Tag: angioplasty

Nuclear Stress Testing Identifies Candidates Most in Need of Angioplasty

Photo by Robina Weermeijer on Unsplash

Patients identified by nuclear stress testing as having severe stress-induced myocardial ischaemia may benefit from angioplasty, while those with mild or no ischaemia will not, according to a new study reported in the Journal of the American College of Cardiology.

Following stress testing, coronary revascularisation restores blood flow to blocked arteries. For patients with severe ischaemia, early revascularisation saw a more than 30% reduction in mortality compared to patients with severe ischaemia who were treated with medication, but there was no benefit for the other groups.

Conducted by the Icahn School of Medicine at Mount Sinai, this is the first large-scale study to investigate stress testing in patient management when applied to the full spectrum of patients who have both varying degrees of myocardial ischaemia and heart function. This new study can help guide physicians on how to manage caring for patients with suspected heart disease.

Stress tests are indicated when physicians suspect that a patient’s chest pain or other clinical symptoms are from coronary artery disease (CAD). These help determine if a patient has obstructive CAD which leads to significant ischaemia. If the ischaemia due to obstructive CAD is severe, adequate blood flow can be restored with coronary artery bypass grafting surgery or percutaneous coronary intervention (PCI), where a catheter is used to place stents in the blocked coronary arteries. Nuclear stress testing is the most common stress test used to detect myocardial ischaemia.

“There is keen interest in assessing how measurement of myocardial ischaemia during stress testing can help shape physicians’ decision to refer patients for coronary revascularisation procedures, but this issue has not been well studied among patients who have underlying heart damage,” explains lead author Alan Rozanski, MD. “Our study, which evaluated a large number of patients with pre-existing heart damage who underwent cardiac stress testing, finally addresses this clinical void.”

The researchers analysed records of more than 43 000 patients who underwent nuclear stress testing with suspected CAD between 1998 and 2017 with a median 11-year follow-up for mortality/survival. The investigators grouped patients according to both their level of myocardial ischaemia during stress testing as well as their left ventricular ejection fraction (LVEF). Low LVEF measurements indicate prior heart damage that could be from scarring of the heart due to a prior heart attack.

The study provides two important clinical insights. First, the study showed that the frequency of myocardial ischemia during stress testing varies according to patients’ heart function. Of the 39 883 patients with normal heart function (LVEF > 55%), fewer than 8% of them had ischaemia. However, among the 3560 patients with reduced heart function (LVEF less than 45%, which indicates prior heart damage), more than 40% of them had myocardial ischaemia. The study also showed that the presence of myocardial ischaemia increases the risk of death in patients with normal and reduced heart function. Among both groups of patients, performing bypass or PCI procedures was not associated with improved survival among patients with either no or only mild ischaemia during the cardiac stress test. Among patients with severe ischaemia, coronary procedures were associated with more than 30% higher survival rates compared to those managed with medication only. This was the case for patients with and without heart damage.

“These results confirm the benefits of stress testing for clinical management. What you want from any test when considering coronary revascularisation procedures is that the test will identify a large percentage of patients who are at low clinical risk and do so correctly, while identifying only a small percentage of patients who are at high clinical risk and do so correctly. That is what we found with nuclear stress testing in this study,” explains Dr Rozanski. “Importantly, the presence of severe ischaemia does not necessarily mean that coronary revascularisation should be applied. New data from a large clinical trial suggests that when medical therapy is optimised it may be as effective as coronary revascularisation in such patients. But regardless, the presence of severe ischaemia indicates high clinical risk which then requires aggressive management to reduce clinical risk.”

Source: The Mount Sinai Hospital / Mount Sinai School of Medicine

Sweet Success for ‘Chocolate Touch’ Angioplasty Device

Credit: QT Vascular

In patients undergoing angioplasty, a study showed that use of the paclitaxel-coated balloon catheter known as the Chocolate Touch device had better outcomes at compared with those from use of a commercially-available balloon catheter. These findings were presented at the American College of Cardiology’s 71st Annual Scientific Session.

The trial showed noninferiority and an improvement in terms of the proportion of patients with adequate blood flow through the artery without subsequent procedures.

“I’m very excited that we now have a head-to-head comparison of a second-generation vs. first-generation drug-coated balloon and data that we can rely on to make decisions for our patients,” said Mehdi Shishehbor, DO, MPH, PhD, the study’s lead author. “I think that the superiority of Chocolate Touch indicates that as we improve the technologies, there is additional benefit to be gained. For me, this study makes the case that this [Chocolate Touch] will be the device of choice between these two devices for patients who require drug-coated balloon therapy.”

