Single vs Dual Antiplatelet Therapy Following Transcatheter Aortic Valve Implantation: A Systematic Review.
ABSTRACT: There is wide variability in prescribing of antiplatelet regimens following transcatheter aortic valve implantation (TAVI). The objective of this review was to evaluate published and unpublished reports regarding the efficacy and safety of dual antiplatelet therapy (DAPT) compared with a single antiplatelet agent in patients undergoing TAVI. We searched MEDLINE, CENTRAL, Embase, and unpublished sources of literature from inception to December 2014 using terms synonymous with TAVI and DAPT. We included randomized controlled trials (RCTs) and cohort or case-control studies that compared DAPT with a single antiplatelet agent post-TAVI. Four articles met the inclusion criteria (2 RCTs, 2 cohort studies), of which all were deemed to be at high risk of bias, for a total of 662 patients. Compared with a single antiplatelet agent, DAPT did not significantly reduce all-cause mortality (risk ratio: 1.22, 95% confidence interval: 0.72-2.09, I(2) = 0%). Due to selective outcome reporting and variable follow-up, other outcomes of interest could not be meta-analyzed; however, evaluation of individual studies demonstrated no significant reduction in thrombotic events with DAPT and a similar or higher risk of bleeding. Current evidence, though limited by low methodological quality, suggests a lack of benefit and potential harm with DAPT compared with a single antiplatelet agent in patients post-TAVI. Therefore, clinicians should evaluate the use of DAPT in patients post-TAVI on a case-by-case basis until more robust evidence is available to guide practice.
Project description:Objective:International guidelines recommend the use of dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI). The recommended duration of DAPT varies between guidelines. In this two-part study, we (1) performed a structured survey of 45 TAVI centres from around the world to determine if there is consensus among clinicians regarding antiplatelet therapy after TAVI; and then (2) performed a systematic review of all suitable studies (randomised controlled trials (RCTs) and registries) to determine if aspirin monotherapy can be used instead of DAPT. Methods:A structured electronic survey regarding antiplatelet use after TAVI was completed by 45 TAVI centres across Europe, Australasia and the USA. A systematic review of TAVI RCTs and registries was then performed comparing DAPT duration and incidence of stroke, bleeding and death. A variance weighted least squared metaregression was then performed to determine the relationship of antiplatelet therapy and adverse events. Results:82.2% of centres routinely used DAPT after TAVI. Median duration was 3 months. 13.3% based their practice on guidelines. 11 781 patients (26 studies) were eligible for the metaregression. There was no benefit of DAPT over aspirin monotherapy for stroke (P=0.49), death (P=0.72) or bleeding (P=0.91). Discussion:Aspirin monotherapy appears to be as safe and effective as DAPT after TAVI.
Project description:We assessed the effectiveness of dual antiplatelet therapy (DAPT) post elective or urgent (i.e., post acute coronary syndrome [ACS]) coronary artery bypass graft surgery (CABG).We systematically searched MEDLINE, EMBASE, and the Cochrane Registry from inception to August 2015. Randomized controlled trials (RCTs) in adults undergoing CABG comparing either dual vs. single antiplatelet therapy or higher- vs. lower-intensity DAPT were identified.Nine RCTs (n?=?4,887) with up to 1y follow-up were included. Five RCTs enrolled patients post-elective CABG (n?=?986). Two multi-centre RCTs enrolled ACS patients who subsequently underwent CABG (n?=?2,155). These 7 RCTs compared clopidogrel plus aspirin to aspirin alone. Two other multi-centre RCTs reported on ACS patients who subsequently underwent CABG comparing higher intensity DAPT with either ticagrelor (n?=?1,261) or prasugrel (n?