Single Antiplatelet Therapy Group Research Articles

Procedural outcomes in patients with dual versus single antiplatelet therapy prior to transcatheter aortic valve replacement

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.

Antiplatelet therapy after transcatheter aortic valve implantation: a systematic review and meta-analysis.

The aim of this study was to compare antithrombotic regimens after transcatheter aortic valve implantation (TAVI) in patients without an indication for long-term anticoagulation. TAVI is a safe and effective approach for patients with symptomatic severe aortic stenosis and an intermediate-to-high surgical risk. Nevertheless, the antithrombotic regimen after procedure remains controversial. We systematically searched PubMed, Embase and Cochrane databases for interventional studies comparing single antiplatelet therapy with double antiplatelet therapy after TAVI. A meta-analysis was carried out to compare thrombotic and bleeding events between both strategies. Four randomized clinical trials were included comprising a total of 1085 patients. Our meta-analysis revealed a higher odds ratio (OR) of major bleeding events (pooled OR 2.45, 95% confidence interval (CI) 1.29-4.67; P < 0.01; I2 = 0%) and minor bleeding (pooled OR 1.73, 95% CI 1.12-2.66; P = 0.01; I2 = 0%) for the double antiplatelet therapy group compared with the single antiplatelet therapy group. There was no difference between groups in the risk of stroke (pooled OR 1.04, 95% CI 0.58-1.86; P = 0.91; I2 = 0%), myocardial infarction (pooled OR 2.10, 95% CI 0.75-5.84; P = 0.16, I2 = 0%) and all-cause mortality (pooled OR 1.07, 95% CI 0.63-1.86; P = 0.08; I2 = 0%) after TAVI. Our pooled analysis suggests that for patients who underwent TAVI, double antiplatelet therapy compared with single antiplatelet therapy alone increased the risk of bleeding without reducing mortality and ischaemic events.

Carotid Restenosis Following Endarterectomy in Patients Managed With Single Antiplatelet Therapy Versus Dual Antiplatelet Therapy

Antiplatelet therapy is a cornerstone in the management of carotid artery disease following carotid endarterectomy (CEA). There is a paucity of data regarding the effect of dual antiplatelet therapy (DAPT) on restenosis rates. A retrospective review of patients who underwent CEA from January 1, 2007 to December 31, 2013 was performed at a single center. Study groups consisted of subjects who received DAPT and those who received single antiplatelet therapy (SAPT) following CEA. Restenosis was evaluated by carotid duplex. Severity and timing of restenosis, postoperative complications, and reinterventions were compared between study groups. Between January 1, 2007 and December 31, 2013, 1453 patients underwent CEA. The SAPT group consisted of 245 patients and the DAPT group consisted of 1208 patients. No difference in restenosis was identified between groups at less than 6 weeks (6.5% vs. 11.7% 50-79% stenosis, 0% vs. 2.2% 80-99% stenosis, 2.2% vs. 0.6% occlusion, p = 0.368), and 6 weeks to 2 years (20.6% vs. 17.9% 50-79% stenosis, 1.1% vs. 1.0% 80-99% stenosis, 1.6% vs. 0.4% occlusion, p = 0.242). A higher rate of restenosis in SAPT was found greater than 2 years from surgery (68.4% vs. 82.4% <50% stenosis, 29.9% vs. 16.1% 50-79% stenosis, 0% vs. 0.6% 80-99% stenosis, 1.7% vs. 0.9% occlusion p = 0.004). This finding persisted on multivariable analysis with 31.6% of the SAPT group showing >50% stenosis vs. 17.6% of the DAPT group (adjusted OR 0.48, 95% CI 0.30-0.76, p = 0.002). In a propensity matched-population, 32.7% of the SAPT group demonstrated restenosis vs. 13.7% of the DAPT group (adjusted OR 0.35, 95% CI 0.16-0.77, p = 0.009). There was no difference in the need for reintervention between study groups (DAPT 3.8% vs SAPT 3.3%, p = 0.684). Following CEA, patients on DAPT exhibited lower rates of late restenosis. Despite this finding, a clinical difference in reintervention was not found during this study period.

