Dual Antiplatelet Therapy in Percutaneous Coronary Intervention
2016; Lippincott Williams & Wilkins; Volume: 9; Issue: 2 Linguagem: Inglês
10.1161/circinterventions.116.003587
ISSN1941-7632
AutoresRaffaele Piccolo, Stephan Windecker,
Tópico(s)Acute Myocardial Infarction Research
ResumoHomeCirculation: Cardiovascular InterventionsVol. 9, No. 2Dual Antiplatelet Therapy in Percutaneous Coronary Intervention Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessEditorialPDF/EPUBDual Antiplatelet Therapy in Percutaneous Coronary InterventionA Tale of 2 Decades With New Perspectives in the Era of New-Generation Drug-Eluting Stents Raffaele Piccolo, MD and Stephan Windecker, MD Raffaele PiccoloRaffaele Piccolo From the Department of Cardiology, Bern University Hospital, Bern, Switzerland. and Stephan WindeckerStephan Windecker From the Department of Cardiology, Bern University Hospital, Bern, Switzerland. Originally published8 Feb 2016https://doi.org/10.1161/CIRCINTERVENTIONS.116.003587Circulation: Cardiovascular Interventions. 2016;9In 2016, dual antiplatelet therapy (DAPT) assumes its 20th anniversary since the publication of the first randomized clinical trial establishing the superiority of DAPT over anticoagulant therapy among patients undergoing percutaneous coronary intervention (PCI) (Figure).1 Because then, both antiplatelet therapy and PCI have undergone continued refinement. Clopidogrel substituted ticlopidine, and subsequently, more potent oral and intravenous P2Y12 receptor inhibitors (prasugrel, ticagrelor, and cangrelor) entered the field of DAPT, whereas the advent of metallic drug-eluting stents (DES) and, more recently, completely bioresorbable scaffolds marked important milestones in the field of PCI. For several years, the duration of DAPT did not play a critical role in the pharmacological therapy after PCI. Indeed, DAPT was prescribed for 2 to 6 months after PCI in pivotal trials leading to the approval of the early-generation DES by the US Food and Drug Administration.2–4 It was only in the aftermath of increasing safety concerns related to the phenomenon of very late stent thrombosis after implantation of early-generation DES that prolongation of DAPT to 12 months was recommended by the American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Interventions guidelines.5 In the meantime, coronary stent technology rapidly evolved with the transition from early- to newer generation DES, featuring lower drug loads, thinner stent struts, more biocompatible or biodegradable polymers, and eventually improved patient outcomes.6 Although new-generation DES are currently recognized as default therapy in almost all lesion and patient subsets, the optimal duration of DAPT still remains the subject of debate.6,7Download figureDownload PowerPointFigure. Randomized clinical trials of oral dual antiplatelet therapy among patients undergoing percutaneous coronary intervention. ACCOAST indicates Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) or as Pretreatment at the Time of Diagnosis in Patients With Non-ST Elevation Myocardial Infarction; ARCTIC-I, Assessment by a Double Randomisation of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and, of Treatment Interruption Versus Continuation 1 Year After Stenting-Interruption; ATLANTIC, Administration of Ticagrelor in the Cath Lab or in the Ambulance for New ST Elevation Myocardial Infarction to Open the Coronary Artery; CHARISMA, Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance; CLARITY TIMI 28, Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction 28; COMMIT, Clopidogrel and Metoprolol in Myocardial Infarction Trial; CREDO, Clopidogrel for the Reduction of Events During Observation; CURE, Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events; CURRENT OASIS 7, Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions; DAPT, dual antiplatelet therapy; EXCELLENT, Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting; FANTASTIC, Full Anticoagulation Versus Aspirin and Ticlopidine; GRAVITAS, Gauging Responsiveness With a VerifyNow Assay—Impact on Thrombosis And Safety; I-LOVE-IT 2, Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for the Treatment of Coronary Revascularization; ISAR, Intracoronary Stenting and Antithrombotic Regimen; ISAR-SAFE, Intracoronary Stenting and Antithrombotic Regimen: Safety and Efficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting; ISAR-TRIPLE, Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation; ITALIC, Is There a Life for DES After Discontinuation of Clopidogrel; MATTIS, Multicenter Aspirin and Ticlopidine Trial After Intracoronary Stenting; OPTIDUAL, Optimal Dual Antiplatelet Therapy; OPTIMIZE, Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice; PEGASUS TIMI 54, Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54; PLATO, Platelet Inhibition and Patient Outcomes; PRODIGY, Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia; REAL-LATE, Correlation of Clopidogrel Therapy Discontinuation in REAL-World Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events; RESET, Real Safety and Efficacy of 3-Month Dual Antiplatelet Therapy Following Endeavor Zotarolimus-Eluting Stent Implantation; SECURITY, Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; START, Stent Anticoagulation Regimen Study; TRILOGY