Serial greyscale and radiofrequency intravascular ultrasound assessment of plaque modification and vessel geometry at proximal and distal edges of bare metal and first-generation drug-eluting stents.

BACKGROUND: Little is known about the correlation between modifications in plaque composition at stent edges and the changes in vessel geometry. This study sought to evaluate, by serial greyscale intravascular ultrasound (IVUS) and Virtual Histology intravascular ultrasound (VH-IVUS), the modifications in plaque composition at the edges of drug-eluting and bare metal stents and the correlation of these findings with changes in the measurements of vessel, lumen and plaque area at those segments. METHODS AND RESULTS: Single-centre, prospective and randomised (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare metal (Driver; Medtronic, Santa Clara, CA, USA; n=20 patients) or drug-eluting stents (Cypher; Cordis, Miami Lakes, FL, USA; n=20 patients). IVUS and VH-IVUS assessments were done post-procedure and at nine months. Primary endpoint included the modification in vessel, lumen and plaque area and in the composition of the plaque in the mean time between the baseline and follow-up procedure. At the proximal edge of the vessel treated with the Cypher stent, a trend toward positive vessel remodelling (D=+0.6 mm², p=0.06) was observed while at the distal edge, less plaque growth (D=+0.2 mm² vs. D=+1.1 mm², p<0.001), resulted in a larger lumen area at follow-up. By VH, there was a marked reduction in the percentage of fibrotic tissue and necrotic core at the edges of both stents and a positive correlation was seen between increase in percentage of fibro-fatty component and increase in plaque area (r=0.78, p=0.01). CONCLUSION: Patients treated with drug-eluting stents (DES) experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty tissue component, may partially explain these findings.

Serial greyscale and radiofrequency intravascular ultrasoundassessment of plaque modification and vessel geometry atproximal and distal edges of bare metal and first-generationdrug-eluting stents

Background: Little is known about the correlation between modifications in plaque composition at stentedges and the changes in vessel geometry. This study sought to evaluate, by serial greyscale intravascularultrasound (IVUS) and Virtual Histology® intravascular ultrasound (VH®-IVUS), the modifications in plaquecomposition at the edges of drug-eluting and bare metal stents and the correlation of these findings withchanges in the measurements of vessel, lumen and plaque area at those segments.Methods and results: Single-centre, prospective and randomised (1:1) evaluation of 40 patients with acutecoronary syndrome treated with bare metal (Driver™; Medtronic, Santa Clara, CA, USA; n=20 patients) ordrug-eluting stents (Cypher™; Cordis, Miami Lakes, FL, USA; n=20 patients). IVUS and VH-IVUS assessmentswere done post-procedure and at nine months. Primary endpoint included the modification in vessel,lumen and plaque area and in the composition of the plaque in the mean time between the baseline and followupprocedure. At the proximal edge of the vessel treated with the Cypher™ stent, a trend toward positive vesselremodelling (Δ=+0.6 mm2, p=0.06) was observed while at the distal edge, less plaque growth (Δ=+0.2 mm2 vs.Δ=+1.1 mm2, p<0.001), resulted in a larger lumen area at follow-up. By VH, there was a marked reduction inthe percentage of fibrotic tissue and necrotic core at the edges of both stents and a positive correlation was seenbetween increase in percentage of fibro-fatty component and increase in plaque area (r=0.78, p=0.01).Conclusion: Patients treated with drug-eluting stents (DES) experienced less plaque growth, especially atthe distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty tissue component,may partially explain these findings.

Experiência inicial com uso de stents eluidores de everolimus em pacientes do mundo real: seguimento clínico de um ano / Early experience with everolimus-eluting stents in real-world patients: one-year clinical follow-up

INTRODUÇÃO: Os stents eluidores de everolimus mostraramse seguros e eficazes em estudos randomizados com pacientes selecionados e de baixa complexidade clínica e angiográfica. No entanto, estudos que avaliam seu impacto em pacientes mais complexos da prática clínica corrente são escassos. MÉTODO: No total, foram avaliados, prospectivamente, 193 pacientes tratados apenas com stents eluidores de everolimus. Os únicos critérios de exclusão foram reestenose de outro stent farmacológico, intervenção em enxertos de veia safena, e infarto agudo do miocárdio com elevação do segmento ST. O desfecho primário foi a ocorrência de eventos cardíacos adversos maiores, definidos como a combinação de morte de origem cardíaca, infarto do miocárdio e revascularização do vaso-alvo. RESULTADOS: A média das idades foi de 60,6 ± 11,8 anos. Metade da população era do sexo feminino e 36,8% eram portadores de diabetes. Doença multiarterial estava presente em 61,6% dos pacientes. Foi tratada 1,8 ± 0,66 lesão em 1,73 ± 0,9 vaso, com 2,27 ± 0,9 stents por paciente. A maioria das lesões (70,6%) era do tipo B2/C, bifurcações verdadeiras foram tratadas em 37,3% dos casos e calcificação moderada a grave estava presente em 17,4% das lesões. Eventos cardíacos adversos maiores ocorreram em 6,7% dos pacientes ao final de um ano, principalmente à custa de eventos da fase hospitalar. Houve apenas um caso (0,5%) de trombose subaguda provável do stent. Não houve casos de trombose tardia. CONCLUSÕES: A presente análise sugere que o uso de stents eluidores de everolimus é seguro e eficaz em pacientes complexos da prática clínica diária, com baixas taxas de eventos cardíacos adversos maiores até o final do primeiro ano. Seguimento mais longo e com maior número de pacientes é necessário para confirmação desses resultados promissores.

BACKGROUND: Everolimus-eluting stents have proved to be safe and effective in the treatment of low-risk, selected patients, from randomized trials. Nonetheless, studies assessing their impact on more complex real-world patients are rare. METHOD: We prospectively evaluated 193 patients treated with everolimus-eluting stents alone. The only exclusion criteria were: in-stent restenosis of another drug-eluting stent, percutaneous coronary intervention of a saphenous vein graft and acute myocardial infarction with ST segment elevation. The primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. RESULTS: Mean age was 60.6 ± 11.8 years. Half of the patients were women and 36.8% were diabetics. Multivessel disease was found in 61.6% of the patients. Patients had 1.8 ± 0.66 lesion treated in 1.73 ± 0.9 vessel, with a mean of 2.27 ± 0.9 stents per patient. The majority (70.6%) of the lesions were type B2/C, true bifurcations were treated in 37.3% of the cases and moderate to severe calcifications were observed in 17.4% of the lesions. The 1-year MACE rate was 6.7%, mainly due to the occurrence of in-hospital events. There was only one (0.5%) case of probable subacute stent thrombosis. No cases of late stent thrombosis were observed. CONCLUSIONS: The present analysis suggests that the use of everolimus eluting stents is safe and effective in the treatment of complex patients from the daily clinical practice, with low major adverse cardiac events rate in the 1-year follow-up. Longer follow-up with a larger number of patients is required to confirm these promising results.