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The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.
Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolim stent implantation | Experimental | In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolim stent deployment | Device | Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE). | consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis. | Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis. | 12 moths |
| Late lumen loss (LLL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Bil, MD, PhD | Central Clinical Hospital of the Ministry of Internal Affairs | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17869634 | Result | Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5. | |
| 26095938 |
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The value (in mm) of LLL assessed in qualitative coronary angiography (QCA) |
| 12 moths |
| The percentage of covered struts assessed in optical coherence tomography (OCT) | The percentage of covered struts assessed in OCT | 12 months |
| The neointima volume assessed in OCT | The neointima volume (in mm3) assessed in OCT | 12 months |
| The device success rate | The percentage of Prolim stents successfully implanted. | intraoperative |
| Result |
| Lavi S, Dzavik V. Biodegradable Stent Platforms: Are We Heading in the Right Direction? Can J Cardiol. 2015 Aug;31(8):957-9. doi: 10.1016/j.cjca.2015.04.005. Epub 2015 Apr 14. No abstract available. |
| 23257388 | Result | Nagoshi R, Shinke T, Otake H, Shite J, Matsumoto D, Kawamori H, Nakagawa M, Kozuki A, Hariki H, Inoue T, Ohsue T, Taniguchi Y, Iwasaki M, Nishio R, Hiranuma N, Konishi A, Kinutani H, Miyoshi N, Takaya T, Yamada S, Yasaka Y, Hayashi T, Yokoyama M, Kato H, Kadotani M, Ohnishi Y, Hirata K. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents. Circ J. 2013;77(3):652-60. doi: 10.1253/circj.cj-12-0610. Epub 2012 Dec 21. |
| 24697948 | Result | Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, Hu J, Ding FH, DU R, Shen WF. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014 Apr;27(2):131-41. doi: 10.1111/joic.12102. |
| 26573577 | Derived | Bil J, Gil RJ, Kern A, Pawlowski T, Seweryniak P, Sliwinski Z. Novel sirolimus-eluting stent Prolim(R) with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis. BMC Cardiovasc Disord. 2015 Nov 14;15:150. doi: 10.1186/s12872-015-0139-5. |