Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Kardiol Pol. 2012;70(7):703-11.
Although durable polymer coated drug-eluting stents (DES) are standard care in percutaneous coronary interventions, new stent platforms employing biodegradable polymer based drug delivery are increasingly being used in clinical practice.
To evaluate the short- (28 days) and medium-term (90 days) vascular effects of the new biodegradable polymer coated sirolimus-eluting stent - the PROLIM stent.
The objectives of the study were evaluated using standard angiographic and histological methods. In addition, the mechanical integrity of tested stents was assessed using Faxitron imaging. A total of 12 PROLIM stents, 11 biodegradable polymer only coated stents (BPCS), and 12 bare metal stents (BMS) were implanted in the coronary arteries of 16 female non-atheroslerotic domestic swine using an overstretch of 1.1:1.0.
At 28 days, neointimal proliferation was significantly lower in the PROLIM and BMS stents compared to the BPCS stents (p ≤ 0.05). Interestingly, despite thin neointima found at this time in the PROLIM group, there was a further significant decrease in neointimal formation between 28 and 90 days (p = 0.04). Although a statistically bigger neointima was found in BPCS stents at 28 days compared to the PROLIM and BMS stents, there was a 50% decrease in the neointimal area at 90 days follow-up (p = 0.02) which reached the level seen in other groups. The endothelialisation was completed in all tested stents after 28 days. There was a significant increase of fibrin depositions in the PROLIM treated arteries at 28 days which were resorbed nearly completely at 90 days follow-up. At 28 days, the inflammatory response was found to be numerically higher in the BPCS stents (p = NS) compared to other tested groups. On the contrary, at 90 days follow-up when the degradation process of the polymer had been completed, the inflammatory reaction decreased substantially to the level seen in the PROLIM and BMS stents. Faxitron analysis of the stented arteries revealed no major abnormalities except for isolated strut fractures observed in the mid portions of two BMS stents and one BPCS stent.
The PROLIM - a biodegradable polymer coated sirolimus-eluting stent - demonstrates very good short-term and medium-term angiographic and histological results. The lack of 'catch-up phenomenon', fast endothelialisation process, and minimal inflammatory reaction may contribute to favourable clinical outcomes using PROLIM stents.
尽管耐用聚合物涂层药物洗脱支架（DES）是经皮冠状动脉介入治疗的标准治疗方法，但越来越多的新型基于可生物降解聚合物的药物输送支架平台正在临床实践中得到应用。
评估新型可生物降解聚合物涂层西罗莫司洗脱支架-PROLIM 支架的短期（28 天）和中期（90 天）血管效果。
使用标准血管造影和组织学方法评估研究目标。此外，还使用 Faxitron 成像评估了测试支架的机械完整性。共将 12 个 PROLIM 支架、11 个仅含可生物降解聚合物的支架（BPCS）和 12 个裸金属支架（BMS）在 16 只非动脉粥样硬化的雌性家猪的冠状动脉中以 1.1:1.0 的过度扩张植入。
在 28 天时，与 BPCS 支架相比，PROLIM 和 BMS 支架的新生内膜增殖明显较低（p≤0.05）。有趣的是，尽管 PROLIM 组此时发现的新生内膜较薄，但在 28 至 90 天之间新生内膜形成有进一步显著减少（p=0.04）。尽管在 28 天时 BPCS 支架中的新生内膜较大，但在 90 天随访时新生内膜面积减少了 50%（p=0.02），达到了其他组的水平。所有测试支架在 28 天后均完成内皮化。在 28 天时，在 PROLIM 治疗的动脉中发现纤维蛋白沉积明显增加，在 90 天随访时几乎完全吸收。在 28 天时，与其他测试组相比，BPCS 支架中的炎症反应在数值上更高（p=NS）。相反，在 90 天随访时，当聚合物的降解过程完成时，炎症反应大大降低到 PROLIM 和 BMS 支架的水平。对支架动脉的 Faxitron 分析显示除了在两个 BMS 支架和一个 BPCS 支架的中部分别观察到孤立的支架断裂外，没有发现其他主要异常。
PROLIM-一种可生物降解聚合物涂层的西罗莫司洗脱支架-显示出非常好的短期和中期血管造影和组织学结果。缺乏“追赶现象”、快速内皮化过程和最小的炎症反应可能有助于 PROLIM 支架的临床获益。
