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

Giuseppe Tarantini, Luca Nai Fovino, Paola Tellaroli, Alaide Chieffo, Alberto Barioli, Alberto Menozzi, Arian Frasheri, Roberto Garbo, Monica Masotti-Centol, Neus Salvatella, Juan Francisco Oteo Dominguez, Luigi Steffanon, Patrizia Presbitero, Edoardo Pucci, Chiara Fraccaro, Josepa Mauri, Gennaro Giustino, Gennaro Sardella, Antonio Colombo

Research output: Contribution to journalArticle

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Abstract

Background/Objectives The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. Methods All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24 months. Results Four hundred-twenty nine DM patients received either 6 (n = 206) or 12 (n = 223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p = 0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p = 0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p = 0.804) and between 12 and 24 months of follow-up (0.5% vs. 0%, p = 0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p = 0.011 and HR 2.28; 95% CI 1.09-4.75; p = 0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p = 0.004 and HR: 2.23; 95% CI 1.09-6.33; p = 0.003) were independent predictors of both primary and secondary endpoint. Conclusions In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6 months, regardless of insulin-requiring status.

Original languageEnglish
Pages (from-to)168-176
Number of pages9
JournalInternational Journal of Cardiology
Volume207
DOIs
Publication statusPublished - Mar 15 2016

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Drug-Eluting Stents
Diabetes Mellitus
Percutaneous Coronary Intervention
Hemorrhage
Stents
Thrombosis
Stroke
Myocardial Infarction
Insulin
Therapeutics
Research
Population

Keywords

  • Diabetes
  • Dual antiplatelet therapy
  • Second-generation drug-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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, Giuseppe; Nai Fovino, Luca; Tellaroli, Paola; Chieffo, Alaide; Barioli, Alberto; Menozzi, Alberto; Frasheri, Arian; Garbo, Roberto; Masotti-Centol, Monica; Salvatella, Neus; Dominguez, Juan Francisco Oteo; Steffanon, Luigi; Presbitero, Patrizia; Pucci, Edoardo; Fraccaro, Chiara; Mauri, Josepa; Giustino, Gennaro; Sardella, Gennaro; Colombo, Antonio.

In: International Journal of Cardiology, Vol. 207, 15.03.2016, p. 168-176.

Research output: Contribution to journalArticle

Tarantini, G, Nai Fovino, L, Tellaroli, P, Chieffo, A, Barioli, A, Menozzi, A, Frasheri, A, Garbo, R, Masotti-Centol, M, Salvatella, N, Dominguez, JFO, Steffanon, L, Presbitero, P, Pucci, E, Fraccaro, C, Mauri, J, Giustino, G, Sardella, G & Colombo, A 2016, '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', International Journal of Cardiology, vol. 207, pp. 168-176. https://doi.org/10.1016/j.ijcard.2016.01.068
Tarantini, Giuseppe ; Nai Fovino, Luca ; Tellaroli, Paola ; Chieffo, Alaide ; Barioli, Alberto ; Menozzi, Alberto ; Frasheri, Arian ; Garbo, Roberto ; Masotti-Centol, Monica ; Salvatella, Neus ; Dominguez, Juan Francisco Oteo ; Steffanon, Luigi ; Presbitero, Patrizia ; Pucci, Edoardo ; Fraccaro, Chiara ; Mauri, Josepa ; Giustino, Gennaro ; Sardella, Gennaro ; Colombo, Antonio. / 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. In: International Journal of Cardiology. 2016 ; Vol. 207. pp. 168-176.
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title = "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",
abstract = "Background/Objectives The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. Methods All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24 months. Results Four hundred-twenty nine DM patients received either 6 (n = 206) or 12 (n = 223) months of DAPT. The primary endpoint occurred in 3.9{\%} and 5.4{\%} of patients in the 6 and 12-month DAPT group, respectively (log-rank test p = 0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4{\%} vs. 7.6{\%}, p = 0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5{\%} vs. 0.4{\%}; p = 0.804) and between 12 and 24 months of follow-up (0.5{\%} vs. 0{\%}, p = 0.291). At multivariable analysis, female gender (HR: 3.42; 95{\%} CI 1.32-8.85; p = 0.011 and HR 2.28; 95{\%} CI 1.09-4.75; p = 0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95{\%} CI 1.15-6.75; p = 0.004 and HR: 2.23; 95{\%} CI 1.09-6.33; p = 0.003) were independent predictors of both primary and secondary endpoint. Conclusions In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6 months, regardless of insulin-requiring status.",
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TY - JOUR

T1 - Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes

T2 - The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

AU - Tarantini, Giuseppe

AU - Nai Fovino, Luca

AU - Tellaroli, Paola

AU - Chieffo, Alaide

AU - Barioli, Alberto

AU - Menozzi, Alberto

AU - Frasheri, Arian

AU - Garbo, Roberto

AU - Masotti-Centol, Monica

AU - Salvatella, Neus

AU - Dominguez, Juan Francisco Oteo

AU - Steffanon, Luigi

AU - Presbitero, Patrizia

AU - Pucci, Edoardo

AU - Fraccaro, Chiara

AU - Mauri, Josepa

AU - Giustino, Gennaro

AU - Sardella, Gennaro

AU - Colombo, Antonio

PY - 2016/3/15

Y1 - 2016/3/15

N2 - Background/Objectives The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. Methods All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24 months. Results Four hundred-twenty nine DM patients received either 6 (n = 206) or 12 (n = 223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p = 0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p = 0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p = 0.804) and between 12 and 24 months of follow-up (0.5% vs. 0%, p = 0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p = 0.011 and HR 2.28; 95% CI 1.09-4.75; p = 0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p = 0.004 and HR: 2.23; 95% CI 1.09-6.33; p = 0.003) were independent predictors of both primary and secondary endpoint. Conclusions In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6 months, regardless of insulin-requiring status.

AB - Background/Objectives The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. Methods All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24 months. Results Four hundred-twenty nine DM patients received either 6 (n = 206) or 12 (n = 223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p = 0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p = 0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p = 0.804) and between 12 and 24 months of follow-up (0.5% vs. 0%, p = 0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p = 0.011 and HR 2.28; 95% CI 1.09-4.75; p = 0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p = 0.004 and HR: 2.23; 95% CI 1.09-6.33; p = 0.003) were independent predictors of both primary and secondary endpoint. Conclusions In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6 months, regardless of insulin-requiring status.

KW - Diabetes

KW - Dual antiplatelet therapy

KW - Second-generation drug-eluting stent

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