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- v.11(1); 2016 May
Dual Antiplatelet Therapy After Drug-eluting Stent Implantation
The current guidelines for percutaneous coronary intervention use recommend dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor after drug eluting stent (DES) implantation. The optimal duration of DAPT is however area of debate. Recent clinical trials and meta-analyses suggest that the choice of DAPT duration should be tailored individually, based on the balance between ischemic and bleeding risk carried by the patient.
Dual antiplatelet therapy (DAPT), defined as the use of a P2Y12 receptor inhibitor (clopidogrel, ticagrelor or prasugrel) and aspirin, is required after percutaneous coronary intervention (PCI) with drug-eluting stents (DES).[ 1 ] Although the use of DES has been shown to reduce the rate of restenosis as compared with bare-metal stents (BMS), there is concern that DES may be associated with a higher risk of late and very late stent thrombosis (ST),[ 2 , 3 ] particularly after DAPT discontinuation.[ 4 ] DAPT prevents thrombotic complications through a double mechanism. First, DAPT protects the stented segment from ST, which occurs as a result of inflammation during healing.[ 5 , 6 ] Second, DAPT confers protection from atherothrombotic events occurring outside the stented segment, lowering the risk of recurrent MI.[ 4 , 7 ] The current American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines/Society for Cardiovascular Angiography and Interventions (ACCF/AHA/SCAI) guidelines on PCI use recommend at least 12 months of DAPT after DES implantation.[ 8 ] The European Society of Cardiology (ESC) guidelines endorse 6–12 months of DAPT after DES implantation,[ 1 ] and the ESC and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) recommend 12 months for all patients with acute coronary syndrome (ACS) irrespective of revascularisation strategy.[ 9 ] However, the optimal duration of DAPT post-DES implantation remains poorly defined.
The most recent clinical trials (see Table 1 ) and meta-analyses in patients who underwent a PCI with stent implantation, have highlighted two key concepts: first, the hazard rate for ischaemic events is not increased with reduced (<12 months) compared with standard (12 months) or prolonged (>12 months) DAPT duration, especially with newer-generation DES[ 10–12 ] and second, prolonged DAPT reduces the rate of ischaemic events at the cost of increased risk of bleeding.[ 4 , 13 ]
|Trial||N||Time at randomisation (months after index PCI)||DAPT regimens (months)||Primary endpoint|
|ISAR-SAFE[ 14 ]||4,005||6||6 versus 12||Composite of death MI, ST, stroke or TIMI major bleeding at 15 months after PCI|
|PRODIGY[ 10 ]||2,013 (75 % DES)||1||6 versus 24||Composite of death, MI or CVA at 24 months after PCI|
|DAPT[ 4 ]||9,961||12||12 versus 30||Definite/probable ST and MACCE defined as composite of death, MI or stroke at 30 months after PCI|
|OPTIDUAL[ 19 ]||1,385||12||12 versus 48||Composite of death, MI, stroke or major ISTH bleeding at 48 months after PCI|
CVA = cerebrovascular accident; DAPT = dual antiplatelet therapy; DES = drug-eluting stent; ISTH = International Society on Thrombosis and Haemostasis; MACCE = major adverse cardiac and cerebrovascular events; PCI = percutaneous coronary intervention; ST = stent thrombosis; TIMI = thrombolysis in myocardial infarction.
Studies Evaluating Reduced Duration of Dual Antiplatelet Therapy
In the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) trial, consisting of a population predominantly presenting with unstable coronary artery disease, the use of DAPT for 24 months in patients who had received DES (75 %) was not significantly more effective than a 6-month clopidogrel regimen followed by aspirin monotherapy in reducing the risk of MI or cardiac death.[ 10 ] However, 24 months of clopidogrel therapy resulted in a significant increase in the number of bleeding episodes, including life-threatening events. In the Safety And Efficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) trial, 6 months of DAPT were related to similar net clinical outcome compared with 12 months of DAPT after PCI with a DES.[ 14 ] Due to a slow enrolment and low event rates, the trial was stopped prematurely after enrolment of 4,005 of the 6,000 planned.
The safety of a reduced DAPT duration compared with 12-month DAPT was confirmed in a meta-analysis of 10 randomised clinical trials (n=32,287), where reduced DAPT duration regimen after PCI with DES was associated with a significant reduction in the rate of major bleeding with no significant differences in ischaemic or thrombotic outcomes.[ 15 ] On the contrary, prolonged DAPT duration reduced the incidence of thrombotic complications, including ST and MI, at the cost of increased rates of major bleeding.
The Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) trial was the first to show that zotarolimus-eluting stent implantation followed by a reduced DAPT duration (median duration of 32 days) resulted in a lower risk of major cardiovascular events, compared with BMS, in a selected population of patients with stable coronary artery disease (SCAD) or ACS at high bleeding or thrombosis risk or at low risk of restenosis.[ 16 ] Lastly, the recent Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk (LEADERS FREE) trial, involving patients at high bleeding risk who underwent PCI and were treated with a reduced (1-month) DAPT duration, showed that a drug-coated stent (polymer-and carrier-free biolimus A9-coated stent) was superior to BMS with respect to the primary safety (composite of cardiac death, MI and ST) and efficacy (clinically driven target-lesion revascularisation) endpoints.[ 17 ]
Studies Evaluating Prolonged Duration of Dual Antiplatelet Therapy
The DAPT trial explored the effect of prolonged (30 months) versus 12-month DAPT (clopidogrel or prasugrel) duration in patients with ACS or SCAD at low risk of ischaemic and bleeding events and undergoing stent implantation.[ 4 ] After first-or second-generation DES implantation, prolonged DAPT significantly reduce the risk of ST, cerebrovascular events and major adverse cardiovascular events. Confirming a general secondary prevention effect of DAPT, much of the benefit shown in the prolonged DAPT group came from a reduction in the rate of MI unrelated to ST. Of particular interest, it was found that overall the rate of ischaemic events increased during the 3-month period after P2Y12 inhibition discontinuation, regardless of when that occurred.[ 4 ] These data are confirmed by observations from the Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction (PEGASUS-TIMI 54) trial, in which patients with previous MI (39 % with previous DES implantation), enrolled after recent P2Y12 inhibitor withdrawal, were shown to be at increased risk of ischaemic events. This group derived greater benefit in terms of ischaemic risk reduction, from prolonged ticagrelor therapy plus aspirin compared with patients who had remained event-free on aspirin alone.[ 13 ]
Prolonged ticagrelor therapy has also been shown to reduce the rate of major cardiovascular events in patients with a history of MI, regardless of stenting history and stent type, as well as the risk of ST in patients with stents.[ 18 ] In the DAPT[ 4 ] and the PEGASUS-TIMI 54[ 13 ] trials, the benefit in the reduced risk of ischaemic events was accompanied by an increase of Global Use of Strategies to Open Occluded Arteries (GUSTO)-defined moderate/severe bleeding and TIMI major bleeding, respectively. Furthermore, in the DAPT trial a higher mortality rate was observed in patients treated with prolonged DAPT compared with placebo.[ 4 ] The increased non-cardiac mortality rate with extended DAPT is of uncertain significance and may be explained by an imbalance in the number of patients with cancer diagnosed before the enrolment, reflected in the higher incidence of cancer-related death observed in the prolonged-DAPT group. Consistent with the findings from the DAPT trial on ischaemic outcomes, a post-hoc analysis from the Optimal Dual Antiplatelet Therapy (OPTIDUAL) trial, showed that in patients at low risk of bleeding who underwent DES implantation, there was a trend toward fewer ischaemic events in the group randomised to prolonged (up to 48 months) DAPT therapy with clopidogrel, compared with those who stopped clopidogrel at 12 months, without increased risk of major bleeding.[ 19 ]
Balancing the Risks of Bleeding and Ischaemic Events
Overall, these observations suggest that a 12-month DAPT period does not represent the optimal duration for all patients undergoing a DES implantation, and that the evaluation of DAPT duration should be tailored individually, considering both the bleeding and ischaemic events risk profiles of the patient.[ 15 ] Individuals at low ischaemic risk, such as patients without ACS who are undergoing PCI, particularly if at high bleeding risk, may be suitable for shortened periods of DAPT, whereas prolonged DAPT (>12 months) could be of more benefit for selected patients without significant bleeding risk or at high ischemic risk, such as patients with previous MI, particularly if presenting with additional cardiovascular risk factors or recurrent ischaemic events. The risk stratification is therefore a crucial step in the decision making regarding DAPT duration. Recently, the DAPT risk score has been presented; this is the first risk score with the advantage of simultaneously assessing both the bleeding and ischaemic risk, thus identifying patients who are likely to derive harm or benefit from prolonged DAPT.[ 20 ] However, this score was demonstrated in a population free of major bleeding or ischaemic events in the 12-month period of DAPT and should also be validated in other datasets.
To further help clinicians in balancing ischaemic and bleeding risks it is necessary to carry out additional studies, as well as exploring secondary analyses of the most recent trials, to individualise the subgroups of patients that derive the greatest benefit from DAPT prolongation. Until then, clinicians should follow a personalised approach, with an ongoing risk–benefit assessment, rather than a standardised approach.
