sirolimus and Foreign-Body-Migration

The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices.. DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Equipment Failure; Foreign-Body Migration; Humans; Neointima; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Restenosis after PCI and/or stent implantation is still one of the challenging problems in the field of interventional cardiology. Different approaches to prevent and to treat restenosis include the use of drug-eluting stents, which have shown to reduce restenosis. Another approach is the treatment with drug-coated balloons. This approach has been proven for different indications, e.g., in-stent restenosis and treatment of peripheral artery disease.. Patients from the PEPCAD III multicentre randomised trial in two study centres (Homburg and Hannover, Germany) were asked to participate in this intravascular ultrasound (IVUS) study at nine-month follow-up. At baseline (nine months before), patients were randomly assigned to receive either a paclitaxel-coated balloon (drug-coated balloon [DCB]) plus a premounted bare metal stent (DCB/BMS) or a sirolimus-eluting stent (drug-eluting stent [DES]) to treat de novo lesions. IVUS at follow-up was performed in order to analyse the restenosis for potential understanding of the mechanism leading to restenosis. IVUS data is available for 55 patients; 26 patients were treated with Cypher(®) DES (Cordis, Miami Lakes, FL, USA) and 29 patients with DCB/BMS. A focal malapposition of the stent was seen in six patients; four after DES and two after DCB/BMS. Stent expansion, calculated as symmetric expansion index, was equal for both groups (0.89 and 0.90). Mean stent area was also equal for both groups (6.25 ± 1.7 vs. 5.65 ± 1.5 mm(2), p=n.s.). The neointimal hyperplasia (calculated as stent area minus lumen area) was significantly different between both groups (0.69 ± 0.49 [DES] vs. 1.08 ± 0.53 mm(2) [DCB/BMS], p<0.01). This resulted in a significantly higher in-stent restenosis in the DCB/BMS group (19.7 vs. 11 %, p<0.01). There is no evidence of geographical mismatch.. First IVUS insights for the DCB/BMS showed a comparable, low incidence of malapposition for the combination of drug-coated balloon and premounted bare metal stent compared to the DES, and stent expansion was good and comparable to DES. However, at nine-month follow-up, the combination of drug-coated balloon and premounted bare metal stent showed higher in-stent restenosis compared to sirolimus DES. Geographical mismatch can be excluded as a reason for this result.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Equipment Failure; Follow-Up Studies; Foreign-Body Migration; Humans; Incidence; Middle Aged; Neointima; Paclitaxel; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Device Removal; Drug-Eluting Stents; Everolimus; Foreign-Body Migration; Humans; Male; Middle Aged; Sirolimus; Treatment Outcome

Topics: Aged; Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Foreign-Body Migration; Humans; Male; Percutaneous Coronary Intervention; Prosthesis Design; Radiography; Sirolimus; Ultrasonography, Interventional

Intravascular ultrasonography (IVUS) has been widely used in percutaneous coronary artery interventions to ensure optimal stent expansion. Entrapment of the IVUS catheter is potentially lethal. We report a case of successful emergent surgical removal of an entrapped catheter within the sirolimus-eluting stent and coronary revascularization.

Topics: Angioplasty, Balloon, Coronary; Cardiopulmonary Bypass; Cardiovascular Agents; Catheters; Coronary Angiography; Coronary Artery Bypass; Device Removal; Drug-Eluting Stents; Equipment Design; Foreign-Body Migration; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Failure; Severity of Illness Index; Sirolimus; Stress, Mechanical; Tomography, X-Ray Computed

A 73-year-old woman with severe congestive heart failure was treated by implantation with a sirolimus-eluting stent (SES; Cypher Bx Velocity(®)) in the left main coronary artery (LMCA) using the staged T-stent, kissing balloon, and hugging balloon techniques. Follow-up coronary multislice computed tomography after 10 months revealed that SES was completely fractured in 2 directions; the fractured stent appeared in the shape of the letter "L" and had migrated into the aorta. An SES fragment was surgically removed and subsequent electron microscopy revealed striations (striped patterns in fractured sections) on the fracture plane, indicating continuous shear stress after SES implantation in the LMCA. This case provides direct evidence of continuous shear stress on the SES and indicates the necessity of improving the structure of the stent such that it can withstand shear stress.

