Giuseppe Tarantini1, Luca Nai Fovino2, Paola Tellaroli2, Alaide Chieffo3, Alberto Barioli2, Alberto Menozzi4, Arian Frasheri5, Roberto Garbo6, Monica Masotti-Centol7, Neus Salvatella8, Juan Francisco Oteo Dominguez9, Luigi Steffanon10, Patrizia Presbitero11, Edoardo Pucci12, Chiara Fraccaro2, Josepa Mauri13, Gennaro Giustino14, Gennaro Sardella15, Antonio Colombo3. 1. Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy. Electronic address: giuseppe.tarantini.1@unipd.it. 2. Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy. 3. San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy. 4. Azienda Ospedaliero-Universitaria di Parma, Cardiology Department, Parma, Italy. 5. ASL Trapani-P.O., Sant'Antonio Abate Cardiology and Hemodynamic Department, Sant Erice, Italy. 6. San Giovanni Bosco Hospital, Cardiology Department, Turin, Italy. 7. Hospital Clínic, Hemodynamic Department, Barcelona, Spain. 8. Hospital del Mar, Hemodynamic Department, Barcelona, Spain. 9. Hospital Puerta de Hierro, Hemodynamic Department, Madrid, Spain. 10. Hesperia Hospital, Hemodynamic Department, Modena, Italy. 11. IRCCS Humanitas, Invasive Cardiology and Hemodynamic Department, Rozzano, Italy. 12. Ospedale Santa Maria Goretti, Hemodynamic Department, Latina, Italy. 13. Hospital Universitari Germans Trias i Pujol, Hemodynamic Department, Badalona, Spain. 14. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States. 15. Policlinico Umberto I, Invasive Cardiology Department, Rome, Italy.
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 12months. 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 24months. RESULTS:Four hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months ofDAPT. 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 24months 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 6months, regardless of insulin-requiring status.
RCT Entities:
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 DMpatients. METHODS: All diabeticpatients 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 12months. 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 24months. RESULTS: Four hundred-twenty nine DMpatients 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 24months 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 diabeticpatients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.
Authors: B Everaert; J J Wykrzykowska; J Koolen; P van der Harst; P den Heijer; J P Henriques; R van der Schaaf; B de Smet; S H Hofma; R Diletti; A Weevers; J Hoorntje; P Smits; R J van Geuns Journal: Neth Heart J Date: 2017-07 Impact factor: 2.380