Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials

Stefanini, Giulio G.; Baber, Usman; Windecker, Stephan; Morice, Marie‐Claude; Sartori, Samantha; Leon, Martin B.; Stone, Gregg W.; Serruys, Patrick W.; Wijns, William; Weisz, Giora; Camenzind, Edoardo; Steg, Philippe Gabriel; Smits, Pieter C.; Kandzari, David E.; Birgelen, Clemens von; Galatius, Søren; Jeger, Raban; Kimura, Takeshi; Mikhail, Ghada; Itchhaporia, Dipti; Mehta, Laxmi S.; Ortega, Rebecca; Kim, Hyo–Soo; Valgimigli, Marco; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

doi:10.1016/s0140-6736(13)61782-1

Cited by 130 publications

(81 citation statements)

References 46 publications

(38 reference statements)

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“…The graph shows that this criterion is met in both cases. This analysis is based on the same primary data as those reported by Stefanini et al [1]. Abbreviations: DES, drug-eluting stents; CI, confidence interval; RD, rate difference, TLR, target lesion revascularization.…”

Section: Resultsmentioning

confidence: 99%

“…Since the interpretation made by Stefanini et al [1] of their results was that the newer-generation of DES is more effective than the early-generation one, and this issue deserves a close scrutiny. As pointed out by Ahn et al [5], when a specific data set indicates, at the same time, equivalence and superiority, the interpretation is controversial, and two different hypotheses can be proposed.…”

Section: Discussionmentioning

confidence: 99%

“…Our clinical material was obtained from the meta-analysis by Stefanini et al [1] who studied this specific comparison according to the end-point of target-lesion revascularisation (TLR), The crude rates of TLR for newergeneration DES and early-generation DES were, respectively, 236/6278 (3.76%) vs 205/4171 (4.91%) at 1 year and 330/6278 (5.26%) vs 294/4171 (7.05%) at 3 years. These findings generate a rate difference (RD) for TLR of −1.16% at 1 year [95% confidence interval (CI): −1.96% to −0.35%] and of −1.79% at 3 years (95% CI: −2.75% to −0.84%) in favour of newer-generation DES.…”

Section: Methodsmentioning

confidence: 99%

“…Any difference within the limit of 2.9% in TLR rates can therefore be assumed to identify an equivalence interval; other randomized studies in this area have generally adopted wider margins (between 3% and 4%). Hence, our equivalence test [5] was designed to combine the values of RD found by Stefanini et al [1] with the margins adopted by Stone et al [2].…”

Section: Methodsmentioning

confidence: 99%

“…Technology advancements of DES have been particularly relevant over the last few years and have resulted in increased safety and efficacy of newer-generation vs early-generation DES, as several randomised trials and meta-analyses have documented [1] [2]. Anyway, the data for safety and efficacy of DES in women are sparse because their inclusion in randomised clinical trials is generally limited [1].…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

Messori¹,

Fadda²,

Maratea³

et al. 2014

WJCD

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Evidence-based research is increasingly aimed at differentiating between no proof of difference (failed demonstration of superiority) and proof of no difference (demonstration of equivalence). The latter requires that equivalence margins are incorporated in the analysis of outcomes. We applied an analysis of equivalence to study the incremental benefit of newer-generation vs earlygeneration drug-eluting stents (DES) in women receiving percutaneous coronary intervention. The clinical material was derived from published data. Our equivalence testing was focused on the end-point of target-lesion revascularisation (TLR). Results were expressed as rate differences (RDs), while the equivalence margins (±2.9%) were derived from the statistical power calculations of a recent trial. Our results clearly indicated that, in women, there was an equivalent effectiveness between newer-generation and early-generation of DES.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

Messori¹,

Fadda²,

Maratea³

et al. 2014

WJCD

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Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction

et al. 2017

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IMPORTANCE Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear.OBJECTIVE To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI. INTERVENTIONS Randomization to early-(sirolimus-or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES. MAIN OUTCOMES AND MEASURESComposite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up. RESULTS Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, −3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, −2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, −0.5% [NNT, 222]; NSTEMI, −3.1% [NNT, 33]; STEMI, −4.0% [NNT, 25] and for definite or probable ST: UA, −0.4% [NNT, 278]; NSTEMI, −2.2% [NNT, 46]; STEMI, −4.0% [NNT, 25]).CONCLUSIONS AND RELEVANCE New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

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Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation

et al. 2017

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Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials

Cited by 130 publications

References 46 publications

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction

Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation

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