Lee Michael S, Shlofmitz Richard A, Shlofmitz Evan, Srivastava Pratyaksh K, Kong Jeremy, Grines Cindy, Revytak George, Chambers Jeffrey W
UCLA Medical Center, Los Angeles, CA, United States.
St. Francis Hospital-The Heart Center, Roslyn, NY, United States.
Cardiovasc Revasc Med. 2018 Apr;19(3 Pt A):268-272. doi: 10.1016/j.carrev.2017.09.017. Epub 2017 Oct 3.
We assessed the safety and efficacy of orbital atherectomy to modify severely calcified coronary plaque prior to stent implantation in patients with small vessel (2.5mm) disease.
Severe coronary artery calcification increases the risk of adverse clinical events during percutaneous coronary intervention (PCI). Patients who undergo PCI of small vessels have worse clinical outcomes including higher rates of perforation and dissection. The outcomes of orbital atherectomy of small diameter vessels (2.5mm) are unknown.
ORBIT II was a single-arm, multicenter trial which prospectively enrolled patients with severely calcified coronary lesions treated with orbital atherectomy prior to stenting in 49U.S. sites. The primary endpoint was the 3year rate of major adverse cardiac events, which was the composite of cardiac death, myocardial infarction, and target vessel revascularization.
Of the 443 patients, 55 (12.4%) had reference vessel diameters (RVD) of 2.5mm and 388 (87.6%) had RVD >2.5. The rates of severe angiographic complications were similar in both groups. The primary endpoint was similar in both groups (30.6% vs. 22.5%, p=0.22), as were the rates of cardiac death (9.8% vs. 6.3%, p=0.33) and myocardial infarction (12.8% vs. 10.9%, p=0.67). Target vessel revascularization was numerically higher in the small vessel group (16.8% vs. 9.3%, p=0.13).
Patients with small coronary vessel disease had comparable clinical outcomes compared to the larger diameter group following orbital atherectomy. Subsequent studies are required to establish the optimal revascularization approach for such patients with small coronary vessel disease burdened by heavily calcified lesions.
我们评估了在小血管（2.5毫米）疾病患者中，在支架植入前进行冠状动脉斑块旋磨术以处理严重钙化冠状动脉斑块的安全性和有效性。
严重冠状动脉钙化会增加经皮冠状动脉介入治疗（PCI）期间发生不良临床事件的风险。接受小血管PCI的患者临床结局更差，包括更高的穿孔和夹层发生率。小直径血管（2.5毫米）冠状动脉斑块旋磨术的结局尚不清楚。
ORBIT II是一项单臂、多中心试验，前瞻性纳入了美国49个地点在支架植入前接受冠状动脉斑块旋磨术治疗的严重钙化冠状动脉病变患者。主要终点是3年主要不良心脏事件发生率，该事件是心脏死亡、心肌梗死和靶血管血运重建的复合事件。
在443例患者中，55例（12.4%）参考血管直径（RVD）为2.5毫米，388例（87.6%）RVD>2.5毫米。两组严重血管造影并发症发生率相似。两组主要终点相似（30.6%对22.5%，p=0.22），心脏死亡发生率（9.8%对6.3%，p=0.33）和心肌梗死发生率（12.8%对10.9%，p=0.67）也相似。小血管组靶血管血运重建在数值上更高（16.8%对9.3%，p=0.13）。
冠状动脉小血管疾病患者在接受冠状动脉斑块旋磨术后，与较大直径组相比临床结局相当。需要后续研究来确定对于这类患有严重钙化病变的冠状动脉小血管疾病患者的最佳血运重建方法。
