Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization A Post Hoc Analysis of the DELTA Registry

被引:28
作者
Capodanno, Davide [1 ]
Gargiulo, Giuseppe [1 ,2 ]
Buccheri, Sergio [1 ]
Chieffo, Alaide [3 ]
Meliga, Emanuele [4 ]
Latib, Azeem [3 ]
Park, Seung-Jung [5 ]
Onuma, Yoshinobu [6 ]
Capranzano, Piera [1 ]
Valgimigli, Marco [7 ]
Narbute, Inga [8 ,9 ]
Makkar, Raj R. [10 ]
Palacios, Igor F. [11 ,12 ]
Kim, Young-Hak [5 ]
Buszman, Pawel E. [13 ]
Chakravarty, Tarun [10 ]
Sheiban, Imad [14 ]
Mehran, Roxana [15 ]
Naber, Christoph [16 ]
Margey, Ronan [10 ]
Agnihotri, Arvind [11 ,12 ]
Marra, Sebastiano [14 ]
Leon, Martin B. [17 ,18 ]
Moses, Jeffrey W. [17 ,18 ]
Fajadet, Jean [19 ]
Lefevre, Thierry [20 ]
Morice, Marie-Claude [20 ]
Erglis, Andrejs [8 ,9 ]
Alfieri, Ottavio
Serruys, Patrick W. [6 ]
Colombo, Antonio [3 ]
Tamburino, Corrado [1 ]
机构
[1] Univ Catania, Ferrarotto Hosp, Cardiothoracic Vasc Dept, Catania, Italy
[2] Univ Naples Federico II, Dept Adv Biomed Sci, Naples, Italy
[3] Ist Sci San Raffaele, Dept Cardiothorac & Vasc Dis, Milan, Italy
[4] AO Ordine Mauriziano Umberto I, Intervent Cardiol Unit, Turin, Italy
[5] Univ Ulsan, Coll Med, Asan Med Ctr, Depat Cardiol,Ctr Med Res & Informat, Seoul, South Korea
[6] Erasmus MC, Thoraxctr, Rotterdam, Netherlands
[7] Univ Hosp Bern, Bern, Switzerland
[8] Pauls Stradins Clin Univ Hosp, Latvian Ctr Cardiol, Riga, Latvia
[9] Univ Latvia, Inst Cardiol, Riga, Latvia
[10] Cedars Sinai Med Ctr, Cedars Sinai Heart Inst, Los Angeles, CA 90048 USA
[11] Massachusetts Gen Hosp, Cardiac Catheterizat Lab, Boston, MA 02114 USA
[12] Harvard Med Sch, Boston, MA USA
[13] Ctr Cardiovasc Res & Dev Amer Heart Poland, Katowice, Poland
[14] Univ Turin, S Giovanni Battista Molinette Hosp, Div Cardiol, Intervent Cardiol, Turin, Italy
[15] Mt Sinai Med Ctr, New York, NY 10029 USA
[16] Elisabeth Hosp, Klin Kardiol & Angiol, Essen, Germany
[17] Columbia Univ, Med Ctr, New York, NY USA
[18] Cardiovasc Res Fdn, New York, NY USA
[19] Clin Pasteur, Toulouse, France
[20] Ramsay Gen Sante, Hop Prive Jacques Cartier, Massy, France
关键词
Andersen-Gill; competing risk; left main; weighted composite event(s); win ratio; DRUG-ELUTING STENTS; BYPASS GRAFT-SURGERY; 5-YEAR OUTCOMES; INTERVENTION; DISEASE; METAANALYSIS; VALIDATION; STENOSIS; EFFICACY; SYNERGY;
D O I
10.1016/j.jcin.2016.08.025
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVES The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years. (C) 2016 by the American College of Cardiology Foundation.
引用
收藏
页码:2280 / 2288
页数:9
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