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The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).
Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPLES | Active Comparator | Biodegradable polymer limus-eluting stents |
|
| PPLES | Active Comparator | Permanent polymer limus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nobori® (Biodegradable polymer limus-eluting stents) | Device | due randomization biodegradable polymer limus-eluting stents will be implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The composite of all cause mortality or myocardial infarction | 6-8 months | |
| Stent thrombosis | 6-8 months | |
| Late luminal loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julinda Mehilli, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany | |||
| Klinikum rechts der Isar der Technischen Universitaet Muenchen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24579987 | Derived | Piccolo R, Nicolino A, Danzi GB. The Nobori biolimus-eluting stent: update of available evidence. Expert Rev Med Devices. 2014 May;11(3):275-82. doi: 10.1586/17434440.2014.894458. Epub 2014 Mar 3. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Xience-V® (Permanent polymer limus-eluting stent) | Device | due randomization permanent polymer limus-eluting stent will be implanted |
|
|
| 6-8 months |
| Binary angiographic restenosis | 6-8 months |
| Munich |
| 81675 |
| Germany |