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Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6‑month vs. 12‑month dual-antiplatelet therapy (DAPT)

Klinische Ergebnisse nach Behandlung mit polymerfreien sirolimusfreisetzenden Stents und 6‑ vs. 12‑monatiger dualer Thrombozytenaggregationshemmertherapie (DAPT) bei Diabetes

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Abstract

Background

Diabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DES). Defining the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation is still under debate. The objective of this subgroup analysis of the all-comers ISAR 2000 registry was to assess the safety and efficacy of a short DAPT (<6 month) versus a longer DAPT (>6 month) in patients with diabetes electively treated with the polymer-free sirolimus-coated ultrathin strut drug-eluting stent (PF-SES).

Methods

Patients who received the PF-SES were investigated in a multicenter all-comers observational study. The primary endpoint was the 9‑month target lesion revascularization (TLR) rate, whereas secondary endpoints included the 9‑month major adverse cardiac event (MACE) and procedural success rates.

Results

In all, 167 patients were treated with DAPT for ≤6 months (S-DAPT group) and 350 patients underwent DAPT treatment for 12 months (L-DAPT group). There was no significant difference in the overall MACE rate (4.6% vs. 3.1%, p = 0.441), the 9‑month accumulated stent thrombosis rates (0.8% vs. 0.3%, p = 0.51), or the accumulated rate of bleeding complications (5.3% vs. 3.4%, p = 0.341).

Conclusion

PF-SES are safe and effective in daily clinical routine with low rates of TLR and MACE in patients with diabetes and stable disease. Our data suggest that extending the duration of DAPT beyond 6 months does not improve MACE or TLR at 9 months in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).

Zusammenfassung

Hintergrund

Patienten mit Diabetes, die sich einer perkutanten Koronarintervention (PCI) mit medikamentenbeschichteten Stents („drug-eluting stents“, DES) unterziehen, haben im Vergleich zu Nichtdiabetikern eine schlechtere Prognose. Ein möglicher Faktor könnte die Notwendigkeit einer verlängerten dualen Thrombozytenaggregationshemmung (DAPT) darstellen. Die optimale Dauer der DAPT nach DES-Implantation wird derzeit kontrovers diskutiert. Es wurde eine Subgruppenanalyse des ISAR-2000-Registers durchgeführt, um zu untersuchen, ob eine verkürzte DAPT (<6 Monate) im Vergleich zu einer längeren DAPT (>6 Monate) bei Diabetikern sicher und wirksam ist, bei denen eine elektive PCI mit einem polymerfreien sirolimusfreisetzenden ultradünnen Stent („polymer-free sirolimus coated ultrathin strut drug eluting stent“, PF-SES) durchgeführt wurde.

Methoden

Die Daten der mit einem PF-SES behandelten Patienten wurden im Rahmen einer multizentrischen Beobachtungsstudie anhand eines Registers in Asien und Europa analysiert. Der primäre Endpunkt war die 9‑monatige Revaskularisationsrate („target lesion revascularization“, TLR); sekundäre Endpunkte beinhalteten die Rate schwerer kardiovaskulärer Ereignisse („major adverse cardiac events“, MACE) und die Rate des prozeduralen Erfolgs.

Ergebnisse

Eine verkürzte DAPT erhielten 167 Patienten (<6 Monate; S‑DAPT-Gruppe), und 350 Patienten wurden mit einer längeren DAPT (>6 Monate; L‑DAPT-Gruppe) behandelt. Es zeigte sich kein signifikanter Unterschied hinsichtlich der MACE-Rate (4,6 % S‑DAPT; 3,1 % L‑DAPT; p = 0,441), der 9‑monatigen Stentthromboserate (0,8 % S‑DAPT; 0,3 % L‑DAPT; p = 0,51) oder der kumulativen Rate an Blutungskomplikationen nach 9 Monaten (5,3 % S‑DAPT; 3,4 % L‑DAPT; p = 0,341).

Schlussfolgerung

Die vorliegenden Daten zeigen, dass der Einsatz von PF-SES in der klinischen Routine bei Patienten mit Diabetes mellitus und stabiler koronare Herzerkrankung sicher und wirksam ist. Diese Daten weisen darauf hin, dass eine DAPT, die länger als 6 Monate dauert, zu keiner Verbesserung der MACE- oder TLR-Rate nach 9 Monaten führt (ClinicalTrials.gov Identifier NCT02629575).

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Authors and Affiliations

  1. Department of Cardiology, Charité – Universitätsmedizin Berlin, Campus Virchow, Augustenburger Platz 1, 13353, Berlin, Germany

    F. Krackhardt & B. Kherad MD

  2. Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany

    M. Waliszewski & M. Boxberger

  3. Hôpital Albert Schweitzer Colmar, Colmar, France

    J. Rischner

  4. Clinique du Millénaire Montpellier, Montpellier, France

    C. Piot

  5. Centre Hospitalier d’Avigon, Avignon, France

    M. Pansieri

  6. Hospital General Universitario de Ciudad Real, Ciudad Real, Spain

    F. L. Ruiz-Poveda

  7. Midgerman Heart Center, Department of Internal Medicine III, Division of Cardiology, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle, Halle, Germany

    M. Noutsias

  8. Complexo Hospitalario Universitario de A Coruña, Coruña, Spain

    X. F. Ríos

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Correspondence to B. Kherad MD.

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Conflict of interest

F. Krackhardt and M. Noutsias have received lecturing fees from B. Braun Melsungen AG . M. Waliszewski and M. Boxberger are currently full-time employed at Medical Scientific Affairs, B. Braun Melsungen AG. J. Rischner, C. Piot, M. Pansieri, F.L. Ruiz-Poveda, X.F. Ríos, and B. Kherad declare that they have no competing interests.

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975 (in its most recently amended version). Informed consent was obtained from all patients included in the study.

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Contributions. All authors were involved in the data analysis plan and interpretation, drafting the article, critical revision, and the final approval.

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Krackhardt, F., Waliszewski, M., Rischner, J. et al. Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6‑month vs. 12‑month dual-antiplatelet therapy (DAPT). Herz 44, 433–439 (2019). https://doi.org/10.1007/s00059-017-4675-x

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