经桡动脉应用MAC指引导管行急诊冠状动脉造影和介入治疗的可行性

Feasibility of single transradial MAC guiding catheter for coronary angiography and intervention in patients with ST elevation myocardial infarction

目的探讨经桡动脉应用MAC3.5指引导管行急性ST段抬高心肌梗死(ST-segment elevated myocardial infarction,STEMI)患者冠状动脉造影和介入治疗的安全性和有效性。方法前瞻性单中心、随机对照研究,自2011年8月至2012年4月,150例发病12 h内,拟行经皮桡动脉急诊介入治疗的STEMI患者按1∶1比例随机分成MAC组(75例)和对照组(75例)。MAC组直接应用MAC3.5指引导管行冠状动脉造影和介入治疗,对照组用多功能造影导管完成冠状动脉造影后选择指引导管行介入治疗。主要终点是操作时间和透视时间,次要终点是穿刺部位合并症和30 d复合事件(包括所有原因的死亡、心肌梗死或非冠状动脉搭桥相关的出血)。采用意向性治疗分析。结果两组基线资料相似。MAC组和对照组桡动脉交换到股动脉的比例(4.0%vs 3.5%),首选指引导管更换比例(10.7%vs 9.3%),局部麻醉至冠状动脉造影完成时间[(7.2±2.6)min vs(7.1±2.3)min]和门囊时间[(86.1±39.4)min vs(88.8±36.3)min],差异均无统计学意义(P均>0.05)。与对照组相比,MAC组的急诊介入治疗(percutaneous coronary intervention,PCI)操作时间、总操作时间和透视时间均明显缩短[(23.7±9.6)min vs(29.0±12.0)min,P=0.003;(30.9±10.4)min vs(36.4±12.3)min,P=0.004;(8.4±2.1)min vs(10.2±4.9)min,P=0.007]。穿刺部位血肿两组各3例,保守治疗后好转。30 d复合事件发生率,MAC组和对照组分别为6.6%(5/75)和5.3%(4/75)(χ2=0.118,P=0.731)。结论经桡动脉应用MAC3.5指引导管行STEMI患者造影和介入治疗能缩短操作时间和透视时间,该方法能否对临床事件产生有益的影响还需要进一步证实。

Objective To investigate the feasibility of using a single guiding catheter（ MAC 3. 5） for left and right coronary angiography and intervention in patients with ST segment elevation myocardial infarction（ STEMI）. Methods This was a single-center,prospective,randomized study conducted from August 2011 to April 2012; Totally 150 patients with STEMI indicated for transradial primary PCI performed by an experienced transradial operator were randomized into two groups： MAC group（ 75 cases） consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter（ MAC3. 5）. Control group（ 75 cases）included patients who first underwent coronary angiography with Tiger diagnostic catheter followed by guiding catheter selection at the operator＇s discretion for intervention. The primary outcomes were procedural time and fluoroscopic time. The secondary outcomes were complications of puncture site and composite of all-cause death,myocardial infarction or non-coronary artery bypass graft（ non-CABG）-related major bleeding at 30 days. Analysis was done by intention to treat mode. Results Baseline patient characteristics were similar between the MAC group and control group. Crossover from radial access to femoral access（ 4. 0% vs 3. 5%）,guiding catheter exchange rate（ 10. 7% vs 9. 3%）,procedure time of coronary angiography [（ 7. 2 ± 2. 6） min vs（ 7. 1 ± 2. 3） min] and door to balloon time[（ 86. 1 ± 39. 4） min vs（ 88. 8 ± 36. 3） min]in the two groups were not statistically significant（ P〉0. 05）,respectively. Compared with the Control group,PCI procedure time,total procedure time and the overall fluoroscopy time were significantly shorter in MAC group[（ 23. 7 ± 9. 6） min vs（ 29. 0 ± 12. 0） min,P = 0. 003;（ 30. 9 ± 10. 4） min vs（ 36. 4 ± 12. 3） min,P = 0. 004;（ 8. 4 ± 2. 1） min vs（ 10. 2± 4. 9） min,P = 0. 007,respectively]. Local hematoma occurred in 3 cases in each of the two groups that improved after physiotherapy.The composite endpoints at 30 days was 6. 6%（ 5 /75） in the MAC group compared with 5. 3%（ 4 /75） in the control group（ χ2= 0. 118,P = 0. 731）,respectively. Conclusion A single transradial MAC 3. 5 guiding catheter for coronary angiography and intervention seems to be a better option for patients with STEMI for whom primary PCI is planned. It can shorten PCI procedure time and fluoroscopy time.Further study is required to determine whether this strategy can favorably affect clinical outcomes.