Articles from Interventional Cardiology Review are provided here courtesy of Radcliffe Cardiology
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Dual Antiplatelet Therapy – DAPT
Feb 16, 2018
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- Author/Summarized by Author:
- Dharam J. Kumbhani, MD, SM, FACC
- Summary Reviewer:
- Deepak L. Bhatt, MD, MPH, FACC
- Trial Sponsor:
- Harvard Clinical Research Institute
- Date Presented:
- Date Published:
- Date Updated:
- Original Posted Date:
Contribution To Literature:
The DAPT study showed that longer duration of DAPT following PCI results in lower stent thrombosis and recurrent MIs, but higher bleeding and all-cause mortality compared with a 12-month duration.
Current guidelines recommend that dual antiplatelet therapy (DAPT) with aspirin and an ADP receptor antagonist be continued for a minimum of 12 months following drug-eluting stent (DES) percutaneous coronary intervention (PCI). The optimal duration, however, remains unclear. This trial sought to investigate if 30 months of DAPT was superior to 12 months in patients undergoing DES and bare-metal stent (BMS) PCI.
- Age >18 years
- PCI with stent deployment within the past 24 hours
- No known contraindication to DAPT for at least 30 months after enrollment and stent implantation
- At 12 months, patient free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis, and compliant with DAPT following stent implantation
Number of screened applicants: 25,682
Number of enrollees: 9,961
Duration of follow-up: 30 months following initial screening
Mean patient age: 61.7 years
Percentage female: 25%
At initial screening:
- Index procedure stent placement with stent diameter <2.25 mm or >4.0 mm
- Pregnant women
- Planned surgery necessitating discontinuation of DAPT within the 30 months following enrollment
- Current medical condition with a life expectancy of <3 years
- Subjects on warfarin or similar anticoagulant therapy
- Subjects with hypersensitivity or allergies to one of the drugs or components
- Subject treated with both DES and BMS during the index procedure
At 12 months:
- Pregnant women
- Subject switched thienopyridine type or dose within 6 months prior to randomization
- PCI or cardiac surgery between 6 weeks post-index procedure and randomization
- Planned surgery necessitating discontinuation of antiplatelet therapy within 21 months
- Current medical condition with a life expectancy of <3 years
- Subjects on warfarin or similar anticoagulant therapy
- MACCE at 18 months following enrollment (30 months from index procedure)
- Stent thrombosis at 18 months (30 months from index procedure)
- Moderate or severe GUSTO bleeding at 18 months (30 months from index procedure)
- All-cause mortality
Patients were enrolled 72 hours after stent placement and were given open-label aspirin and thienopyridine for 12 months, per current practice norms. At 12 months, patients without an ischemic or bleeding complication and with documented compliance, were randomized in a 1:1 fashion to receive an additional 18 months of DAPT or matching placebo. Stratification was performed based on DES versus bare-metal stents (BMS), hospital, clopidogrel versus prasugrel, and risk factors for stent thrombosis.
DES PCI: A total of 9,961 patients were randomized at 452 sites in 11 countries: 5,020 to prolonged DAPT and 4,941 to placebo. Baseline characteristics were fairly similar between the two arms. Approximately 30% had diabetes mellitus, 25% were smokers and 6% had peripheral arterial disease. Indication for PCI was stable angina in 38%, ST-segment elevation myocardial infarction (STEMI) in 10% and NSTE-acute coronary syndrome (NSTE-ACS) in 32%. Approximately two thirds of the patients received clopidogrel, whereas the rest received prasugrel. Stents implanted during index PCI was everolimus-eluting stent (EES) in 47%, paclitaxel-eluting stent (PES) in 27%, zotarolimus-eluting stent (ZES) in 13%, sirolimus-eluting stent (SES) in 11%, and multiple in the others. The mean number of lesions treated was 1.1, with about 1.5 stents/patient. The vessel treated was left anterior descending in 41% and right coronary artery in 32%.
The primary endpoint of major adverse cardiac and cerebrovascular events (MACCE) was significantly lower in the continued DAPT arm compared with placebo (4.3% vs. 5.9%, hazard ratio 0.71, 95% confidence interval 0.59-0.85, p < 0.001). There were reductions in all MI (2.1% vs. 4.1%, p < 0.001) and stent thrombosis (0.4% vs. 1.4%, p < 0.001), but all-cause mortality was higher (2.0% vs. 1.5%, p = 0.05), driven mostly by an increase in noncardiovascular deaths (1% vs. 0.5%, p = 0.002), including cancer-related death (0.62% vs. 0.28%, p = 0.02) and bleeding-related death (0.22% vs. 0.06%, p = 0.06). GUSTO moderate and severe bleeding was also higher with DAPT (2.5% vs. 1.6%, p = 0.001), as was BARC 2, 3, or 5 bleeding (5.6% vs. 2.9%, p < 0.001).