ACS, Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes; TRITON TIMI-38, Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38; WOEST, What Is the Optimal Antiplatelet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting; and ZEST-LATE, Evaluation of the Long-Term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or Paclitaxel-Eluting Stent Implantation for Coronary Lesions–Late Coronary Arterial Thrombotic Events.See Article by Han et alAvailable evidence suggests that prolonging DAPT in patients undergoing PCI is associated with a lower risk of long-term atherothrombotic events, including stent thrombosis and myocardial infarction, benefits that are partially offset by an increased risk of clinically relevant bleeding.6,8 Although these data are derived from >10 randomized trials involving >30 000 patients, they are driven to a large extent by the DAPT study that included 9961 patients randomly assigned to 12-month versus 30-month DAPT after DES implantation.9 Several converging lines of evidence, however, indicate that the effects of prolonged DAPT on stent-related outcomes may be attenuated by new-generation DES and that previous concerns of DES safety are replaced by focus on long-term patient-related outcomes.6,9In this issue of Circulation: Cardiovascular Interventions, Han et al10 report the results of a randomized trial comparing 6-month versus 12-month DAPT among 1829 patients who received a thin-strut, cobalt-chromium, polylactide-co-glycolide, biodegradable polymer–based, sirolimus-eluting stent (Tivoli; Essen Tech, Beijing, China). The study population represents the experimental arm of the Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for the Treatment of Coronary Revascularization (I-LOVE-IT 2) trial that compared the biodegradable polymer sirolimus-eluting stents against durable polymer sirolimus-eluting stents among 2737 patients.11At 1-year, 6-month DAPT was found noninferior to the 12-month DAPT regimen for the primary end point target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization (6.8% versus 5.9%; P for noninferiority=0.0065). The rate of target-lesion failure (7.5% versus 6.3%; P=0.32) and net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding (7.8% versus 7.3%; P=0.60), was similar at 18 months of follow-up. Of note, there were no differences in rates of the individual components of the primary end point, as well as definite or probable stent thrombosis (0.6% versus 0.2%; P=0.25). Consistent findings were observed in the subgroup of patients presenting with ST-segment–elevation myocardial infarction (n=248) and non–ST-segment–elevation acute coronary syndrome (n=1248). Bleeding events (type ≥3 according to Bleeding Academic Research Consortium Criteria) occurred at comparable rates (5.5% versus 5.7%; P=0.90) although rates of bleeding were somewhat higher than in previously reported trials despite the prevalent use (>90%) of radial access with the corollary effect to reduce access-site related bleeding.What are the clinical implications of the study? First, the study provides the largest source of data comparing different durations of DAPT among patients treated with metallic, biodegradable polymer–based DES. Before the I-LOVE-2 trial, only 763 (54%) and 336 (8%) patients enrolled in the Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy (SECURITY) and Intracoronary Stenting and Antithrombotic Regimen: Safety And Efficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) trials, respectively, had been treated with biodegradable polymer–based DES.12,13 However, there was no randomization according to stent type in SECURITY and ISAR-SAFE, and no data were specifically provided for patients who had been implanted solely with biodegradable polymer–based DES.12,13Second, the findings are in line with 6 other randomized trials comparing ≤6-month DAPT versus 12-month DAPT. In a network meta-analysis, Palmerini et al8 found that ≤6-month versus 12-month DAPT was associated with a similar risk of all-cause mortality (hazard ratio, 0.95; 95% credible intervals, 0.76–1.20), myocardial infarction (hazard ratio, 1.00; 95% credible interval, 0.75–1.30), and definite or probable stent thrombosis (hazard ratio, 1.10; 95% credible interval, 0.66–1.70) but a lower risk of major bleeding (hazard ratio, 0.59; 95% credible interval, 0.36–0.95). Individually, none of these studies reported a significant difference in the risk of major bleeding. Although these data indicate that previous concerns of stent-related outcomes are less dependent on DAPT duration, they do not resolve the competing risks of long-term atherothrombotic versus bleeding adverse events associated with prolonged DAPT.Third, ≈80% of participants had an acute coronary syndrome at the time of inclusion although acute myocardial infarction was present only in a quarter of patients. The analysis of this patient subset did not reveal a greater risk of adverse events with 6-month DAPT. This supports the notion that new-generation, biodegradable polymer–based DES have addressed the unmet needs of early-generation DES in this setting.14–16 However, it should be noted that both the European Society of Cardiology and American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Interventions guidelines recommend DAPT for at least 12 months in the absence of contraindications in patients