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Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients
Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EES Group | Experimental | Patients who received an everolimus eluting stent |
|
| SES Gruop | Active Comparator | Patients who received a sirolimus eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary stent | Device | coronary angioplasty with stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Revascularization | Incidence of clinically driven target vessel revascularization at 2 year follow up | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac death | incidence of death for cardiac causes at 2 year | 2 year |
| non fatal myocardial infarction | incidence of non fatal Q or non Q wave reinfarction at 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EMILIO DI LORENZO, MD PhD | DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology Aorn Moscati | Avellino | 83100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20445180 | Background | Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496. | |
| 20060578 | Background |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| stent | Device | coronary angioplasty with stent implantation |
|
|
| 2 year |
| stent thrombosis | incidence of definite, probable or possible stent thrombosis at 2 year | 2 year |
| Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7. |
| 19712798 | Background | Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077. |
| 19781402 | Background | Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |