Extended Dual Versus Single Anti-Platelet Therapy Following Percutaneous Coronary Intervention: A Bayesian Meta-Analysis and Regression on All-Cause Mortality.
Current ESC/EACTS guidelines recommend standard-duration dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI). However, the subsequent transition to either extended DAPT or single antiplatelet therapy (SAPT) remains debated due to limited comparative outcome data. This Bayesian meta-analysis and meta-regression evaluate the clinical safety of DAPT versus SAPT, and the impact of potential confounders on all-cause mortality. Following PRISMA guidelines, a systematic search of PubMed, Embase, Cochrane Library, ScienceDirect, and Scopus was conducted till April 2025 to identify randomized clinical trials (RCTs) and cohort studies. Primary outcomes were all-cause mortality and bleeding events. Bayesian random-effects meta-analysis was performed using the brms package in R with Markov Chain Monte Carlo sampling and weakly informative priors. Bayesian meta-regression of log-transformed odds ratios (OR) assessed associations with relevant covariates. Fourteen studies (9 RCTs and 5 cohort studies) comprising 56,572 patients were included. Compared with SAPT, DAPT was associated with increased all-cause mortality (OR 1.25; 95% credible interval [CrI], 1.04-1.51; posterior probability of harm, Pr[OR > 1] = 84%). DAPT also increased the risk of net adverse clinical events [NACE] (OR, 1.29; 95% CrI, 1.08-1.53), minor bleeding (OR, 1.60; 95% CrI, 1.10-2.33), major bleeding (OR, 1.70; 95% CrI, 1.30-2.23), and BARC 2-5 bleeding (OR, 1.78; 95% CrI, 1.40-2.26) with Pr [OR > 1] >90% for all outcomes. No significant differences were observed in cardiac death, cardiovascular mortality, major adverse cardiac and cerebrovascular events (MACCE), myocardial infarction (MI), stent thrombosis, or stroke. Meta-regression revealed that higher baseline odds of dyslipidemia (-0.89), hypertension (-1.19), prior MI (-0.94), and previous revascularization (-0.30) were associated with greater mortality benefit from DAPT. However, in the DAPT cohort, increased odds of adverse events, including cardiac death (0.41), MACCE (0.55), stroke (0.60), MI (0.29), and NACE (0.98), were significantly associated with higher all-cause mortality. Extended DAPT is associated with a higher all-cause mortality, bleeding events, and NACE. While DAPT may benefit high-risk populations, the increased odds of adverse events are significantly associated with mortality, warranting that it be carefully considered and monitored in post-PCI patients.
- # Dual Antiplatelet Therapy
- # Major Adverse Cardiac And Cerebrovascular Events
- # Bayesian Meta-analysis
- # Single Antiplatelet Therapy
- # Higher All-cause Mortality
- # All-cause Mortality
- # Markov Chain Monte Carlo Sampling
- # Percutaneous Coronary Intervention
- # Bayesian Random-effects Meta-analysis
- # Bleeding Events
- Research Article
40
- 10.1016/j.amjcard.2012.10.030
- Dec 1, 2012
- The American Journal of Cardiology
Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry
- Research Article
5
- 10.1016/j.ijcard.2022.05.060
- May 30, 2022
- International journal of cardiology
Antithrombotic strategies after transcatheter aortic valve implantation: A systematic review and network meta-analysis of randomized controlled trials
- Research Article
2
- 10.1097/hpc.0000000000000342
- Nov 9, 2023
- Critical pathways in cardiology
The use of dual antiplatelet therapy (DAPT) after coronary revascularization for left-main disease is still debated. The study aimed to characterize patients who received dual versus single antiplatelet therapy (SAPT) after coronary artery bypass grafting (CABG) for unprotected left-main disease and compare the outcomes of those patients. This multicenter retrospective cohort study included 551 patients who were grouped into 2 groups: patients who received SAPT (n = 150) and those who received DAPT (n = 401). There were no differences in age ( P = 0.451), gender ( P = 0.063), smoking ( P = 0.941), diabetes mellitus ( P = 0.773), history of myocardial infarction ( P = 0.709), chronic kidney disease ( P = 0.615), atrial fibrillation ( P = 0.306), or cerebrovascular accident ( P = 0.550) between patients who received SAPT versus DAPT. DAPTs were more commonly used in patients with acute coronary syndrome [87 (58%) vs. 273 (68.08%); P = 0.027], after off-pump CABG [12 (8%) vs. 73 (18.2%); P = 0.003] and in patients with radial artery grafts [1 (0.67%) vs. 32 (7.98%); P < 0.001]. While SAPTs were more commonly used in patients with low ejection fraction [55 (36.67%) vs. 61 (15.21%); P < 0.001] and in patients with postoperative acute kidney injury [27 (18%) vs. 37 (9.23%); P = 0.004]. The attributed treatment effect of DAPT for follow-up major adverse cerebrovascular and cardiac events was not significantly different from that of SAPT [β, -2.08 (95% confidence interval (CI), -20.8-16.7); P = 0.828]. The attributed treatment effect of DAPT on follow-up all-cause mortality was not significantly different from that of SAPT [β, 4.12 (CI, -11.1-19.32); P = 0.595]. There was no difference in bleeding between groups ( P = 0.666). DAPTs were more commonly used in patients with acute coronary syndrome, after off-pump CABG, and with radial artery grafts. SAPTs were more commonly used in patients with low ejection fraction and acute kidney injury. Patients on DAPT after CABG for left-main disease had comparable major adverse cerebrovascular and cardiac events and survival to patients on SAPT, with no difference in bleeding events.
- Research Article
1
- 10.1007/s00380-018-1148-y
- Mar 16, 2018
- Heart and vessels
Previous reports have focused on cardiovascular and bleeding events in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, antithrombotic treatment strategies and clinical outcomes after second-generation drug-eluting stents (DES) implantation in AF patients remain to be determined. We enrolled 244 consecutive AF patients treated with second-generation DES. The study population was derived from multi-center AF registry (including 8 centers in Japan) from 2010 to 2012. Prescription of antithrombotic agents and clinical outcomes were retrospectively examined. Ninety-two patients (37.7%) were prescribed dual antiplatelet therapy (DAPT) at discharge and 152 patients (62.3%) were given DAPT plus oral anticoagulation (OAC) with warfarin. The median follow-up period was 730days. Kaplan-Meier analysis showed that major adverse cardiac and cerebrovascular events (MACCE) were not significantly different (2-year event rate, 17.6 vs. 13.5%, p = 0.37), but bleeding events were significantly higher in the DAPT plus OAC group than in the DAPT group (2-year event rate, 6.1 vs. 17.9%, p = 0.033). In a sub-analysis of DAPT plus OAC patients, adequate time in the therapeutic range (TTR) group (TTR ≥ 65%) was not significantly different from the suboptimal OAC group (TTR < 65%) for bleeding events, but it had a lower incidence of MACCE, resulting in better net clinical outcomes (composite of MACCE and major bleeding, 2-year event rate, 9.2 vs. 27.8%, p = 0.008). DAPT plus OAC remains more common in AF patients undergoing PCI with second-generation DES. Under adequate TTR, DAPT plus OAC showed better net clinical outcomes by reducing MACCE without increasing bleeding.
- Research Article
22
- 10.1002/ccd.27582
- Mar 8, 2018
- Catheterization and Cardiovascular Interventions
We aim to evaluate the efficacy of dual versus single anti-platelet therapy (SAPT) after TAVR through a systematic review and meta-analysis of published research. Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is a commonly practiced strategy after transcatheter aortic valve replacement (TAVR). However, there is lack of sufficient evidence supporting this approach. We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials (RCT) and observational studies comparing DAPT with SAPT post TAVR. Event rates were compared using a forest plot of relative risk with 95% confidence intervals using a random-effects model assuming inter-study heterogeneity. A total of six studies (3 RCTs and 3 observational studies, n = 840) were included in the final analysis. Compared to SAPT, DAPT was associated with increased risk of significant bleeding (life threatening and major) [RR = 2.52 (95% CI 1.62-3.92, P < 0.0001)] with the number needed to harm for major or life-threatening bleeding calculated to be 10.4. There was no significant difference in the incidence of stroke [RR = 1.06 (95% CI, 0.43-2.60, P = 0.90)], spontaneous myocardial infarction [RR = 2.08 (95% CI, 0.56-7.70, P = 0.27)] and all-cause mortality [RR = 1.18 (95% CI, 0.68-2.05, P = 0.56] in the DAPT and SAPT groups. In this small meta-analysis of DAPT versus SAPT after TAVR, DAPT did not prevent stroke, myocardial infarction or death while the risk of bleeding was higher. Results from ongoing trials are awaited to determine the best anti-thrombotic approach after TAVR.
