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 language | English |
|---|---|
| Pages (from-to) | 168-176 |
| Number of pages | 9 |
| Journal | International Journal of Cardiology |
| Volume | 207 |
| DOIs | |
| Publication status | Published - Mar 15 2016 |
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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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84958025606&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84958025606&partnerID=8YFLogxK
U2 - 10.1016/j.ijcard.2016.01.068
DO - 10.1016/j.ijcard.2016.01.068
M3 - Article
AN - SCOPUS:84958025606
VL - 207
SP - 168
EP - 176
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -