血管内超声指导与药物洗脱支架治疗后临床结局的关系：药物洗脱支架双重抗血小板治疗评估（ADAPT-DES）研究。
Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study.
机构信息
From Amper Kliniken AG, Dachau, Germany (B.W.); NewYork-Presbyterian/Columbia University Medical Center, New York, NY (A.M., G.W., G.W.S.); Cardiovascular Research Foundation, New York, NY (A.M., G.W., K.X., H.P., R.M., G.S.M., G.W.S.); Universitäts-Herzzentrum Freibrug Bad Krozingen, Bad Krozingen, Germany (F.N.); Sanger Heart and Vascular Institute/Carolinas HealthCare System, Charlotte, NC (M.J.R.); Wellmont CVA Heart Institute, Kingsport, TN (D.C.M.); Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN (T.D.H.); Lehigh Valley Health Network, Allentown, PA (D.A.C.); Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, NC (P.L.D.); LeBauer Cardiovascular Research Foundation/Moses Cone Hospital, Greensboro, NC (B.R.B., T.D.S.); The Ohio State University, Columbus, OH (E.L.M.); and Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
出版信息
Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.
BACKGROUND
Prior small to modest-sized studies suggest a benefit of intravascular ultrasound (IVUS) guidance in noncomplex lesions. Whether IVUS guidance is associated with improved clinical outcomes after drug-eluting stent (DES) implantation in an unrestricted patient population is unknown.
METHODS AND RESULTS
Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) was a prospective, multicenter, nonrandomized "all-comers" study of 8583 consecutive patients at 11 international centers designed to determine the frequency, timing, and correlates of stent thrombosis and adverse clinical events after DES. Propensity-adjusted multivariable analysis was performed to examine the relationship between IVUS guidance and 1-year outcomes. IVUS was utilized in 3349 patients (39%), and larger-diameter devices, longer stents, and/or higher inflation pressures were used in 74% of IVUS-guided cases. IVUS guidance compared with angiography guidance was associated with reduced 1-year rates of definite/probable stent thrombosis (0.6% [18 events] versus 1.0% [53 events]; adjusted hazard radio, 0.40; 95% confidence interval, 0.21-0.73; P=0.003), myocardial infarction (2.5% versus 3.7%; adjusted hazard radio, 0.66; 95% confidence interval, 0.49-0.88; P=0.004), and composite adjudicated major adverse cardiac events (ie, cardiac death, myocardial infarction, or stent thrombosis) (3.1% versus 4.7%; adjusted hazard radio, 0.70; 95% confidence interval, 0.55-0.88; P=0.002). The benefits of IVUS were especially evident in patients with acute coronary syndromes and complex lesions, although significant reductions in major adverse cardiac events were present in all patient subgroups those with including stable angina and single-vessel disease.
CONCLUSIONS
In ADAPT-DES, the largest study of IVUS use to date, IVUS guidance was associated with a reduction in stent thrombosis, myocardial infarction, and major adverse cardiac events within 1 year after DES implantation.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT00638794.
背景
先前一些较小规模的研究表明血管内超声（IVUS）指导在非复杂病变中的有益作用。但在不受限制的患者人群中，药物洗脱支架（DES）植入后，IVUS 指导是否与改善临床结局相关，目前尚不清楚。
方法和结果
药物洗脱支架双联抗血小板治疗评估（ADAPT-DES）是一项前瞻性、多中心、非随机的“所有患者”研究，在 11 个国际中心纳入了 8583 例连续患者，旨在确定 DES 后支架血栓形成和不良临床事件的频率、时间和相关因素。进行了倾向性调整多变量分析，以检查 IVUS 指导与 1 年结局之间的关系。3349 例患者（39%）接受了 IVUS 检查，74%的 IVUS 指导病例中使用了更大直径的器械、更长的支架和/或更高的扩张压力。与血管造影指导相比，IVUS 指导与 1 年时明确/可能的支架血栓形成发生率降低相关（0.6%[18 例事件]与 1.0%[53 例事件]；校正后危险比，0.40；95%置信区间，0.21-0.73；P=0.003），心肌梗死发生率降低（2.5%与 3.7%；校正后危险比，0.66；95%置信区间，0.49-0.88；P=0.004），复合终点主要不良心脏事件（即心脏死亡、心肌梗死或支架血栓形成）发生率降低（3.1%与 4.7%；校正后危险比，0.70；95%置信区间，0.55-0.88；P=0.002）。IVUS 的益处尤其在急性冠状动脉综合征和复杂病变患者中明显，尽管在所有患者亚组（包括稳定型心绞痛和单支血管疾病）中均观察到主要不良心脏事件显著减少。
结论
在 ADAPT-DES 中，这是迄今为止最大规模的 IVUS 使用研究，与 DES 植入后 1 年内支架血栓形成、心肌梗死和主要不良心脏事件减少相关。
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