.

At present, percutaneous coronary intervention with drug-eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long-term safety of first-generation DES have prompted the development of novel DES systems such as the NEVO (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus-eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res-Elution I study.

Comparison between sirolimus-eluting stents and intracoronary catheter-based beta radiation for the treatment of in-stent restenosis.

We report the outcomes of patients who had in-stent restenosis (IRS) that was treated with intravascular brachytherapy (IVBT) or sirolimus-eluting stent (SES) implantation. The benefit of IVBT for treating ISR is well documented. SES implantation decreases first-time ISR and, in preliminary reports, has been used to treat ISR. Fifty consecutive patients who had ISR were treated; the first 25 patients underwent SES implantation and the next 25 patients were treated with IVBT using a beta-Cath System (a 40-mm strontium-90/yttrium-90 source). Quantitative angiographic and intravascular ultrasound follow-up were performed at 5.2 +/- 1.1 and 12.1 +/- 1.2 months; clinical follow-up was performed at 15 months. SES deployment and IVBT were successful in all patients. At 12-month follow-up, 8 patients who underwent IVBT had angiographic recurrence (4 in the stent and 4 at the stent edge); only 1 patient who underwent SES implantation developed recurrent ISR. At 12 months, in-stent late luminal loss was similar between the SES and IVBT groups (0.35 +/- 0.45 vs 0.34 +/- 0.46 mm, p = 0.9); however, in-stent net luminal gain was higher in the SES group than in the IVBT group (1.32 +/- 0.13 vs 0.57 +/- 0.19 mm, p <0.0001), and in-lesion late luminal loss was higher in the IVBT group (0.48 +/- 0.32 vs 0.16 +/- 0.42 mm, p = 0.004). At 12 months, intravascular ultrasound stent volume obstruction was higher after IVBT versus than after SES implantation (38.7% vs 6.7%, p <0.0001). At 15-month clinical follow-up, 64% and 96% (p <0.01) of patients who underwent IVBT and SES implantation, respectively, were free of major adverse cardiac events. In conclusion SES implantation for the treatment of ISR was effective and superior to catheter-based IVBT in preventing recurrent neointimal proliferation and angiographic restenosis at 1-year follow-up.

Serial angiography and intravascular ultrasound: results of the SISC Registry (Stents In Small Coronaries).

OBJECTIVES: The aim of this study was to evaluate the novel CardioMind Sparrow (CMS) stent (CardioMind, Inc., Sunnyvale, California) against the Multi-Link Pixel (MLP) stent (Guidant Corp., Santa Clara, California) for small vessel percutaneous coronary intervention (PCI). BACKGROUND: The CMS consists of a guidewire-based, self-expandable, ultra-thin nitinol stent with smaller profile and improved flexibility and deliverability. The performance of this novel device against a standard balloon-expandable stent for small vessel PCI has not been determined. METHODS: Twenty-one patients were treated with the CMS and compared with 30 patients treated with MLP. Only single de novo lesions <14 mm in length, in native vessels of 2.0 to 2.5 mm were included. The primary goal was the comparison of quantitative coronary angiography lumen loss and intravascular ultrasound intimal hyperplasia (IH) formation between groups at 6 months. RESULTS: Clinical characteristics were similar between groups. The CMS cohort had smaller vessels (2.20 +/- 0.20 mm vs. 2.43 +/- 0.16 mm, p < 0.0001) and shorter lesions (10.86 +/- 3.19 mm vs. 13.12 +/- 2.79 mm, p = 0.0091). Six-month late loss was significantly lower among CMS cohort (0.73 +/- 0.57 mm vs. 1.11 +/- 0.72 mm, p = 0.038). By intravascular ultrasound, 6-month IH volume was similar between groups (1.45 +/- 0.46 mm(3)/mm vs. 1.65 +/- 1.02 mm(3)/mm, p = 0.50). However, CMS presented a mean 13.39% expansion of its volumes, resulting in a significantly lower percentage of IH volumetric obstruction (31.94 +/- 8.19% vs. 39.90 +/- 4.72%, p = 0.0005). CONCLUSIONS: Despite producing similar amounts of IH volume, the self-expanding CMS stent presented chronic expansion of its volumes, better accommodating the neoformed tissue and resulting in significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLP stent.

