After TAVR, patients who do not have an indication for oral anticoagulation fare better with aspirin alone than with dual antiplatelet therapy, the POPular TAVI trial shows.
Patients treated with aspirin monotherapy rather than aspirin plus 3 months of clopidogrel had much lower rates of bleeding without an increase in thromboembolic events, Jorn Brouwer, MD (St. Antonius Hospital, Nieuwegein, the Netherlands), reported during the virtual European Society of Cardiology Congress 2020.
He explained that the optimal post-TAVR antithrombotic strategy has not been established. European guidelines recommend aspirin plus clopidogrel early after the procedureand a single antiplatelet thereafterfor patients without an indication for oral anticoagulation based on the coronary stenting literature. Patients undergoing TAVR, however, have a greater risk of bleeding compared with stenting patients due to older age, a heavier comorbidity burden, and use of large-bore catheters, he noted.
These findings from POPular TAVI, published simultaneously online in the New England Journal of Medicine, indicate that physicians can easily and safely reduce the rate of bleeding by omitting clopidogrel after TAVI, Brouwer said during a press conference. And the take-home message is: aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulation and have not recently undergone coronary stenting.
Answering questions for the press, Jurrin ten Berg, MD, PhD (St. Antonius Hospital), principal investigator for the trial, noted that there were two cohorts in POPular TAVI. In the group of patients who had an indication for oral anticoagulation (cohort B), the investigators had previously shown that adding clopidogrel to anticoagulation increased bleeding without a clear benefit in terms of reducing ischemic events.
It might come as a surprise that we didnt have any randomized data on the optimal treatment, so the guidelines are just based on expert opinion, ten Berg said. These two cohorts definitely show that aspirin alone or oral anticoagulation alone should be used in these patients.
As for what impact there might be on guidelines due to these data from patients without an indication for anticoagulation (cohort A), ten Berg said: I think its going to change because it definitely shows that it is safer to use aspirin alone and it doesnt come with an increase of thrombotic events, so its also effective to use aspirin alone.
POPular TAVI Cohort A
In cohort A of the trial, which was conducted at 17 European centers, 665 patients (mean age 80 years; 48.7% women) who did not require anticoagulation were randomized to aspirin alone or to aspirin plus 3 months of clopidogrel (followed by aspirin alone). The doses were 80 to 100 mg daily for aspirin and 75 mg daily for clopidogrel. Follow-up lasted 1 year.
There were two primary outcomes, both of which favored aspirin alone:
Procedure-related bleeding was defined as BARC type 4 severe bleeding only, so most of the bleeding that occurred at the TAVR access site fell into the non-procedure-related category. Among patients who bled, the access site was the location of bleeding in 58.0% of those treated with aspirin alone and 53.9% of those treated with aspirin plus clopidogrel. Only six patients, all in the aspirin plus clopidogrel group, had a BARC type 4 bleed.
The rate of major, life-threatening, or disabling bleeding was lower with aspirin monotherapy (5.1% vs 10.8%), driven mostly by a reduction in major bleeding (2.4% vs 7.5%).
There were also two secondary outcomes in the trial. The firsta composite of CV death, non-procedure-related bleeding, stroke, or MIfavored aspirin alone (23.0% vs 31.1%), meeting criteria for both noninferiority (P < 0.001) and superiority (RR 0.74; 95% CI 0.57-0.95). The seconda composite of CV death, ischemic stroke, or MIoccurred at similar rates in the two trial arms: 9.7% with aspirin alone and 9.9% with aspirin plus clopidogrel (P = 0.004 for noninferiority).
Although there were no signs of a numerically higher incidence of thromboembolic events with aspirin alone than with aspirin plus clopidogrel, no clinical inferences should be drawn from these data, Brouwer et al write in their paper, noting that the trial was not powered to look at differences in these endpoints.
After Brouwers presentation, ten Berg was asked about an apparent catch-up in death, stroke, and MI in the aspirin monotherapy arm. He acknowledged that there might be some benefit of clopidogrel early after TAVR but said it was likely small. I think that the catch-up is not as important as the bleedings we inflict with dual antiplatelet therapy. So in the end, the conclusion stays the same: do not use clopidogrel in these patients, he said.
