Patients with diabetes have an increased risk of complications after stent implantation, according to a study from Karolinska Institutet published in Diabetes Care. The study emphasises the importance of tailoring treatment strategies for this specific patient group.
Researchers have conducted a comprehensive study to investigate the risk of stent complications in patients with diabetes. The study consists of data from over 160 000 patients who received drug-eluting stents (small tubes placed in the coronary arteries of the heart that slowly release drugs to reduce the risk of the vessel becoming blocked again) between 2010 and 2020. The patients were divided into three groups: type 1 diabetes, type 2 diabetes, and patients without diabetes.
Highest risk in type 1 diabetes
The results show that patients with type 1 diabetes have more than twice the risk of stent complications compared to patients without diabetes. For patients with type 2 diabetes, the risk is also elevated, but not as significantly. Complications include both narrowing of the artery in the stent and blood clots in the stent.
“Our results show that people with diabetes, especially type 1 diabetes, have a much higher risk of stent complications. Therefore, it is important to carefully consider how we treat these patients,” says first author Irene Santos-Pardo, researcher at the Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet.
Tailored treatment strategies
The study also shows that the risk of stent complications is highest during the first few months after stent implantation. During the first month, the incidence of stent complications was 9.27 per 100 person-years for patients with type 1 diabetes, compared with 4.34 for patients without diabetes. After six months, the risk decreased but remained higher for patients with diabetes.
“We need to continue to investigate how we can improve treatment for patients with diabetes who undergo stent implantation. Our results indicate that there is a need to adapt treatment and follow-up for them,” says last author Thomas Nyström, professor at the Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and senior physician at Södersjukhuset,
Underweight patients may face higher risk of poor outcomes after surgery
Source: Pixabay CC0
Higher BMI is not linked to increased risk of death or other complications following shoulder replacement surgery, according to a new study by Epaminondas Markos Valsamis from the University of Oxford, UK, and colleagues publishing November 20th in the open-access journal PLOS Medicine.
Joint replacement surgeries – including hip, knee and shoulder replacements – can significantly improve quality of life. Many patients with obesity are denied these procedures despite a lack of formal recommendations from national organisations. Evidence on the risks of joint replacement surgery in patients with obesity is limited and mixed.
In this study, researchers analysed more than 20 000 elective shoulder replacement surgeries performed across the UK and Denmark to see whether BMI was associated with death or other complications.
Compared to patients with a healthy BMI (21.75 kg/m2), patients with obesity (BMI 40 kg/m2) had a 60% lower risk of death within the year following surgery. Those considered underweight (BMI <18.5 kg/m2) had a slightly higher risk of death. The study does not support restricting patients with a high BMI from having elective shoulder replacement surgery, contrary to evidence that some hospitals are starting to restrict patients.
One main limitation of this study was the small sample size of the underweight population (131 for the UK data, 70 for the Denmark data). However, this was a large study that consistently showed a lower risk of death and complications in patients with obesity undergoing shoulder replacement surgery across multiple outcomes and two countries. The results can help patients, surgeons, and policymakers make informed decisions about who should be considered fit for these surgeries.
Lead author Epaminondas Markos Valsamis says, “Shoulder replacements offer patients the opportunity for excellent pain relief and improved quality of life. Our research shows that patients with a higher BMI do not have poorer outcomes after shoulder replacement surgery.”
Senior author Professor Jonathan Rees adds, “While BMI thresholds have been used to limit access to joint replacement surgery, our findings do not support restricting higher BMI patients from accessing shoulder replacement surgery.”
Oliver Staub, 2, smiles while recovering from two complex spinal cord surgeries at UChicago Medicine Comer Children’s Hospital that reattached his head to his spinal cord. Image credit: University of Chicago Medicine
With monitors quietly beeping and multiple tubes going into his small body, Oliver Staub lay in a hospital bed as his parents tearfully started saying goodbye.
On April 17, an armoured car going 70mph (112kph) slammed into the family’s minivan during their vacation in Mexico. Everyone in the car was injured, but no one more than Oliver.
The impact disconnected the 2-year-old’s head from his spine, resulting in a transection of his spinal cord.
