Carotid Artery Stenting vs Endarterectomy: Similar Efficacies, Different Safety Profiles

MedicalResearch.com Interview with:
Jay S. Giri, MD, MPH
Director, Peripheral Intervention
Assistant Professor of Clinical Medicine
Penn Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We analyzed data from 6,526 patients in the 5 most recent randomized trials comparing carotid artery stenting to carotid endarterectomy.  These procedures are performed to prevent long-term stroke in patients with severe narrowings of their carotid arteries.  We learned that the procedures are equally effective in preventing stroke over the long-term.  However, the procedures have quite different safety profiles, defined as adverse events that the patients experienced within 30 days of their procedure.

Carotid artery stenting was associated with a higher risk of stroke in the initial 30 days after the procedure.  Carotid endarterectomy was associated with greater risks of myocardial infarction (heart attack) and cranial nerve palsy, a variable condition that most often results in difficulty with swallowing or speaking, over this timeframe.

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Study Evaluates Effects of Calcification of Occluded Coronary Arteries During PCI

MedicalResearch.com Interview with:

Emmanouil S. Brilakis, MD, PhD Director, Center for Advanced Coronary Interventions Minneapolis Heart Institute Minneapolis, Minnesota 55407 Adjunct Professor of Medicine University of Texas Southwestern Medical School at Dallas

Dr, Brilakis

Emmanouil S. Brilakis, MD, PhD
Director, Center for Advanced Coronary Interventions
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Adjunct Professor of Medicine
University of Texas Southwestern Medical School at Dallas

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Calcification in the coronary arteries might hinder lesion crossing, equipment delivery and stent expansion and contribute to higher rates of in-stent restenosis, as well as stent thrombosis. In this project we sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a contemporary, multicenter registry.

We analyzed the outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients between 2012 and 2016 at 11 US centers. Data collection was performed in a dedicated online database (PROGRESS CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, Clinicaltrials.gov Identifier: NCT02061436).

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High risks of mortality following bleeding and ischemic events occurring 1 year after coronary stenting

MedicalResearch.com Interview with:

Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research

Dr. Eric Secemsky

Eric A. Secemsky, MD, MSc
Interventional Cardiology Fellow
Massachusetts General Hospital Harvard Medical School
Baim Institute for Clinical Research 

MedicalResearch.com: What is the background for this study?  What are the main findings?

Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events.

The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting.

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Use of Oral Anticoagulation at Time of PCI Surgery Linked To Increase in Adverse Events

MedicalResearch.com Interview with:

Eric A. Secemsky, MD MSc Interventional Cardiology Fellow Massachusetts General Hospital, Harvard Medical School Fellow, Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center

Dr. Eric A. Secemsky

Eric A. Secemsky, MD MSc
Interventional Cardiology Fellow
Massachusetts General Hospital
Harvard Medical School
Fellow, Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center

MedicalResearch.com: What is the background for this study?

Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown.

Therefore, we used PCI data from a large, integrated healthcare system to determine current use of  oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy.

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Studies Evaluates Outcomes of Carotid Artery Stenting in Real World Settings

MedicalResearch.com Interview with:
Soko Setoguchi-Iwata, M.D
MPH
Adjunct Associate Professor
Department of Medicine
Duke Clinical Research Institute

Medical Research: What is the background for this study? What are the main findings?

Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting vs Carotid Endarterectomy in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population.

Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting.

Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated  Carotid Artery Stenting proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse.

We found that unadjusted mortality risks over study period of 5 years with an mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.  
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Intensive Medical Therapy vs Stent Angioplasty for Stoke : Which is Better?

Aggressive medical therapy could help prevent stroke

To prevent a common type of stroke, intensive medical therapy could be better by itself than in combination with surgery that props open affected arteries. But it remains to be seen whether the apparent advantage will prove true over the long term.

The findings, from a national clinical trial conducted by University of Florida researchers and colleagues, will be published online in The New England Journal of Medicine online on Wednesday, Sept. 7.

