Meta-Analysis of Long-Term Clinical Outcomes of Everolimus-Eluting Stents

Takahashi, Toshiaki; Shiomi, Hiroki; Morimoto, Takeshi; Kimura, Takeshi

doi:10.1016/j.amjcard.2015.03.059

Cited by 27 publications

(15 citation statements)

References 26 publications

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“…Several previous meta-analyses have clearly demonstrated the markedly lower ST risk with G2-DES, EES in particular, as compared with G1-DES as well as bare-metal stents (odds ratio: 0.26-0.48). 31,32 A previous meta-analysis comparing a G2-DES (EES) with a G1-DES (SES) also demonstrated a significantly lower TLR risk with the EES (odds ratio: 0.83, P=0.03); however, the magnitude of risk reduction for TLR was much smaller than for ST. 22 In the present study, we could not demonstrate the superiority of G2-DES over G1-DES for the prevention of TLR in the entire study population; however, the magnitude of risk reduction for TLR in the present study (HR: 0.78) was not different from that in the previous meta-analysis. Therefore, the negative TLR result in the present study may be a type II error caused by a lack of adequate statistical power, but G2-DES were associated with a significantly lower risk for the secondary composite endpoints than G1-DES.…”

Section: Disclosurescontrasting

confidence: 95%

“…[15][16][17][18] Several previous randomized controlled trials suggested noninferiority of G2-DES to G1-DES for TLR, and a metaanalysis demonstrated superiority of G2-DES for TLR in patient populations including both calcified and noncalcified lesions. [19][20][21][22] However, there has not been a study comparing G2-DES with G1-DES in patients with lesion calcification. Therefore, the aim of the present study was to compare the clinical outcomes between G2-DES and G1-DES according to the presence or absence of lesion calcification in a pooled database of 2 large DES-vs.-DES trials conducted in Japan.…”

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confidence: 99%

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Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―

Nishida

Nakatsuma

Shiomi

et al. 2018

Circ J

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Section: Disclosurescontrasting

confidence: 95%

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confidence: 99%

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―

Nishida

Nakatsuma

Shiomi

et al. 2018

Circ J

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“…This is true because only a recent meta-analysis showed better midterm results on the angiographic efficacy of EES over SES in terms of TLR by recruiting update studies. 20) The present study also showed overall better midterm angiographic outcomes for BES compared to those of SES, regarding angiographic surrogate endpoints (Tables III and IV, and Figure 2). Biodegradable polymers were designed to overcome the long-term adverse vascular reactions related to durable polymers, and the adverse vascular reactions were expected to emerge during the late phase after stent implantation.…”

Section: Discussionmentioning

confidence: 51%

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

et al. 2017

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SummaryWe conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus-(EES) or biolimus-(BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes. The endpoint, as an angiographic surrogate marker of clinical efficacy, was the distribution of in-stent follow-up percent diameter stenosis (%DS) which comprised the percentages of 1) follow-up %DS < 20 and 2) follow-up %DS > 50. Propensityscore matched analyses were conducted to adjust 21 baselines.In 1215 baseline adjusted lesions, the endpoints in the EES group [1) 74.1%, and 2) 4.6%] were significantly different from those in the SES group [57.9%; P < 0.001, 7.2%; P = 0.006, respectively). In 307 baseline adjusted lesions, the endpoints in the BES group [1) 80.5%, 2) 2.0%] were significantly different from those in the SES group [59.3%; P < 0.001, 2) 8.1%; P = 0.001, respectively].The present study is the first to confirm the superiority of midterm angiographic outcomes after the placement of EES and BES over SES for de novo coronary stenosis in a clinical setting. (Int Heart J 2017; 58: 320-327) Key words: Follow-up result, Angioplasty, Binary restenosis, Target lesion revascularization, Late luminal loss E verolimus-eluting stents (EES; Xience and Promus) have exhibited benefits associated with a favorable vascular response compared to sirolimus-eluting stents (SES; Cypher BxV and Select+), owing to their advanced drug-eluting stent (DES) technology that consists of the revised thin and flexible stent platform, anti-thrombogenic fluoropolymer, and drug. 1,2) The biolimus-eluting stent (BES; Nobori) also showed a better midterm intravascular response compared to SES, owing to its properties such as being a biodegradable polymer and the highest lipophilicity among the limus analogues. 3,4) However, despite these advanced aspects of EES and BES compared with the former evidence-based first generation "-limus" DES, that is, SES, prospective randomized trials have not demonstrated significantly better midterm angiographic outcomes for either EES 5,6) or BES 7,8) in terms of binary in-stent restenosis, TLR, or mean magnitude of in-stent late luminal loss compared to those of SES.In the present study, we conducted a retrospective comparison to examine the impact of the advances in coronary stent technology, represented by improved intravascular and pathological findings of either EES or BES over SES 1-4) on the overall midterm angiographic outcomes. For this purpose, 3420 lesions angiographically followed-up ...