Doctors offered a grim prognosis. They told Oliver’s parents, Laura and Stefan, that their son’s neck was broken, he was a quadriplegic, brain dead and would die in a matter of days.
But following a surreal turn of events – which included support from German soccer star Toni Kroos, viral Instagram posts, and traveling more than 2,000 miles for two risky spinal cord surgeries at the University of Chicago Medicine Comer Children’s Hospital — Oliver is now talking, laughing, smiling, moving his fingers and toes and starting to breathe on his own.
“To see someone survive an injury like this? Nothing like this has ever been reported in neurosurgery or spinal cord injuries,” said Mohamad Bydon, MD, Chair of the Department of Neurological Surgery at UChicago Medicine and health system leader for Neurological Surgery, who performed Oliver’s surgeries in July with a multidisciplinary team of surgeons.
“We didn’t think he’d ever be able to move, and now he’s moving all four limbs,” Bydon said. “This is a unique and special case. It’s beyond our wildest expectations.”
‘We have a reason to fight’
As family members gathered at the Mexico City hospital to say goodbye, something incredible happened: Oliver began to show signs of recovery.
His eyes would follow his parents when they were in the room. Stefan and Laura raised the issue with his doctors, who ultimately determined that their son did, in fact, have brain function. They kept his life-sustaining ventilator on.
“It was at that moment that I thought, ‘We have a reason to fight,’” Laura said. “My son was there.”
When doctors could do nothing more for Oliver, they trained his parents on how to care for him and operate his ventilator. Wearing a neck collar and vest to stabilise his head – which, internally, was not connected to his body – Oliver was moved to his grandparents’ home eight hours away, near Morelia, Mexico.
With help from a daily nurse visit, Oliver survived for two months without moving and once having an incident of cardiac arrest. Bydon finds this astounding, given how unlikely it is that someone with an unstable, transected spine could survive at all, much less under the care of his parents.
“If Oliver’s parents and caretakers had made one wrong move in those two months, it could have resulted in death,” Bydon said.
A journey to Chicago
Stefan and Laura researched treatments for severe spinal cord injuries, hoping to provide a better life for their son. They contacted top spinal cord specialists around the world, including Bydon, whose groundbreaking stem cell therapy research impressed them.
They were repeatedly told that surgery, and the travel involved, would be too risky. But Bydon saw hope, in part because Oliver had survived this long.
“You should never count out a 2-year-old. They can surprise you,” Bydon said. “But it would require a complex multidisciplinary team, which is where the University of Chicago could help.”
The surgery needed to be done as soon and safely as possible, Bydon told them.
But travel to the United States for the surgery would be difficult and expensive. The Staubs received aid from family, friends and charities, but were still far short of what they needed.
Global outreach and support
A friend encouraged them to write to the Toni Kroos Foundation, the soccer player’s charity which helps seriously ill children. Stefan and Laura knew it was a long shot.
Two days later, the phone rang at midnight. It was foundation director Claudia Bartz. She’d seen Oliver’s journey on Instagram and was so moved by his story, she decided the foundation would cover the cost of Oliver’s surgery and transport to Chicago.
“We cried and cried. We couldn’t believe it,” Laura said, adding that they only posted on Instagram to keep their friends and family updated on Oliver. “None of this would have been possible without Toni Kroos.”
Oliver soon became a top-trending news story in Germany and their Instagram account blew up, going from a few hundred followers to more than 100 000. Strangers across the world continue to hold fundraisers and prayer vigils, sending the family encouraging messages and donations for his medical expenses.
“We would gladly trade all of this to go back to our normal life,” said Laura, who still has large scars on her head from the accident. “What I’m seeing here? It’s miraculous. We call it ‘The Oliver Effect.’ This is bigger than us.”
‘Harrowing’ surgery, major recovery
When Oliver arrived at Comer in July via medical jet, Bydon performed the first surgery, an occipital cervical fusion, with a team of UChicago Medicine surgeons.
This surgery for a 2-year-old is risky, not only because of how long it is, but also because a toddler cannot tolerate blood loss.
The surgery involved reconstructing Oliver’s spine, repairing his spinal cord and stabilising the back of his head to his cervical spine using titanium rods and screws.
