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Women with coronary artery calcification (CAC) undergoing percutaneous coronary intervention (PCI) have an increased ischemic risk, despite new-generation drug-eluting stents, according to research published in JACC: Cardiovascular Interventions.
Researchers from Mount Sinai and Columbia University in New York City as well as sites in Germany and the Netherlands, collected data from 11,557 women undergoing PCI for calcified lesions in 26 randomized clinical trials. They sought to evaluate the longitudinal prognostic impact of target lesion CAC and the effect of said CAC in women in high-risk clinical and angiographic subsets.
The 2 primary end points were the 3-year risk of a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR) and the composite of death, MI, or definite or probable stent thrombosis. The secondary end points were the individual components of the primary end points and cardiac death.
After the researchers excluded patients who were part of studies that used bare-metal stents and/or did not have CAC data available, 6371 women were included in the final analysis. More than 25% of these women had moderate or severe CAC. Those patients were significantly older with higher prevalence of hypertension or hypercholesterolemia. They were also more likely to have had prior coronary artery bypass graft surgeries, higher serum creatinine levels, and lower left ventricular ejection fractions.
For both primary end points of death, MI, or TLR, women with moderate or severe CAC had higher crude and adjusted risks (18.2% vs 13.1%; adjusted hazard ratio [HR]: 1.56; 95% CI, 1.33-1.84; P <.0001) and death, MI, or stent thrombosis (12.7% vs 8.6%; adjusted HR: 1.48; 95% CI, 1.21-1.80; P=.0001).
The risk of stent thrombosis, on the other hand, was attenuated after multivariate adjustment (adjusted HR: 1.52; 95% CI, 0.89-2.59; P =.13). In addition, TLR rates were higher in the first year of analysis, but not in the very late period.
Between new-generation and early-generation drug-eluting stents, the effect of CAC on TLR and stent thrombosis was consistent (new-generation stents: TLR, adjusted HR: 1.57; 95% CI, 1.14-2.16 and stent thrombosis, adjusted HR: 1.78; 95% CI, 0.87-3.64 vs early-generation stents: TLR, adjusted HR: 1.19; 95% CI, 0.83-1.70 and stent thrombosis, adjusted HR: 1.41; 95% CI, 0.65-3.07). There was also no evidence of interaction (TLR, P interaction = .23 and stent thrombosis, P interaction = .49).
“The adverse effect of CAC on ischemic outcomes appears to be uniform across clinical and angiographic subsets, including new-generation DES [drug-eluting stents],” the researchers wrote.
They added that optimizing both lesion preparation and stent implantation will become even more important with the use of bioresorbable scaffolds since stent expansion and strut opposition are not always achieved.
Study Limitations
- Major advances in interventional approaches and technologies have been made since the time span of these trials (>10 years). These advances could affect subsequent outcomes.
- Some patient population heterogeneity existed due to the varying inclusion and exclusion criteria among the trials.
- Severe CAC was among one of the exclusion criterion which may have limited the external validity of this analysis.
- Since there were no male participants, the researchers cannot comment on whether there is a difference in outcomes between men and women after PCI by CAC severity.
- Laboratory variability across the studies was not available.
- Dual antiplatelet therapy data were unavailable.
- These trials were not initially designed to assess safety and efficacy of drug-eluting stents in women with calcified lesions, so these analysis results must be considered “hypothesis generating.”
Disclosures: Dr Stefanini has received speaking fees from Abbott Vascular, AstraZeneca, Biosensors, and Biotronik. Dr Windecker has received research contracts to the institution from Abbott Vascular, Boston Scientific, Biosensors, Cordis, and Medtronic. Dr Wijns has received institutional research grants and/or honoraria from Boston Scientific, Medtronic, Abbott Vascular, Terumo, and Biosensors, and is an investigator for trials sponsored by the same pharmaceutical companies. Dr Von Birgelen serves as a consultant to and has received fees from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, and Merck Sharp and Dohme. Dr Valgimigli has received honoraria and/or grants from Merck, Iroko, Eli Lilly, Medtronic, The Medicines Company, Daiichi-Sankyo, St. Jude Medical, Abbott Vascular, Cordis, Carbostent and Implantable Devices, and Terumo. Dr Galatius has received grant support and/or honoraria from St. Jude Medical, Abbott Vascualr, Terumo, Biotronik, Eli Lilly, and Servier. Dr Smits has received grants from Abbott Vascular, Boston Scientific, St. Jude Medical, and Terumo. Dr Steg has received research grants from Servier and Sanofi, and has served as a speaker or consultant for Amarin, AstraZeneca, Bayer, Boehringer- Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Eli Lilly, Medtronic, Merck-Sharpe Dohme, Novartis, Orexigen, Pfizer, Regado, Sanofi, Servier, and The Medicines Company. He is also a stockholder of Aterovax. Dr Kastrati has received honoraria from Abbott Vascular, Biosensors, Biotronik, Cordis, and Medtronic, and a patent application with respect to a biodegradable polymer stent coating. Dr Mehran has received research grant support and/or consulting fees from The Medicines Company, Bristol-Myers Squibb, Sanofi, Eli Lilly, Astra Zeneca, Bayer, CSL Behring, Jansseen, Merck, Osprey Medical, and Watermark Research Partners. He also serves on the advisory boards of Abbott Laboratories, Boston Scientific, Covidien, Janssen, The Medicines Company, and Sanofi.
