Ital Heart J. 2003 Nov;4(11):782-90.
Despite advances in the treatment of non-ST-elevation acute coronary syndromes (ACS) based on randomized studies and published guidelines, the extent to which such treatments are applied in daily clinical practice remains elusive. The R.OS.A.I.-2 registry was undertaken to assess the modalities of the treatment of non-ST-elevation ACS, both in terms of the use of drugs, with particular attention to glycoprotein IIb/IIIa inhibitors and clopidogrel, as well as type of strategy, aggressive versus conservative, in a consecutive series of patients admitted to 76 coronary care units (CCU) in Italy.
The R.OS.A.I.-2 study group consisted of 76 hospitals in 7 regions of Northern and Central Italy: 38 centers had a CCU without cath lab facilities (type 1), whereas 38 type 2 centers had a CCU with an on-site interventional cath lab. Globally, 1581 patients with a diagnosis of non-ST-elevation ACS entered the registry during an 8-week period and had a 30-day follow-up. Patients were considered as being aggressively treated if they had coronary arteriography within 96 hours of admission, whereas all other patients were considered as being conservatively treated even if they underwent coronary arteriography after the first 96 hours of hospitalization.
An aggressive approach was employed in 789 patients (50%), whereas of the 792 (50%) conservatively treated patients 363 had a late coronary arteriography at a mean of 10.5 +/- 13 days after admission. Aggressively treated patients were younger (p < 0.0001), had less frequently ST-segment depression (p = 0.04), troponin positivity (p = 0.02), elevated creatine kinase (CK) and/or CK-MB levels within 24 hours of admission (p = 0.01), and had been more often admitted to type 2 hospitals (p < 0.0001) than those treated conservatively. Glycoprotein IIb/IIIa blockers (predominantly "small molecules") were more frequently used in younger patients (p = 0.04), in those treated aggressively (p < 0.0001), with ST-segment depression (p = 0.01), and in those with a high TIMI risk score (p = 0.001), whereas the use of clopidogrel did not differ in any patient subgroup except in patients < 70 years (p = 0.01) and in those treated aggressively (p < 0.0001). Percutaneous coronary interventions were performed in 656 patients (481 in the aggressively treated group and 175 in the conservatively treated group). At 30 days, the death rate was 3.4% and the myocardial infarction rate was 5.8%. Age, ST-segment depression, elevated CK and/or CK-MB levels within 24 hours of admission and a conservative approach were significant predictors of an unfavorable outcome.
The R.OS.A.I.-2 registry confirms that the population admitted to the CCU with non-ST-elevation ACS has a higher risk profile than that included in recent clinical trials. The aggressive approach is still more dependent on the cath lab availability than on a risk stratification process. Conservatively treated patients have worse clinical features and short-term prognosis. Applying an invasive approach to higher risk groups might further improve the global outcome of non-ST-elevation ACS.
尽管基于随机研究和已发表的指南，非ST段抬高型急性冠状动脉综合征（ACS）的治疗取得了进展，但此类治疗在日常临床实践中的应用程度仍不明确。开展R.OS.A.I.-2注册研究旨在评估非ST段抬高型ACS的治疗方式，包括药物使用情况，尤其关注糖蛋白IIb/IIIa抑制剂和氯吡格雷，以及治疗策略类型（积极与保守），研究对象为意大利76个冠心病监护病房（CCU）连续收治的患者。
R.OS.A.I.-2研究组由意大利北部和中部7个地区的76家医院组成：38个中心设有无导管室设施的CCU（1型），而38个2型中心设有现场介入导管室的CCU。总体而言，1581例诊断为非ST段抬高型ACS的患者在8周内进入注册研究并接受了30天的随访。如果患者在入院96小时内进行冠状动脉造影，则被视为接受积极治疗，而所有其他患者即使在住院首96小时后进行冠状动脉造影，也被视为接受保守治疗。
789例患者（50%）采用了积极治疗方法，而在792例（50%）接受保守治疗的患者中，363例在入院后平均10.5±13天进行了延迟冠状动脉造影。接受积极治疗的患者更年轻（p<0.0001），ST段压低（p=0.04）、肌钙蛋白阳性（p=0.02）、入院24小时内肌酸激酶（CK）和/或CK-MB水平升高（p=0.01）的情况较少见，并且比接受保守治疗的患者更常入住2型医院（p<0.0001）。糖蛋白IIb/IIIa阻滞剂（主要是“小分子”）在更年轻的患者（p=0.04）、接受积极治疗的患者（p<0.0001）、有ST段压低的患者（p=0.01）以及TIMI风险评分高的患者（p=0.001）中使用更为频繁，而氯吡格雷的使用在任何患者亚组中均无差异，除了<70岁的患者（p=0.01）和接受积极治疗的患者（p<0.0001）。656例患者接受了经皮冠状动脉介入治疗（积极治疗组481例，保守治疗组175例）。30天时，死亡率为3.4%，心肌梗死率为5.8%。年龄、ST段压低、入院24小时内CK和/或CK-MB水平升高以及保守治疗方法是不良结局的重要预测因素。
R.OS.A.I.-2注册研究证实，入住CCU的非ST段抬高型ACS患者的风险状况高于近期临床试验中的患者。积极治疗方法仍然更多地依赖于导管室可用性，而非风险分层过程。接受保守治疗的患者具有更差的临床特征和短期预后。对高危组采用侵入性治疗方法可能会进一步改善非ST段抬高型ACS的总体结局。