1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial.

OBJECTIVES: We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg). BACKGROUND: Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology. METHODS: A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and

Resultados clínicos tardios do stent farmacológico liberador de sirolimus firebird® no tratamento de pacientes com doença arterial coronária na prática diária: seguimento de 24 Meses do registro CLARIFIRE / Late clinical outcomes of firebird™ sirolimus-eluting stent for the treatment of coronary artery disease in daily practice – 24-month follow-up of the CLARIFIRE registry

Introdução: O stent farmacológico liberador de sirolimus Firebird® já demonstrou eficácia na inibição de hiperplasia neointimal em pacientes selecionados submetidos à intervenção coronária percutânea. Nosso objetivo foi avaliar o desempenho e o resultado clínico tardio do dispositivo Firebird® em pacientes submetidos à intervenção coronária percutânea na prática diária nacional. Métodos: O Registro CLARIFIRE foi um estudo prospectivo, não randomizado, multicêntrico, que incluiu 455 pacientes (536 lesões) em 14 centros no Brasil entre dezembro de 2008 e maio de 2011. O seguimento clínico foi realizado aos 1, 6, 12 e 24 meses, e os eventos adversos foram adjudicados por um Comitê de Eventos Clínicos independente. Resultados: A média das idades foi de 61,1 ± 10,4 anos, 30,8% eram do sexo feminino, 41,9% tinham diabetes e 58,2% apresentaram-se com angina estável. O vaso-alvo mais prevalente foi a artéria descendente anterior (46,5%), 29,9% eram lesões reestenóticas e 8% lesões em bifurcação. Foram implantados 613 stents e as médias de extensão e diâmetro nominal dos stents foram 22,0 ± 6,4 mm e 2,90 ± 0,40 mm, respectivamente. O sucesso do procedimento foi de 97,6%. A taxa cumulativa de eventos cardíacos adversos maiores aos 12 meses (desfecho primário) foi 8,1%. Considerando-se os eventos pós-hospitalização até 24 meses (409/455), observaram-se eventos cardíacos adversos maiores em 9,8%, morte cardíaca em 3,9% e revascularização do vaso-alvo em 7,6%. Já a trombose de stent (definitiva/provável) ocorreu em nove casos (2%) até 30 dias, sem ocorrências subsequentes. Conclusões: O stent farmacológico liberador de sirolimus Firebird ® demonstrou desempenho favorável, Além de segurança e eficácia sustentadas no tratamento de pacientes da prática diária, conforme evidenciado pela elevada taxa de sucesso do procedimento e pela ocorrência relativamente baixa de eventos adversos ao final de 2 anos...

Background: The Firebird™ sirolimus-eluting stent has proven to be effective in inhibiting neointimal hyperplasia in selected patients undergoing percutaneous coronary intervention. Our objective was to evaluate the performance and long-term outcomes of Firebird ™ in patients undergoing percutaneous coronary intervention in daily practice in Brazil. Methods: The CLARIFIRE Registry was a prospective, non-randomized, multicenter study enrolling 455 patients (536 lesions) in 14 Brazilian sites between December 2008 and May 2011. Clinical follow-up was performed at 1, 6, 12, and 24 months, and adverse events were adjudicated by the independent Clinical Events Committee. Results: Mean age was 61.1 ± 10.4 years, 30.8% were women, 41.9% had diabetes, and 58.2% had stable angina. The left anterior descending artery was the most prevalent target vessel (46.5%), 29.9% were restenotic lesions, and 8% were bifurcations. Six hundred and thirteen stents were implanted, and the mean nominal stent length and diameter were 22.0 ± 6.4 mm and 2.90 ± 0.40 mm, respectively. Procedural success was 97.6%. The cumulative major adverse cardiac events rate at 12 months (primary endpoint) was 8.1%. Considering post-discharge events up to 24 months (409/455), major adverse cardiac events were observed in 9.8%, cardiac death in 3.9%, and target vessel revascularization in 7.6% of the patients. Definite/probable stent thrombosis was observed in nine cases (2%) up to 30 days, and no further occurrences were found. Conclusions: The Firebird ™ sirolimus-eluting stent has demonstrated good performance and sustained safety and efficacy for patients treated in daily practice, as evidenced by the high procedural success rates and relatively low adverse event rates after 2 years...

Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions a first-in-human analysis of a third-generation drug-eluting stent system.

OBJECTIVES: We sought to investigate the performance and efficacy of the third-generation polymer-free Vestasync-eluting stent (VES). BACKGROUND: Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 mum). METHODS: In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and < or =14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. RESULTS: Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 +/- 0.32 mm and 9.98 +/- 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 +/- 0.25 mm and percent of stent obstruction was 2.8 +/- 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. CONCLUSIONS: The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

EXCELLA First-in-Man (FIM) study: safety and efficacy of novolimus-eluting stent in de novo coronary lesions.

AIMS: First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS. METHODS AND RESULTS: In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up. CONCLUSIONS: In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.

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

BACKGROUND: The TriMaxx 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 x 15 or 3 x 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 +/- 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 +/- 0.57 mm. CONCLUSIONS: These results demonstrate that the TriMaxx 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.

A three-dimensional intravascular ultrasound comparison between the new zotarolimus-eluting stent (ZoMaxx) and the non-drug-eluting TriMaxx stent.

BACKGROUND: Despite the effectiveness of sirolimus- and paclitaxel-eluting stents in reducing intimal hyperplasia (IH) and the need for repeat revascularization, concerns about their long-term safety have motivated the search for new drug-eluting stents (DES). Recently developed, the ZoMaxx stent combines a sirolimus-analogous agent (zotarolimus), featuring a phosphorycoline polymer and stainless steel and tantalum platform. We sought to assess the efficacy of this new DES in reducing IH. METHODS: A total of 40 patients were treated with the ZoMaxx stent and compared to 50 patients treated with its non-drug-eluting equivalent, the TriMaxx stent. Only single de novo lesions in native coronary vessels greater than or equal to 3.0 mm were enrolled. Serial quantitative coronary angiography and intravascular ultrasound (IVUS) images were obtained at baseline and 6- month follow up. All patients were clinically followed for 1 year. This analysis aimed to compare the percent of IH between the 2 stents. Secondarily, we assessed in-segment late loss, binary restenosis and major adverse cardiac events. RESULTS: Baseline patient and lesion characteristics were comparable between the 2 groups. At follow up, zotarolimus efficiently suppressed neointimal hyperplasia formation with a marked reduction in the percentage of stent obstruction by IVUS (4.6 +/- 3.6% vs. 31.2 +/- 16%; p < 0.0001). Almost 90% of the segments stented with ZoMaxx did not exhibit more than 10% of obstruction. After 1 year, 12 patients treated with the TriMaxx and 2 patients treated with the ZoMaxx presented in-segment binary restenosis (p = 0.03). CONCLUSIONS: In this initial experience, ZoMaxx proved to be clinically safe and superior to its non-drug-coated equivalent in reducing in-stent IH formation and restenosis.

Randomized, double-blind, multicenter study of the polymer-based 17-beta estradiol-eluting stent for treatment of native coronary artery lesions: six-month results of the ETHOS I trial.

OBJECTIVES: The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-beta estradiol-eluting R-Stent versus uncoated control stents for the treatment of patients with single de novo native coronary lesions. BACKGROUND: Estrogens were reported to inhibit neointimal proliferation and to accelerate endothelial regeneration after coronary angioplasty and thus could be an ideal compound to deliver on a stent for the purpose of reducing in-stent restenosis. METHODS: Ninety-five patients were randomized to receive a slow-release (n = 32) or the moderate release (n = 31) formulations or the bare metal stent (n = 32). The primary end point was the 6-month percent in-stent volume obstruction by intravascular ultrasound (IVUS). RESULTS: Diabetes was present in 29.5% of patients; the mean reference vessel diameter was 2.90 mm; and the mean lesion length was 13.5 mm. Primary endpoint, 6-month percent in-stent volume obstruction by IVUS, did not differ significantly between the 3 groups (31% +/- 14%, 33% +/- 11%, and 31% +/- 14%, P = 0.83). Secondary endpoints also did not differ significantly between the groups including 6-month rates of in-lesion binary angiographic restenosis (13.3%, 14.3%, and 12.5%, P = 0.98), in-stent late loss (0.82 +/- 0.49 mm, 0.86 +/- 0.53 mm, and 0.84 +/- 0.46 mm, P = 0.97), target lesion revascularization (12.5%, 6.9%, and 6.5%, P = 0.64), and major adverse cardiac events (18.8%, 10.3%, and 6.5%, P = 0.31). CONCLUSIONS: In this first-in-man randomized trial, the 17-beta estradiol-eluting R-Stent, in either slow- or moderate-release formulations, was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls.