with acute coronary syndrome.5,7 Moreover, continuation of thienopyridines on a background of aspirin beyond 1 year in the DAPT trial prevented major adverse cardiovascular and cerebrovascular events to a greater extent in patients with acute myocardial infarction (4.4% versus 5.3%; P=0.08) than among patients without an index presentation of acute myocardial infarction (3.9% versus 6.8%; P 1 year) of myocardial infarction.18 An earlier initiation of ticagrelor monotherapy after new-generation DES is currently tested in the Comparative Effectiveness of 1 Month of Ticagrelor Plus Aspirin Followed by Ticagrelor Monotherapy Versus a Current-Day Intensive Dual Antiplatelet Therapy in All-Comers Patients Undergoing Percutaneous Coronary Intervention With Bivalirudin and BioMatrix Family Drug-Eluting Stent Use (GLOBAL-LEADERS) trial, which will compare a short course of ticagrelor plus aspirin followed by 23-month ticagrelor monotherapy versus 12-month standard DAPT among 16 000 patients.19 Thus, the focus is shifting toward antiplatelet strategies that afford long-term prevention against atherothrombotic adverse events while minimizing the risk of bleeding.Some limitations of the present study are noteworthy. The 1-year rate of target-lesion failure was lower than expected (6.3% versus 8.3%), resulting in a relatively wide margin of noninferiority. Moreover, approximately half of primary end point events occurred during the periprocedural period and therefore well before the timepoint when the 2 randomized treatment regimens actually differed in terms of DAPT duration. In view of the high proportion of patients included with acute coronary syndrome, the use of clopidogrel instead of more potent and effective P2Y12 receptor inhibitors represents another important limitation.20 Finally, the extrapolation of trial findings to other biodegradable polymer–based DES is not feasible because of the wide-ranging differences in degradation products and kinetics, which may importantly affect DAPT duration. Furthermore, there remains limited evidence supporting the Firebird DES when compared with other thin-strut, biodegradable polymer DES that have been tested against US Food and Drug Administration–approved, new-generation DES.21–23In summary, the I-LOVE-IT 2 trial reports noninferiority of 6-month versus 12-month DAPT with respect to the primary end point target-lesion failure in a cohort of patients undergoing PCI with a new-generation, biodegradable polymer–based DES. How can we reconcile the differences between trials investigating DAPT ≤12 months versus beyond 1 year? Unfortunately, a definitive answer cannot be provided at the present time. However, it is plausible that trials investigating DAPT duration beyond 1 year are more likely to capture atherothrombotic manifestations, particularly outside the stented coronary segments. In contrast, trials investigating different DAPT durations within 1 year are more sensitive to stent-related adverse events linked to the arterial healing processes. The advent of DAPT >2 decades ago importantly contributed to improve safety and efficacy of PCI and, as a result, its widespread diffusion in clinical practice. In the meantime, various iterations in coronary stent technology have largely resolved stent-related adverse events with rates of definite stent thrombosis amounting to <0.50% per 100 person-years with new-generation DES.24 Accordingly, the optimal DAPT duration will largely be determined by the prevention of new atherothrombotic events rather than the nuisance of stent-related thrombotic complications, and novel, more personalized concepts toward the optimal DAPT duration are under clinical investigation.DisclosuresDr Windecker has received research grants to the institution from Abbott, Biotronik, Boston Scientific, Biosensors, Medtronic, Edwards, and St Jude. Dr Piccolo reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Stephan Windecker, MD, Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland. E-mail [email protected]References1. Schömig A, Neumann FJ, Kastrati A, Schühlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K.A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents.N Engl J Med. 1996; 334:1084–1089. doi: 10.1056/NEJM199604253341702.CrossrefMedlineGoogle Scholar2. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. 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Boyd A, Ndukwe C, Dileep A, Everin O, Yao Y, Welland B, Field J, Baumann M, Flores Jr J, Shroff A, Groo V, Dickens C, Doukky R, Francis R, Peacock G and Wilkie D (2020) Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial, JMIR mHealth and uHealth, 10.2196/15900, 8:6, (e15900) Shah V, Dileep A, Dickens C, Groo V, Welland B, Field J, Baumann M, Flores J, Shroff A, Zhao Z, Yao Y, Wilkie D and Boyd A (2016) Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent, Frontiers in Public Health, 10.3389/fpubh.2016.00272, 4 February 2016Vol 9, Issue 2 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.116.003587PMID: 26858081 Originally publishedFebruary 8, 2016 KeywordsEditorialspercutaneous coronary interventioncoronary artery diseasedrug-eluting stentsdual antiplatelet therapyPDF download Advertisement SubjectsPercutaneous Coronary InterventionPharmacologyRevascularizationStent
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