Trials may change outlook on interventional management for ACS

TWILIGHT-ACS, Colchicine-PCI COMPLETE-OCT, COACT, Impella®

In a Late-Breaking Clinical Trial session during Scientific Sessions, investigators exploring interventional management for acute coronary syndrome patients found:

  • Ticagrelor alone was as effective as ticagrelor plus aspirin in reducing ischemic events while reducing bleeding risk in a subgroup of high-risk patients after percutaneous coronary intervention for ACS.
  • More work is needed to test dosing regimen for colchicine in reducing vascular injury and inflammation after PCI.
  • Keys to benefits of routine PCI of obstructive non-culprit lesions may lie in plaque morphology Immediate coronary angiography and percutaneous intervention after out-of-hospital coronary arrest without ST segment elevation didn’t improve outcomes.
  • More adequately powered randomized trials needed to better define the appropriate use of MCS devices in patients undergoing PCI. Real-world observational analysis shows more adverse events and higher costs associated with Impella ® use compared to IABP in cardiogenic shock and high-risk PCI patients.

Ticagrelor monotherapy:  less bleeding and as effective as DAPT in some high-risk ACS patients

In a subgroup analysis of the TWILIGHT trial, patients who completed three months on DAPT without cardiac events were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months in TWILIGHT-ACS. The primary endpoint was Bleeding Academic Research Consortium types 2, 3 or 5 bleeding. Key secondary endpoints were all-cause death, myocardial infarction or stroke.

Patients in the ticagrelor monotherapy arm had a 53% reduction in bleeding compared to DAPT with similar differences in ischemic outcomes over one year, said Usman Baber, MD, assistant professor of medicine at Mount Sinai Hospital in New York City.

“At present, many patients with ACS who might benefit from potent antiplatelet therapy do not receive such treatment due to concerns over bleeding,” Baber said. “The TWILIGHT-ACS results suggest a novel strategy for such patients wherein bleeding risk is minimized, yet the benefits from strong platelet inhibition are preserved.” He cautioned that care is needed in interpreting these data.

Pre-procedural colchicine didn’t reduce short-term myocardial injury after PCI

A commonly used anti-inflammatory agent didn’t reduce myocardial injury after PCI compared to placebo, according to the Colchicine-PCI trial.

In the single-site randomized study, researchers compared 1.8 mg colchicine one to two hours before PCI and a placebo in 400 patients who underwent PCI. While inflammatory markers (interleukin-6 and high sensitivity C-reactive protein) increased less over 24 hours in the colchicine group compared to placebo, colchicine didn’t reduce the risk of PCI-related myocardial injury (57.3% for colchicine versus 64.2% for placebo, p=0.19) or major cardiovascular events (11.27 versus 12.9%, p=0.82) when compared with placebo during the first 30 days after PCI.

Colchicine was well-tolerated by study participants.

“Colchicine has long been used to treat gout and other inflammation-related conditions, but more work is needed to determine the optimal dosing regimen for patients undergoing PCI,” said lead author Binita Shah, MD, MS, assistant professor of medicine and associate director of research in the NYU Langone’s Cardiac Catheterization Laboratory in New York City.

Findings may explain benefit of routine PCI of non-culprit lesions after STEMI

A substudy of the COMPLETE trial identified a complex vulnerable plaque morphology that may be responsible for the outcome benefits of complete revascularization of culprit and non-culprit lesions in STEMI patients.

The subgroup analysis of patients who had intracoronary imaging in the non-culprit PCI arteries found that nearly half of non-culprit lesions are obstructive and contain complex vulnerable plaque morphology.

Researchers used optical coherence tomography to visualize at least two major epicardial coronary arteries prior to non-culprit revascularization with PCI in 93 patients with STEMI and multivessel disease. Overall, 47.3% of patients had at least one obstructive, thin cap fibroatheroma lesion in a non-culprit lesion. The obstructive TCFA lesions contained more lipids (78.4% versus 36.5%), macrophages (94.8% versus 52.2%) and cholesterol crystals (82.8% versus 45.7%) than non-TCFA obstructive lesions.

