Paclitaxel‐ and sirolimus‐eluting stents in older patients with diabetes mellitus

Buja, Paolo; Facchin, Michela; Musumeci, Giuseppe; Frigo, Anna Chiara; Saia, Francesco; Menozzi, Alberto; Meliga, Emanuele; Sardella, Gennaro; Tamburino, Corrado; Tarantini, Giuseppe

doi:10.1002/ccd.24636

Cited by 8 publications

(3 citation statements)

References 27 publications

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“…Patients with DM have more accelerated, diffuse and complex atherosclerotic coronary artery disease (CAD), as well as higher rates of restenosis and ST after PCI with DES. As such, they carry a higher risk of both stent-and patient-related adverse events after PCI [5][6][7]. DAPT after DES implantation is used to reduce the risk for thrombotic events weeks to months after PCI.…”

Section: Discussionmentioning

confidence: 99%

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

Tarantini

Fovino

Tellaroli

et al. 2016

International Journal of Cardiology

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Section: Discussionmentioning

confidence: 99%

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

Tarantini

Fovino

Tellaroli

et al. 2016

International Journal of Cardiology

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“…It is known that the diabetic status is associated with a higher risk of both stent-and patient-related adverse events after PCI [8][9][10].…”

Section: Discussionmentioning

confidence: 99%

Abluminal biodegradable polymer biolimus-eluting versus durable polymer everolimus-eluting stent in patients with diabetes mellitus

Paradies

Vlachojannis

Royaards

et al. 2019

International Journal of Cardiology

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Background: Drug eluting stents with biodegradable polymers have been developed to address the risk of very late adverse events. Long-term comparison data between the biodegradable polymer-coated biolimus-eluting stent (BES; Nobori®) and the second-generation durable polymer-coated everolimus-eluting stent (EES; XIENCE V® or XIENCE PRIME® or PROMUS™) in diabetic patients are scarce. Methods: The COMPARE II trial was an investigator-initiated, multicenter, open-label, randomized, all-comers trial which assigned patients undergoing percutaneous coronary intervention (PCI) in a 2:1 fashion to either BES or EES. We analyzed the safety and efficacy outcomes in diabetic patients at 5 year follow-up. The primary pre-specified composite endpoint major adverse cardiac event (MACE) was defined as cardiac death, non-fatal target-vessel myocardial infarction (TV-MI), or clinically indicated target vessel revascularization (CD-TVR). Results: Out of 2707 study patients, 588 were diabetics (21.7%) of whom 391 were treated with BES and 197 with EES. At 5 years follow-up, MACE occurred in 87 patients (22.2%) in the BES group and in 34 patients (17.2%) in the EES group (p = .34). Other safety and efficacy endpoints did not differ between stent groups. Conclusions: At 5 years follow-up, no differences in terms of MACE as well as all analyzed safety and efficacy measures, including stent thrombosis, between the biodegradable polymer-coated BES and the durable polymercoated EES in diabetic patients were observed.

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“…The first‐generation sirolimus (SES) and paclitaxel (PES) drug eluting stents (DES) revolutionized interventional practice through enhanced and predictable durability of even complex percutaneous coronary interventions (PCI). In this issue, Buja et al report no difference in adjusted hazard of death, myocardial infarction (MI), or target lesion revascularization (TLR) with SES versus PES in 1,417 diabetics more than 65 years of age with median follow‐up of 24 months from a multicenter observational registry . SES equals PES in older diabetics, story over?…”

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confidence: 99%

Stent paleology

Hillegass

2013

Cathet Cardio Intervent

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The first-generation sirolimus (SES) and paclitaxel (PES) drug eluting stents (DES) revolutionized interventional practice through enhanced and predictable durability of even complex percutaneous coronary interventions (PCI). In this issue, Buja et al. report no difference in adjusted hazard of death, myocardial infarction (MI), or target lesion revascularization (TLR) with SES versus PES in 1,417 diabetics more than 65 years of age with median follow-up of 24 months from a multicenter observational registry [1]. SES equals PES in older diabetics, story over? Since SES and PES are essentially extinct in the current everolimus (EES) generation, so why care?EES is clearly better than PES in randomized trials (RCTs) in nondiabetics (n ¼ 3,911) with hazard ratio (HR) for major adverse cardiovascular events (MACE) of 0.44 [95% (0.35-0.55), p < 0.0001] but not diabetics (n ¼ 1,869), HR ¼ 1.01 [(0.72-1.42), p ¼ 0.95] [2]. One in six individuals undergoing PCI in the United States is a diabetic more than the age of 65. With 5-year follow-up after PCI, older diabetics have higher adjusted HR of death [insulin treated 1.91; (1.86-1.96), p < 0.001/ not insulin treated HR ¼ 1.32; (1.29-1.35), p < 0.001] and MI [HR ¼ 1.87; (1.79-1.95), p < 0.001/ HR ¼ 1.29; (1.25-1.34), p < 0.001] compared to nondiabetics. With PCI largely applied for acute coronary syndromes (ACS) in older diabetics, the adjusted HR for additional revascularization compared to nondiabetics are not so different, HR ¼ 1.14; [1.10-1.18], p < 0.001 with insulin/HR ¼ 1.08; [1.05-1.10], p < 0.001 without insulin. The MACE composite endpoint in older diabetics is largely driven by death and MI, not TLR [3].Diabetics have greater burden of disease, more vulnerable plaque, a prothrombotic state, inflammation, and more rapid progression of disease. In the diabetic patient, therefore, a superior lesion-specific treatment such as EES is unlikely to overcome these systemic factors which yield most of the subsequent death and MI. In diabetics, long segment revascularization and thus more extensive plaque event protection with coronary bypass grafts likely explains the superiority of surgery over even "complete" multivessel DES PCI to prevent death and MI.Death, MI, and even TLR (since it is mainly driven by ACS) rates are inadequate to fully differentiate the relative efficacy of two lesion-specific treatments (e.g., SES vs. PES, EES vs. PES) in older diabetics. Potential stent specific outcome differences are diluted by albeit the important "background noise" of death and MI which largely cannot be prevented by any stent no matter how superior. Clearly, DES is better than bare metal stents (BMS) in diabetics in RCTs. Meta-analyses show that DES reduces the odds of instent restenosis and TLR to at least 1/4th compared to BMS in diabetics. In meta-analysis of all the 16 randomized trials of SES versus PES, SES reduced the hazards of reintervention ) and stent thrombosis [HR ¼ 0.66 (0.46-0.94)] compared to PES with no difference in death or MI between stent types [4]. In th...

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Paclitaxel‐ and sirolimus‐eluting stents in older patients with diabetes mellitus

Abstract: In this real-life multicenter registry, PES and SES showed a comparable safety and efficacy profile in diabetic patients older than 65 years throughout 1-to-5 years follow-up.

Cited by 8 publications

References 27 publications

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

Abluminal biodegradable polymer biolimus-eluting versus durable polymer everolimus-eluting stent in patients with diabetes mellitus

Stent paleology

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