Yeh Robert W, Kereiakes Dean J, Steg P Gabriel, Cutlip Donald E, Croce Kevin J, Massaro Joseph M, Mauri Laura
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts.
Christ Hospital Heart and Vascular Center and the Lindner Center for Research and Education, Cincinnati, Ohio.
J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.
Subjects undergoing coronary stenting with complex lesion anatomy may experience different risks and benefits with prolonged dual antiplatelet therapy.
The authors assessed the effect of 30 months versus 12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) based on the presence or absence of anatomically-complex target lesions.
In the DAPT Study, combined myocardial infarction (MI) or stent thrombosis and moderate/severe bleeding were assessed in enrolled (n = 25,416) and randomized (n = 11,554) subjects. Complex lesions had any of the following characteristics: unprotected left main, >2 lesions/vessel, length ≥30 mm, bifurcation with side branch ≥2.5 mm, vein bypass graft, or thrombus-containing lesion. Events were evaluated according to increasing number of complexity characteristics and compared according to DAPT score.
Enrolled subjects with more complex target lesions had higher rates of MI or stent thrombosis in the first 12 months after PCI (3.9% vs. 2.4%; p < 0.001). Among those who were event-free at 12 months, rates of MI or stent thrombosis between 12 and 30 months were similar between those with versus without complex anatomy (3.5% vs. 2.9%; p = 0.07). Reduction of MI or stent thrombosis with continued thienopyridine beyond 12 months versus placebo was similar for subjects with (2.5% vs. 4.5%; hazard ratio: 0.55; 95% confidence interval: 0.38 to 0.79; p = 0.001) and without (2.0% vs. 3.8%; hazard ratio: 0.52; 95% confidence interval: 0.39 to 0.69; p < 0.001) anatomic complexity (p = 0.81), as was increase in moderate/severe bleeding (p = 0.44). Among subjects with anatomic complexity, those with DAPT scores ≥2 randomized to continued thienopyridine had greater reductions in MI or stent thrombosis (3.0% vs. 6.1%; p < 0.001) compared with subjects with scores <2 (1.7% vs. 2.3%; p = 0.42; p value comparing risk differences = 0.03).
Complex target-lesion anatomy is associated with increased ischemic events, particularly within the first year after PCI. Among those without events in the first 12 months, the benefits of extending DAPT were similar in subjects with and without complex lesions. A high DAPT score identified those experiencing the most benefit from extended treatment among patients with and without complex anatomy. (The Dual Antiplatelet Therapy Study [DAPT Study]; NCT00977938).
接受冠状动脉支架置入术且病变解剖结构复杂的患者,延长双联抗血小板治疗可能会有不同的风险和获益。
作者基于是否存在解剖结构复杂的靶病变,评估经皮冠状动脉介入治疗(PCI)后30个月与12个月双联抗血小板治疗(DAPT)的效果。
在DAPT研究中,对入组(n = 25416)和随机分组(n = 11554)的受试者评估合并心肌梗死(MI)或支架血栓形成以及中度/重度出血情况。复杂病变具有以下任何特征:无保护左主干、病变/血管>2处、长度≥30 mm、分支且分支≥2.5 mm、静脉旁路移植血管或含血栓病变。根据复杂特征数量增加评估事件,并根据DAPT评分进行比较。
靶病变更复杂的入组受试者在PCI后前12个月发生MI或支架血栓形成的比率更高(3.9%对2.4%;p<0.001)。在12个月时无事件发生的受试者中,解剖结构复杂与不复杂的受试者在12至30个月期间发生MI或支架血栓形成的比率相似(3.5%对2.9%;p = 0.07)。对于有(2.5%对4.5%;风险比:0.55;95%置信区间:0.38至0.79;p = 0.001)和无(2.0%对3.8%;风险比:0.52;95%置信区间:0.39至0.69;p<0.001)解剖结构复杂性的受试者,超过12个月继续使用噻吩吡啶与安慰剂相比,MI或支架血栓形成的减少情况相似(p = 0.81),中度/重度出血的增加情况也相似(p = 0.44)。在解剖结构复杂的受试者中,与DAPT评分<2的受试者(1.7%对2.3%;p = 0.42;风险差异比较的p值 = 0.03)相比,DAPT评分≥2且随机分组至继续使用噻吩吡啶的受试者MI或支架血栓形成的减少幅度更大(3.0%对6.1%;p<0.001)。
复杂的靶病变解剖结构与缺血事件增加相关,尤其是在PCI后的第一年。在最初12个月无事件发生的受试者中,有和无复杂病变的受试者延长DAPT的获益相似。高DAPT评分可识别出有和无复杂解剖结构的患者中从延长治疗中获益最大的人群。(双联抗血小板治疗研究[DAPT研究];NCT00977938)