=?485) plus aspirin to clopidogrel plus aspirin. Post-operative anti-platelet therapy was started when chest tube bleeding was no longer significant, typically within 24-48 h. There were no differences in all-cause mortality in clopidogrel plus aspirin vs. aspirin RCTs; conversely, all-cause mortality was significantly lower in ticagrelor and prasugrel vs. clopidogrel RCTs (risk ratio[RR] 0.49, 95% confidence interval[CI] 0.33-0.71, p?=?0.0002; 2 RCTs, n?=?1695; I(2) ?=?0%; interaction p?<?0.01 compared to clopidogrel plus aspirin vs aspirin RCTs). There were no differences in myocardial infarctions, strokes, or composite outcomes. Overall, major bleeding was not significantly increased (RR 1.31, 95% CI 0.81-2.10, p?=?0.27; 7 RCTs, n?=?4500). There was heterogeneity (I(2) ? =?42%) due almost entirely to higher bleeding reported for the prasugrel RCT which included mainly CABG-related major bleeding (RR 3.15, 95% CI 1.45-6.87, p?=?0.004; 1 RCT, n?=?437).Most RCT data for DAPT post CABG is derived from subgroups of ACS patients in DAPT RCTs requiring CABG who resume DAPT post-operatively. Limited RCT data with heterogeneous trial designs suggest that higher intensity (prasugrel or ticagrelor) but not lower intensity (clopidogrel) DAPT is associated with an approximate 50% lower mortality in ACS patients who underwent CABG based on post-randomization subsets from single RCTs. Large prospective RCTs evaluating the use of DAPT post-CABG are warranted to provide more definitive guidance for clinicians.
Project description:Background:Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) in degenerated surgical aortic valve replacement (SAVR) is an alternative to redo-SAVR. However, reports on leaflet thrombosis following ViV-TAVI are emerging and subclinical thrombosis has gained recent attention. Although the incidence of transcatheter heart valve (THV) thrombosis after TAVI for native aortic valve disease is low, current imaging studies suggest the incidence of subclinical THV thrombosis may be significantly higher. While anticoagulation strategies for THV patients for native aortic stenosis presenting with symptomatic obstructive thrombosis has been described, the optimal management and anticoagulation therapy of patients with THV thrombosis following ViV-TAVI are less evident. Case summary:We report a case series of three patients presenting with early and late THV thrombosis after ViV-TAVI. Two patients presented clinically on single antiplatelet therapy and one patient presented with subclinical valve thrombosis whilst taking a non-vitamin K oral anticoagulation agent. Discussion:Leaflet thrombosis after ViV-TAVI is an important cause of THV degeneration and may present subclinically. Imaging modalities such as serial transthoracic echocardiograms and multidetector computerized tomography aid diagnosis and guide management. Patient-individualized risk- vs. -benefit prophylactic post-procedural oral anticoagulation may be indicated.
Project description:The respective ischemic and bleeding risks of early aspirin discontinuation following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) remain uncertain. We performed a prospero-registered review of randomized controlled trials (RCTs) comparing a P2Y12 inhibitor-based single antiplatelet strategy following early aspirin discontinuation to a strategy of sustained dual antiplatelet therapy (DAPT) in ACS or PCI patients requiring, or not, anticoagulation for another indication (CRD42019139576). We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included nine RCTs comprising 40,621 patients. Compared to prolonged DAPT, major bleeding (2.2% vs. 2.8%; RR 0.68; 95% CI: 0.54 to 0.87; p = 0.002; I²: 63%), non-major bleeding (5.0 % vs. 6.1 %; RR: 0.66; 95% CI: 0.47 to 0.94; p = 0.02; I² : 87%) and all bleeding (7.4% vs. 9.9%; RR: 0.65; 95% CI: 0.53 to 0.79; p < 0.0001; I²: 88%) were significantly reduced with early aspirin discontinuation without significant difference for all-cause death (p = 0.60), major adverse cardiac and cerebrovascular events (MACE) (p = 0.60), myocardial infarction (MI) (p = 0.77), definite stent thrombosis (ST) (p = 0.63), and any stroke (p = 0.59). In patients on DAPT after an ACS or a PCI, early aspirin discontinuation prevents bleeding events with no significant adverse effect on the ischemic risk or mortality.
