Journal article

Drug-eluting stents in large coronary vessels improve both safety and efficacy compared with bare-metal stents in women: a pooled analysis of the BASKET-PROVE I and II trials.

  • Bjerking LH Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.
  • Hansen KW Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.
  • Sørensen R Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
  • Prescott E Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.
  • Biering-Sørensen T Department of Cardiology, Herlev Gentofte University Hospital, Hellerup, Denmark.
  • Jeger R Department of Cardiology, University Hospital Basel, Basel, Switzerland.
  • Kaiser C Department of Cardiology, University Hospital Basel, Basel, Switzerland.
  • Pfisterer M Department of Cardiology, University Hospital Basel, Basel, Switzerland.
  • Galatius S Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.
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  • 2019-06-21
Published in:
  • Open heart. - 2019
English Background
Drug-eluting stents (DES) have proven superior to bare-metal stents (BMS) in terms of safety and efficacy. However, inference to the female subgroup has been limited by low enrolment rates of women in clinical trials. The objective of this study was to investigate the safety and efficacy of DES versus BMS in women and men.


Methods
In a pooled analysis of two all-comers randomised trials (Basel Stent Kosten-Effektivitäts Trial-Prospective Validation Examination (BASKET-PROVE) and BASKET-PROVE II) (n=4605), we examined safety and efficacy of DES versus BMS according to sex. Patients were followed 2 years for a composite endpoint of cardiac death, non-fatal myocardial infarction (MI) and clinically driven target-vessel revascularisation not related to MI.


Results
Among the 1076 women and 3529 men included in the analysis, 65.6% of the women and 67.2% of the men were randomised to receive DES. At baseline, men had more complex coronary artery disease than women. After 2 years, DES reduced rates of major adverse cardiac events (MACE) compared with BMS in both women (cumulative incidence, 6.1% vs 14.7%; adjusted HR 0.36 (95% CI 0.24 to 0.54)) and men (7.7 vs 12.1%, HR 0.62 (0.50 to 0.77)), although the reduction in MACE rates was more pronounced in women (adjusted p=0.02 for sex-stent interaction). Event rates were lower in DES for both safety and efficacy outcomes, with the largest effect seen for non-MI TVR, in both women (2.3 vs 9.2%, adjusted HR 0.24 (0.13 to 0.44)) and men (4.0 vs 7.8%, adjusted HR 0.48 (0.36 to 0.64)) (adjusted p=0.049 for sex-stent interaction).


Conclusions
In patients requiring stenting of large coronary arteries, DES were associated with improved safety in women and superior efficacy in both sexes as compared with BMS.
Language
  • English
Open access status
gold
Identifiers
Persistent URL
https://sonar.ch/global/documents/84243
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