意大利缺血性心脏病患者经皮冠状动脉介入治疗的适宜性：APACHE 试点研究
APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study.
作者信息
Leonardi Sergio, Marino Marcello, Crimi Gabriele, Maiorana Florinda, Rizzotti Diego, Lettieri Corrado, Bettari Luca, Zuccari Marco, Sganzerla Paolo, Tresoldi Simone, Adamo Marianna, Ghiringhelli Sergio, Sponzilli Carlo, Pasquetto Giampaolo, Pavei Andrea, Pedon Luigi, Bassan Luciano, Bollati Mario, Camisasca Paola, Trabattoni Daniela, Brancati Marta, Poli Arnaldo, Panciroli Claudio, Lettino Maddalena, Tarelli Giuseppe, Tarantini Giuseppe, De Luca Leonardo, Varbella Ferdinando, Musumeci Giuseppe, De Servi Stefano
机构信息
Coronary Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Cardiology, Ospedale Maggiore di Crema, Crema, Italy.
出版信息
BMJ Open. 2017 Sep 5;7(9):e016909. doi: 10.1136/bmjopen-2017-016909.
OBJECTIVES
To first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation.
DESIGN
Retrospective, pilot study.
SETTING
22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery.
PARTICIPANTS
440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics.
PRIMARY AND SECONDARY OUTCOME MEASURES
Proportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD.
RESULTS
Of the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001).
CONCLUSIONS
Use of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting is limited. This pilot study documents the feasibility of measuring appropriateness and guideline adherence in clinical practice and identifies substantial opportunities for quality improvement.
TRIAL REGISTRATION NUMBER
NCT02748603.
目的
首先在意大利探讨冠状动脉血运重建的适应症适宜性、对指南建议的遵循情况以及选择方式。
设计
回顾性试点研究。
地点
22家开展经皮冠状动脉介入治疗（PCI）的医院（每个地点20例患者），其中13家（59%）有现场心脏外科手术。
参与者
440例因稳定型冠状动脉疾病（CAD）或非ST段抬高型急性冠状动脉综合征接受PCI治疗的患者，按照4:1的比例独立选取，其中一半为糖尿病患者。
主要和次要结局指标
使用经过验证的适宜性评分（即AUS≥7）来确定接受适宜PCI治疗的患者比例。此外，对于稳定型CAD患者，我们检查了对以下欧洲心脏病学会建议的遵循情况：（A）心脏团队讨论后治疗的复杂冠状动脉解剖结构患者的百分比；（B）在无缺血记录的患者中，血流储备分数引导的PCI用于临界狭窄的百分比；（C）PCI时接受指南指导的药物治疗的患者百分比，以及根据CAD的预测试概率（PTP）进行缺血激发试验的使用情况。
结果
在401例可映射的PCI中（91%），38.7%（95%CI 33.9至43.6）被分类为适宜，47.6%（95%CI 42.7至52.6）为不确定，13.7%（95%CI 10.5%至17.5%）为不适宜。无已知冠状动脉解剖结构的稳定型CAD患者的中位PTP为69%（78%为中度PTP，22%为高度PTP）。中度PTP患者（n = 140，63%）和高度PTP患者（n = 40，66%）的缺血检测使用率相似（p = 0.71）。在稳定型CAD患者（n = 352）中，对所探讨的三项建议的指南遵循情况为：（A）11%；（B）25%；（C）23%。与未由心脏团队评估的患者相比，由心脏团队评估的患者的AUS更高（7（6.8）对5（4.7）；p = 0.001）。
结论
在现实环境中，心脏团队方法的使用以及对冠状动脉血运重建指南建议的遵循情况有限。这项试点研究证明了在临床实践中测量适宜性和指南遵循情况的可行性，并确定了质量改进的大量机会。
试验注册号
NCT02748603。
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