Early, Aggressive BP Lowering Tied to Better ICH Outcomes
Initiating intensive blood pressure (BP) lowering within a few hours of intracerebral hemorrhage (ICH) was associated with better neurologic outcomes, fewer serious adverse events, and better mortality compared to the more conservative standard treatment, new research confirmed.
Best results were found when treatment was administered within 3 hours of ICH symptoms, a pooled analysis of the four Intensive BP Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1-4) showed.
While current guidelines set a target systolic BP of < 180 mm Hg within 1 hour of ICH symptom onset, the intensive treatment systolic target is < 140 Hg within 1 hour.
The new findings were published online on June 18 in The Lancet Neurology .
Timing Dependent?
In addition to evaluating the safety and efficacy of early intensive treatment for ICH, the investigators also aimed to assess the impact of treatment timing.
The INTERACT1-3 studies included 10,269 adults with acute ACH who presented within 6 hours of symptom onset and had a systolic BP of > 150 mm Hg.
INTERACT4 included 1043 patients with suspected acute stroke who had a systolic BP of ≥ 150 mm Hg within 2 hours of symptom onset. In addition, 1029 study participants had a hemorrhagic form of stroke.
All were randomly assigned to receive either intensive or guideline recommended BP-lowering treatment with locally available BP drugs within 1 hour.
Scores on the modified Rankin scale were used to determine functional recovery, the primary outcome measure for the pooled analysis.
Additionally, a CT substudy of nearly 3000 INTERACT participants was conducted to measure hematoma volume.
Mean systolic BP rates at 1 hour were significantly lower for the intensive treatment group compared to the guideline group (149.6 mm Hg vs 158.8 mm Hg, respectively; P < .0001).
Poor physical function, defined as a modified Rankin scale score of 3-6 at the end of follow-up, was significantly less likely after intensive BP lowering (odds ratio [OR], .85; P = .0001).
The intensive group also had reduced odds of neurologic deterioration within 7 days compared to the guideline group (OR, .76; P = .0002), as well as lower odds of any serious adverse event (OR, .84; P = .0003) or death (OR, .83; P = .002).
CT substudy results showed no significant effect on either relative or absolute hematoma growth in the first 24 hours from intensive vs guideline treatment.
However, when intensive BP lowering was initiated within 3 hours of symptom onset, functional recovery was improved and hematoma growth was reduced in almost 25% of the patients with serial CT scans, investigators noted.
Patients with mild-to-moderate severity, as measured by ICH scores, had even greater reductions in hematoma growth after early intensive BP-lowering treatment.
The new pooled analysis of all four INTERACT trials confirms findings from INTERACT4, presented at the 2024 European Stroke Organization Conference Annual Meeting and reported by Medscape Medical News .
'Time Is Brain'
In an accompanying editorial, David J. Werring, PhD, Department of Translational Neuroscience and Stroke, University College London Queen Square Institute of Neurology, London, noted that several previous studies showed no benefit of BP lowering in acute ischemic stroke, 'probably because acutely elevated blood pressure has a role in maintaining brain perfusion.'
However, the pathophysiology of stroke from ICH 'is different, with a major role for hematoma expansion within the first few hours, a therapeutic target which might be reduced' by intensive BP lowering, he wrote.
Still, Werring noted that possible benefits need to be weighed against possible risks; and he pointed out several study limitations, such as the low severity of ICH overall and the inclusion of INTERACT3 data, which may have introduced confounding from BP lowering being just one component of its treatment 'bundle,' alongside strict glucose control and anticoagulant reversal.
'Notwithstanding these important limitations, the data presented make a compelling case for ultra-early intensive blood pressure reduction as a potentially useful intervention to improve outcomes in people with acute ICH,' he wrote, adding that more research is needed.
'Meanwhile, the clear message from this meta-analysis is that earlier treatment is better, meaning that, once again, time is brain for patients with ICH,' Werring concluded.