Topics: Aged; Angioplasty, Balloon, Coronary; Aorta, Thoracic; Coronary Angiography; Device Removal; Drug-Eluting Stents; Female; Follow-Up Studies; Foreign-Body Migration; Heart Failure; Humans; Immunosuppressive Agents; Microscopy, Electron; Prosthesis Failure; Sirolimus; Tomography, X-Ray Computed

Topics: Aged; Aorta; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Sirolimus; Ultrasonography

Late complications of drug-eluting stent, such as stent malapposition or aneurysm formation have emerged major concern. However, there is no available standard therapeutic guideline about them because the clinical course of those is variable and long-term follow- up data is not sufficient. A case presented here is acute ST-elevation myocardial infarction as a result of very late stent thrombosis developed in a patient with stent malapposition and peri-stent aneurysm formation 52 months after sirolimus-eluting stent implantation. In conclusion, more careful long-term follow-up studies are required to access the significance of these late vascular pathologic changes.

Topics: Coronary Aneurysm; Coronary Thrombosis; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Time Factors

Drug-eluting stents (DES) have been shown to significantly reduce the incidence of restenosis and target lesion revascularization in a wide variety of clinical situations. DES have also been shown to significantly reduce neointimal hyperplasia as compared to bare-metal stents. However, the antiproliferative properties of DES also delay vascular healing and have been associated with stent malapposition, hypersensitivity reactions and late stent thrombosis. Stent thrombosis could result in myocardial infarction or death. We describe here a case report of late stent malapposition following sirolimus-eluting stent implantation observed by angiography, intravascular ultrasound, optical coherence tomography and angioscopy.

Topics: Acute Coronary Syndrome; Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Risk Factors; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

In this case report, we describe a rare patient who experienced complete fracture of a sirolimus-eluting stent that was implanted for a focally calcified lesion of the right coronary artery ostium. Although the fractured fragment migrated somewhere in the systemic circulation, fortunately there were no complications. Implantation for ostial lesions of the right coronary artery should be performed with great care.

Topics: Aged, 80 and over; Drug-Eluting Stents; Equipment Failure; Foreign-Body Migration; Humans; Male; Postoperative Complications; Sirolimus

Confirming complete neointimal coverage after implantation of a drug-eluting stent is clinically important because incomplete stent coverage is responsible for late thrombosis and sudden cardiac death. Optical coherence tomography is a high-resolution (approximately 10 microm) imaging technique capable of detecting a thin layer of neointimal hyperplasia (NIH) inside a sirolimus-eluting stent (SES) and stent malapposition. This investigation evaluated stent exposure and malapposition 3 months after SES implantation using optical coherence tomography in a different clinical presentations, such as acute coronary syndrome (ACS) and non-ACS. Motorized optical coherence tomographic pullback (1 mm/s) was performed at 3-month follow-up to examine consecutive implanted 31 SESs in 21 lesions in 21 patients (9 with ACS and 12 with non-ACS). NIH thickness inside each strut and percent NIH area in each cross section were measured. In total, 4,516 struts in 567-mm single-stented segments were analyzed. Overall, NIH thickness and percent NIH area were 29 +/- 41 microm and 10 +/- 4%, respectively. Rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. These were more frequent in patients with ACS than in those with non-ACS (18% vs 13%, p <0.0001; 8% vs 5%, p <0.005, respectively). In conclusion, neointimal coverage over a SES at 3-month follow-up is incomplete in ACS and non-ACS. Our study suggests that dual antiplatelet therapy might be continued >3 months after SES implantation.

Topics: Adult; Aged; Aged, 80 and over; Anatomy, Cross-Sectional; Angina, Unstable; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Fibrinolytic Agents; Follow-Up Studies; Foreign-Body Migration; Humans; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Stents; Surface Properties; Tomography, Optical Coherence; Tunica Intima