Individual Patient Data Meta-analysis of Drug-eluting Versus Bare-metal Stents for Percutaneous Coronary Intervention in Chronic Versus Acute Coronary Syndromes

https://doi.org/10.1016/j.amjcard.2022.07.035Get rights and content

New-generation drug-eluting stents (DES) strongly reduce restenosis and repeat revascularization compared with bare-metal stents (BMS) for percutaneous coronary intervention. There is residual uncertainty as to whether other prognostically relevant outcomes are affected by DES versus BMS concerning initial presentation (chronic coronary syndrome [CCS] vs acute coronary syndrome [ACS]). We performed an individual patient data meta-analysis of randomized trials comparing new-generation DES versus BMS (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction (MI). Outcomes were examined at maximum follow-up and with a 1-year landmark. Risk estimates are expressed as hazard ratio (HR) with 95% confidence interval (CI). A total of 22,319 patients were included across 14 trials; 7,691 patients (34.5%) with CCS and 14,628 patients (65.5%) with ACS. We found evidence that new-generation DES versus BMS consistently reduced the risk of cardiac death or MI in both patients with CCS (HR 0.83, 95% CI 0.70 to 0.98, p <0.001) and ACS (HR 0.83, 95% CI 0.75 to 0.92, p <0.001) (p-interaction = 0.931). This benefit was mainly driven by a similar reduction in the risk of MI (p-interaction = 0.898) for both subsets (HRCCS 0.80, 95% CI 0.65 to 0.97; HRACS 0.79, 95% CI 0.70 to 0.89). In CCS and ACS, we found a time-dependent treatment effect, with the benefit from DES accumulating during 1-year follow-up, without offsetting effects after that. In conclusion, patients with CCS were slightly underrepresented in comparative clinical trials. Still, they benefited similarly to patients with ACS from new-generation DES instead of BMS with a sustained reduction of cardiac death or MI because of lower event rates within 1 year.

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Methods

This study is an individual patient data (IPD) meta-analysis of randomized clinical trials comparing new-generation DES versus BMS for PCI.10 The search algorithm of the study and the assembled anonymized dataset are shown in the Supplementary Material. We included randomized trials comparing new-generation DES versus BMS in patients who underwent PCI. New-generation DES were considered as any DES after the Cypher sirolimus-eluting stent (Cordis, Miami Lakes, Florida) and the Taxus

Results

Of the initial 26,616 participants, 4 trials (n = 3,629) were excluded because they enrolled only patients with ACS, and 246 patients were excluded because information on presenting coronary syndrome was missing. Therefore, the final population consisted of 22,319 patients enrolled across 14 trials; 7,691 patients (34.5%) with CCS and 14,628 patients (65.5%) with ACS. The Supplementary Material describes trial characteristics, patient populations, and the definitions used for outcomes (

Discussion

Using the totality of available evidence from randomized trials comparing new-generation DES with BMS, our collaborative IPD analysis provides strong evidence that DES reduce the risk of cardiac death or MI compared with BMS in patients with CCS. The observed treatment effect in the CCS population was similar to that observed in patients with ACS, representing most included patients. There is also robust evidence that DES, compared with BMS, decreases the risk of MI and TVR in patients with

Disclosures

The authors have no conflicts of interest to declare.

References (21)

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This study was funded by institutional support from the Department of Cardiology at Bern University Hospital, Bern, Switzerland. There was no industry involvement in the design, analysis, or funding of this study.

Systematic Review Registration: PROSPERO CRD42017060520.

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