The second surgery, two days later, stabilised the front of his spinal cord and repaired a spinal cord herniation.
“Those first few days after the surgeries were harrowing,” Bydon said. “His heart stopped at one point, and he had swelling in the brain.”
But about five days later, Oliver was making progress and smiled for the first time since the accident. One month later, he was able to grab his mom’s hand, push someone away and recognise the sensation that he needs to urinate. Most impressively, Bydon said, he can now take breaths on his own.
“We know the spine is communicating with the brain and body again,” Bydon said.
Moving forward with family
Oliver was discharged from Comer Children’s on August 15. The family will permanently move from Germany to Mexico, near Laura’s family, and now have hope for the future.
Oliver will have regular physical therapy and take medications for inflammation. In about six months, he’ll be able to remove his neck brace, Bydon said.
Laura and Stefan plan to return to Comer in spring 2026, when Bydon may be able to use novel stem cell therapy clinical trials to improve Oliver’s physical functions, pending special FDA approval.
Stefan and Laura said they’ll always be grateful to Bydon and UChicago Medicine.
“He didn’t promise us a miracle,” Laura said, “but he delivered one.”
Phase III clinical trial by Cedars-Sinai and other institutions shows no significant differences for mortality, stroke or rehospitalisation at seven years post-treatment
People who underwent TAVR, a minimally invasive procedure to have their heart’s aortic valve replaced had similar health outcomes years after treatment as people who had surgery, Cedars-Sinai investigators and colleagues report.
“These results show that seven years after treatment, health outcomes for patients were similar whether they underwent a minimally invasive procedure or open-heart surgery,” said Makkar.
Aortic valve disease affects about 2% of the US population, and risk rises with age, so the disorder is expected to become increasingly common.
The international PARTNER 3 trial involved 1000 patients at 71 healthcare locations. Study participants had a severe form of aortic valve stenosis, a condition in which the heart’s aortic valve becomes so narrow and stiff that it cannot open fully to allow blood to pass through. The condition can cause heart failure or stroke.
Clinical trial participants were randomly chosen to undergo either open-heart surgery or a procedure called a transcatheter aortic valve replacement, also known as TAVR. All participants received a commercially available bioprosthetic valve called the SAPIEN 3 valve.
During TAVR, an interventional cardiologist threads a catheter through an artery to reach the heart and replace the diseased valve. Previous randomised controlled trials, including an earlier version of PARTNER 3, reported similar outcomes with TAVR and surgery five years after treatment in people with low to high risk for surgical complications.
For this study, investigators limited participation to patients considered to be at low surgical risk. Seven years after treatment, composite rates of death, stroke or rehospitalisation related to treatment were 34.6% for TAVR (496 people) and 37.2% for surgery (454 people), a difference that was not statistically significant. The rates of failure for the bioprosthetic valve were similar: 6.9% for TAVR and 7.3% for surgery. In addition, patients in both groups reported comparable quality of life outcomes.
“These rich data exemplify the vital information clinicians need to guide patient treatment,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and the Mark Siegel Family Foundation Distinguished Chair. “We are proud to offer leading-edge clinical care while also advancing the field of cardiology with groundbreaking research.”
The Smidt Heart Institute is a global leader in treating heart valve disease surgically and with transcatheter procedures. Makkar, vice president of Cardiovascular Innovation and Intervention, leads a team of interventional cardiologists who perform almost 800 TAVRs each year.
The investigators next plan to report patient outcomes and valve durability at 10 years posttreatment.
For older people with irregular heart rhythms who are at high risk of stroke and bleeding, standard care (including the use of blood thinners when indicated) was found to be the better choice compared to a promising, catheter-based procedure, according to a preliminary late-breaking science presentation today at the American Heart Association’s Scientific Sessions 2025.
The trial, Left Atrial Appendage CLOSURE in Patients with Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy (CLOSURE-AF), compared a catheter-based procedure to medical therapy among patients with atrial fibrillation (AFib), an irregular heart rhythm.
