Abstract 649 10-Year clinical outcomes of biodegradable versus durable polymer new-generation DES in patients with coronary artery disease with and without diabetes mellitus

Background: New generation drug-eluting stents (DES) with biodegradable or permanent polymer offer the potential to improve long-term clinical outcome. Extended long-term follow-up data in the specific subset of patients with diabetes mellitus are scant. The aim of this study is to compare the 10 years clinical outcome of new-generation biodegradable polymer-based sirolimus-eluting stents (BP-SES) versus permanent polymer-based everolimus-eluting stents (PP-EES) in patients with and without diabetes mellitus.

Methods: In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with BP-SES or PP-EES were compared. The primary endpoint of this analysis was major adverse cardiac events (MACE), the composite of death, myocardial infarction (MI) or target lesion revascularization (TLR) at 10-years clinical follow-up. The main secondary endpoint of interest was definite/probable stent thrombosis at 10 years.

Results: The analysis includes a total of 1951 patients, (560 patients with diabetes mellitus and 1391 patients without diabetes) randomized to treatment with new-generation BP-SES (n=1299) or PP-EES (n=652). Regarding the primary endpoint, at 10 years there was no significant difference between patients treated with BP-SES versus PP-EES, neither in the subgroup of patients with diabetes mellitus (P=0.91; HR 0.99; 95% CI, 0.77-1.26) nor in the subgroup of patients without diabetes (P=0.50; HR 1.06; 95% CI, 0.83-1.27). Irrespective of treatment allocation, patients with diabetes showed significantly higher MACE rates (P<0.001; HR 1.41; 95% CI 1.22-1.63). Rates of definite/probable stent thrombosis were low and comparable patients with diabetes mellitus and without diabetes treated with BP-SES versus PP-EES.

Conclusion: New-generation DES with biodegradable or permanent polymer, show consistently comparable clinical event-rates at 10 years, irrespective of diabetic status. The clinical outcome of diabetic patients after PCI with new-generation DES is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years.

Clin Res Cardiol (2021) DOI DOI https://doi.org/10.1007/s00392-021-01843-w
10-Year clinical outcomes of biodegradable versus durable polymer new-generation DES in patients with coronary artery disease with and without diabetes mellitus
T. Koch¹, T. Lenz¹, M. Joner², E. Xhepa¹, J. Wiebe¹, J. Coughlan¹, A. Aytekin¹, T. Ibrahim³, M. Fusaro², S. Cassese², K.-L. Laugwitz³, H. Schunkert¹, A. Kastrati¹, S. Kufner¹, für die Studiengruppe: ISAResearch Center
¹Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München; ²Deutsches Herzzentrum München, München; ³Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar Technischen Universität München, München;
Background: New generation drug-eluting stents (DES) with biodegradable or permanent polymer offer the potential to improve long-term clinical outcome. Extended long-term follow-up data in the specific subset of patients with diabetes mellitus are scant. The aim of this study is to compare the 10 years clinical outcome of new-generation biodegradable polymer-based sirolimus-eluting stents (BP-SES) versus permanent polymer-based everolimus-eluting stents (PP-EES) in patients with and without diabetes mellitus. Methods: In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with BP-SES or PP-EES were compared. The primary endpoint of this analysis was major adverse cardiac events (MACE), the composite of death, myocardial infarction (MI) or target lesion revascularization (TLR) at 10-years clinical follow-up. The main secondary endpoint of interest was definite/probable stent thrombosis at 10 years. Results: The analysis includes a total of 1951 patients, (560 patients with diabetes mellitus and 1391 patients without diabetes) randomized to treatment with new-generation BP-SES (n=1299) or PP-EES (n=652). Regarding the primary endpoint, at 10 years there was no significant difference between patients treated with BP-SES versus PP-EES, neither in the subgroup of patients with diabetes mellitus (P=0.91; HR 0.99; 95% CI, 0.77-1.26) nor in the subgroup of patients without diabetes (P=0.50; HR 1.06; 95% CI, 0.83-1.27). Irrespective of treatment allocation, patients with diabetes showed significantly higher MACE rates (P<0.001; HR 1.41; 95% CI 1.22-1.63). Rates of definite/probable stent thrombosis were low and comparable patients with diabetes mellitus and without diabetes treated with BP-SES versus PP-EES. Conclusion: New-generation DES with biodegradable or permanent polymer, show consistently comparable clinical event-rates at 10 years, irrespective of diabetic status. The clinical outcome of diabetic patients after PCI with new-generation DES is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years.
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