Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery System via Radial Approach With 5 Fr Catheters.

PURPOSE: To evaluate the safety and efficacy of the Svelte Acrobat integrated delivery system (IDS) via radial approach with 5 Fr catheters. The direct stenting (DS) system enables easy delivery, deployment, and postdilatation of a cobalt-chromium stent. METHODS: Patients with coronary artery disease (CAD) were prospectively enrolled at three centers to undergo percutaneous coronary intervention with DS via radial approach using 5 Fr catheters. The primary endpoint was IDS success, which was defined as DS without postdilatation and final stenosis <20% with Thrombolysis in Myocardial Infarction (TIMI)-3 flow. RESULTS: Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The device could not cross the lesion in 2 cases, so DS success was 96%. Fifty lesions met the primary study objective; thus, IDS success rate was 91%. The procedure duration was 21 ± 9 minutes, fluoroscopy time was 7.3 ± 4.7 minutes, and contrast volume per vessel was 103 ± 33 cm3. The final residual stenosis, by quantitative coronary angiography, was 3.4 ± 4%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications. At 8 months, the event-free survival rate was 84%. CONCLUSIONS: DS using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings.

Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.

IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.

Three vs twelve months of dual antiplatelet therapy after Zotarolimus-Eluting Stents the OPTIMIZE andomized trial

The current recommendation is for at least 12 months of dual antiplatelettherapy after implantation of a drug-eluting stent. However, the optimal duration of dualantiplatelet therapy with specific types of drug-eluting stents remains unknown.OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months(long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronaryintervention (PCI) with zotarolimus-eluting stents.DESIGN, SETTING, AND PATIENTS The OPTIMIZE trialwas an open-label, active-controlled, 1:1randomized noninferiority study including 3119 patients in 33 sites in Brazil between April2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligiblepatients were those with stable coronary artery disease or history of low-risk acute coronarysyndrome (ACS) undergoing PCI with zotarolimus-eluting stents.INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin(100-200mg daily) and clopidogrel (75mg daily) for 3 months (n = 1563) or 12 months(n = 1556), unless contraindicated because of occurrence of an end point.MAIN OUTCOMES AND MEASURES The primary end pointwas net adverse clinical and cerebralevents (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or majorbleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%.Secondary end points were major adverse cardiac events (MACE; a composite of all-causedeath, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization)and Academic Research Consortium definite or probable stent thrombosis.RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receivinglong-term therapy...

Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study.

BACKGROUND: Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS: The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS: The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study

Background Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation includeprolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short durationDAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined.Methods The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice.Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause),myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure.Conclusions The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the secondgeneration E-ZES in real-world patients undergoing percutaneous coronary intervention.

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.

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 wereincluded. 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 mm3/mm vs. 1.65 1.02 mm3/mm, p 0.50). However, CMS presenteda 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 resultingin significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLPstent.

Análise comparativa da intervenção coronária percutânea com stents famacológicos versus stents não-farmacológicos na vigência de infarto do miocárdio com supradesnivelamento do segmento ST: dados do registro brasileiro CENIC / Comparative analysis of percutaneous coronary intervention (PCI) with drug-eluting stents versus bare-metal stents in acute ST-segment elevation myocardial infarction (STEMI): data from the CENIC registry

Fundamento: A intervenção coronária percutânea primária (ICPP) com stents farmacológicos apresenta resultados ainda incipientes e controversos na literatura. Objetivo: Comparar os resultados da ICPP com stents farmacológicos e não-farmacológicos no Brasil, no biênio 2006-2007. Método: De janeiro de 2006 a dezembro de 2007, todos os pacientes consecutivos acometidos de infarto agudo do miocárdio (IAM) com supradesnivelamento do segmento ST, tratados por meio da ICPP com stents farmacológicos ou não, devidamente relacionados no banco de dados da Central Nacional de Intervenções Cardiovasculares (CENIC) foram analisados quanto às características clínicas e angiográficas e aos resultados na fase hospitalar. Resultados: Foram analisados 4.876 pacientes tratados por meio da ICPP, e em 4.674 (95,9%) dos quais foram utilizados stents não-farmacológicos e em 202 (4,1%), stents farmacológicos. O sucesso do procedimento foi maior após os stents farmacológicos em relação aos não-farmacológicos (97,5% vs. 93,5%; p = 0,02). Não houve diferenças entre os grupos quanto à trombose da endoprótese (1,5% vs. 1,3%; p = 0,869) ou mesmo quanto à incidência geral de complicações (1,0% vs. 2,8%; p = 0,119). A mortalidade tendeu a ser menor após stents farmacológicos (2,0% vs. 4,4%; p = 0,098). Conclusão: No Brasil, a ICPP com stents farmacológicos apresenta baixas taxas de trombose e de mortalidade na fase hospitalar, comparáveis às taxas observadas com stents sem fármacos, em amostra populacional relativamente restrita de pacientes, nos quais...