- Abstract
- 10.1016/j.jvs.2022.03.642
- May 19, 2022
- Journal of Vascular Surgery
Factor Xa Inhibitor in Peripheral Revascularization: A Vascular Quality Initiative Analysis
- Research Article
3
- 10.3389/fcvm.2021.783344
- Nov 24, 2021
- Frontiers in Cardiovascular Medicine
Background: There is ongoing debate regarding the optimal antiplatelet strategy beyond 12 months in patients with acute myocardial infarction (AMI) who undergo successful percutaneous coronary intervention (PCI). This study therefore aimed to investigate the clinical outcomes of single (SAPT) vs. dual antiplatelet therapy (DAPT) beyond 12 months in patients with stable AMI and second-generation drug-eluting stent (DES) implantation.Methods: Of 13,104 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health database, we selected 4,604 patients who underwent PCI with second-generation DES and exhibited no adverse clinical events within 12 months; they were classified into SAPT (aspirin or clopidogrel) or DAPT (aspirin and clopidogrel) groups. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE), including the composite of all-cause death, myocardial infarction (MI), and stroke between 12 and 36 months.Results: The SAPT group (n = 1,862) was associated with a significantly lower risk of MACCE between 12 and 36 months [4.2 vs. 8.5%, hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.37–0.61; p < 0.001] than the DAPT group (n = 2,742). The results were consistent after adjusting for confounders through multivariable and propensity score matching analysis. Moreover, in patients with complex features (defined as an unprotected left main PCI, implanted stent length of ≥38 mm, multivessel PCI, or ≥3 stents per patients), the SAPT group (n = 678) also demonstrated a significantly lower risk of MACCE between 12 and 36 months (4.9 vs. 9.9%, HR: 0.46, CI: 0.31–0.68, p < 0.001) than the DAPT group (n = 1,167).Conclusions: In patients with AMI who underwent successful PCI with second-generation DES and exhibited no adverse clinical events within 12 months, the use of SAPT was associated with a significantly lower MACCE between 12 and 36 months compared with the use of DAPT.
- Research Article
2
- 10.1038/s41598-021-94599-2
- Jul 29, 2021
- Scientific reports
The impact of uninterrupted dual antiplatelet therapy (DAPT) on bleeding events among patients undergoing transcatheter aortic valve replacement (TAVR) has not been well studied. We conducted an analysis of 529 patients who underwent transfemoral TAVR in our centre and were receiving either DAPT or single antiplatelet therapy (SAPT) prior to the procedure. Accordingly, patients were grouped into a DAPT or SAPT group. Following current guidelines, patients in the SAPT group were switched to DAPT for 90 days after the procedure. The primary endpoint of our analysis was the incidence of bleeding events at 30 days according to the VARC-2 classification system. Any VARC-2 bleeding complications were found in 153 patients (28.9%), while major/life-threatening or disabling bleeding events occurred in 60 patients (11.3%). Our study revealed no significant difference between the DAPT vs. SAPT group regarding periprocedural bleeding complications. Based on multivariable analyses, major bleeding (HR 4.59, 95% CI 1.64–12.83, p = 0.004) and life-threatening/disabling bleeding (HR 8.66, 95% CI 3.31–22.65, p < 0.001) events were significantly associated with mortality at 90 days after TAVR. Both pre-existing DAPT and SAPT showed a comparable safety profile regarding periprocedural bleeding complications and mortality at 90 days. Thus, DAPT can be safely continued in patients undergoing transfemoral TAVR.