Abstract 15428: Network Meta-analysis of Duration of Antiplatelet Therapy Following Transcatheter Aortic Valve Replacement

Background: Although current guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months following transcatheter aortic valve replacement (TAVR), there are no studies directly comparing outcomes of different durations of DAPT following TAVR. Methods: Pubmed and EMBASE were searched through May, 2020 to identify clinical studies that investigated single antiplatelet therapy (SAPT) versus DAPT use following TAVR. Studies using oral anticoagulants and antiplatelet therapy concomitantly were excluded. The DAPT group was subdivided by the duration of DAPT. We extracted the risk ratios (RRs) of major or life-threatening bleeding, stroke, and all-cause mortality. Results: Three randomized controlled trials, two propensity-score matched studies, and one observational study were identified, yielding a total of 1,833 patients who underwent TAVR assigned to the SAPT group (n=918), 3-month DAPT group (n=151), or 6-month DAPT group (N=764). Pooled analyses demonstrated that the rates of major or life-threatening bleeding were significantly higher in the 6-month DAPT group compared with the SAPT group (RR [95% CI] =2.54 [1.49-4.33], P =0.007) while no such difference was observed between the SAPT vs. 3-month DAPT groups or the 3-month DAPT vs. 6-month DAPT groups (Figure). P-scores were 98.1% (SAPT), 32.3% (3-month DAPT), and 19.6% (6-month DAPT). The rates of stroke and all-cause mortality were similar among the groups. Conclusions: In our network meta-analysis, we observed that DAPT for 6 months following TAVR was associated with increased risk of bleeding without decreasing the risk of stroke compared with SAPT, while there was no difference between DAPT for 3 months and 6 months.

Abstract 12787: Meta-analysis of Dual Antiplatelet Theraphyversus Single Antiplatelet Theraphyafter Transcatheter Aortic Valve Implatation: A Popular Forecast

Background: Despite improving experience and techniques, ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and affect survival. Recent guidelines recommend dual antiplatelet therapy (DAPT) in the initial period after TAVI. Explorative studies have suggested DAPT is associated with higher rate of major bleeding without a decrease in thromboembolic complications. Purpose: To compare DAPT (aspirin plus clopidogrel) versus single antiplatelet therapy (SAPT) (as aspirin) alone as antithrombotic treatment following TAVI for the prevention of cerebrovascular events, bleeding events and all-cause death. Methods: We systematically searched PubMed, Embase and Cochrane databases, in April 2020, for both interventional or observational studies comparing DAPT with (SAPT) following TAVI. Random-effects and meta-analysis for DAPT and SAPT were performed. Results: Nine studies were included (six registry-based or unrandomized studies and three randomized clinical trials) providing a total of 19389 patients, and 631 pooled stroke or transient ischemic attack. There was no statistically difference between DAPT and SAPT for the prevention of cerebrovascular events after TAVI (pooled OR 1.04 [0.85, 1.26], P=0.04, I 2 = 0%). Similarly, there was a similar rate of all-cause mortality (pooled OR 1.07 [0.81, 1.42], P=0.33, I 2 = 50%). Furthermore, the rate of major bleeding or life-threatening events was significantly higher for the DAPT compared with SAPT group (pooled OR 1.46 [1.19, 1.78], P&lt;0.01, I 2 = 79%), although with a considerable amount of heterogeneity between studies in the magnitude of effect. Conclusions: Our pooled data suggests that after TAVI, the clinical benefit of DAPT compared to SAPT is questionable. The POPular-TAVI trial Cohort A is expected to clarify this research question during 2020.

Novel Approach of Antithrombotic Potency Amongst Patients Admitted to Hospital with Bleeding Using HEMORR2HAGES Score: A Retrospective Cohort Study.

The purpose of this study was to evaluate whether a relationship exists between baseline HEMORR2HAGES score and antithrombotic potency amongst patients presenting with bleeding complication. We hypothesized that the more antithrombotic regimen potency, the less HEMORR2HAGES score you have. This is a retrospective observational study of patients admitted with a diagnosis of active bleeding between November 1, 2013 and August 31, 2015. The antithrombotic groups included patients on the following regimens: single antiplatelet therapy (SAP), single oral anticoagulant therapy (SOAC), dual antiplatelet therapy (DAPT), dual combination (SOAC+SAP), and triple antithrombotic therapy. The primary outcome was to review the mean HEMORR2HAGES score among the various groups. There were a total of 180 patients in the study. No significant difference was noted among the five groups in the HEMORR2HAGES score (P = .36). The highest HEMORR2HAGES score was in the SAP group (3.23 ± 1.1). The lowest HEMORR2HAGES score was in the DAPT group (2.59 ± 1.2). In the Sub Group analysis, we compared single versus dual versus triple therapy, and we found the lowest HEMORR2HAGES score in the triple therapy group (2.70 ± 1.6); (P = .29). Among patients admitted with active bleeding, the HEMORR2HAGES score did not differentiate antithrombotic potency amongst groups with various regimens. This study highlights the necessity to evaluate antithrombotic therapy according to benefits and harms.

Single or dual antiplatelet therapy after transcatheter aortic valve replacement: an updated systemic review and meta-analysis.