More Is Not Always Better
Commenting for TCTMD, Mary Cushman, MD (University of Vermont, Burlington), said via email she was really excited to see a cardiology trial that focused on bleeding as the primary endpoint. Abnormal bleeding often has more morbidity associated with it than ischemic outcomes might. She contrasted a major GI bleed that requires hospitalization, transfusion, and endoscopy with an NSTEMI that requires a short hospital stay and a small adjustment in medications. Even minor bleeding can be very bothersome to patients, she added.
Its not surprising, said Cushman, an American Heart Association spokesperson, that bleeding would be reduced by using aspirin alone rather than dual antiplatelet therapy. This would be expected, especially in an older population, such as that which would be receiving TAVI (mean age in this study was 80), she explained.
The US guidelines state that adding clopidogrel to aspirin after TAVR may be reasonable, which means that the recommendation is weak and based on unclear evidence, Cushman said. In these cases the recommendation is often based on expert opinion and studies that have limitations of design. As such, given the findings of this new study, guideline makers will need to synthesize results in context of those studies to update them.
Moreover, POPular TAVI might help guide treatment decisions by physicians and patients, she suggested. Is an expected tiny difference in a thrombotic outcome worth that added risk of bleeding and expense? she wrote. The authors of the POPular TAVI trial reported they collected quality-of-life data, so future analysis of that would be helpful to physicians and patients to inform decision-making on this topic.
What Cushman takes away from the trials results is that more is not always better in antithrombotic treatment.
In addition, there are implications for future research, she indicated. In the current era where we have excellent treatments for patients with thrombotic conditions (everything from stroke to MI to venous thromboembolism or valvular heart disease), we need to increasingly consider the burden of bleeding on the well-being and quality of life of patients, and reconsider how we conduct future trials, she said. In this setting of excellent secondary prevention, an emphasis on studying the impact of treatments on death and disabling outcomes (like disabling stroke or intracerebral hemorrhage) will become much more important to consider in large trials.
Follow this link:
Go With Aspirin Alone After TAVR When Anticoagulation Isn't Needed: POPular TAVI - TCTMD
- Best 30 Cardiology in Secaucus, NJ with Reviews - YP.com - April 12th, 2018 [April 12th, 2018]
- Cardiology | Weill Cornell Medicine - April 14th, 2018 [April 14th, 2018]
- Cardiology Conferences 2018 | Cardiology Meetings 2018 ... - April 26th, 2018 [April 26th, 2018]
- Dr. Anil Goel, MD - Birmingham, MI - Cardiology & Clinical ... - April 26th, 2018 [April 26th, 2018]
- Clinical Physiology (Cardiology) MSc/PGDip | Middlesex ... - May 15th, 2018 [May 15th, 2018]
- Cardiology Conferences 2018 | Upcoming Cardiology ... - May 16th, 2018 [May 16th, 2018]
- Clinical Cardiology Section | Cleveland Clinic - May 27th, 2018 [May 27th, 2018]
- Journal of Clinical and Experimental Cardiology - Open ... - June 6th, 2018 [June 6th, 2018]
- Cardiology Summit 2018 | Cardiology Conferences | Heart ... - June 23rd, 2018 [June 23rd, 2018]
- Cardiology Clinical and Research Faculty Members ... - June 26th, 2018 [June 26th, 2018]
- Cardiology Conferences 2018 | Cardiology Congress 2018 ... - June 26th, 2018 [June 26th, 2018]
- About Us - New Jersey Cardiology Associates - July 8th, 2018 [July 8th, 2018]
- About Us - Ventura Clinical Trials - August 16th, 2018 [August 16th, 2018]
- Clinical Cardiology Made Ridiculously Simple: Michael A ... - August 22nd, 2018 [August 22nd, 2018]
- Clinical Cardiology - American Society of Preventive Cardiology - October 2nd, 2018 [October 2nd, 2018]
- Heart Surgery Hospital in india | Cardiology Treatment ... - October 7th, 2018 [October 7th, 2018]
- Clinical Cardiology - American Society of Preventive ... - December 3rd, 2018 [December 3rd, 2018]
