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. 2023 Jan 20:18:e02.
doi: 10.15420/icr.2022.07. eCollection 2023 Feb.

Sex-specific Inequalities in the Treatment of Severely Calcified Coronary Lesions: A Sub-analysis of the PREPARE-CALC Trial

Sean Fitzgerald  1   2 , Maria Rubini Gimenez  1 , Abdelhakim Allali  3 , Ralph Toelg  3 , Dmitriy S Sulimov  1 , Volker Geist  3 , Adnan Kastrati  4 , Holger Thiele  1 , Gert Richardt  3 , Mohamed Abdel-Wahab  1
Affiliations

Sex-specific Inequalities in the Treatment of Severely Calcified Coronary Lesions: A Sub-analysis of the PREPARE-CALC Trial

Sean Fitzgerald et al. Interv Cardiol. .

Abstract

Background: Coronary vessels in women may have anatomical and histological particularities. The aim of this study was to investigate sex-specific characteristics and outcomes of patients with calcified coronary arteries in the Prepare-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) trial. Methods: The Prepare-CALC trial randomised patients with severe coronary calcification to coronary lesion preparation either using modified balloons (MB; cutting or scoring) or rotational atherectomy (RA). Results: Of 200 randomised patients, 24% were women. Strategy success in general was similar between women (93.8%) and men (88.2%; p=0.27). For men, strategy success was significantly more common with an RA-based strategy than an MB-based strategy (98.7% in the RA group versus 77.3% in the MB group, p<0.001), whereas for women there was no evidence of a significant difference in strategy success between RA and MB (95.7% in the RA group versus 92% in the MB group, p>0.99, p for interaction between sex and treatment strategy=0.03). Overall, significant complications such as death, MI, stent thrombosis, bypass operation and perforations were rare and did not differ significantly by gender or treatment strategy. Plaque rupture and disrupted calcified nodules were more common in women. Conclusion: In a well-defined patient population with severely calcified coronary arteries, lesion preparation with an RA-strategy was superior to an MB-strategy in men. For women, both RA and MB strategies appear to have a similar success rate, although definitive conclusions are limited due to the small number of women in the trial.

Keywords: Optical coherence tomography; rotational atherectomy; sex differences.

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Conflict of interest statement

Disclosure: MRG reports research grants from the Swiss Heart Foundation and Swiss National Foundation (P400PM_180828) and speakers’ honoraria from Roche, Ortho Clinical Diagnostics, Abbott, Quidel and Siemens (all of them outside the submitted work). MA-W reports that his hospital receives speakers’ honoraria and/or consulting fees on his behalf from Medtronic and Boston Scientific. All other authors have no conflicts of interest to declare. Informed Consent/Consent to publish: All patients have given informed consent. Data Availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request. Ethics: This study was performed in line with the principles of the Declaration of Helsinki. Clinical Trial Registration: https://clinicaltrials.gov/show/NCT02502851. Funding: This study was financed by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Author Contributions: Conceptualisation: SF, MRG, MA-W; Data curation: AA, RT, DSS, VG, AK, HT, GR; Formal analysis: AA, RT, DSS, VG, AK, HT, GR; Writing: original draft preparation: SF, MRG, MA-W; Writing: review & editing: SF, MRG, MA-W; Funding acquisition: MA-W, GR; Investigation: AA, RT, DS, VG, AK, HT, GR, MA-W; Methodology: MA-W, GR; Project administration: MA-W; Resources: MA-W, GR, HT, AK; Software: SF; Supervision: MA-W; Validation: SF, MRG, AK, HT, GR, MA-W; Visualisation: SF, MRG, MA-W.

Figures

Figure 1:
Figure 1:. Optical Coherence Tomography of Calcified Nodules
Figure 2:
Figure 2:. Study Flow Chart
Figure 3:
Figure 3:. Strategy Success According to Sex
See this image and copyright information in PMC

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