Although current guidelines recommend dual antiplatelet therapy (DAPT) with aspirin and clopidogrel as an antiplatelet strategy after transcatheter aortic valve replacement (TAVR), it is not based on clinical evidence. Here we aim to review updated evidence systemically and assess safety and efficacy of the two antiplatelet regimens. PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to retrieve studies involving single antiplatelet therapy (SAPT) versus DAPT after TAVR. We screened the records and extracted the data from publications independently. Relative risks (RRs) and the corresponding 95% confidence intervals (CIs) were used to compare the efficacy and safety of SAPT with that of DAPT in fixed-effects model with Mantel-Haenszel method. The quality of evidence was assessed by the scoring system, GRADE (Grading of Recommendations Assessment, Development, and Evaluation). A total of 2,489 patients from 8 studies were enrolled in this meta-analysis. Compared with DAPT, SAPT was associated with a lower all-cause mortality (RR =0.57; 95% CI, 0.36-0.89; P=0.014) and major/life-threatening bleeding (RR =0.62; 95% CI, 0.50-0.76; P=0.000) in 30 days. Furthermore, there was no significant difference found between SAPT and DAPT group in terms of 30-day stroke (RR =0.85; 95% CI, 0.45-1.63; P=0.631) and death beyond 3 months (RR =0.96; 95% CI, 0.81-1.15; P=0.664). This meta-analysis suggests that compared with DAPT, SAPT after TAVR is more likely to lead to a decline of 30-day mortality along with the reduced risk of bleeding and no increased risk of stroke. However, more clinical data and evidence from randomized controlled trials are warranted to clarify the optimal post-TAVR antiplatelet strategy.

Preliminary outcomes of single antiplatelet therapy for surface-modified flow diverters in an animal model: analysis of neointimal development and thrombus formation using OCT

ObjectiveTo evaluate the rate of neointimal development and thrombus formation of surface-modified flow diverters in single antiplatelet therapy (SAPT) using optical coherence tomography (OCT) in a porcine model.MethodsWe divided 10...

Meta-Analysis Comparing Single Versus Dual Antiplatelet Therapy Following Transcatheter Aortic Valve Implantation

To compare dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) as antithrombotic treatment after transcatheter aortic valve implantation (TAVI) for the prevention of ischemic events, vascular and bleeding events, and death. Data from the 3 randomized trials comparing DAPT versus SAPT post-TAVI were pooled and analyzed in a patient-level meta-analysis. The primary end point was the occurrence of death, major or life-threatening bleedings, and major vascular complications at 30-day follow-up. Events were adjudicated according to the Valve Academic Research Consortium 2 definitions. A total of 421 patients randomized to DAPT (210 patients) or SAPT (211 patients) post-TAVI were analyzed. There were no differences between groups in baseline clinical and procedural characteristics. The occurrence of the 30-day combined primary end point was higher in the DAPT group (17.6% vs 10.9%, odds ratio 1.73, 95% confidence interval 1.00 to 2.98, p = 0.050), with an increased rate of major or life-threatening bleeding events in the DAPT group (11.4% vs 5.2%, odds ratio 2.24, 95% confidence interval 1.12 to 4.46, p = 0.022). There were no differences between DAPT and SAPT groups in the incidence of death (5.2% vs 3.8%, p = 0.477), global ischemic events (3.8% vs 3.8%, p = 0.999), or stroke (2.4% vs 2.4%, p = 0.996). DAPT (vs SAPT) was associated with a higher rate of major adverse events after TAVI, mainly driven by an increased risk of major or life-threatening bleeding complications along with a lack of beneficial effect on ischemic events. These results do not support the current recommendation of DAPT as antithrombotic therapy after TAVI.

Comparison of single versus dual antiplatelet therapy after TAVR: A systematic review and meta-analysis.

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.

Impact of preoperative dual antiplatelet therapy on bleeding complications in patients with acute coronary syndromes who undergo urgent coronary artery bypass grafting