IMPACT Trial: angiographic and intravascular ultrasound observations of the first human experience with mycophenolic acid-eluting polymer stent system.

The purpose of the study was to examine the safety and efficacy of two different formulations of mycophenolic acid (MPA)-eluting Duraflex stents on coronary de novo lesions. Recent data indicate that local delivery of MPA in the porcine overstretch coronary model significantly reduces neointimal hyperplasia (NIH). Patients were divided into three consecutive groups. The first (n=50) and second (n=55) groups received moderate- and slow-release MPA-eluting Duraflex stent, respectively. The last group (n=50) received the bare metal Duraflex stent. Clinical, angiographic, and intravascular ultrasound analysis were performed at 6-month follow-up. All stents were successfully deployed and patients were discharged home without clinical events. Compared to controls, 6-month in-lesion and in-stent minimum luminal diameter as well as late lumen loss were not significantly different in the moderate- and slow-release treatment groups. At follow-up, percentage obstruction and NIH volume were also similar between the three groups. At 30 days and 6 and 12 months, there were no differences noted between the three groups with respect to major adverse cardiac events as well as the individual rates of mortality, myocardial infarction, or repeat revascularization. There were no cases of subacute or late thrombosis. In this feasibility trial, the MPA-eluting Duraflex stents in either slow- or moderate-release formulations were well tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. Further testing with different drug dosing or delivery rate might improve these results.

Emprego do stent farmacológico supralimus, com sirolimus e polímero absorvível, no tratamento de pacientes com síndrome coronária aguda submetidos a intervenção coronária percutânea / Use of Supralimus™ drug eluting stent with sirolimus and absorbable polymer in the treatment of acute coronary syndrome patients undergoing percutaneous coronary intervention

INTRODUÇÃO: Apesar da eficácia dos stents farmacológicos de primeira geração em reduzir a necessidade de novas intervenções, seu uso em cenários de maior complexidade, como as síndromes coronárias agudas, pode estar associado a maiores taxas de trombose. Estudos pré-clínicos têm atribuído papel central aos polímeros duráveis na gênese desses eventos adversos. O stent SupralimusTM combina uma plataforma de aço inoxidável com um polímero bioabsorvível com eluição de sirolimus. Esta análise teve por objetivo determinar a eficácia e a segurança clínica desse novo stent farmacológico no tratamento de pacientes não-selecionados com síndrome coronária aguda. MÉTODO: O Registro E-SERIES é um estudo multicêntrico e prospectivo, que inclui pacientes consecutivos tratados com SupralimusTM. Virtualmente todos os subtipos de pacientes e lesões encontram-se representados nesse registro. Toda informação pertinente ao procedimento e aos desfechos clínicos é coletada via internet, sendo os eventos adversos avaliados por comitê independente. RESULTADOS: Foram incluídos, no total, 1.263 pacientes, entre os quais 454 (35,9%) tiveram diagnóstico inicial de síndrome coronária aguda. A maioria era do sexo masculino (68,9%), com média de idade de 63 ± 11,4 anos. A incidência de diabetes melito nessa população foi elevada (36,8%). Em 6% dos casos havia trombo à angiografia pré-intervenção. Ao final do procedimento, fluxo TIMI 3 foi obtido em 96,8% dos procedimentos. A taxa de eventos cardíacos adversos na fase hospitalar foi de 1% (mortalidade de 0,4%). A taxa cumulativa de eventos cardíacos adversos maiores aos seis meses foi de 10%, com 0,4% de trombose do stent. CONCLUSÕES: Quando utilizado para tratar pacientes complexos portadores de síndrome coronária aguda, o stent farmacológico SupralimusTM demonstrou bom desempenho e segurança no seguimento de médio prazo, com baixas taxas de eventos adversos e trombose.