Project description:Dual antiplatelet therapy (DAPT) is recommended following percutaneous coronary intervention (PCI) with drug-eluting stent (DES). DAPT is a risk factor for gastrointestinal bleeding. We aimed to quantify (1) the rate of gastroscopy within 12 months after PCI, (2) the rate of adverse cardiac events and gastroscopy-related bleeding complications within 30 days of gastroscopy, and (3) the association between antiplatelet therapy and these events.Patients receiving gastroscopy within 12 months of PCI were identified and two nested case-control analyses were performed within the PCI cohort by linking Danish medical registries. Cases were patients with adverse cardiac events (cardiac death, myocardial infarction, or stent thrombosis) or hemostatic intervention. In both studies, controls were patients with gastroscopy including biopsy without adverse cardiac events and hemostatic intervention, respectively. Medical records were reviewed to obtain information on exposure to DAPT.We identified 22 654 PCI patients of whom 1497 patients (6.6 %) underwent gastroscopy. Twenty-two patients (1.5 %) suffered an adverse cardiac event, 93 patients (6.2 %) received hemostatic intervention during or within 30 days of the index gastroscopy. Interrupting DAPT was associated with a 3.46 times higher risk of adverse cardiac events (95 %CI 0.49 - 24.7). Discontinuation of one antiplatelet agent did not increase the risk (OR 0.65, 95 %CI 0.17 - 2.47). No hemostatic interventions were caused by endoscopic complications.Gastroscopy can be safely performed in PCI patients treated with DES and single antiplatelet therapy while interruption of DAPT may be associated with an increased risk of adverse cardiac events.
Project description:Background: Drug-eluting stent(DES) implantation is the main interventional treatment for coronary artery disease, and dual antiplatelet therapy(DAPT) remains the gold standard strategy to prevent ischemic events. However, the optimal duration of DAPT after DES implantation remains controversial. Therefore, we aimed to evaluate the best duration of DAPT following DES implantation. Method: We searched PubMed, Embase, Cochrane Library, and clinicaltrials.gov for all randomized clinical trials(RCTs) that compared different durations of DAPT after DES implantation. Major adverse cardiac events(MACE) and major bleeding were the primary and secondary outcomes, respectively. Results: We included 16 RCTs (n = 42,993). The mean age of included patients was 63.1 ± 10.1. The primary outcome was statistically significant for lower MACE in patients who received DAPT for 24-48 months (mo) following DES when compared with those who received 3-6 mo of DAPT (odds ratio [OR] 0.75; 95% credible interval [CI] 0.58-0.97). There was nonstatistically significant difference in MACE when comparing those who received 12 mo of DAPT to those taking either 3-6 mo of DAPT (OR 0.86; 95% CI 0.69-1.08) or 24-48 mo of DAPT (OR 0.87; 95% CI 0.72-1.05). In contrast, major bleeding was significantly lower in those who received 3-6 mo of DAPT (OR 0.32; 95% CI 0.17-0.54) and 12 mo of DAPT (OR 0.43; 95% CI 0.27-0.63) than in those who received 24-48 mo of DAPT. Conclusion: In patients who undergo DES implantation, a longer duration of DAPT is associated with lower MACE, despite the increased risk of major bleeding events. Therefore, individualizing the duration of DAPT after DES according to the patient's risk of bleeding and recurrent ischemia is recommended.
Project description:OBJECTIVES:The authors assessed the use of dual antiplatelet therapy (DAPT) and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). BACKGROUND:The frequency, patterns, and outcomes when adding DAPT to non-vitamin K antagonist oral anticoagulants in the setting of PCI in patients with AF are largely unknown. METHODS:The study population included all patients in the treatment group of the ROCKET AF trial divided by the receipt of PCI during follow-up. Clinical characteristics, PCI frequency, and rates of DAPT were reported. Clinical outcomes were adjudicated independently as part of the trial. RESULTS:Among 14,171 patients, 153 (1.1%) underwent PCI during a median 806 days of follow-up. Patients treated with rivaroxaban were significantly less likely to undergo PCI compared with warfarin-treated patients (61 vs. 92; p = 0.01). Study drug was continued during PCI in 81% of patients. Long-term DAPT (?30 days) was used in 37% and single antiplatelet therapy in 34%. A small number switched from DAPT to monotherapy within 30 days of PCI (n = 19 [12.3%]) and 15% of patients received no antiplatelet therapy after PCI. Rates of stroke/systemic embolism and major bleeding events were high in post-PCI patients (4.5/100 patient-years and 10.2/100 patient-years) in both treatment groups. CONCLUSIONS:In patients with AF at moderate to high risk for stroke, PCI occurred in <1% per year. DAPT was used in a variable manner, with the majority of patients remaining on study drug after PCI. Rates of both thrombotic and bleeding events were high after PCI, highlighting the need for studies to determine the optimal antithrombotic therapy.
