A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

Carlo di Mario, Yves Louvard, Alfredo R Galassi, Anthony H Gershlick, James C Spratt, Javier Goicolea, Kris Bogaerts, Bernward Lauer, Alexander Bufe, Luis Teruel, Thomas Hovasse, Gerald S Werner, Javier Escaned, Evald Høj Christiansen, Andrejs Erglis, Jose Ramon Rumoroso, Valery Gelev, Georgios Sianos, Nicolas Boudou, David Hildick-Smith, Victoria Martin-Yuste

Journal: European heart journal 2019;39(26):2484-2493

PMID: 29722796

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Abstract

AIMS

The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO.

METHOD AND RESULTS

Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups.

CONCLUSION

Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone.

TRIAL REGISTRATION

NCT01760083.

Address: Klinikum Darmstadt GmbH, Medizinische Klinik I, Grafenstrasse 9, Darmstadt, Germany.; Hospital Clinic, Sección de Hemodinámica Cardíaca; Villaroel 170, Barcelona, Spain.; Royal Sussex County Hospital, Sussex Cardiac Centre, Eastern Road, Brighton, UK.; Hopital de Rangueil CHU Toulouse, Department of Cardiology, 1 avenue Jean Poulhès, Toulouse Cedex 9, France.; AHEPA University Hospital, 1st Department of Cardiology, Stilponos Kyriakidi 1, Thessaloniki, Greece.; Cardiology Clinic, MHAT "Tokuda Hospital Sofia", 51B Nikola Vaptsarov Blvd., Sofia, Bulgaria.; Hospital Galdakao-Usansolo, Sección de Hemodinámica, barrio de labeaga s/n, Galdakao, Spain.; Pauls Stradins Clinical University Hospital, Institute of Cardiology and Regenerative Medicine, 13 Pilsonu street, Riga, Latvia.; Aarhus University Hospital, Department of Cardiology B, Skejby Aarhus N, Denmark.; Hospital Clinico San Carlos, Unidad de Cardiología Intervencionista, Profesor Martin Lagos s/n, Madrid, Spain.; University Hospital Careggi, Division of Structural Interventional Cardiology, Largo Brambilla 3, Florence, Italy.; Institut Jacques Cartier, 6 avenue Noyer Lambert, Massy, France.; Bellvitge University Hospital, Unidad de Hemodinàmica y Cardiologia, C/ Feixa Llarga s/n, L'Hospitalet de Llobregat, Barcelona, Spain.; HELIOS Klinik Krefeld, Medizinische Klinik I, Lutherplatz 40, Krefeld, Germany.; Zentralklinik Bad Berka, Klinik für Kardiologie, Robert-Koch-Allee 9, Bad Berka, Germany.; Leuven Biostatistics and Statistical Bioinformatics Centre, L-BioStat. Kapucijnenvoer 35, Leuven, Belgium.; Hospital Universitario Puerta de Hierro, Servicio de hemodinamica y arritmias, Joaquin Rodrigo, 2, Majadahonda, Spain.; Royal Infirmary of Edinburgh, Department of Cardiology, 51 Little France Crescent, Edinburgh, UK.; Glenfield Hospital, Leicester Cardiovascular Biomedical Research Unit, Groby Road, Leicester, UK.; Department of Clinical and Experimental Medicine, University of Catania, Via Antonello da Messina 75, Catania, Italy.

DOI: 10.1093/eurheartj/ehy220

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MeSH Terms: Adrenergic beta-Antagonists, Aged, Angina Pectoris, Angiotensin-Converting Enzyme Inhibitors, Chronic Disease, Coronary Occlusion, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Nitrates, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Quality of Life