BACKGROUND: Despite the efficacy of first generation drug eluting stents in reducing the need of new interventions, its use in more complex conditions, such as acute coronary syndromes, may be associated to higher thrombosis rates. Pre-clinical analyses have attributed a major role to durable polymers in the genesis of these adverse events. The SupralimusTM stent combines a stainless steel platform with a bioabsorbable polymer loaded with sirolimus. This study was aimed at establishing the safety and clinical efficacy of this new drug eluting stent in non-selected acute coronary syndrome patients. METHOD: The E-SERIES Registry is a multicenter and prospective study, including consecutive patients treated with SupralimusTM stent. Virtually all subtypes of patients and lesions are represented in this registry. Information regarding the procedure and clinical outcomes is collected through the internet and adverse events are adjudicated by an independent committee. RESULTS: A total of 1,263 patients were included and 454 (35.9%) had an initial diagnosis of acute coronary syndrome. Most patients were male (68.9%) with mean age of 63 ± 11.4 years. Diabetes mellitus was highly prevalent in this subset (36.8%). Thrombus was visible at pre-intervention angiography in 6% of the cases. Final TIMI 3 flow was achieved in 96.8% of the patients. In-hospital major adverse cardiac events rate was 1% (mortality of 0.4%). Six-month cumulative major adverse cardiac events rate was 10% with 0.4% of stent thrombosis. CONCLUSIONS: The use of SupralimusTM drug eluting stent in the treatment of complex patients with acute coronary syndromes demonstrated excellent performance and safety profile in the midterm follow-up, with low adverse events and thrombosis rates.

Análise volumétrica tardia após implante de stents eluidores de sirolimus versus biolimus A9 / Late volumetric analysis after implantation of sirolimus versus biolimus A9-eluting stents

Os stents eluidores de sirolimus (SES) reduaem significativamente a incidência de reestenose e de eventos cardíacos maiores em comparação a stents convencionais. O sirolimus A9 (BA9), um análogo do sirolimus, demosntrou eficácia e segurança simulares no estudo randomizado e controlado STEALTH I. O objetivo deste estudo é comparar a eficácia do stent eluidor de BA9 com os SES, assim como seu desempenho em relação ao respectivos grupos controle, utilizando a análise volumétrica pelo ultra-som intracoronário (3D-USIC). Método: No total, 45 pacientes foram randomizados 2:1 para o grupo submetido a implante de stents eluidores de BA9(n igual 30) ou para o grupo conrole (n igual 15). Os resultados de angiografia coronária quantitativa e 3D-USIC foram comparados a uma série histórica de pacientes submetidos a implante de SES (n igual 30) ou controle (n igual 15). As características clínicas e angiográficas foram semelhantes entre os grupos , exceto pela maior quantidade de lesões tipo C e mulheres no grupo dos stents eluidores de BA9. Resultados: Aos seis meses de seguimento, a perda tardia intra-stent foi significativamente inferior...

Introduction: Sirolimus-eluting stents (SES) significantly reduce restenosis and major adverse cardiac events (MACE) compared to bare metal stents (BMS). The novel sirolimus analog, Biolimus A9T (BA9), presented similar safety and efficacy in the randomized, controlled STEALTH I trial. This study compared the efficacy of a BA9-eluting stent versus sirolimus-eluting and bare metal control stents. Methods: Forty-five patients with de novo coronary lesions were randomly assigned in a 2:1 basis to receive either BA9-eluting (n = 30) or bare metal (n=15) S-stents. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), at 6 months, were then compared to a matched series of patients who received either sirolimus-eluting (n = 30) or bare metal (n = 15) Bx Velocity stents. Baseline clinical and angiographic characteristics were similar among all groups, except for a significantly higher percentage of females and Class C lesions in the BA9-eluting stent group. Results: At 6 month follow-up, there was no significant difference in clinical outcomes between any of the groups. QCA revealed significantly lower late loss in both drug-eluting stents (DES) groups compared to bare metal controls, but no significant difference between BA9 and SES groups was observed (0.24 ± 0.39mm vs. 0.15 ± 0.38mm, p = NS). Obstruction volume measured by 3D IVUS was significantly reduced in both DES groups compared to bare metal controls, but did not differ between the BA9 and SES groups (2.23% vs. 3.30%, BA9 vs. SES, p=NS). Conclusions: BA9-eluting stents reduce neointimal hyperplasia, safely and effectively, compared to BMS, and the magnitude of this inhibition is similar to that of SES.

