Lesser Poland Cardiovascular Center of American Heart of Poland, Chrzanów, Poland.
University of Technology, Katowice, Poland.
Vasc Med. 2021 Aug;26(4):401-408. doi: 10.1177/1358863X20988360. Epub 2021 Mar 9.
The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; < 0.01). Binary restenosis occurred in 23% vs 52% of patients ( = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. .
BIOPAC 试验旨在确定一种新型的紫杉醇微结晶涂层球囊（mcPCB）的长期安全性和有效性，该球囊采用生物相容性聚合物作为赋形剂，用于治疗闭塞性股腘动脉病变。在这项首例人体前瞻性对照随机试验中，66 名股腘动脉、有症状（Rutherford 分期 2B 至 5 期）闭塞性动脉疾病患者按 1:1 比例随机分为 mcPCB（研究组）或 POBA（普通球囊血管成形术）（对照组）。6 个月时的晚期管腔丢失（LLL）是研究的主要终点，严重不良事件（SAE：死亡、截肢、再次血运重建）被认为是复合次要终点。所有研究对象在 6 个月随访时均行常规血管造影，在干预后 12 个月和 36 个月安排门诊预约。6 个月时，mcPCB 组的 LLL 比 POBA 组低 63%（0.52 ± 1.2 对 1.39 ± 1.1mm；<0.01）。二元再狭窄发生率在患者中分别为 23%和 52%（=0.02）。3 年时，mcPCB 组 SAE 的发生率明显较低（33.3%比 63.3%；=0.02），这主要是由于靶血管血运重建率降低了两倍（28.6%比 59.3%；=0.02）。死亡率的差异无统计学意义（7.4%比 14.3%；=0.42）。mcPCB 组患者的症状较轻，且不太可能坚持二级预防措施。在这项关键试验中，与 POBA 相比，新型 mcPCB 在 6 个月随访时在 LLL 方面表现更好，在 12 个月时在 SAE 方面表现更好。这一结果持续到 3 年。两组之间的死亡率没有差异。
