New drug cuts costs, time in AMI care, & can revolutionize patient outcomes
Reteplase is also easier, simpler to administer
There’s a new type of thrombolytic drug for acute myocardial infarction (AMI) patients that has dramatically improved their costs and care — and has quickly become part of best practices for AMI.Reteplase (r-PA, Penzberg, Germany-based Boehringer Mannheim’s Retavase) is the the first of these drugs and the only FDA-approved thrombolytic that can be administered in a simple double-bolus dose. (See story on FDA approval, p. 17.)
The interventional cardiology staff at the University of Michigan Medical Center in Lansing is using this new thrombolytic on its AMI patients and improving AMI treatment dramatically.
"The new drug gives us the opportunity to treat patients rapidly in situations where every minute counts," says Eva Kline-Rogers, MS, RN, a researcher there. The double-bolus administration requires an hour less delivery time and is easier to administer during an AMI emergency situation. Ease of administration translates into other cost advantages such as reduced need for infusion pumps, tubing, and bags. By comparison, t-PA, or alteplase (Genentech’s Activase), is administered as an initial bolus followed by a continuous infusion over 90 minutes.
Door-to-needle time is of utmost importance with these patients. "You want to expedite the start of infusion from the time they hit the door," says Joanne Tolliver, PharmD, director of pharmacy services at Middletown (OH) Regional Hospital, "The lower that time, the less heart damage and morbidity."
And here’s another advantage to using reteplase: "If you transport a patient from the emergency department (ED) to the ICU while he or she is receiving the drug, you need to monitor the patient," says Tolliver. "You need to take all that equipment with you in transport. You can give one bolus of reteplase in the ED, transport the patient, then give the other bolus. It’s just easier."
Upfront cost is the same as other drugs
The upfront cost of reteplase is about the same as that of other thrombolytics. Tolliver says her facility’s average wholesale price from VHA is $2,640. Other sources quoted a price of $2,200 for both reteplase and activase. "There was no cost savings when we changed from activase to reteplase," says Tolliver. "There are a couple of new drugs out now in studies. They should hit the market by the end of next year, so the prices of thrombolytics could come down soon."The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) clinical trial demonstrated the safety and efficacy of reteplase this past fall, and now investigators are exploring strategies to improve the time spent in diagnosis and treatment of AMI. (See related story on the GUSTO III trial, p. 17.) That will allow emergency medical service (EMS) and ED workers to administer reteplase quickly, even in pre-hospital settings. The quicker any thrombolytic is administered, the less damage to the heart muscle, and that results in reduced costs — fewer hospital days, fewer recurrent problems, and reduced morbidity rates — because of decreased tissue damage to the heart.
Duke University Medical Center in Durham, NC, was one of 800 hospitals participating in the GUSTO III clinical trial. Deborah D. Smith, RN, a staff nurse in the ED, says, "I haven’t observed signs or symptoms following reteplase administration that were any different from those following administration of other thrombolytic agents, such as t-PA. There’s nothing unusual."
Smith says, "At our institution people receiving reteplase do so in connection with research studies, and they receive it within the confines of the hospital, not in the ambulance." (See story on pre-hospital field administration of reteplase, p. 15.) In other parts of the country, thrombolytic therapy is being administered en route to the hospital, but such pre-hospital administration is somewhat controversial.
"What I as an ED nurse like about reteplase is that with t-PA, you have to hang a 90-minute IV drip," says Smith. "You can give reteplase in two 2-minute IV boluses 30 minutes apart. The newer drug doesn’t require an additional IV line."
Two instead of three lines
Patients with heart attacks often have trouble perfusing. "It’s sometimes difficult to attach IV lines," continues Smith. "If we can get by with two instead of three lines, that’s a real benefit from a nursing perspective as well as from the perspective of the patient." An infusion of heparin, for example, can be stopped while the nurse gives the reteplase bolus. Then the line is flushed, and the nurse continues the heparin. Thirty minutes later, the second bolus of reteplase is given.And there’s another benefit: A nurse has to stay at the bedside for the duration of therapy with these agents because patients are at high risk for arrhythmias. "If a patient has an occluded coronary artery opened by a thrombolytic agent, he or she may have a temporary reperfusion arrhythmia or ventricular tachycardia," explains Smith. The nurse’s bedside time is saved when the therapy can be administered in two boluses thirty minutes apart instead of one 90-minute infusion.
"It’s clear to me that if reteplase uses less resources and frees up a nurse, that’s a real benefit," says Smith. Conceptually those advantages exist, but clinical trials have not been run on saved nursing hours or nurse management issues.
"It takes work to switch from one drug to another," she continues. "You have to re-inservice the staff, and so on. That may be a potential roadblock to the use of reteplase. Even if nurses find reteplase easier to administer, if one lytic agent is not superior to another in other ways, and the cost is the same, institutions may tend to keep the older thrombolytics."
Should angioplasty follow lytic use?
"The physicians are not concerned about a bleed following lytic therapy in these patients," says Esther Perez, a paramedic instructor for Ingham Region Medical Center in Lansing, MI. "We routinely take patients to the cath lab with heparin as well as thrombolytics on board. There’s a slightly higher risk of complications, but the patients are already screened for high risk factors."Perez is participating in a study that started in December that is investigating outcomes when percutaneous transluminal coronary angioplasties (PTCA) follow lytic use. "What we’re trying to demonstrate is that giving thrombolytics early, then going to the cath lab can save heart muscle. The lytic opens the vessel immediately, then patency is maintained with stents."
One arm of the study will take patients who received two pre-hospital doses of reteplase, then went to standard CCU procedures including the cath lab if necessary. The second arm will involve patients who received one dose of reteplase in the field, then went to immediate PTCA. The third arm will involve patients who go without the lytic therapy and go to immediate catheterization. All three groups will have some heparin on board.
T-PA has a half life of five minutes, so it leaves the system quickly. Reteplase has a half life of 11 to 19 minutes, so 75 minutes after the bolus it’s out of the system. If after the first bolus, it’s determined that the patient needs to go to the cath lab, the second bolus isn’t given. The drug is effectively gone by the time the patient gets to the cath lab.
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