BackgroundA 5- to 7-day washout period before coronary artery bypass grafting (CABG) is recommended for patients who have recently received a thienopyridine derivative; however, data supporting this guideline recommendation are lacking in Japanese patients. MethodsUrgent isolated CABG was performed in 130 consecutive patients with acute coronary syndromes (ACS) (101 men; mean age, 69 years). Urgent CABG was defined as operation performed within 5 days after coronary angiography. All patients continued to receive aspirin 100mg/day. The subjects were retrospectively divided into 2 groups: 30 patients with preoperative thienopyridine (clopidogrel in 15 patients, ticlopidine in 15) exposure within 5 days [dual antiplatelet therapy (DAPT) group] and 100 patients without exposure [single antiplatelet therapy (SAPT) group]. ResultsAlthough the DAPT group had a higher proportion of patients who received perioperative platelet transfusions than the SAPT group (50% vs. 18%, p<0.001), intraoperative bleeding (median, 1100ml; interquartile range, 620–1440 vs. 920ml; 500–1100) and total drain output within 48h after surgery (577±262 vs. 543±277ml) were similar. CABG-related major bleeding, which was defined as type 4 or 5 bleeding according to the Bleeding Academic Research Consortium definitions, occurred in a significantly higher proportion of patients in the DAPT group than in the SAPT group (20% vs. 3%, p=0.005). This difference in major bleeding was driven mainly by the higher rate of transfusion of ≥5U red blood cells within a 48-h period in the DAPT group (13% vs. 1%, p=0.01). There was no significant difference in the 30-day composite endpoint including death, myocardial (re)infarction, ischemic stroke, and refractory angina between the DAPT group and SAPT group (17% vs. 19%). ConclusionsPreoperative DAPT increases the risk of CABG-related major bleeding in Japanese patients with ACS undergoing urgent CABG.

Dual antiplatelet therapy in patients with a long coronary artery lesion over 30 mm: Determinants and impact on prognosis

The ideal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is under debate. Lesion length is a well-recognized predictor of PCI complexity and long-term outcome. To evaluate the determinants and impact on outcome of long-term DAPT in a retrospective cohort of patients treated for a long coronary lesion. Patients (n=460) who underwent PCI for a long lesion (>30 mm) were divided into two groups according to antiplatelet regimen at 1 year: patients who stopped DAPT before 1 year (single antiplatelet therapy group; n=168) and patients who continued DAPT for longer than 1 year (n=292). Mean lesion length was 35.7±7.1 mm. The proportion of patients who continued DAPT after 1 year was 63.5%. The main determinants of long-term DAPT were initial presentation as myocardial infarction and implantation of a drug-eluting stent. Median follow-up was 37.4 (23-51) months after the 1-year period following the index PCI. Long-term DAPT was highly associated with a lower risk of all-cause and cardiovascular mortality by multivariable analysis and after adjustment for other predictors: hazard ratios 0.11 (95% confidence interval 0.03-0.32) and 0.15 (95% confidence interval 0.04-0.62), respectively. No increase in major bleeding was noted. In a contemporary practice, nearly two-thirds of patients who undergo PCI for a long lesion are treated with DAPT for several years. Our results suggest that long-term DAPT is beneficial in this subset of patients identified as being at high risk.

Continuous aspirin use does not increase post-endoscopic dissection bleeding risk for gastric neoplasms in patients on antiplatelet therapy.

Background and study aims: Discontinuation of all antiplatelet agents before endoscopic procedures may cause serious complications in some patients. The aim of this study was to evaluate the hemorrhagic risk of post-endoscopic submucosal dissection (ESD) in patients on antiplatelet therapy (APT). Patients and methods: The subjects were 350 patients (377 lesions) who underwent gastric ESD between January 2007 and July 2013. The patients were categorized based on antiplatelet therapies. The primary outcome was post-ESD bleeding. Multivariate analysis was performed to identify independent risk factors for post-ESD bleeding. Results: The patients were categorized into three groups: (1) no APT, 261 patients with 281 lesions; (2) single APT, 58 patients with 63 lesions (53 patients with low dose aspirin [LDA] and 5 patients with a thienopyridine); and (3) dual APT (DAPT), 31 patients with 33 lesions (DAPT with LDA and a thienopyridine). Post-ESD bleeding occurred in 16 of 261 patients in the no APT group (6.1 %), 9 of 58 patients in the single APT group (15.5 %), and 11 of 31 patients in the DAPT group (35.5 %). In multivariate analysis with a Cox proportional hazards model in the no APT and single APT groups, APT (HR 2.7, 95 %CI 1.1 – 6.6, P = 0.03) and diameter of the resected specimen of 40 mm or greater (HR 2.7, 95 %CI 1.2 – 5.9, P = 0.01) were significant risk factors for post-ESD bleeding. In multivariate analysis in the no APT and DAPT groups, DAPT was the only significant risk factor for post-ESD bleeding (HR 16.3, 95 %CI 3.4 – 78.2, P < 0.01). Continuous LDA was not a significant risk factor for post-ESD bleeding in both analyses (HR 0.8, 95 %CI 0.2 – 3.6, P = 0.72 in the no APT and single APT groups; HR 1.0, 95 %CI 0.2 – 5.1, P = 0.95 in the no APT and DAPT groups). Conclusions: APT increased the risk for post-ESD bleeding, and DAPT markedly increased the risk for bleeding. Continuous LDA did not produce an additional hemorrhagic risk in all patients treated with APT. Thus, patients treated with APT should be careful monitored for post-ESD bleeding, and LDA should not be interrupted in patients with a high thromboembolic risk.