Project description:While dual antiplatelet therapy (DAPT) is essential after percutaneous coronary intervention (PCI), the optimal duration is affected by various factors. However, the effect of ethnicity on DAPT duration has not been fully evaluated. In this study, we evaluated the different effect of DAPT duration by ethnicity. We searched Pubmed, Embase, Cochrane library, and relevant websites to search for randomized clinical trials (RCT) assessing the clinical impact of long term DAPT (L-DAPT) and short term DAPT (S-DAPT). Studies were divided by ethnicity, and we compared the efficacy and safety of DAPT duration in each ethnic group. Thirteen RCTs including 38,255 patients (five East Asian studies and eight non-East Asian studies) were eligible for analysis. For the primary outcome, L-DAPT showed a significantly lower rate of primary outcome only in non-East Asians (S-DAPT vs. L-DAPT, odds ratio (OR) = 1.16, 95% confidence interval (CI): 1.02-1.32, p = 0.02), while in East Asians, the effect of S-DAPT and L-DAPT were comparable. S-DAPT significantly increased ischemic events only in non-East Asians (S-DAPT vs. L-DAPT, OR = 1.24, 95% CI: 1.09-1.42, p <0.01), while bleeding events were decreased by S-DAPT in both ethnicities. These results demonstrate that the adequate DAPT duration after PCI may be different in East Asians.
Project description:The benefit of ?6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ?6-month versus 12-month DAPT in patients undergoing PCI with DES placement.We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel-Haenszel method. Fixed-effect models were used; if heterogeneity (I)?>?40 was identified, effects were obtained with random models.Nine RCTs were included with total n?=?19,224 patients. No significant differences were observed between ?6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69-1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66-1.21), non-CV mortality (OR 0.85; 95% 0.58-1.24), myocardial infarction (OR 1.10; 95% CI: 0.89-1.37), stroke (OR 0.97; 95% CI: 0.67-1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89-2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77-1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49-1.05) was observed, though the all-bleeding event rate was significantly lower in the ?6-month DAPT group (OR 0.76; 95% CI: 0.59-0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ?6-month DAPT.DAPT for ?6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES.
Project description:Dual antiplatelet therapy (DAPT) - a combination of a P2Y?? receptor inhibitor and aspirin - has revolutionized antithrombotic treatment. Potent P2Y?? inhibitors such as prasugrel and ticagrelor exhibit a strong and more consistent platelet inhibition when compared to clopidogrel. Therefore, ticagrelor and prasugrel significantly reduce ischemic events, but at an expense of an increased bleeding risk in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). These observations have engaged intensive clinical research in alternative DAPT regimens to achieve sufficient platelet inhibition with an acceptable bleeding risk. Our review focusses on P2Y?? receptor therapy de-escalation defined as a switch from a potent antiplatelet agent (ticagrelor or prasugrel) to clopidogrel. Recently, both unguided (platelet function testing independent) and guided (platelet function testing dependent) DAPT de-escalation strategies have been investigated in different clinical studies and both switching strategies could be possible options to prevent bleeding complications without increasing ischemic risk. In light of the still limited data currently available, future large-scale trials should accumulate more data on various DAPT de-escalation regimens with both ticagrelor and prasugrel in unguided and guided de-escalation approaches. In the current review we aim at summarizing and discussing the current evidence on this still emerging topic in the field of antiplatelet treatment.