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Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up.
Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biodegradable polymer |
| ||
| durable-polymer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary interventions | Device | Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| major cardiac adverse events | a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| rate of definite stent thrombosis in revascularized patients according with ARC definition | 4 years | |
| Rate of composite of all-cause death in all participants | 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive diabetic patients with coronary artery diseases undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Rate of myocardial infarction according with definition of MI type 1in all participants |
| 4 years |
| Rate of target-vessel revascularization (TVR) in all participants | 4 years |
| D019060 | Minimally Invasive Surgical Procedures |