While blood thinners can be highly effective at reducing the risk of stroke among people with AFib, the medication may cause severe bleeding in some people. Due to this risk, researchers are exploring alternative treatments including this catheter-based procedure. The procedure, called a left atrial appendage closure, seals a small pouch in the heart called the left atrial appendage, or LAA, where blood clots can form. If these blood clots enter the bloodstream, it increases the risk of stroke. Closing this pouch reduces the risk of stroke. It also can allow people to stop taking blood thinners for clot prevention.
The CLOSURE AF study compared catheter-based left atrial appendage closure with physician-directed standard medical care (including timely anticoagulant blood thinning when eligible) in patients with atrial fibrillation at high risk for stroke and bleeding. The aim of the study was to demonstrate non-inferiority for catheter-based LAA closure regarding risk of stroke, systemic embolism, cardiovascular/unexplained death or major bleeding. However, this was not reached.
“We expected that catheter-based LAA closure would be comparable to physician-directed standard medical care often using blood thinning anticoagulant medications,” said study lead researcher Ulf Landmesser, MD, chairman of the department of cardiology, angiology and intensive care medicine at Deutsche Herzzentrum Charité and professor of cardiology at Charité University Medicine in Berlin. “However, this was not the case in this trial of older patients at very high risk of bleeding and stroke.
“Our findings indicate that standard physician-directed medical care, including blood thinners for eligible patients, remains a valid management option for those older patients with irregular heartbeat who are at very high risk for stroke and bleeding.”
Landmesser said that the results of the procedure are different for lower-risk patients, and studies investigating this are currently underway. Moreover, ongoing studies are comparing LAA closure in addition to blood thinning in very high-risk patients.
Because medical treatments and LAA closure for AFib remain in development the results of this study may not apply to future research, other techniques or procedures.
Study details, background and design:
More than 900 adults with AFib who were at high risk of stroke and major bleeding participated in this study.
Participants’ average age was 78 years, and 39% were women.
They were enrolled at 42 health care sites in Germany from March 2018 to April 2024, and they were followed for a median of 3 years.
Participants were randomly assigned to one of two treatment groups: standard medical care (including anticoagulant blood thinners, if eligible); or LAA closure.
Researchers compared the frequency of stroke, life-threatening blood clots, cardiovascular/unexplained death and major bleeding between the two treatment groups.
Placebo-controlled trial shows shunt surgery improves walking, balance and safety for older adults with idiopathic normal pressure hydrocephalus
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Idiopathic normal pressure hydrocephalus (iNPH) is a treatable condition caused by a buildup of cerebrospinal fluid in the brain that leads to walking and balance problems, memory decline, and bladder control issues. Researchers report the disorder affects up to 1.5% of people in their late 60s and as many as 1 in 13 over age 86. Left untreated, iNPH can cause falls, loss of independence and progressive disability.
A new international study led by Johns Hopkins University School of Medicine researchers, and published in The New England Journal of Medicine, has provided definitive proof that shunt surgery restores mobility and physical safety in older adults with iNPH. The Placebo-Controlled Effectiveness in iNPH Shunting (PENS) Trial is the first large, double-blind, placebo-controlled study to resolve decades of debate on whether shunts truly help patients.
“Although shunts have been used for 50 years, scepticism persisted because of the placebo effect and the risks of operating in frail, elderly patients,” says Mark Luciano, MD, PhD, principal investigator and director of the Johns Hopkins Hydrocephalus and Cerebral Fluid Center. “This study shows surgery is both effective and has an acceptable safety profile. We’ve proven this treatment works, definitively and safely, in the most rigorous type of study possible.”
The National Institutes of Health–supported trial enrolled 99 patients across 17 centres in the US, Canada, and Sweden. All patients underwent shunt surgery and received a functioning shunt. However, in half, the shunt was initially adjusted to a placebo setting. Neither patients nor their doctors knew which group they were in.
After three months, patients with functioning shunts walked significantly faster than they did before surgery, while the placebo group showed virtually no change. On average, walking speed in the shunt group improved by 0.23 metres per second — more than double the threshold considered by researchers to be a meaningful change in older adults. Eighty percent of patients with a functioning shunt achieved meaningful improvement, compared with just 24% of those in the placebo group.
