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2. TCT-204 Optimal duration of dual antiplatelet therapy (DAPT) after second generation drug-eluting stent (DES) implantation in elderly patients: the SECURITY-ELDERLY substudy

Author

Ferri, Luca Angelo, primary, Chieffo, Alaide, additional, Giustino, Gennaro, additional, Frasheri, Arian, additional, Garbo, Roberto, additional, Masotti-Centol, Monica, additional, Salvatella, Neus, additional, Oteo Dominguez, Juan Francisco, additional, Steffanon, Luigi, additional, Tarantini, Giuseppe, additional, Presbitero, Patrizia, additional, Menozzi, Alberto, additional, Pucci, Edoardo, additional, Mauri, Josepa, additional, Sardella, Gennaro, additional, and Colombo, Antonio, additional

Published
2016
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3. Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial

Author

Colombo, Antonio, Chieffo, Alaide, Frasheri, Arian, Garbo, Roberto, Masotti-Centol, Monica, Salvatella, Neus, Oteo Dominguez, Juan Francisco, Steffanon, Luigi, Tarantini, Giuseppe, Presbitero, Patrizia, Menozzi, Alberto, Pucci, Edoardo, Mauri, Josepa, Cesana, Bruno Mario, Giustino, Gennaro, and Sardella, Gennaro

Subjects
stents, percutaneous coronary intervention, platelet aggregation inhibitors, coronary artery disease, prospective studies, thrombosis
Abstract

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated.ObjectivesThe aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES.MethodsThe SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, 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 stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months.ResultsOverall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval [CI]: −2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: −1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: −0.7%; 95% CI: −2.1 to 0.6; p = 0.289). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: −0.1%; 95% CI: −0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: −0.1 to 0.4; p = 0.305).ConclusionsIn a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death, MI, stroke, definite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333)

Published
2014

4. Second-Generation Drug-Eluting Stent Implantation Followed by 6- Versus 12-Month Dual Antiplatelet Therapy

Author

Colombo, Antonio, primary, Chieffo, Alaide, additional, Frasheri, Arian, additional, Garbo, Roberto, additional, Masotti-Centol, Monica, additional, Salvatella, Neus, additional, Oteo Dominguez, Juan Francisco, additional, Steffanon, Luigi, additional, Tarantini, Giuseppe, additional, Presbitero, Patrizia, additional, Menozzi, Alberto, additional, Pucci, Edoardo, additional, Mauri, Josepa, additional, Cesana, Bruno Mario, additional, Giustino, Gennaro, additional, and Sardella, Gennaro, additional

Published
2014
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5. Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry.

Author

Rubboli A, Saia F, Sciahbasi A, Bacchi-Reggiani ML, Steffanon L, Briguori C, Calabrò P, Palmieri C, Rizzi A, Imperadore F, Sangiorgi GM, Valgimigli M, Carosio G, Steffenino G, Galvani M, Di Pasquale G, La Vecchia L, Maggioni AP, and Bolognese L

Subjects
Administration, Oral, Clopidogrel, Databases, Bibliographic, Drug Therapy, Combination, Follow-Up Studies, Hemorrhage chemically induced, Prospective Studies, Registries, Ticlopidine adverse effects, Ticlopidine therapeutic use, Treatment Outcome, Angioplasty, Balloon, Coronary, Aspirin adverse effects, Aspirin therapeutic use, Drug-Eluting Stents, Ticlopidine analogs & derivatives, Warfarin adverse effects, Warfarin therapeutic use
Abstract

Objectives: To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S)., Background: The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined., Methods: We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period., Results: Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases., Conclusion: In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.

Published
2014

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