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Bivalirudin as Safe as Unfractionated Heparin for Pre-PCI Switch
WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.
SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.
Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).
However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.
The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.
The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.
The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.
All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.
For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.
Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.
The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.
Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.
The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.
"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.
Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.
The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.
Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.
SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.
CORRECTION: The name of the institution has been corrected.
WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.
SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.
Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).
However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.
The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.
The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.
The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.
All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.
For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.
Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.
The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.
Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.
The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.
"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.
Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.
The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.
Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.
SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.
CORRECTION: The name of the institution has been corrected.
WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.
SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.
Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).
However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.
The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.
The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.
The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.
All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.
For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.
Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.
The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.
Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.
The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.
"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.
Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.
The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.
Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.
SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.
CORRECTION: The name of the institution has been corrected.
FROM A SYMPOSIUM SPONSORED BY THE CARDIOVASCULAR RESEARCH INSTITUTE AT MEDSTAR WASHINGTON HOSPITAL CENTER
Major Finding: The combined primary end point of clinically overt, in-hospital major bleeds occurred in 2% of patients switched from fondaparinux to bivalirudin prior to PCI, and 0% of patients switched to unfractionated heparin.
Data Source: This was a small, prospective, multicenter study of 100 ACS patients undergoing PCI.
Disclosures: Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.
Transcatheter Valve Replacement Takes Center Stage
WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.
"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.
One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.
"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.
In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.
The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.
"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.
"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."
The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.
Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.
"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."
Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.
"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."
CORRECTION: The name and location of the institution have been corrected.
WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.
"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.
One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.
"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.
In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.
The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.
"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.
"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."
The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.
Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.
"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."
Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.
"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."
CORRECTION: The name and location of the institution have been corrected.
WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.
"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.
One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.
"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.
In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.
The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.
"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.
"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."
The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.
Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.
"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."
Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.
"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."
CORRECTION: The name and location of the institution have been corrected.
FROM A SYMPOSIUM SPONSORED BY THE CARDIOVASCULAR RESEARCH INSTITUTE AT MEDSTAR WASHINGTON HOSPITAL CENTER