sirolimus and Shock--Cardiogenic

Very late stent thrombosis (VLST) is a catastrophic complication after implantation of a drug-eluting stent (DES). It has been reported that VLST is associated with pathological changes, which often include late acquired incomplete stent apposition (LAISA) with thrombus formation. In addition, the vascular response to the stent (evaginations, neointimal growth, and thrombosis) and the incidence of LAISA are reported to vary among the different types of DES. We experienced a patient with cardiogenic shock induced by simultaneous VLST of both the left anterior descending artery (LAD) and the left circumflex artery (LCX) at 3 years after implantation of two sirolimus-eluting stents. Intravascular ultrasound (IVUS) showed LAISA of both arteries. A paclitaxel-eluting stent, which had been implanted in the right coronary artery 3 years earlier, did not show such a finding. IVUS revealed "different vascular reactions" to "different types of DES" in this patient.

Topics: Coronary Angiography; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Paclitaxel; Postoperative Complications; Shock, Cardiogenic; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

A 67-year-old man with recent myocardial infarction underwent a total of five sirolimus-eluting stents (SES) implantation for three vessels stage by stage. A follow-up angiography showed no significant restenosis except one in the side branch. Thereafter, he had remained asymptomatic. Sixty-six months later, he had an acute myocardial infarction with cardiogenic shock due to simultaneous 3-vessel very late stent thrombosis (VLST). After successful percutaneous coronary intervention, final angiography revealed serious peri-stent contrast staining along with positive remodeling and grade V stent fracture. This rare case illustrates simultaneous 3-vessel VLST, associating with multiple SES-related problems, under continuation of aspirin and cilostazol.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Platelet Aggregation Inhibitors; Radiography; Recurrence; Shock, Cardiogenic; Sirolimus; Time Factors; Treatment Outcome

A 58-year-old man underwent an elective coronary bypass graft for severe four-vessel stenosis. Cardiogenic shock developed just after coronary bypass grafting with a left internal mammary artery (LIMA) to left anterior descending (LAD) artery and superficial venous graft to 1st and 2nd obtuse marginal (OM1/OM2) arteries the posterior descending artery (PDA) was too small to graft. Despite significant inotropes and an intra-aortic balloon pump, the patient deteriorated in intensive care unit with cardiogenic shock and ventricular arrhythmia. Urgent coronary angiography revealed a rupture or torn LIMA graft with extravasation of contrast into the left pleural cavity. There was no distal LIMA to LAD flow probably due to graft thrombosis. Revascularisation was performed on the severe ostial native LAD stenosis with a drug eluting stent. The rupture graft was then stented with a polytetrafluoroethylene-covered stent, which stopped the bleeding, and latter, led to total graft thrombosis. The patient improved significantly and supportive inotropes could be weaned down. At 11 month follow-up, the patient had mild left ventricular dysfunction, widely patent ostial LAD stent and thrombosed LIMA graft.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Male; Mammary Arteries; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Rupture; Severity of Illness Index; Shock, Cardiogenic; Sirolimus; Treatment Outcome; Vascular System Injuries

To determine the risk of short- and long-term mortality and major adverse cardiac events (MACE) in acute myocardial infarction (AMI) patients complicated by cardiogenic shock (CS) in the contemporary practice of primary percutaneous coronary intervention with stenting.. Of the 1,755 consecutive AMI patients undergoing percutaneous coronary intervention with stenting enrolled, 103 had CS at admission. Primary endpoints were early mortality (within 30 days after the index event) and late mortality (from day 31 up to 4 years). Secondary endpoints included MACE [all-cause death, myocardial infarction or target vessel revascularization (TVR)], myocardial infarction, TVR and stent thrombosis.. Thirty-day mortality was higher among CS patients, and CS was a strong independent predictor of a higher risk of early death (adjusted HR 3.64, 95% CI 2.44-5.44). The late mortality rate was significantly higher in CS patients, and CS was also a predictor of higher risk of death at a 4-year follow-up (adjusted HR 1.95, 95% CI 1.11-3.45). Recurrent AMI, TVR and stent thrombosis rates were similar among patients with and without CS.. CS complicating AMI is still a severe clinical event, mainly with regard to a significant higher risk of early mortality, but also associated with a worse prognosis in 30-day survivors.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Prognosis; Shock, Cardiogenic; Sirolimus; Stents; Tubulin Modulators

Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.. We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.. These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Prospective Studies; Registries; Renal Insufficiency; Risk Factors; ROC Curve; Severity of Illness Index; Shock, Cardiogenic; Sirolimus; Stroke; Treatment Outcome; Ventricular Function, Left

Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem.