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“…Few studies have ever investigated the relationship between the angiographic residual stenosis and clinical outcomes in patients undergoing PCI using DES. Moreover, the new‐generation DES is widely used in current clinical practice, with reduced rates of ST as well as restenosis 15, 16, 17. However, the optimal angiographic residual stenosis in the new‐generation DES era still needs discussion.…”

Section: Discussionmentioning

confidence: 99%

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New‐Generation Drug‐Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials

Watanabe

Morimoto

Shiomi

et al. 2018

JAHA

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BackgroundPrevious intravascular ultrasound studies suggested the association of stent underexpansion with increased risk of stent thrombosis and restenosis. However, no previous study has addressed the association of the suboptimal angiographic result with target‐lesion revascularization (TLR) in patients receiving new‐generation drug‐eluting stents (DES).Methods and Results RESET (Randomized evaluation of sirolimus‐eluting versus everolimus‐eluting stent trial) and NEXT (NOBORI biolimus‐eluting versus XIENCE/PROMUS everolimus‐eluting stent trial) are prospective, multicenter, randomized “DES versus DES” trials; 3196 patients and 3235 patients were enrolled in the RESET and NEXT, respectively. Using the pooled individual patient‐level data, the current study population consisted of 3679 patients who received single‐lesion treatment using new‐generation DES such as everolimus‐eluting stent and biolimus‐eluting stent. The study population was divided into 3 groups according to the residual in‐stent % diameter stenosis (%DS) after stent implantation by offline quantitative coronary angiography assessed in a core angiographic laboratory (optimal group: %DS <10%, intermediate group: %DS=10% to 20%, suboptimal group: %DS ≧20%). The cumulative 3‐year incidence of TLR was significantly higher in the suboptimal group than in the intermediate and optimal groups (9.8% versus 5.8% versus 5.7%, log‐rank P=0.004). Even after adjusting for the clinical, angiographic, and procedural characteristics, the excess TLR risk of the suboptimal group relative to the optimal group remained significant (hazard ratio: 1.65, 95% confidence interval, 1.14–2.41, P=0.009). The excess TLR risk of the suboptimal group relative to the optimal group was consistently seen across all the subgroups including heavy calcification.ConclusionsThe residual angiographic in‐stent %DS ≥20% was associated with increased risk for TLR in patients treated with the new‐generation DES.

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Meta-Analysis of Long-Term Clinical Outcomes of Everolimus-Eluting Stents

Cited by 27 publications

References 26 publications

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New‐Generation Drug‐Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials

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Meta-Analysis of Long-Term Clinical Outcomes of Everolimus-Eluting Stents

Cited by 27 publications

References 26 publications

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions ― Pooled Analysis From the RESET and NEXT Trials ―

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions ― Pooled Analysis From the RESET and NEXT Trials ―

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for <i>De Novo</i> Coronary Stenosis

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New‐Generation Drug‐Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials

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Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　― Pooled Analysis From the RESET and NEXT Trials ―