Background: Primary percutaneous coronary interventions (PPCI) with drug-eluting stents have incipient and still controversial results in the literature. Objective: To compare PPCI with drug-eluting and bare-metal stents in Brazil during the period 2006-2007. Method: All consecutive patients with ST-segment elevation myocardial infarction (STEMI) treated with PPCI with drug-eluting or bare-metal stents, reported to the database of the National Center for Cardiovascular Interventions (CENIC) from January 2006 to December 2007, were compared as to their clinical and angiographic characteristics and in-hospital results. Results: 4,876 patients treated with PPCI were analyzed; 4,674 (95.9%) used bare-metal stents and 202 (4.1%), drug-eluting stents. Procedural success rates were higher with drug-eluting stents (97.5% vs. 93.5%; p = 0.02). There were no differences in the rates of stent thrombosis (1.5% vs. 1.3%; p = 0.869) or overall complications (1.0% vs. 2.8%; p = 0.119). Mortality tended to be lower with drug-eluting stents (2.0% vs. 4.4%; p = 0.098). Conclusion: In Brazil, PPCI with drug-eluting stents has a low rate of thrombosis and in-hospital mortality, compared to that observed for bare-metal stents in a relatively selected...

Stents auto-expansíveis versus balão-expansível para tratamento de lesões em vasos de fino calibre: estudo com ultra-som intracoronário tridimensional / Self-expanding versus balloon-expandable stents for the treatment of small coronary vessels: a three-dimensional intracoronary ultrasound study

Introdução: Intervenção coronária pecutânea em vasos de fino calibre (VF) está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose. Estudos prévios têm sugerido que stents auto-expansíveis causam menos injúria vascular no momento do implante, com expansão de seus volumes com o tempo, gerando maiores áreas luminais que stents balão-expansíveis. A influência desses fenômenos em VF ainda é desconhecida. Objetivos: Avaliar as propriedades mecânicas e a eficácia do novo stent CardioMind no tratamento de lesões em VF em comparação ao stent balão-expansível Multi-link Pixel (Pixel). Método: Treze pacientes portadores de lesões únicas primárias < 14 mm de extensão, em artérias coronárias nativas < 2,5 mm de diâmetro, foram tratados com o stent CardioMind e comparados a uma corte histórica de 25 pacientes, com os mesmos critérios de inclusão, tratados com o stent Pixel. Ultrasom intracoronário (USIC) seriado foi realizado pós-procedimento e aos 7,3 +/- 1,0 meses. Resultados: A média das idades foi de 58,1 +/- 9,9 anos, com 60,5 por cento do sexo masculino e 39,4 por cento diabéticos. Ambos os stents produziram volumes de hiperplasia neo-intimal (HNI) smelhantes...

Background: Percutaneous coronary intervention in small vessels (SV) is associated with poor short- and long-term outcomes, with high rates of restenosis. Previous studies have suggested that self-expanding stents can cause less vessel injury at implantation, expanding their volumes over time, and leading to larger luminal areas than those of balloon-expandable stents. The influence of these phenomena on SV remains unknown. Objectives: To assess the mechanical properties and efficacy of the novel CardioMind™ stent in comparison with the balloon-expandable Multi-Link Pixel™ (Pixel) stent in the treatment of SV. Methods: Thirteen patients with single, de novo, < 14 mm length lesions in native coronary arteries < 2.5 mm in diameter were treated with the CardioMind™ stent and compared with a historical cohort of 25 patients, with the same inclusion criteria, treated with the Pixel™ stent. Intravascular ultrasound (IVUS) was performed serially after the procedure and at 7.3 ± 1.0 months of follow-up. Results: Mean age was 58.1 ± 9.9 years; 60.5% were male and 39.4% were diabetic. Both stents produced similar neointimal hyperplasia (NIH) volumes (indexed NIH volume: 1.45 ± 0.46 mm³/mm for CardioMind™ versus 1.66 ± 1.02 mm³/mm for Pixel™; p = 0.48). However, the CardioMind™ stentpresented a 12% expansion of its volume, leading to a...

[Comparative analysis of intimal hyperplasia after sirolimus-eluting stent and thin-strut bare-metal stent implantation in small coronary arteries]. / Análise comparativa da hiperplasia intimal após o implante de stents com e sem sirolimus em artérias coronárias de pequeno calibre.

