Four-Year Angiographic and Intravascular Ultrasound Follow-Up of Patients Treated With Sirolimus-Eluting Stents

Abstract

Background-Despite the proven superiority of sirolimus-eluting stents (SESs) 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; nϭ15] and fast release [FR; nϭ15]). 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 total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41Ϯ0.49 mm) than the SR group (0.09Ϯ0.23) 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 (FRϭ9.1% and SRϭ5.7%). 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). Key Words: angiography Ⅲ restenosis Ⅲ stents D rug-eluting stent (DES) implantation is rapidly becoming the prime revascularization strategy for obstructive coronary artery disease because of reduced incidence of in-stent restenosis. 1-3 Despite much enthusiasm, only a few DES devices have proven clinical effectiveness, and longterm data are lacking.Most bioactive agents of DESs alter cell cycle division and have unpredictable long-term effects in the vessel wall. 4 These cellular effects, which may resemble the mechanism of action of radiation therapy, have raised concerns about the safety of the DES beyond the initial years after implantation. In addition, nonbiodegradable polymer coatings, as well as residual medication in some devices, remain on the stent surface in close contact with arterial wall structures and represent a potential source for late inflammation, restenosis, or other side effects. The present study provides a unique opportunity to evaluate clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with sirolimus-eluting stents (SESs) 4 years after implantation. MethodsThe study sample and study protocol have been described previously. 1 In brief, 30 consecutive patients were implanted with a single sirolimus-eluting Bx Velocity stent fro...

Effectiveness of a Sirolimus-Eluting Stent (Cypher ) for Diffuse In-Stent Restenosis Inside a Bare Metal Stent

“…Thus, the further long-term efficacy of SES, including MACE, the incidence of LST, 18) and adverse complications such as bleeding due to the long-term potent antiplatelet therapy should be carefully studied, as previously reported. 33) Conclusion: SES for diffuse ISR was far superior to POBA, CB, and BMS due to the marked reduction of 6-month re-ISR and re-TLR.…”

Ocena potencjału terapeutycznego Temsirolimusu w zaawansowanym stadium renal cell carcinoma

“…Preparat wykorzystywano w zabiegach implantacji stentgraftów u chorych z miażdżycą naczyń wieńcowych. Pokryte Rapamycyną stentgrafty ograniczały proliferację komórek mięśni gładkich indukowaną przez lokalny proces zapalny [25]. Niemniej, w literaturze brak doniesień na temat immunosupresyjnego działania Temsirolimusu, jak i dowodów wykluczających hamujący wpływ na układ immunologiczny.…”

“…Wyższy odsetek myszy z ogniskami nowotworowymi w płucu w grupie przyjmującej preparat w stosunku do grupy kontrolnej może świadczyć o zahamowaniu odpowiedzi układu odpornościowego przez Temsirolimus. Wymykanie się RCC spod nadzoru immunologicznego może być związane z ograniczeniem przez Temsirolimus odpowiedzi limfocytów T na sygnalizację IL-1, Il-2, IL-3, IL-4, IL-6 [25]. Dane przedstawono na ryc.…”

Conflitos éticos e judiciais no emprego dos stents farmacológicos no Brasil: análise das principais controvérsias para incorporação dessa tecnologia nos sistemas de saúde público e privado no país

“…O advento dos stents farmacológicos aumentou o perfil de eficácia das ICP 8 , possibilitando seu emprego em situações clínicas não consideradas previamente. Ampliou-se, por conseguinte, o cenário de sua aplicação em cardiologia 9 , constituindo-se em alternativa segura e eficaz no tratamento da DAC, notadamente, por reduzir, de forma significativa, a frequência de ocorrência do fenômeno da reestenose.…”