Background Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. Methods We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. Results The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting ...

https://www.nejm.org/doi/pdf/10.1056/NEJMoa035071

Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

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A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization

The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) 2005 Guideline Update for Percutaneous Coronary Intervention (PCI) contains changes in the recommendations, along with supporting text. For the purpose of comparison

https://cdr.lib.unc.edu/downloads/k3569637k

ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention-summary article : A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)

Background— The US Food and Drug Administration recently issued a warning of subacute thrombosis and hypersensitivity reactions to sirolimus-eluting stents (Cypher). The cause and incidence of these events have not been determined. Methods and Results— We present findings of a 58-year-old man who died of late stent thrombosis 18 months after receiving 2 Cypher stents for unstable angina. Although angiographic and intravascular ultrasound results at 8 months demonstrated the absence of neointimal formation, vessel enlargement was present. An autopsy showed aneurysmal dilation of the stented arterial segments with a severe localized hypersensitivity reaction consisting predominantly of T lymphocytes and eosinophils. Conclusions— The known pharmacokinetic elution profile of Cypher stents and the presence of polymer fragments surrounded by giant cells and eosinophils suggest that a reaction to the polymer may have caused late stent thrombosis. Careful long-term follow-up of patients with vessel enlargement af...

Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious?

Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents.

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. METHODS 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 analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months. CONCLUSIONS: The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.

/pdf/lack-of-neointimal-proliferation-after-implantation-of-3mtf6c2d5x.pdf

Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study

The ventricular septal rupture (VSR) following acute myocardial infarction (AMI) is a rare and catasthrophic complication with a high mortality rate. Surgery is the only effective procedure to try to control this complication. However the surgical mortality is elevated and is closely related to the post-infarct period thus making the indication for the precise time for surgery one the fundamental aspects for its success. In a population of 48 patients with diagnosis of VSD following AMI, according to the criteria of the Myocardial Infarction Research United, we treated 32 (67%) with surgery. The diagnosis was confirmed by hemodynamic in all patients. The AMI was anterior in 18 cases (56%) and inferior in 14 (44%); the mortality rate is 6 (33%) and 4 (29%) cases respectively. Severe heart failure (Killip III and IV) was present in 26 cases (81%) and life threatening arrhythmias in 13 (41%). A Swan-Ganz catheter was introduced at bedside in 18 (56%) patients to confirm the diagnosis and provide a better therapeutic management. Angiographic studies were performed in 31 (97%). Cineangiography showed a critical lesion (obstruction equal or greater than 70% of the lumen) in one vessel in 22 patients (71%): left anterior descending coronary artery in 15 (68%), right coronary artery in 6 (27%) and left circunflex in 1 (5%). Nine cases (29%) had critical lesions in two vessels. The pulmonary artery pressure was always elevated in those patients in whom the pressure was measured. Clinical treatment was used in 16 (33%) cases and all died during hospitalization. Eight patients (25%) underwent the surgery within the first two weeks and 24 (75%) after this period; mortality rate was 6 (75%) and 4 (17%) cases respectively. Nine patients were re-catheterized in the post operative period and only one presented signs of significant shunt in the ventricular level. This patient who was the oldest of the group was reoperated later. Of the 22 patients discharged from the hospital 15 are long-term survivors. In 3 the follow-up was lost and 4 died. The accumulated data allows us to conclude that: 1) the attempt to postpone surgery by keeping the patients under medical treatment waiting for a more favorable time for surgery did not produce satisfactory results; 2) surgery should be performed in the acute phase (first two weeks) in spite of a still elevated mortality in this group; 3) after the first two weeks the results are good with low mortality rate for this kind of surgery; 4) VSD reappearence was infrequent.

/pdf/tratamento-cirurgico-da-rotura-do-septo-interventricular-pos-zzfhcjazge.pdf

Tratamento cirúrgico da rotura do septo interventricular pós infarto agudo do miocárdio

A cirurgia de revascularizacao do miocardio (CRM) e frequentemente empregada como metodo complementar no tratamento da lesao coronaria residual, apos a reperfusao, no infarto agudo do miocardio (IAM). Pode ser feita tanto na fase aguda como tardiamente. Neste trabalho, sao analisados os resultados obtidos em 45/159 (28%) pacientes (p) submetidos a CRM apos reperfusao miocardica, com sucesso. Foram divididos em dois grupos, segundo o metodo de reperfusao utilizado: I) 27 (60%) reperfundidos com estreptoquinase (STK), sendo intracoronaria em 22 (81%) e intravenosa em 5 (18%); II) 18 (40%) reperfundidos atraves da angioplastia coronaria (AC), isolada em 10 (55%) e precedida de STK em 8 (45%). Estes pacientes foram analisados quanto ao momento da cirurgia, a evoluao clinica, reestudos angiograficos, avaliacao da funcao ventricular e obitos. Os mesmos foram seguidos num periodo de 2 a 55 meses. Os autores discutem os achados encontrados, assim como a capacidade da CRM de complementar a reperfusao, com sucesso, no IAM.

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Ibraim Francisco Pinto

Papers

Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study

Tratamento cirúrgico da rotura do septo interventricular pós infarto agudo do miocárdio

Revascularização cirúrgica após reperfusão no infarto agudo do miocárdio