“These substudy results help us to better understand the complex underlying plaque morphology in the STEMI population,” said Natalia Pinilla, assistant professor of cardiology at McMaster University in Ontario, Canada. “The presence of vulnerable plaque in the non-culprit lesions may explain why the COMPLETE trial showed such significant benefits from revascularization of non-culprit lesions after successful primary PCI.”

Immediate intervention didn’t improve 12-month outcomes after cardiac arrest

Immediate coronary angiography and percutaneous intervention following out-of-hospital coronary arrest without ST segment elevation didn’t improve outcomes compared to usual care, according to Coronary Angiography After Cardiac Arrest (COACT).

Twelve-month results from the COACT trial mirror 90-day data reported earlier.

“It has been suggested that out-of-hospital cardiac arrest patients without ST-segment elevation on the ECG should be cathed immediately, but that was in the absence of randomized data,” said Jorrit S. Lemkes, MD, interventional cardiologist at Amsterdam University Medical Center in the Netherlands.

“These results tell clinicians not to rush these patients to the cath lab, but to stabilize them in intensive care first. You can perform angiography once the patient is stable and with good neurological function.”

The most common cause of cardiac arrest is ischemic heart disease, Lemkes said, leading to the hypothesis that immediate CAG and PCI might improve outcomes.

COACT is the first randomized trial to compare immediate coronary angiography in cardiac arrest patients without ST-elevation with delayed intervention

Survival at 12 months was 61.4% for the immediate angiography group versus 64% in the delayed invasive strategy group. There were no significant differences in myocardial infarction, revascularization or heart failure hospitalizations following the index event.

Impella use associated with higher mortality, costs versus intra-aortic balloon pump in patients with acute MI, cardiogenic shock undergoing PCI.

In patients with acute myocardial infarction complicated by cardiogenic shock who undergo PCI, use of the Impella device for mechanical circulatory support is associated with increased risk of death (10.9%) and major bleeding (15.4%) compared to intra-aortic balloon pump devices. An observational analysis of patients with AMI-CS undergoing PCI from the NCDR® CathPCI Registry® and the Chest Pain – MI RegistryTM included 10,239 patients and more than 2,500 hospitals between October 2015 and December 2017. About 10% of MI patients have CS.

Impella use grew from 3.5% to 8.7% during the study period. A propensity-matched cohort analylsis of in-hospital clinical outcomes found increased risk for death and major bleeding whether the device was implanted before or during PCI or after the procedure.

“These data provide important insights into the performance of MCS devices in routing clinical practice,” said Sanket S. Dhruva, MD, MHS, postdoctoral fellow at Yale University School of Medicine. “And they show that better evidence and guidance are needed regarding the optimal management of patients with AMI-CS as well as the role of MCS devices in general and Impella in particular.”

Impella use associated with higher mortality, morbidity and costs versus intra aortic balloon pump

The Impella device is associated with a higher risk of death (24%), bleeding (10%), acute kidney injury, or AKI (8%) and stroke (34%) in patients undergoing PCI with mechanical circulatory support for high-risk PCI compared to intra-aortic balloon pump devices. An observational analysis of Premier Healthcare data in 48,306 patients undergoing PCI with MCS at 432 U.S. hospitals in January 2004-December 2016 found that  when analyzed by time periods (pre-Impella era versus Impella era), by hospital (low Impella use hospitals versus high Impella use hospitals) or by patients, Impella use was associated with higher rates of adverse events and hospital costs.

“These results tell us that perhaps a more measured approach is needed in clinical practice that balances risks and benefit in these sick patients,” said Amit Amin, MD, MSc, associate professor of cardiology at Washington University School of Medicine in St. Louis, Missouri.

“This reflects how MCS devices are being used in everyday clinical practice and the associated outcomes,” said Amin, who is also medical director of quality and outcomes, interventional cardiology at Barnes Jewish Hospital in St. Louis. “These observational data underscore the need for adequately powered, randomized trials to better define the appropriate use of MCS devices in patients undergoing PCI.”

 

 

 

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