“When a person walks better and doesn’t fall, everything improves: their independence, their safety and their quality of life,” says Luciano.
Patients in the treatment group also displayed improved balance and reported fewer falls. Forty-six percent of patients in the placebo group reported falling during the trial, compared with just 25% of those who received a functioning shunt. These gains are especially impactful for older adults, as poor mobility and frequent falls are directly tied to loss of independence, increased injury as well as higher mortality risk.
Despite its potential for treatment, iNPH is often overlooked. Researchers report that only about 20% of patients who could benefit from surgery are referred for evaluation because their symptoms are dismissed as normal signs of aging. That said, diagnosis can be simple.
“If there appears to be imbalance that’s increasing, or memory loss that’s increasing, it’s a diagnosis that can be explored with a routine brain scan,” says Luciano. “If the ventricles are enlarged and the symptoms are there, then patients can be referred to specialists who can further evaluate and treat.”
Looking ahead, the PENS Trial will continue to follow participants for 12 months to measure long-term outcomes, including cognition, daily functioning and quality of life. Early findings already suggest gains beyond walking.
“It has always been suspected that cognitive changes take longer to improve and need more detailed testing,” says Luciano. “At the 12-month period, we’ll have more to say not only about cognition, but how much patients are improving in their activities and independence.”
The research team is also working to develop noninvasive diagnostic methods that could replace current spinal fluid drainage trials, making it easier for clinicians to diagnose patients with iNPH and connect them to treatment.
A large Cleveland Clinic study has found that people with obesity and type 2 diabetes who undergo weight-loss surgery live longer and face fewer serious health problems compared with those treated with GLP-1 receptor agonist medicines alone.
Patients who had weight-loss surgery (also known as bariatric or metabolic surgery) lost more weight, achieved better blood sugar control, and relied less on diabetes and heart medications over 10 years. The research is published in Nature Medicine.
“Even with today’s best medicines, metabolic surgery offers unique and lasting benefits for people with obesity and diabetes,” said Ali Aminian, MD, director of Cleveland Clinic’s Bariatric & Metabolic Institute and primary investigator of the study. “The benefits we observed went beyond weight loss. Surgery was linked to fewer heart problems, less kidney disease, and even lower rates of diabetes-related eye damage.”
GLP-1 (glucagon-like peptide-1) receptor agonists are a class of medications widely used to treat type 2 diabetes and obesity and to reduce health risks. Both metabolic surgery and GLP-1 medicines improve cardiovascular health and metabolism.
The M6 study (Macrovascular and Microvascular Morbidity and Mortality after Metabolic Surgery versus Medicines) followed 3932 adults with diabetes and obesity who received care at Cleveland Clinic for up to 10 years. Among them, 1657 underwent metabolic surgery (including gastric bypass or sleeve gastrectomy), while 2275 were treated with GLP-1 medicines (including liraglutide, dulaglutide, exenatide, semaglutide, and tirzepatide).
At the end of the study, patients who had metabolic surgery had a:
32% lower risk of death
35% lower risk of major heart problems (such as heart attack, heart failure, or stroke)
47% lower risk of serious kidney disease
54% lower risk of diabetes-related eye damage (retinopathy)
On average, people who had metabolic surgery lost 21.6% of their body weight over 10 years, compared with 6.8% weight loss in people who took GLP-1 medicines. Hemoglobin A1c, a marker of average blood sugar, improved more with surgery (-0.86%) than with GLP-1 medicines (-0.23%). Patients in the surgery group also required fewer prescriptions for diabetes, blood pressure, and cholesterol.
“Even in the era of these powerful new drugs to treat obesity and diabetes, metabolic surgery may provide additional benefits, including a survival advantage,” said Steven Nissen, MD, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic and senior author of the study.
“Our findings indicate that surgery should remain an important treatment option for obesity and diabetes,” said Dr Aminian. “These long-term benefits are harder to achieve with GLP-1 medicines alone, as many patients stop using the medications over time.”
