Aims: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD. Methods: Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy. Results: COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56–2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59–1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67–0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (pinteraction = 0.544). Conclusions: COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death. Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050 Graphic abstract: [Figure not available: see fulltext.]
Bibliographical noteFunding Information:
The SYNTAX Extended Survival study was supported by the German Foundation of Heart Research (Frankfurt am Main, Germany). The SYNTAX trial, during 0–5 year follow-up, was funded by Boston Scientific Corporation (Marlborough, MA, USA). Both sponsors had no role in the study design, data collection, data analyses and interpretation of the study data, nor were involved in the decision to publish the final manuscript. The principal investigators and authors had complete scientific freedom.
The design and the primary results of the SYNTAX trial have been published elsewhere [–]. In brief, the SYNTAX trial (NCT00114972) was an international, multicenter, randomized controlled trial conducted between March 2005 and April 2007. Based on clinical judgment and the consensus of a Heart Team, all-comers patients with de novo 3VD and/or LMCAD deemed eligible for both PCI and CABG were enrolled and randomized in a 1:1 fashion to either CABG (n = 897) or PCI (n = 903) with the TAXUS Express paclitaxel-drug eluting stents (Boston Scientific Corporation, Marlborough, MA, USA). The trial completed the patient follow-up to 5 years . The SYNTAXES study (NCT03417050) was an investigator-driven initiative that extended follow-up and aimed to evaluate vital status up to 10 years . The longest follow-up was 14.1 years. The extended follow-up study was funded by the German Heart Research Foundation (GHF; Frankfurt am Main, Germany). Follow-up was conducted in accordance with local regulations of each participating center and complied with the declaration of Helsinki.
Dr. Serruys reports personal fees from Biosensors, Micel Technologies, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow, outside the submitted work. Dr. van Geuns reports personal fees from Abbott vascular, grants and personal fees from AstraZeneca, grants and personal fees from Amgen, grants and personal fees from Boston Scientific, personal fees from Sanofi, outside the submitted work. Dr. Morice reports to work as the CEO of CERC, a CRO which was never involved in the SYNTAX trial at any level, except that submitted the 10 years additional follow-up (for free) to French authorities to get approval. Dr. Morice also reports to work as minor shareholder of electroducer. Dr. Burzotta reports speaker’s fees from Abiomed, Abbott and Medtronic. Dr. Kappetein reports to work as an employee of Medtronic, outside the submitted work. Dr. James’s institution has received research grants from Boston Sc, Abbot, Biotronik, Medtronic, Astra Zeneca, Bayer, Jansen, The MedCo, and has received lecture fees from Biotronik, Astra Zeneca. All other authors have no disclosures.
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