- Research Article
40
- 10.1016/j.ijcard.2018.07.083
- Jul 19, 2018
- International Journal of Cardiology
Dual versus single antiplatelet therapy after coronary artery bypass graft surgery: An updated meta-analysis
- Research Article
- 10.4330/wjc.v17.i10.111941
- Oct 26, 2025
- World Journal of Cardiology
BACKGROUNDPeripheral artery disease (PAD) affects millions globally, with a 5.6% prevalence in 2015 impacting 236 million adults, rising above 10% in those over 60 due to factors like diabetes and smoking. Post-revascularization, single antiplatelet therapy (SAPT) is standard, but dual antiplatelet therapy (DAPT) may improve outcomes, though duration and bleeding risks are unclear. The 2024 American College of Cardiology/American Heart Association guidelines endorse short-term DAPT, yet evidence gaps remain in comparative efficacy and safety. We hypothesized that DAPT reduces cardiovascular events and reinterventions vs SAPT without significantly elevating bleeding in PAD patients’ post-lower extremity revascularization.AIMTo evaluate the efficacy and safety of DAPT vs SAPT in PAD patients’ post-revascularization.METHODSThis systematic review and meta-analysis followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, searching PubMed, EMBASE, and ScienceDirect up to July 2025. Included were randomized controlled trials (RCTs) and cohort studies from various global settings (e.g., hospitals, tertiary care) comparing DAPT (aspirin plus P2Y12 inhibitor for > 1 month) to SAPT in symptomatic PAD patients undergoing endovascular or surgical revascularization (n up to 28244 participants selected via eligibility criteria). Data were pooled using random-effects models for risk ratio (RR) with 95%CI; heterogeneity was assessed via the I² statistic. Quality appraisal used Risk of Bias in Non-randomized Studies of Interventions for cohorts and Risk of Bias 2.0 for RCTs; certainty was evaluated via Grading of Recommendations Assessment, Development and Evaluation (GRADE).RESULTSTwelve studies (3 RCTs, 9 cohorts, conducted 2010–2025 with follow-ups of 6 months to 5 years) were included. DAPT showed no significant difference but a trend toward reduced all-cause mortality (RR: 0.52, 95%CI: 0.27–1.01, P = 0.05, DAPT of 298/9545 events vs SAPT of 165/566 events) or stroke (RR: 0.72, 95%CI: 0.30–1.72, P = 0.46, DAPT of 16/3729 events vs SAPT of 41/7673 events) vs SAPT. DAPT significantly reduced cardiac mortality (RR: 0.46, 95%CI: 0.27–0.80, P = 0.006, DAPT of 78/2903 events vs SAPT of 171/1465 events, risk difference: -5.4%), myocardial infarction (RR: 0.82, 95%CI: 0.71–0.94, P = 0.004, DAPT of 233/7704 events vs SAPT of 262/9130 events, risk difference: -1.8%), and major reintervention (RR: 0.58, 95%CI: 0.35–0.98, P = 0.04, DAPT of 803/205 events vs SAPT of 1197/4 events, risk difference: -42%). Bleeding showed no difference (RR: 1.12, 95%CI: 0.42–3.03, P = 0.82, DAPT of 195/2775 events vs SAPT of 202/8234 events). Heterogeneity was high (I2 = 59%–97%). Quality revealed moderate to serious bias in cohorts and some concerns in RCTs; GRADE certainty moderate for cardiac mortality, myocardial infarction, reintervention, low for others due to inconsistency and imprecision.CONCLUSIONDAPT reduces cardiac mortality, myocardial infarction, and major reintervention risks compared to SAPT in PAD post-revascularization without apparent bleeding increase, though limited by heterogeneity and low certainty for some outcomes.
- Research Article
17
- 10.1253/circj.cj-20-0786
- Dec 25, 2020
- Circulation journal : official journal of the Japanese Circulation Society
The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI. The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.