According to the authors, the study has some limitations. It was observational rather than a randomized comparison of drugs and surgery, and it did not focus exclusively on the newest and most effective GLP-1 medicines. The researchers note that future studies should directly compare surgery with newer GLP-1 therapies, such as semaglutide and tirzepatide, to further guide treatment decisions.
A new study from Karolinska Institutet challenges previous findings that suggested early surgery is more beneficial in the long term than medical treatment for patients with Crohn’s disease. The study replicates a Danish registry study using Swedish data and finds that the results are not comparable. The study was published in Clinical Gastroenterology and Hepatology.
A few years ago, a randomised controlled trial showed that early ileocecal resection – removal of the junction between the small and large intestine – could be a reasonable alternative to advanced drug therapy for patients with Crohn’s disease. This study gained significant attention and was widely discussed around the world. Recently, a Danish research group published a registry-based study in the journal Gastroenterology, concluding that real-world data showed that early ileocecal resection was clearly superior to medical treatment in the long term.
In the new Swedish study, researchers attempted to replicate the Danish study using nationwide Swedish registry data. They found that it is impossible to identify comparable populations in current observational data, as patients who underwent surgery or received medication during the study period differ according to existing treatment guidelines.
The Danish researchers made several design choices that further reduced the comparability between the groups. When the Swedish researchers applied the same definitions as the Danish study, they obtained similar results. However, when they used stricter definitions that more closely resembled the original randomized study, they no longer found a significant difference between the groups.
“We argue that the Danish study cannot be interpreted as proof that early surgery is better. That may very well be the case, but the data we currently have simply cannot answer that question,” says Ola Olén.
Photo by cottonbro studio: https://www.pexels.com/photo/close-up-shot-of-a-person-holding-a-scalpel-5721557/
Chronic rhinosinusitis (CRS), or sinusitis, is a long-term condition affecting one in 10 UK adults. Symptoms include a blocked and runny nose, loss of smell, facial pain, tiredness and worsening of breathing problems, such as asthma. It’s often similar to the symptoms of a bad cold, but it can last for months or even years.
The team carried out a randomised controlled patient trial comparing sinus surgery with long-term use of antibiotics, and a placebo.
More than 500 patients took part from around the UK, and all of them used nasal steroids and saline rinses as part of their usual care – both of which have been shown to help the condition.
The researchers found that surgery was effective at relieving sinusitis symptoms, and trial participants who underwent surgery were still feeling better six months later, according to the findings published in The Lancet. Of those who underwent surgery, 87% said their quality of life had improved six months on.
A three-month course of low dose antibiotics was not found to be helpful as there was no significant difference in outcomes between those on antibiotics and those in the placebo arm of the trial.
The study is part of the MACRO programme, involving a collaborative group of researchers from UCL (the trial’s sponsor), the University of East Anglia (UEA), Guy’s and St Thomas’ NHS Foundation Trust, the University of Southampton, the University of Oxford, UCLH, and Imperial College London. The programme is funded by the National Institute for Health and Care Research.
Lead author Professor Carl Philpott, from UEA’s Norwich Medical School, one of the Chief Investigators of the MACRO trial, said: “What we found is that surgery was effective at reducing symptoms six months on, while taking the course of antibiotics seemed to make little difference. Until now, there was no evidence in the form of a trial that showed sinus surgery works better than medical treatment and access to sinus surgery has been restricted in some parts of the UK in recent years. This could be a real game-changer for sufferers worldwide.
“We hope our findings will help reduce the length of time for patients to get treatment. Streamlining clinical pathways will help reduce unnecessary visits and consultations, and save on healthcare resources.”
For the trial, all participants received nasal steroids and saline rinses as standard care, alongside their randomly allocated treatment option of either sinus surgery, antibiotics or placebo tablets. They were followed up after three and six months, where researchers examined their nose and sinuses, took airflow readings and conducted smell tests, to gauge the success of each treatment in terms of improvement of symptoms, quality of life and possible side effects.
Jim Boardman, MACRO patient representative, said: “I’ve lived under a cloud for years with CRS, as have many others I’ve met with the same condition. There’s a persistent headache and blocked nose along with the loss of sense of smell, which removes a whole dimension of everyday experience and enjoyment. A clear path to successful treatment will be welcomed by all CRS sufferers.”