Against expectations, the short-term risk of stroke and related death was twice as high in some cases for patients whose diseased arteries were widened via balloon angioplasty and stent insertion, compared with patients who received medical therapy alone. Although the 30-day risk of stroke for the stenting patients is concerning, long-term results could be more favorable, the researchers said.

“Five years from now, who will be doing better — the patients who are being medically managed, or those who received a stent?” said study co-author Michael F. Waters, M.D., Ph.D., director of the Shands at UF Stroke Program, who along with Brian L. Hoh, M.D., the William Merz associate professor of neurological surgery in the College of Medicine, led the UF portion of the trial.

The study will have a substantial impact on clinical practice and research, the researchers said, because it is the first randomized stroke trial to pit stenting against nonsurgical treatment for symptomatic intracranial atherosclerosis, a type of stroke caused by artery blockage in the brain. Early results clearly show that intensive medical management is key to improving health, the researchers said.

“This study provides an answer to a longstanding question by physicians — what to do to prevent a devastating second stroke in a high-risk population. Although technological advances have brought intracranial stenting into practice, we have now learned that when tested in a large group this particular device did not lead to a better health outcome,” said Walter Koroshetz, M.D., deputy director of the NIH National Institute of Neurological Disorders and Stroke, which funded the clinical trial.

Every 40 seconds, someone in the U.S. has a stroke. Stroke is the fourth leading cause of death and a leading cause of disability in the U.S. Almost 800,000 people a year have a new or recurring stroke, according to the American Heart Association. With higher than average rates of stroke and related deaths, parts of the southeastern U.S. are together termed the “Stroke Belt.”

Patients with the type of stroke known as symptomatic intracranial atherosclerosis do not respond well to existing treatments. One-quarter of those patients have another stroke within 12 months, and the risk of additional strokes continues in subsequent years. Doctors are unsure what the best course of treatment is.

To find out, the UF researchers and colleagues launched a clinical trial, nicknamed SAMMPRIS, at 50 sites around the country, including at the Medical University of South Carolina, the lead site. The study recruited 451 participants age 30 to 80 who had at least 70 percent narrowing in the arteries in the brain, and had experienced symptoms within the previous 30 days. UF recruited the second-highest number of patients among all sites, through its stroke program, which has been designated a Comprehensive Stroke Center by the Agency for Health Care Administration.

Patients in one group were randomly assigned to receive intensive management involving smoking cessation and medications for blood pressure, cholesterol, diabetes and blood-clot prevention. A second group of patients had that same medical treatment but also had balloon angioplasty and stent implantation into the affected brain artery to improve blood flow.

Almost 15 percent of patients who received stents had a stroke or died within 30 days of enrolling in the study, compared with just under 6 percent of patients in the medical therapy group. The stark difference between the groups persisted almost a year, by which time about 21 percent of patients who had received stents had had negative effects, compared with 12 percent in the medical group.

The researchers initially thought that patients who received stents would have fared better, given the successful use of similar procedures in clinical practice at the Shands at UF Stroke Program and other medical centers.

But the striking difference between the two patient groups prompted the study’s independent safety monitoring body to call off new recruitment. The researchers will, however, continue to monitor previously enrolled patients for the next two years.

It’s not unusual for surgical patients to have more complications at first, the researchers said. That’s because the invasiveness of surgery poses an inherent risk regardless of the illness being treated.

“The real question is, is there a benefit to patients over the long term,” said study co-author and co-principal investigator Hoh, who is an associate professor of radiology and neuroscience in the UF College of Medicine. “If you think about it, when people are concerned about stroke, it’s not just their first month that matters, so we’re waiting to see what the longer-term results will be.”

Over time, improvement of stent design and honing of surgical techniques could help improve outcomes for patients.

“This is certainly not the final say on managing this disease,” Waters said. “This is another piece of the puzzle that helps to guide our hand.”