- Guideline Clinical App - American College of Cardiology - December 7th, 2018 [December 7th, 2018]
- Journal of Clinical and Experimental Cardiology- Open ... - December 12th, 2018 [December 12th, 2018]
- Clinical Cardiology - Baptist Health - December 30th, 2018 [December 30th, 2018]
- Cardiology at Cancun: Topics in Clinical Cardiology - February 5th, 2019 [February 5th, 2019]
- Department of Cardiovascular Medicine, KU School of Medicine - March 10th, 2019 [March 10th, 2019]
- Towards Health Equality: Improving the Management of Cardiovascular Diseases in Women - International Atomic Energy Agency - September 21st, 2019 [September 21st, 2019]
- Lifetime Risk of PAD Varies by Race, but All Are Vulnerable to Traditional Risk Factors - TCTMD - September 21st, 2019 [September 21st, 2019]
- DEFINE-HF: Dapagliflozin Improves Function and QoL, but Not Biomarkers, in HFrEF - TCTMD - September 21st, 2019 [September 21st, 2019]
- Combining Nature and Technology, Luye Medical and Cleveland Clinic Join to Build a Future Hospital in Shanghai - Yahoo Finance - September 21st, 2019 [September 21st, 2019]
- Will Renal Denervation for Hypertension Rise Again? - Medscape - September 21st, 2019 [September 21st, 2019]
- Obstructive Sleep Apnea, Sleep Symptoms, and their Association with Cardiovascular Disease - DocWire News - September 21st, 2019 [September 21st, 2019]
- CNE expands pulmonary, sleep services with Brigham & Women's physicians - Warwick Beacon - September 21st, 2019 [September 21st, 2019]
- What I Am Most Looking Forward to at TCT 2019 - TCTMD - September 21st, 2019 [September 21st, 2019]
- Serelaxin Not Linked to CV Mortality Reduction in Patients Hospitalized for Acute HF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Sacubitril-Valsartan Not Linked to Lower Hospitalization Risk, CV Death in HFpEF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- FDA clears multiuse angiography systems from Siemens Healthineers - DOTmed HealthCare Business News - September 21st, 2019 [September 21st, 2019]
- Balloon Pulmonary Angioplasty Effective for Chronic Thromboembolic PH - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- RWJBarnabas Health, St. Luke's University Health launch clinical affiliation - FierceHealthcare - September 21st, 2019 [September 21st, 2019]
- Bilirubin: A Novel Indicator of Infective Endocarditis Adverse Outcomes - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Major Bleeding Mostly Early, Not Severe With Rivaroxaban Plus Aspirin in COMPASS - TCTMD - September 21st, 2019 [September 21st, 2019]
- Community-based Care Model Reduces CVD Risk - Managed Healthcare Executive - September 21st, 2019 [September 21st, 2019]
- American College of Cardiology Steps Up: Equal Pay, Opportunities for All - TCTMD - September 21st, 2019 [September 21st, 2019]
- FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form - AJMC.com Managed Markets Network - September 21st, 2019 [September 21st, 2019]
- A New Drug for HF? DEFINE-HF Bolsters Dapagliflozin Cardio Cred - Medscape - September 21st, 2019 [September 21st, 2019]
- Seeking Synergy: Bringing Cardiology into Your Enterprise Imaging Strategy - Health Imaging - September 21st, 2019 [September 21st, 2019]
- TCT 2019 Day Two: Transcatheter Valves, New and Old - TCTMD - September 30th, 2019 [September 30th, 2019]
- Transcatheter Options Best for Tricuspid Regurgitation in Matched Registry Analysis - TCTMD - September 30th, 2019 [September 30th, 2019]
- Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival - Diagnostic and Interventional Cardiology - September 30th, 2019 [September 30th, 2019]
- TAVR Improves Health Status Over Surgery in Low-Risk Patients at 1 Year: PARTNER 3 - TCTMD - September 30th, 2019 [September 30th, 2019]
- Eidos Therapeutics to Present Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study of AG10 in Patients with TTR Amyloid Cardiomyopathy... - September 30th, 2019 [September 30th, 2019]
- Off Script: The New Gatekeepers of Procedural Education - TCTMD - September 30th, 2019 [September 30th, 2019]
- Study Shows Safety and Efficacy of Near Infrared Spectroscopy (NIRS) Imaging to Identify Patients and Plaques at an Increased Risk for MACE - BioSpace - September 30th, 2019 [September 30th, 2019]