OBJECTIVE: This study aimed at evaluating reduction in intimal hyperplasia volume following angioplasty using sirolimus-eluting stents (Cypher) compared with thin-strut bare-metal stents (Pixel) in patients with small vessels. METHODS: Eighty patients with coronary artery disease were prospectively included in two consecutive series, the first using sirolimus-eluting stents (50) and the second using bare-metal stents (30). RESULTS: The use of sirolimus-eluting stents reduced: in-stent net volume obstruction [5.0% (SE = 0.77) x 39.0% (SE = 4.72), p < 0.001], in-stent late loss [0.25 mm (SE = 0.03) x 1,11 mm (SE = 0.13), p < 0.001], in-segment late loss [0.30 mm (SE = 0.04) x 0.83 mm (SE = 0.11), p < 0.001], in-stent restenosis (0% x 33.3%, p < 0.001) and in-segment restenosis (4% x 36.7%, p < 0.001). The event-free survival rate was 96% in the sirolimus-eluting stent group versus 86.7% in the bare-metal stent group (BMS) (p = 0.190). CONCLUSION: Sirolimus-eluting stents are superior to thin-strut bare-metal stents in reducing intimal hyperplasia (less in-stent obstruction and less late lumen loss) in patients with small vessels. The use of these stents significantly reduced angiographic restenosis at eight months.

Análise comparativa da hiperplasia intimal após o implante de stents com e sem sirolimus em artérias coronárias de pequeno calibre / Comparative analysis of intimal hyperplasia after sirolimus-eluting stent and thin-strut bare-metal stent implantation in small coronary arteries

OBJETIVO: Avaliar a redução do volume de hiperplasia intimal após angioplastia com stents com sirolimus (Cypher®) comparados com os stents não-recobertos de estrutura metálica fina (Pixel®) em pacientes com vasos pequenos. MÉTODOS: Oitenta pacientes com doença arterial coronariana foram prospectivamente incluídos em duas séries consecutivas de tratamento, sendo a primeira empregando stents com sirolimus (50) e a segunda stents não-recobertos de estrutura metálica fina (30). RESULTADOS: Os resultados foram: menor porcentual de obstrução da prótese através do ultra-som intracoronário [5,0 por cento (EP = 0,77) x 39,0 por cento (EP = 4,72), p < 0,001], menor perda tardia intra-stent [0,25 mm (EP = 0,03) x 1,11 mm (EP = 0,13), p < 0,001] e no segmento do vaso [0,30 mm (EP = 0,04) x 0,83 mm (EP = 0,11), p < 0,001], e também menor reestenose intra-stent (0 por cento x 33,3 por cento, p < 0,001) e no segmento do vaso (4 por cento x 36,7 por cento, p < 0,001) com os stents com sirolimus. A sobrevivência livre de eventos foi de 96 por cento com os stents com sirolimus x 86,7 por cento com os stents não-recobertos (p = 0,190). CONCLUSÃO: Os pacientes com vasos de pequeno calibre após o implante de stents com sirolimus evoluem com menor hiperplasia intimal (menor porcentual de obstrução intra-stent e menor perda tardia) do que quando são utilizados stents não-recobertos de estrutura metálica fina. Isto resultou em redução significativa da reestenose angiográfica aos oito meses de evolução.

Reperfusão mecânica no infarto agudo do miocárdio / Percutaneous coronary intervention in acute myocardial infarction

A recanalização da artéria epicárdica culpada foi o grande avanço no tratamento do infarto agudo do miocárdio. A estratégia farmacológica com fibrinolíticos permitiu a obtenção de amplo benefício clínico, documentado pela redução da mortalidade em diversos estudos. A utilização endovenosa dessas drogas, entretanto, também exibe limitações, entre outras o baixo porcentual de patência do vaso culpado, com fluxo veloz e persistente. A obtenção desse fluxo TIMI 3 correlaciona-se diretamente com maior sobrevida, adquirindo grande importância em qualquer estratégia de reperfusão no infarto agudo do miocárdio. Paralelamente, a estratégia mecânica de reperfusão no infarto agudo do miocárdio demonstrou sua vantagem em relação aos fibrinolíticos, já na angioplastia com balão, nos estudos clínicos da década de 90. Assim sendo, a intervenção percutânea, nessa condição, promove maior sobrevida, menor reinfarto e menor necessidade de nova revascularização, com maior segurança. A incorporação dos stents coronarianos ampliou tais benefícios, tanto pelo alto perfil de segurança de implante como pela redução da reestenose. Mais recentemente, atenção especial foi dada à microcirculação e à reperfusão tecidual completa no infarto agudo do miocárdio, permitindo a introdução de novos fármacos (inibidores da glicoproteína IIb/IIIa), que, com sinergismo, potencializaram a vantagem da angioplastia primária, na otimização dos resultados apresentados. Recentemente, com o estudo CADILLAC, a Cardiologia Intervencionista sintetiza a estratégia mecânica de reperfusão no infarto agudo do miocárdio, que, no momento, direciona nossas condutas.