Impact of Insulin-Treated and Noninsulin-Treated Diabetes Mellitus in All-Comer Patients Undergoing Percutaneous Coronary Interventions With Polymer-Free Biolimus-Eluting Stent (from the RUDI-FREE Registry)

Martino Pepe, Gennaro Sardella, Giulio G. Stefanini, Nicola Corcione, Palma Luisa Nestola, Alberto Morello, Carlo Briguori, Corrado Tamburino, Franco Fabbiocchi, Francesco Luigi Rotolo, Fabrizio Tomai, Anita Paggi, Mario Lombardi, Gaetano Gioffrè, Rocco Sclafani, Andrea Rolandi, Alessandro Sciahbasi, Francesco Scardaci, Nicola Signore, Massimo ManconeArturo Giordano

Research output: Contribution to journalArticle

Abstract

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.

Original languageEnglish
Pages (from-to)1518-1527
Number of pages10
JournalAmerican Journal of Cardiology
Volume124
Issue number10
DOIs
Publication statusPublished - Nov 15 2019

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Pepe, M., Sardella, G., Stefanini, G. G., Corcione, N., Nestola, P. L., Morello, A., Briguori, C., Tamburino, C., Fabbiocchi, F., Rotolo, F. L., Tomai, F., Paggi, A., Lombardi, M., Gioffrè, G., Sclafani, R., Rolandi, A., Sciahbasi, A., Scardaci, F., Signore, N., ... Giordano, A. (2019). Impact of Insulin-Treated and Noninsulin-Treated Diabetes Mellitus in All-Comer Patients Undergoing Percutaneous Coronary Interventions With Polymer-Free Biolimus-Eluting Stent (from the RUDI-FREE Registry). American Journal of Cardiology, 124(10), 1518-1527. https://doi.org/10.1016/j.amjcard.2019.08.015