BMS PCI: A total of 1,580 patients were randomized; 842 to prolonged DAPT and 845 to placebo. Indication for PCI was STEMI in 38% and NSTEMI in 21%. Clopidogrel was prescribed on discharge at 88% of patients, and prasugrel in the rest. The primary endpoint of MACCE was similar in the continued DAPT arm compared with placebo (4.0% vs. 4.7%, HR 0.92, 95% CI 0.57-1.47, p = 0.72; p for interaction = 0.32). There were no differences in all-cause mortality (1% vs. 1.2%, p = 0.83), MI (2.7% vs. 3.1%, p = 0.74), stroke (0.7% vs. 0.6%, p = 0.74), or stent thrombosis (0.5% vs. 1.1%, p = 0.24; p for interaction = 0.42). GUSTO moderate and severe bleeding was also higher with DAPT (2.0% vs. 0.9%, p = 0.07), as was BARC 2, 3, or 5 bleeding (4.6% vs. 1.8%, p = 0.002).
EES PCI: The primary MACCE endpoint was similar for prolonged DAPT vs. placebo (4.3% vs. 4.5%, HR 0.89, 95% CI 0.67-1.19, p = 0.42). Stent thrombosis (0.3% vs. 0.7%, p = 0.04) and MI (2.1% vs. 3.2%, p = 0.01) were lower, whereas moderate and severe bleeding (2.5% vs. 1.3%, p = 0.01) and mortality (2.2% vs. 1.1%, p = 0.02) were higher.
Matched propensity analysis of DES vs. BMS: MACCE events were lower in DES at 33 months compared with BMS (11.4% vs. 13.4%, p < 0.0001), as was stent thrombosis (1.7% vs. 2.6%, p < 0.0001). No differences were observed in all-cause mortality (4.2% vs. 5.1%, p = 0.16) or MI (7.2% vs. 8.1%, p = 0.27). The highest hazard for stent thrombosis for BMS was within the first 12 months (while on open-label DAPT) (0.7% vs. 1.7% within first 12 months vs. 1.7% vs. 2.6% within 33 months of index PCI). Differences between DES and BMS were most pronounced for EES vs. BMS. Bleeding risk was not different between DES and BMS (4.0% vs. 3.7%, p = 0.32).
Cause-specific mortality: Increased mortality signal led to second blinded CEC review, with particular focus on bleeding and cancer. Mortality for DAPT vs. placebo: 1.9% vs. 1.5%, p = 0.07; cardiovascular mortality: 1.0% vs. 1.0%, p = 0.97; noncardiovascular mortality: 0.9% vs. 0.5%, p = 0.01; bleeding-related death: 0.3% vs. 0.2%, p = 0.36; cancer-related death: 0.6% vs. 0.3%, p = 0.02; cancer incidence: 2.0% vs. 1.6%, p = 0.12. On longer follow-up to 33 months, mortality remained higher: 2.2% vs. 1.8%, p = 0.05, again due to higher noncardiovascular mortality: 1% vs. 0.7%, p = 0.02.
DAPT score: Based on the relative risks of ischemia (stent thrombosis and MI) and bleeding (GUSTO moderate or severe) between 12 and 30 months, a prediction score (DAPT score) was created. Final variables were age, prior PCI or MI, stent diameter <3 mm, chronic heart failure or left ventricular ejection fraction <30%, MI at presentation, PES, smoking and diabetes (range for score: 3-8). Patients with lower scores (<2) had a lower ischemic risk and a higher bleeding risk, while patients with higher scores (≥2) had a higher ischemic risk and a lower bleeding risk.
- For DAPT <2: stent thrombosis or MI: 1.7% vs. 2.3%, p = 0.07; bleeding: 3% vs. 1.4%, p < 0.001
- For DAPT ≥2: stent thrombosis or MI: 2.7% vs. 5.7%, p < 0.001; bleeding: 1.8% vs. 1.4%, p = 0.26
Interaction with optimal medical therapy (OMT): Comparing prolonged DAPT to placebo, rates of MACCE were 4.2% vs. 5.0% among patients on OMT (HR 0.82, CI 0.66-1.02, p = 0.077) and 4.5% vs. 7.0% among those off OMT (HR 0.63, CI 0.49-0.82, p < 0.001; p for interaction = 0.25). Patients on OMT had lower rates of MI (2.7% vs. 3.7%, p = 0.003), MACCE (4.6% vs. 5.7%, p = 0.007), and bleeding (1.6% vs. 2.5%, p < 0.001), but not stent thrombosis (0.8% vs. 1.0%, p = 0.17) in comparison with patients off OMT.