- The Heart of the Matter: Cardiovascular Fitness in Horses - United States Eventing Association - September 30th, 2019 [September 30th, 2019]
- Google parent Alphabet hires former FDA head Robert Califf to lead health strategy and policy - FierceHealthcare - September 30th, 2019 [September 30th, 2019]
- Inclisiran Benefits Patients With Familial Hypercholesterolemia and ASCVD - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- AUGUSTUS: Best Benefit With Apixaban, P2Y12 Inhibitor Dual Therapy - Medscape - September 30th, 2019 [September 30th, 2019]
- New TAVR System Safe and Effective for High-Risk Surgical Patients with Severe Aortic Stenosis - Newswise - September 30th, 2019 [September 30th, 2019]
- Dapagliflozin Improves Heart Failure-Related Health Status in HFrEF - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Remote Ischemic Conditioning Did Not Improve 12 Month Clinical Outcomes After STEMI - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Insights from the European Society of Cardiology congress | Speaking of Medicine - PLoS Blogs - September 30th, 2019 [September 30th, 2019]
- Smokers Have More Pulmonary Emboli, Leading to Higher Hospital Readmission Rates | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- AZ's Farxiga gets heart failure prevention okay from FDA - PMLiVE - October 22nd, 2019 [October 22nd, 2019]
- Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 - BioSpace - October 22nd, 2019 [October 22nd, 2019]
- The Epidemic Of The Metabolic Syndrome Among The Palestinians In The G | DMSO - Dove Medical Press - October 22nd, 2019 [October 22nd, 2019]
- Optina Diagnostics and the Montreal Heart Institute Partner to Develop a New Biomarker for Atherosclerosis - PRNewswire - October 22nd, 2019 [October 22nd, 2019]
- Even With Same Diagnosis, Women Get Half the Heart Attack Treatments as Men - AJMC.com Managed Markets Network - October 22nd, 2019 [October 22nd, 2019]
- Eva Dickerman, Andrew Weil - The New York Times - October 22nd, 2019 [October 22nd, 2019]
- EHR vendor Veradigm and partners creating new shared data tools for researchers - Healthcare IT News - October 22nd, 2019 [October 22nd, 2019]
- Evolocumab Well-tolerated as Add-on for Hypercholesterolemia Therapy - DocWire News - October 22nd, 2019 [October 22nd, 2019]
- Deborah Heart and Lung Center announces affiliation with Cleveland Clinic Heart & Vascular Institute - Health Essentials from Cleveland Clinic - October 22nd, 2019 [October 22nd, 2019]
- New Registry to Provide Insight into STEMI Occurrence, Treatment in North India | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- Finding Your Best Fit in Cardiology - TCTMD - October 22nd, 2019 [October 22nd, 2019]
- Cardiology team expands to meet community need - The Union of Grass Valley - October 22nd, 2019 [October 22nd, 2019]
- Deaths After Ablation of Atrial Fibrillation 'Concerning' in Real-World Analysis - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cutler Family gifts $15 million to University Hospitals to transform mens health care - Newswise - November 1st, 2019 [November 1st, 2019]
- Troponin Increases After Elective PCI Tied to Complexity, Extent of CAD - TCTMD - November 1st, 2019 [November 1st, 2019]
- Caregiving and the Soul of Medicine - Medscape - November 1st, 2019 [November 1st, 2019]
- STEMI Mortality Unaffected by Weekend, Weeknight, or Holiday Admission in France - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical publishes positive results from the AMBULATE pivotal study Cardiology2.0 - Cardiology2.0 - November 1st, 2019 [November 1st, 2019]
- Gaps in Access to TAVR and SAVR: 'Something Needs to Be Done' - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical Announces Publication of Data From the AMBULATE Pivotal Study in the Journal of the American College of Cardiology: Clinical... - November 1st, 2019 [November 1st, 2019]
- Raymond James 4 Analyst Favorite Health Care Picks With Huge Upside Potential - 24/7 Wall St. - November 7th, 2019 [November 7th, 2019]
- Global Computed Tomography (CT) Scanners Devices and Equipment Market Report 2020: Major Players are GE Healthcare, Koninklijke Philips, Hitachi,... - November 7th, 2019 [November 7th, 2019]