The researchers are now continuing their research to assess the cost-effectiveness of sinus surgery, while also continuing to follow up trial participants over longer periods of time to see how long the benefits last.
Early withdrawal of aspirin following successful percutaneous coronary intervention (PCI) for acute coronary syndrome and in low-risk patients following an acute myocardial infarction (MI) was the focus of two separate hot line trials presented at ESC Congress 2025. A third trial provided insights into early escalation and late de-escalation of antiplatelet therapy after complex PCI.
In the NEO-MINDSET trial, simultaneously published in NEJM, researchers in Brazil randomised approximately 3400 patients within the first four days of hospitalisation following a successful PCI to either stop treatment with aspirin and receive potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to receive dual antiplatelet therapy (DAPT) that included aspirin and a potent P2Y12 inhibitor for 12 months.
At 12 months, the primary endpoint of death from any cause, MI, stroke or urgent revascularisation had occurred in 119 patients in the monotherapy group and in 93 patients in the DAPT group (p = 0.11 for noninferiority). Researchers also noted that major or clinically relevant nonmajor bleeding occurred in 33 patients assigned to monotherapy vs 82 patients assigned to DAPT. Stent thrombosis occurred in 12 patients in the monotherapy group and in 4 in the dual antiplatelet therapy group.
“We failed to demonstrate the noninferiority of aspirin-free monotherapy initiated immediately after PCI with regard to the ischaemic primary endpoint over 12 months,” said Principal Investigator Pedro Lemos, MD. “Results from the landmark analysis suggest that the excess ischaemic risk with monotherapy occurred in the first 30 days, with comparable outcomes thereafter. Bleeding appeared to be lower at both 30 days and 12 months with monotherapy versus DAPT.”
In TARGET-FIRST, also simultaneously published inNEJM, P2Y12-inhibitor monotherapy was noninferior to continued DAPT with respect to the occurrence of adverse cardiovascular and cerebrovascular events among low-risk patients with acute MI who had undergone early complete revascularisation and had completed one month of DAPT without complications. It also resulted in lower incidence of bleeding events.
Nearly 2000 patients from 40 centres in Europe were randomised to receive P2Y12-inhibitor monotherapy or to continue DAPT for 11 months. A primary-outcome event occurred in 20 patients (2.1%) in the P2Y12-inhibitor monotherapy group and in 21 patients (2.2%) in the dual antiplatelet therapy group (p = 0.02 for noninferiority). Major bleeding occurred in 2.6% of the patients assigned to P2Y12-inhibitor monotherapy group compared with 5.6% of those assigned to DAPT (p = 0.002 for superiority). The incidence of stent thrombosis and serious adverse events appeared to be similar in the two groups, researchers said.
Principal Investigator Giuseppe Tarantini, MD, noted that no previous randomised trials have assessed early aspirin discontinuation in acute MI patients who achieve early, complete revascularisation with modern stents. “These results reflect the benefits of modern stents, high procedural success and optimal medical therapy, making early aspirin discontinuation feasible in this selected population,” he said.
The TAILORED-CHIP trial found early escalation and late de-escalation of antiplatelet therapy is not beneficial in patients with high-risk anatomical or clinical characteristics undergoing complex PCI.
Researchers in South Korea randomised approximately 2000 patients to standard DAPT (clopidogrel plus aspirin for 12 months) or a tailored antiplatelet strategy consisting of early escalation (low-dose ticagrelor at 60mg twice daily plus aspirin for 6 months) followed by late de-escalation (clopidogrel monotherapy for 6 months).
Overall findings showed no significant difference in the incidence of major ischemic events at 12 months with tailored therapy compared with standard DAPT. However, the incidence of clinically relevant bleeding was significantly higher with tailored therapy, according to study investigators.
“Our results suggest that a tailored strategy in patients undergoing complex high-risk PCI does not provide a net clinical benefit,” said Principal Investigator Duk-Woo Park, MD, PhD, FACC. “We observed an increase in bleeding complications without a significant reduction in ischaemic events. This challenges the notion that ‘more is better’ even in carefully selected patients at high ischaemic risk.”