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Dr. Sanjay Gupta 00:10:09 You can't really tell by looking at them, but these tiny piglets have been genetically engineered to make their organs more acceptable for transplantation into humans. It's something known as xenotransplantation. Dr. Sanjay Gupta 00:10:22 So Mike, how unusual is it for us to even be here? Mike Curtis 00:10:25 This is very unusual. We usually try to limit this to only the staff that takes care of the animals. Dr. Sanjay Gupta 00:10:31 Mike Curtis is the CEO of biotech company eGenesis. Never before has he let cameras onto this very special pig farm. Mike Curtis 00:10:40 Everything's controlled, like all of the feed is clean, water's clean, the staff is clean. Dr. Sanjay Gupta 00:10:45 And I should just point out that I walked into a room, turned on a filter, essentially cleaned the air for five minutes before I could then go shower. That's why my hair is wet. I put on everything new here, including underwear, socks, shoes. Dr. Sanjay Gupta 00:10:59 The goal is to protect the pigs from us. Dr. Sanjay Gupta 00:11:14 You know, I got to tell you, I did not know what to expect, but it's powerful just to be here with these pigs. Dr. Sanjay Gupta 00:11:23 After all, these pigs are among the most genetically modified mammals on the planet. Mike Curtis 00:11:29 These piglets carry a total of 69 edits to the genome. Dr. Sanjay Gupta 00:11:34 Alterations to their DNA. Mike Curtis 00:11:37 We're trying to reduce the risk of disease transmission from the porcine donor to human, we're editing in a way that reduces or eliminates hypercute rejection, and then we add human regulatory trans genes to control rejection. Dr. Sanjay Gupta 00:11:50 'To do that, scientists take the unedited pig cells and use a gene editing tool called CRISPR. They add special CRISPR fluids to the cells, which splices out certain genes and adds other genes. You can't really see anything with the naked eye and it takes only seconds, but what is happening in this vial is truly remarkable. Let me take a second and explain. First of all, remember that all DNA is made up of four chemical bases, A, C, G and T. Think of that as your genetic blueprint. Now, a pig's DNA and a human's DNA, they actually look pretty similar, but there are some important differences. For example, the GGTA1 gene that is responsible for a carbohydrate that forms around a pig cell known as alpha-gal. Now if you put that into a human, it would cause almost instantaneous rejection. But by knocking out that specific sequence and then adding in others. Scientists can make the pig's organs much more compatible for humans. Mike Curtis 00:12:55 So in the freezer are all these cells that we've edited. We thaw that vial, we grow those cells, and then we take the nucleus from that edited cell and we transfer it. It's akin to what was done with Dolly back in the 90s, cloning. Dr. Sanjay Gupta 00:13:09 'And that is the process by which they have created a modern-day assembly line of genetically modified pigs. Mike Curtis 00:13:17 We've selected the Yucatan Mini Pig because fully grown, they're about 70 kilos, 150 pounds. Right, so the organs are correctly sized for a human recipient. Dr. Sanjay Gupta 00:13:27 Ultimately, you've got to get the size right. Dr. Sanjay Gupta 00:13:31 Now, if the idea of using animals for human transplants sounds familiar to you, it's because the concept has been around for a long time. There have been at least 48 cases reported in the medical literature since the 1900s. You may remember one of the most famous. Robert Montgomery 00:13:46 This is Baby Faye. Dr. Sanjay Gupta 00:13:47 Little baby Faye in 1984. She had a baboon heart that kept her alive for 20 days. But there was always the stubborn issue of rejection. And so for a long time, xenotransplants faded into the background. 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I'm not gonna make it, but I'll make it to this. And I'll tell you right up front, if it's one day and you learn something, thank God. Dr. Riella 00:17:50 His eyes really sparked up and he said, tell me what I need to do. Speaker 11 00:17:56 And they said, prepare your body for battle, because it's gonna be a battle. He had to do dental work, he had to go to physical therapy. We signed up for the gym. When he came back to see Dr. Riella, he had lost 22 pounds. Dr. Sanjay Gupta 00:18:13 Did you have any doubts along the way? Tim Andrews 00:18:16 You know, there's always doubt with it, but I'm like, this is my chance to do something. Dr. Sanjay Gupta 00:18:23 You're going to be in medical history books forever. Tim Andrews 00:18:27 Kids are going to be taught how to do it, watching me have one put in me. Dr. Sanjay Gupta 00:18:33 They'll know your name. Dr. Sanjay Gupta 00:18:38 It's a crisp January morning back at the Egenesis Pig Farm in Wisconsin. Dr. Sanjay Gupta 00:18:44 It's been more than a year since our first visit. Speaker 3 00:18:47 This is many years in the making. So Raphael, she'll be able to donate one of her kidneys to a man who's in dire need. And essentially, she's saving his life. Speaker 15 00:18:59 Go, Raphael! It's a really big moment. There's a lot of emotions. We love our piglets like our own. Thinking about the purpose that Raphael is serving, like getting to go and give someone a new lease on life is just such a gift. Dr. Sanjay Gupta 00:19:18 That someone is Tim Andrews. Raphael will be his donor. Tim Andrews 00:19:25 What a gift. Dr. Sanjay Gupta 00:19:30 'As Rafael departs for the 17-hour trip to Boston, Tim settles in at Mass General. Tim Andrews 00:19:37 I knew I was in great hands, these guys are just so good. Dr. Sanjay Gupta 00:19:42 Were you nervous the morning of? Dr. Riella 00:19:45 And we'll see you on the other side, getting