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Randomized Controlled Trial
. 2022 Jan 24;15(2):193-204.
doi: 10.1016/j.jcin.2021.10.026. Epub 2021 Dec 29.

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification

Hideyuki Kawashima  1 , Patrick W Serruys  2 , Hironori Hara  1 , Masafumi Ono  1 , Chao Gao  3 , Rutao Wang  3 , Scot Garg  4 , Faisal Sharif  5 , Robbert J de Winter  6 , Michael J Mack  7 , David R Holmes  8 , Marie-Claude Morice  9 , Arie Pieter Kappetein  10 , Daniel J F M Thuijs  10 , Milan Milojevic  11 , Thilo Noack  12 , Friedrich-Wilhelm Mohr  12 , Piroze M Davierwala  13 , Yoshinobu Onuma  5 ; SYNTAX Extended Survival Investigators
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Free article
Randomized Controlled Trial

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification

Hideyuki Kawashima et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Background: Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization.

Methods: This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG).

Results: The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (Pinteraction = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264).

Conclusions: At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).

Keywords: SYNTAX; calcification; coronary artery bypass grafting; long-term mortality; percutaneous coronary intervention.

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Conflict of interest statement

Funding Support and Author Disclosures The SYNTAX Extended Survival study was supported by the German Foundation of Heart Research. The SYNTAX trial, during 0- to 5-year follow-up, was funded by Boston Scientific. Both sponsors had no role in the study design, data collection, data analyses, and interpretation of the study data and were not involved in the decision to publish the final manuscript. The principal investigators and authors had complete scientific freedom. Dr Serruys has received personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Merillife. Dr Hara has received a grant for studying overseas from the Japanese Circulation Society and a grant from Fukuda Foundation for Medical Technology, outside the submitted work. Dr Morice is a CEO and shareholder of CERC, a contract research organization based in Paris, with no role in this trial. Dr Kappetein is an employee of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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