Feature | September 26, 2013

Paradigms for Dual Antiplatelet Therapy after PCI Challenged by PARIS Trial

Icahn School of Medicine at Mount Sinai presents new findings of its Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients (PARIS) study at European Society of Cardiology 2013 Congress

Icahn School of Medicine at Mount Sinai PARIS Study Antiplatelet Therapy PCI

September 26, 2013 — Lead study investigators from Icahn School of Medicine at Mount Sinai presented their Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients (PARIS) study findings at the ESC Congress 2013 in Amsterdam organized by the European Society of Cardiology. Their new study results show among patients undergoing percutaneous coronary intervention (PCI) with stents, the risk of cardiovascular complications after stopping dual antiplatelet therapy (DAPT) is highly variable depending on the context, and some patients experience no complications at all.

“Our findings challenge existing paradigms for prolonging antiplatelet therapy in otherwise stable patients after PCI, and show that in a real-world setting physicians are making appropriate decisions in selecting low-risk patients for discontinuation,” said lead investigator Roxana Mehran, M.D., professor of Medicine in Cardiology and director of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai.

“Conversely, when patients simply don’t comply or are forced off antiplatelet therapy because they are bleeding, their risk is significantly elevated,” she adds.

The PARIS study, a prospective, international, multicenter, observational registry trial led by Icahn School of Medicine at Mount Sinai, enrolled more than 5,000 patients with coronary artery disease undergoing PCI with stent implantation at 15 clinical sites in five countries between July 2009 and December 2010.

Follow-up at 30 days, six months, one, and two years determined whether patients had discontinued, interrupted, or disrupted antiplatelet therapy and whether this resulted in any major adverse cardiovascular events (MACE).

“Discontinuation” was defined as a physician-recommended cessation of medication for subjects believed to no longer need it, while “interruption” was defined as temporary (up to 14 days) due to surgical necessity, and “disruption” was due to bleeding or non-compliance.

In a final analysis of 5,018 patients at two years, the study showed a cumulative incidence of discontinuation, interruption, and disruption of 40.8 percent, 10.5 percent, and 14.4 percent, respectively, while the cumulative incidence of MACE was 11.5 percent.

At one-year, which is the duration currently recommended for antiplatelet therapy, the cumulative incidence of discontinuation, interruption, and disruption was 11.5 percent, 4.6 percent, and 9.8 percent respectively, with a 7.4 percent cumulative incidence of MACE.

The majority of MACE (74 percent) occurred in patients who had remained on their recommended antiplatelet therapy, but among those who had not, there was a 50 percent increased risk of MACE associated with disrupting compared to staying on medication, and a 37 percent decreased risk associated with discontinuation compared to staying on. In contrast, brief interruptions did not increase risk for thrombotic events such as stent thrombosis or myocardial infarction.

“The findings show that when physicians recommend discontinuation presumably because patients are stable, there is no risk of adverse events, but when patients simply don’t comply or are forced off antiplatelet therapy because they are bleeding, their risk is significantly elevated,” said Mehran.

For the latter group, a novel finding was that the risk of MACE was highest in the first seven days of disruption (when there was a seven-fold increase), after which it decreased.

Importantly, the study also showed that sustained antiplatelet therapy was not associated with reduced thrombotic risk compared to recommended discontinuation — a finding that goes against common assumption.

“In fact, there was a slight, though statistically non-significant reduction in risk associated with recommended discontinuation, which contrasts with some previous studies that have suggested a potential protective effect with prolonged antiplatelet therapy,” she said.

The PARIS study results show that the effect of antiplatelet cessation on cardiovascular risk is “modest” offering insight on this interaction in the modern era of post-PCI therapy.

Previous studies have not included such a broad range of subjects and did not account for the context around antiplatelet cessation, according to Mehran.

“We hope that these novel findings will spur initiatives to standardize and harmonize criteria for DAPT cessation, analogous to previous efforts used for myocardial infarction and bleeding.”

The PARIS study was supported by a Mount Sinai investigator-initiated grant from Bristol Myers Squib/Sanofi-Aventis. Representatives of the funding agency were not directly involved in the collection, management, analysis or interpretation of the data.

For more information www.mountsinai.org

Related Content

microtubules, heartbeat mechanics, Perelman School of Medicine study

Microtubules in a cardiomyocyte at rest (top) and when compressed. Image courtesy of the lab of Ben Prosser, Ph.D., Perelman School of Medicine, University of Pennsylvania

News | EP Lab| April 29, 2016
Using new high-resolution microscopy, researchers have found that molecular struts called microtubules (MT) interact...
breast cancer, herceptin chemotherapy drug, heart damage, monitoring, Journal of Clinical Oncology study
News | Cardiac Diagnostics| April 28, 2016
April 28, 2016 — Breast cancer patients undergoing treatment with trastuzumab-containing regimens should be monitored
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
coronary CT angiography, CCTA, SCOT-HEART trial substudy, SCCT
News | Computed Tomography (CT)| April 26, 2016
The results of a secondary analysis of the SCOT-HEART trial show that coronary computed tomography angiography (CCTA)...
sleep patterns, metabolic syndrome, risk factors, ACC study
News | Cardiac Diagnostics| April 26, 2016
Taking long naps or being excessively tired during the day is associated with a higher risk for developing metabolic...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
Overlay Init