ready. As a new man. We're all anxious and nervous about going through a procedure that has not been done before. And having that reassurance from him also brings a lot of positivity to the entire team. Dr. Sanjay Gupta 00:20:02 It's early morning, January 25th, when Dr. Riella and the surgical team travel about 50 miles outside of Boston to meet Rafael. Dr. Riella 00:20:11 It was an OR, very similar to what we see in the hospital, and the surgery to retrieve the organs occur there. They look very similar to how we do procurements. I think uniqueness is really that, who was a donor, who was coming, yeah, it was a pig. Dr. Sanjay Gupta 00:20:29 It's go time! Speaker 11 00:20:30 It's a dance to get the pig kidney there and get him in the operating room. Dr. Sanjay Gupta 00:20:37 They gotta coordinate it. Speaker 11 00:20:37 So a nurse came and said, okay, good to go. I'm like, wait, wait. We haven't said goodbye. You can't say goodbye. Oh, yes, I can. So, I actually made them wait and they said, we've got to go, I'm saying goodbye to my husband before he leaves for surgery and he may not come back. Speaker 17 00:21:00 It's a little chilly in here, okay, Tim? Tim Andrews 00:21:01 I like cold. Dr. Sanjay Gupta 00:21:02 The operation lasts a little over two hours, around the same as a traditional transplant, and the big kidney. It looks, feels, and functions very much like a human kidney. And here is when surgeons connect the pig kidney to Tim's artery and vein. After that, the moment of truth. Surgeons release the clamp so blood can flow into the kidneys and the organ turns pink. And now this, urine, successfully flowing through the kidneys. Dr. Riella 00:21:36 Wow, look at that. We were very surprised. We were hoping that we would start making urine within a day or two, but seeing the urine being produced right away was not what at least I expected to be happening that close. Everything went well. Speaker 11 00:21:53 They said, they put the kidney on the table and started connecting him to the kidney and he actually peed across the room. So they were very, very excited. Of course, I started bawling like a baby. We were all crying. I mean, we were all. oh my goodness, I mean, this is not the end, but we're getting there, we're getting there. Tim Andrews 00:22:19 'I felt great and all of a sudden I had energy and I was like, this is beyond what I thought I was going to get. So right away you felt that coming? Right away I felt that. I was, like, look at me, I'm a new man, it was like a new birth, I said, I have a new birthday, 125-25 is my new birthday. Because I was alive and I hadn't been for a long time and I'm like, this is amazing. Dr. Sanjay Gupta 00:22:57 But there was still a long way to go. This is still so experimental after all. And Tim and Karen knew how quickly things could change. It was just a year earlier that Lisa Passano also needed a kidney. Her daughter, Brittany Rydell, remembers just how sick her mother was. Brittany Rydell 00:23:17 It means no more dialysis, hopefully. Dr. Sanjay Gupta 00:23:20 'Like Tim, she was an end-stage kidney disease, but Lisa's heart was also failing. And that is why a traditional kidney transplant was not an option for her. Dr. Sanjay Gupta 00:23:30 She was too sick. Brittany Rydell 00:23:32 Yeah, absolutely. Robert Montgomery 00:23:34 Lisa Passano was on death's door. I mean, she was not gonna live. You know, days to weeks from dying. Dr. Sanjay Gupta 00:23:44 So Dr. Montgomery, who was her surgeon, suggested a pig kidney. Robert Montgomery 00:23:48 But there are some people who are willing to take that chance, and she was one of them. Dr. Sanjay Gupta 00:23:54 'In the spring of 2024, Lisa Pisano became one of the first two patients in the world to receive a gene-edited pig kidney transplant. Brittany Rydell 00:24:02 I got more energy. I feel energized. After her kidney transplant, I have to say she looked the best that she looked in so I've seen her so happy. It was definitely the healthiest I had seen her in a while. Dr. Sanjay Gupta 00:24:15 She was doing well at that point. Brittany Rydell 00:24:17 Yeah, we were so hopeful, because I had seen her so much better, and I figured if anything was going to go wrong, it would have went wrong at that moment, and not months later. Dr. Sanjay Gupta 00:24:28 Pesano developed several infections and never recovered enough to leave the hospital. Brittany Rydell 00:24:33 I don't have regrets about the surgery, I just wish that she could have had the opportunity to really enjoy it more. Dr. Sanjay Gupta 00:24:40 I know it's probably hard to sort of think of it this way, but she was a real pioneer. Brittany Rydell 00:24:45 One of the first things she said to me was even if this doesn't work for me, it can work for someone else. And I think about that a lot. Robert Montgomery 00:24:52 The first patient that we did was in this bed, in the bed that I was in, Lisa Passano. You know, taking care of that one life. And if they were just that, that would be great, but then you have this opportunity to really impact maybe thousands, maybe millions of lives. Dr. Sanjay Gupta 00:25:11 Now Tim knew Lisa's story. He knew that there was a tremendous amount of uncertainty. Tim Andrews 00:25:17 Stepping forward, you're gonna do something for humanity. This is a way that we can bring this forward. And this is the hope for all these people that it's gonna be okay. We're gonna find a way, which is amazing to me. It was just, I have to be part of this. Dr. Sanjay Gupta 00:25:40 So would this be a success for Tim, and what does it all mean for the 100,000 people currently waiting? Tim Andrews 00:25:47 There's bumps in the road. Dr. Sanjay Gupta 00:25:48 We'll dive into that when we come back next week with part two of Animal Farm. Thanks for listening.