Análise angiográfica e ultra-sonográfica do stent liberador de novolimus para o tratamento de lesões coronárias de novo: resultados do estudo EXCELLA I / Preliminary results from the first-in-man study EXCELLA

A reestenose intra-stent coronário sofreu marcante redução com o surgimento dos stents liberadores de medicamentos, alcançando níveis de 10 por cento na maioria dos cenários clínicos e angiográficos. Desde então, novos dispositivos com diferentes fármacos vêm sendo testados com a finalidade de se obter perfil de eficácia pelo menos equivalente ao dos stents farmacológicos de primeira geração (Cypher e Taxus), mas com maior segurança tardia. Objetivo: Avaliar a segurança e a eficácia na inibição da proliferação neointimal com implante de stent liberador de novolimus. Método: Estudo unicêntrico, tipo first-in-man, com inclusão de 15 pacientes portadores de angina pectoris submetidos a implante de stent liberador de novolimus. Resultados: Análise por meio de angiografia coronária quantitativa (ACQ) e ultra-som intracoronário (USIC), realizada imediatamente após implante do stent e aos quatro meses, revelou perda tardia intra-stent de 0,15 mais ou menos 0,29 mm e no segmento, de 0,07 mais ou menos 0,3 mm. O volume de obstrução intra stent foi de 2,6 mais ou menos 2,6 por cento. Não foram observados casos de reestenose binária. O seguimento clínico aos seis meses foi obtido em todos os pacientes, não sendo observados eventos cardíacos adversos...

Background: Stent restenosis suffered a marked reduction with drug-eluting stents (DES) reaching levels below 10% in most clinical and angiographic scenarios. Since then, new devices with different drugs have been tested in order to obtain an efficiency equivalent to first generation DES (Cypher® and Taxus®), although with better long-term safety. Our objective was to evaluate safety and neointimal proliferation inhibition with novolimuseluting stent through clinical and angiographic endpoints. Methods: Single-center, first-in-man study, including 15 patients with angina pectoris submitted to novolimuseluting stent implantation. Results: Angiographic analysis with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) performed immediately after stent implantation and at 4-month follow-up revealed instent and in-segment late loss of 0.15 mm ± 0.29 mm and 0.07 mm ± 0.3 mm, respectively. In-stent volume obstruction was 2.6 ± 2.6%. No cases of binary restenosis were observed. The six-month clinical follow-up revealedno major acute cardiovascular events (MACE). Conclusion: The new novolimus-eluting stent proved to be efficient in reducing late loss and supressing neointimal proliferation. Late results in more complex group of patients are needed to confirm the safety of this new device...

Inibição da proliferação neointimal após o implante de stents eluidores de biolimus A9: Análise volumétrica tardia com ultra-som intracoronário / Supressiion of intimal proliferation after implantation of biolimus A9-eluting stents: 6-month single-center intravascular ultrasound follow-up

Introdução: O estudo STEALTH I demonstrou a eficácia e segurança dos stents eluidores de Biolimus A (BA9) em reduzir a perda-tardia angiográfica e apresentar uma baixa incidência de eventos cardíacos maiores, entretanto os achados de ultra-som intracoronário (USIC) ainda não foram descritos. O objetivo deste estudo é descrever os achados de análise volumétrica por USIC nos pacientes recrutados em nossa instituição. Métodos e Resultados: Quarenta e cinco pacientes apresentando lesão coronária de novo, única, foram randomizados 2:1 para receber stents eluidores de BA9 (n igual 30) ou stents controle (n igual 15). A média de idade foi de 58 anos, com 16 por cento diabéticos e 62 por cento do sexo masculino. As características clínicas e angiográficas foram similares entre os grupos. Aos 6 meses de seguimento não houve diferença significativa entre os grupos quanto a desfechos clínicos. O índice de hiperplasia intimal intra-stent foi inferior no grupo dos stents eluidores de BA9 em comparação ao grupo controle 0,19 mais/menos 0,08 vs. 2.71 mais/menos 0.50, ) menor 0.0001), assim como o percentual de obstrução...