- Components
- 10.3389/fcvm.2021.783344.s001
- Nov 30, 2021
Background: There is ongoing debate regarding the optimal antiplatelet strategy beyond 12 months in patients with acute myocardial infarction (AMI) who undergo successful percutaneous coronary intervention (PCI). This study therefore aimed to investigate the clinical outcomes of single (SAPT) versus dual antiplatelet therapy (DAPT) beyond 12 months in patients with stable AMI and second-generation drug-eluting stent (DES) implantation. Methods: Of 13,104 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health database, we selected 4,604 patients who underwent PCI with second-generation DES and exhibited no adverse clinical events within 12 months; they were classified into SAPT (aspirin or clopidogrel) or DAPT (aspirin and clopidogrel) groups. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE), including the composite of all-cause death, myocardial infarction (MI), and stroke between 12 and 36 months. Results: The SAPT group (n=1,862) was associated with a significantly lower risk of MACCE between 12 and 36 months (4.2% vs. 8.5%, hazard ratio [HR]: 0.47, 95% confidence interval [CI]: 0.37–0.61; p<0.001) than the DAPT group (n=2,742). The results were consistent after adjusting for confounders through multivariable and propensity score matching analysis. Moreover, in patients with complex features (defined as an unprotected left main PCI, implanted stent length of ≥38 mm, multivessel PCI, or ≥3 stents per patients), the SAPT group (n=678) also demonstrated a significantly lower risk of MACCE between 12 and 36 months (4.9% vs. 9.9%, HR: 0.46, CI: 0.31–0.68, p<0.001) than the DAPT group (n = 1,167). Conclusions: In patients with AMI who underwent successful PCI with second-generation DES and exhibited no adverse clinical events within 12 months, the use of SAPT was associated with a significantly lower MACCE between 12 and 36 months compared with the use of DAPT.
- Research Article
13
- 10.1001/jamacardio.2024.3216
- Oct 9, 2024
- JAMA Cardiology
The optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) remains under debate. To analyze the efficacy and safety of DAPT strategies in patients with ACS using a bayesian network meta-analysis. MEDLINE, Embase, Cochrane, and LILACS databases were searched from inception to April 8, 2024. Randomized clinical trials (RCTs) comparing DAPT duration strategies in patients with ACS undergoing PCI were selected. Short-term strategies (1 month of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by P2Y12 inhibitors, 3 months of DAPT followed by aspirin, and 6 months of DAPT followed by aspirin) were compared with conventional 12 months of DAPT. This systematic review and network meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The risk ratio (RR) with a 95% credible interval (CrI) was calculated within a bayesian random-effects network meta-analysis. Treatments were ranked using surface under the cumulative ranking (SUCRA). The primary efficacy end point was major adverse cardiac and cerebrovascular events (MACCE); the primary safety end point was major bleeding. A total of 15 RCTs randomizing 35 326 patients (mean [SD] age, 63.1 [11.1] years; 26 954 male [76.3%]; 11 339 STEMI [32.1%]) with ACS were included. A total of 24 797 patients (70.2%) received potent P2Y12 inhibitors (ticagrelor or prasugrel). Compared with 12 months of DAPT, 1 month of DAPT followed by P2Y12 inhibitors reduced major bleeding (RR, 0.47; 95% CrI, 0.26-0.74) with no difference in MACCE (RR, 1.00; 95% CrI, 0.70-1.41). No significant differences were observed in MACCE incidence between strategies, although CrIs were wide. SUCRA ranked 1 month of DAPT followed by P2Y12 inhibitors as the best for reducing major bleeding and 3 months of DAPT followed by P2Y12 inhibitors as optimal for reducing MACCE (RR, 0.85; 95% CrI, 0.56-1.21). Results of this systematic review and network meta-analysis reveal that, in patients with ACS undergoing PCI with DES, 1 month of DAPT followed by potent P2Y12 inhibitor monotherapy was associated with a reduction in major bleeding without increasing MACCE when compared with 12 months of DAPT. However, an increased risk of MACCE cannot be excluded, and 3 months of DAPT followed by potent P2Y12 inhibitor monotherapy was ranked as the best option to reduce MACCE. Because most patients receiving P2Y12 inhibitor monotherapy were taking ticagrelor, the safety of stopping aspirin in those taking clopidogrel remains unclear.