MI risk: Discontinuing thienopyridine after either 12 or 30 months was associated with an early increase in MI risk. The majority of MIs (~75%) occurring after thienopyridine discontinuation were not related to stent thrombosis. MI risk was noted in patients with both low and high DAPT scores.
The results of the DAPT trial indicate that prolonged duration of DAPT up to 30 months following index PCI with a DES results in lower stent thrombosis and recurrent MIs compared with a 12-month duration of DAPT, although bleeding and all-cause mortality were higher with prolonged therapy. The BMS subset shows a less impressive treatment effect, although the p-value for interaction between DES versus BMS was not significant. Similarly, the EES subset showed no difference for the primary endpoint with prolonged therapy. Both stent thrombosis and spontaneous MIs were reduced in DES patients, but not in BMS patients. The mechanism of benefit is unclear, since a non-stent thrombosis-related MI reduction would be expected to be observed equally in DES and BMS patients. In the propensity-matched analysis, the highest difference between DES and BMS for stent thrombosis and MACCE appeared to be within the first year (while on open-label DAPT). The DAPT score may be a useful tool for individualizing decisions regarding dual antiplatelet duration in patients post-PCI, but will need further validation.
Following concerns regarding late and very late stent thrombosis with first-generation DES, American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommended a minimum duration of 12 months of DAPT following DES PCI. However, the optimal duration remains unknown and trials have sought to study both sides of the duration spectrum. On the one hand, trials such as PRODIGY, RESET, and OPTIMIZE sought to assess shorter durations (3-6 months) of DAPT with at least 50% second-generation DES use in mostly stable patients. On the other hand, trials such as DES-LATE and EXCELLENT sought to assess if prolonged DAPT treatment would be superior to 12 months.
The DAPT trial is the largest trial on this topic to date, and suggests that although there may be an ischemic benefit with prolonged DAPT therapy, there is a price to pay in terms of bleeding risk. The excess in mortality is concerning, and appears to be predominantly due to cancer-related mortality. It is unclear if this is a chance finding or a true biological effect. Moreover, these results only apply to patients who have not had an ischemic or bleeding event within the first year, and were also fully compliant with DAPT therapy, thus somewhat limiting the generalizability of this trial. Patients in this trial received contemporary stents, although nearly a quarter received PES, which are inferior to EES and ZES. The magnitude of benefit appeared to be highest in the PES patients, and lower in patients receiving EES. It is unclear to what extent this trial will immediately impact clinical practice. Further follow-up and data from other ongoing trials are awaited.
Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, et al., on behalf of the DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation 2017;135:1720-32 .
Resor CD, Nathan A, Kereiakes DJ, et al., on behalf of the Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation 2016;134:989-98 .
Presented by Dr. Charles Resor at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.
Presented by Dr. Robert W. Yeh at the American Heart Association Scientific Sessions, Orlando, FL, November 10, 2015.
Hermiller JB, Krucoff MW, Kereiakes DJ, et al., on behalf of the Dual Antiplatelet Therapy (DAPT) Study Investigators. Benefits and risks of extended dual antiplatelet therapy after everolimus-eluting stents. JACC Cardiovasc Interv 2016;9:138-47 .
Presented by Dr. Laura Mauri at the European Society of Cardiology Congress, London, September 1, 2015.
Mauri L, Kereiakes DJ, Yeh RW, et al., on behalf of the DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155-66 .
Presented by Dr. Laura Mauri at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2014.
Presented by Dr. Dean J. Kereiakes at the American Heart Association Scientific Sessions, Chicago, IL, November 18, 2014.
Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and ACS, Interventions and Vascular Medicine, Chronic Angina
Keywords: Myocardial Infarction, Acute Coronary Syndrome, Stroke, Angina, Stable, Drug-Eluting Stents, Peripheral Arterial Disease, Risk Factors, Ticlopidine, Piperazines, American Heart Association, Sirolimus, Aspirin, Purinergic P2Y Receptor Antagonists, Stents, Percutaneous Coronary Intervention, Paclitaxel, Thrombosis, Coronary Vessels, Diabetes Mellitus, Transcatheter Cardiovascular Therapeutics, AHA Annual Scientific Sessions, ESC Congress, AHA Annual Scientific Sessions
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