Background: Biolimus A9 (BA9) is a novel sirolimus analog with similar antiproliferative properties. BA9-eluting stents reduce angiographic late-loss compared to bare metal stents (BMS), with a low incidence of major adverse cardiac events (MACE), as reported in the randomized, controlled STEALTH I trial. We describe the intravascular ultrasound (IVUS) volumetric findings of patients enrolled at our institution. Methods and Results: Forty-five patients presenting a single, de novo coronary lesion (2.5-4.0 mm vessels; lesion length <24 mm) were randomly assigned in a 2:1 basis to receive either BA9-eluting (n=30) or bare metal stents (n=15). Mean age was 58 years, with 16% diabetics and 62% men. Baseline clinical and angiographic characteristics were similar between groups. At 6 month follow-up, there was no statistical difference in clinical outcomes between groups. In-stent intimal hyperplasia index measured by IVUS was 0.19+/-0.08 mm3/ mm3 for the BA9 group vs. 2.71+/-0.50 mm3/mm3 for BMS controls. The percentage of stent obstruction was also significantly lower for the BA9 group when compared to BMS (2.2+/-0.80% vs. 19.9+/-4.67%, P<0.0001). No stent thrombosis, aneurysm formation or incomplete stent apposition was observed in any group. Conclusions: Using IVUS volumetric analysis, we showed that BA9-eluting stents have a potent inhibitory effect on neointimal proliferation when compared to BMS at 6-month follow-up.

Estudo prospectivo e randomizado de pacientes tratados com e sem stents revestidos com carbeto de silício amorfo para a prevenção da reestenose coronariana. Avaliação ultra-sonográfica / Randomized intravascular ultrasound comparison between endoprostheses with and without amorphous silicon-carbide

OBJETIVO: A reestenose intra-stent é a maior limitação das intervenções coronárias percutâneas. O carbeto de silício amorfo (SiC-a), substância antitrombótica e antiinflamatória capaz de reduzir a deposição de fibrina, plaquetas e leucócitos sobre o stent, apresenta potencial de prevenir a hiperplasia neo-intimal e a reestenose. MÉTODOS: Estudo prospectivo, randomizado e tipo rótulo aberto comparando pacientes com doença coronariana tratados com e sem stents revestidos com o SiC-a, utilizando a angiografia quantitativa e o ultra-som intracoronário. Foram incluídos 100 pacientes (50 em cada grupo) a fim de mensurar o volume de hiperplasia neo-intimal intra-stent/extremidades. Como os stents comparados apresentavam extensões diferentes, o volume de hiperplasia foi analisado em valores absolutos (por paciente) e relativos (por milímetro de extensão do stent). Avaliaram-se ainda os eventos cardíacos maiores e os resultados da angiografia quantitativa. RESULTADOS: Os grupos apresentaram características de base semelhantes. Todos os pacientes foram tratados com sucesso. No 6° mês de evolução foram reestudados 94 por cento dos casos dos dois grupos, obtendo-se ultra-som em 92 por cento. O volume de hiperplasia neo-intimal absoluto foi significativamente maior nos tratados com os stents revestidos (51.2 DP 18.8 mm³ vs 41.9 DP 16.4 mm³; p=0.014), porém o relativo foi semelhante (2.9 DP 1.0 mm³/mm stent vs 2.5 DP 0.9 mm³/mm stent; p=0.108). A obstrução volumétrica da luz também foi similar (36.4 DP 11.1 por cento vs 37.9 DP 10.9 por cento; p=0.505). O diâmetro mínimo da luz (1.9 DP 0.7 mm vs 1.8 DO 0.6 mm; p=0.552), a reestenose (19.1 por cento vs 17 por cento; p>0.999) e a revascularização do vaso-alvo (16 por cento vs 14 por cento; p>0.999) não diferiram. CONCLUSÃO: Os stents revestidos apresentaram resultados clínicos, angiográficos e ultra-sonográficos similares aos controles.