- Research Article
14
- 10.3310/mnjy9014
- May 1, 2023
- Health technology assessment (Winchester, England)
Bleeding among populations undergoing percutaneous coronary intervention or coronary artery bypass grafting and among conservatively managed patients with acute coronary syndrome exposed to different dual antiplatelet therapy and triple therapy (i.e. dual antiplatelet therapy plus an anticoagulant) has not been previously quantified. The objectives were to estimate hazard ratios for bleeding for different antiplatelet and triple therapy regimens, estimate resources and the associated costs of treating bleeding events, and to extend existing economic models of the cost-effectiveness of dual antiplatelet therapy. The study was designed as three retrospective population-based cohort studies emulating target randomised controlled trials. The study was set in primary and secondary care in England from 2010 to 2017. Participants were patients aged ≥ 18 years undergoing coronary artery bypass grafting or emergency percutaneous coronary intervention (for acute coronary syndrome), or conservatively managed patients with acute coronary syndrome. Data were sourced from linked Clinical Practice Research Datalink and Hospital Episode Statistics. Coronary artery bypass grafting and conservatively managed acute coronary syndrome: aspirin (reference) compared with aspirin and clopidogrel. Percutaneous coronary intervention: aspirin and clopidogrel (reference) compared with aspirin and prasugrel (ST elevation myocardial infarction only) or aspirin and ticagrelor. Primary outcome: any bleeding events up to 12 months after the index event. Secondary outcomes: major or minor bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular events. The incidence of any bleeding was 5% among coronary artery bypass graft patients, 10% among conservatively managed acute coronary syndrome patients and 9% among emergency percutaneous coronary intervention patients, compared with 18% among patients prescribed triple therapy. Among coronary artery bypass grafting and conservatively managed acute coronary syndrome patients, dual antiplatelet therapy, compared with aspirin, increased the hazards of any bleeding (coronary artery bypass grafting: hazard ratio 1.43, 95% confidence interval 1.21 to 1.69; conservatively-managed acute coronary syndrome: hazard ratio 1.72, 95% confidence interval 1.15 to 2.57) and major adverse cardiovascular events (coronary artery bypass grafting: hazard ratio 2.06, 95% confidence interval 1.23 to 3.46; conservatively-managed acute coronary syndrome: hazard ratio 1.57, 95% confidence interval 1.38 to 1.78). Among emergency percutaneous coronary intervention patients, dual antiplatelet therapy with ticagrelor, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.06, 95% confidence interval 0.89 to 1.27). Among ST elevation myocardial infarction percutaneous coronary intervention patients, dual antiplatelet therapy with prasugrel, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.48, 95% confidence interval 1.02 to 2.12), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.10, 95% confidence interval 0.80 to 1.51). Health-care costs in the first year did not differ between dual antiplatelet therapy with clopidogrel and aspirin monotherapy among either coronary artery bypass grafting patients (mean difference £94, 95% confidence interval -£155 to £763) or conservatively managed acute coronary syndrome patients (mean difference £610, 95% confidence interval -£626 to £1516), but among emergency percutaneous coronary intervention patients were higher for those receiving dual antiplatelet therapy with ticagrelor than for those receiving dual antiplatelet therapy with clopidogrel, although for only patients on concurrent proton pump inhibitors (mean difference £1145, 95% confidence interval £269 to £2195). This study suggests that more potent dual antiplatelet therapy may increase the risk of bleeding without reducing the incidence of major adverse cardiovascular events. These results should be carefully considered by clinicians and decision-makers alongside randomised controlled trial evidence when making recommendations about dual antiplatelet therapy. The estimates for bleeding and major adverse cardiovascular events may be biased from unmeasured confounding and the exclusion of an eligible subgroup of patients who could not be assigned an intervention. Because of these limitations, a formal cost-effectiveness analysis could not be conducted. Future work should explore the feasibility of using other UK data sets of routinely collected data, less susceptible to bias, to estimate the benefit and harm of antiplatelet interventions. This trial is registered as ISRCTN76607611. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 8. See the NIHR Journals Library website for further project information.
- Research Article
- 10.1161/circinterventions.113.000848
- Oct 1, 2013
- Circulation: Cardiovascular Interventions
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