Topics: Age Factors; Case-Control Studies; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus, Type 1; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Netherlands; Registries; Shock, Cardiogenic; Sirolimus; Time Factors

Stent thrombosis is a feared complication of percutaneous coronary intervention, although there is a low incidence of thrombotic events following drug-eluting stent implantation. We report a case with cardiogenic shock complicated by acute myocardial infarction due to simultaneous subacute stent thrombosis occurring 3 days after implantation of two sirolimus-eluting stents in the proximal left anterior descending artery (LAD) and in the proximal right coronary artery (RCA).

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Thrombosis; Humans; Immunosuppressive Agents; Male; Shock, Cardiogenic; Sirolimus; Stents

Medical therapy alone often insufficiently alters the clinical course of patients who have experienced acute myocardial infarction and concomitant cardiogenic shock, and in whom the left main coronary artery is the culprit vessel. Emergency coronary artery bypass grafting is an effective yet time-consuming approach that entails the risk of extensive, irreversible myocardial damage. Percutaneous coronary intervention in the unprotected left main coronary artery can enable initial revascularization and rapid stabilization even in high-risk patients, but outcomes from the procedure since the recent advent of drug-eluting stents are still being determined. Herein, we report the successful deployment of a sirolimus-eluting stent in a 65-year-old man who had experienced acute myocardial infarction and cardiogenic shock consequent to an occluded left main coronary artery. The patient recovered rapidly and completely. We review the medical literature and compare percutaneous coronary intervention with other methods of treatment.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Shock, Cardiogenic; Sirolimus; Stents; Ultrasonography, Interventional

Topics: Acute Kidney Injury; Adult; Coronary Angiography; Coronary Thrombosis; Creatinine; Cyclosporine; Electrocardiography; Endomyocardial Fibrosis; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Shock, Cardiogenic; Sirolimus

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.

Topics: Age Factors; Angina, Unstable; Angioplasty, Balloon; Case-Control Studies; Coronary Restenosis; Diabetes Mellitus; Female; Follow-Up Studies; Humans; Hypertension; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Netherlands; Prosthesis Design; Registries; Regression Analysis; Shock, Cardiogenic; Sirolimus; Stents

Topics: Adult; Angioplasty, Balloon, Coronary; Blood Component Removal; Combined Modality Therapy; Drug Delivery Systems; Granulocyte Colony-Stimulating Factor; Hematopoietic Stem Cell Mobilization; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Peripheral Blood Stem Cell Transplantation; Shock, Cardiogenic; Sirolimus; Stents

Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs.. The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002.. From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs.. In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.

Topics: Administration, Topical; Aged; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coated Materials, Biocompatible; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Follow-Up Studies; Germany; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Outcome Assessment, Health Care; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Shock, Cardiogenic; Sirolimus; Stents; Treatment Outcome

We describe a severe preoperative cardiogenic shock in a patient scheduled for a breast surgery. The cardiogenic shock was in relation with thrombosis of two sirolimus-eluting stents received 3 months ago. A percutaneous transluminal coronary angioplasty was successfully performed. The patient recovered well after a 1-day treatment including intraaortic balloon counter pulsation and dobutamine infusion. We discuss about the ideal timing to plan surgery and how to manage the shift of antiplatelet agents.

Topics: Aged; Angioplasty, Balloon, Coronary; Breast; Breast Neoplasms; Cardiotonic Agents; Dobutamine; Female; Humans; Immunosuppressive Agents; Shock, Cardiogenic; Sirolimus; Stents; Thrombosis