The trial enrolled 313 randomised patients treated for superficial femoral and popliteal artery disease – conditions that involve blocked arteries in the upper leg. All patients underwent balloon angioplasty, a procedure to reopen the artery by threading a tiny device into the blocked area and inflating a small drug-coated balloon that helps prevent reoccurance of the blockage . In half of the patients, a commercially-available Lutonix drug-coated balloon was used, and in the other half the Chocolate Touch balloon was used. The Chocolate Touch device has a constrained balloon, creating characteristic pillows and grooves reminiscent of a chocolate bar.

At 12 months, 78.8% of the patients who received the Chocolate Touch device and 67.7% of those receiving the Lutonix device achieved patency, or blood flow as measured by the peak systolic velocity ratio. No statistical difference in safety was seen between the devices, with a rate of major adverse events of 11.1% in the Chocolate Touch arm and 15.4% in the Lutonix arm. Major adverse events included a composite of death related to the targeted limb, major amputation and revascularidation procedures.

Dr Shishehbor said that estimates of mortality on a cumulative, year-by-year basis are consistently lower in the Chocolate Touch arm as compared to the Lutonix arm. For patients at the three-year follow-up, estimated mortality is 6.8% among patients receiving the Chocolate Touch device, which was also well below the trial’s goal of 13.2%, reinforcing confidence in the device’s safety profile.

“At a minimum, this [Chocolate Touch] device is as safe as the Lutonix, with a trend for lower mortality rates,” Dr Shishehbor said.

The Chocolate Touch device is designed to provide a more even and controlled widening of the artery. This design lets operators use a slightly larger balloon to further widen the artery and provide increased contact between the balloon surface with the paclitaxel coating, Dr Shishehbor said.

Although balloon angioplasty is the preferred treatment for blocked arteries in the leg, many patients experience recurring blockages, requiring additional procedures.

“If we are able to offer patients therapies that can keep the artery open for as long as possible, that will be welcome news,” Dr Shishehbor said. “As we advance our technologies and get more patency, or blood flow, over time, the patients will enjoy that benefit and have a lower likelihood of needing repeat procedures.”

Dr Shishehbor said that the trial paused enrollment for six months in response to industry-wide concerns over the safety of paclitaxel but said that the study ultimately achieved a high follow-up rate of 94%. The trial is also the first to allow combining the drug-coated balloon treatment with atherectomy, in which a blade is used to first remove plaque from the vessel prior to catheter balloon use. Dr Shishehbor said that while only a small number of patients was treated with atherectomy, the patency rate was promising. Future studies could determine whether Chocolate Touch treat longer and more complex blockages.

Source: American College of Cardiology

Angioplasty Needed by Smokers 10 years Before Non-smokers

Photo by Elsa Olofsson on Unsplash

Smokers needed their blocked arteries fixed nearly 10 years earlier than non-smokers, and patients with obesity underwent these procedures four years earlier than non-obese patients, according to a new US study.

Angioplasty is a nonsurgical procedure that opens clogged or narrow coronary arteries. The procedure involves inserting an inflatable balloon-tipped catheter through the skin in extremities and then inflating the balloon once it reaches the stenosed arterial site. The balloon pushes the atherosclerotic intraluminal plaque against the arterial wall and restores the luminal diameter, and so restores blood flow to the heart muscle.

The study included patients with no heart attack history, treated at hospitals across Michigan. The patients had all undergone angioplasty and/or stenting to widen or unblock their coronary arteries and restore blood flow. Nearly all of them had at least one traditional risk factor, including smoking, obesity, high blood pressure, high cholesterol and diabetes. Most patients had three or more.

Furthermore, compared to men, women generally had their first procedure at a later age. Over the past ten years, among patients undergoing their first angioplasty or stent procedure, obesity and diabetes rates have increased, while smoking and high cholesterol have decreased.

“Smoking is a completely preventable risk factor,” said senior author Devraj Sukul, MD, MSc, an interventional cardiologist and a clinical lecturer at the University of Michigan Health Frankel Cardiovascular Center. “If we direct additional efforts at preventing smoking and obesity we could significantly delay the onset of heart disease and the need for angioplasty and stenting.”

“In Michigan, we will work to help every smoker quit at the time of cardiac care because it is an unmatched teachable moment for patients,” said Michael Englesbe, M.D., a surgeon and professor at Michigan Medicine who serves as portfolio medical director for the Collaborative Quality Initiatives.

Source: Medical Xpress

Journal information: Zoya Gurm et al, Prevalence of coronary risk factors in contemporary practice among patients undergoing their first percutaneous coronary intervention: Implications for primary prevention, PLOS ONE (2021). DOI: 10.1371/journal.pone.0250801