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Cardiovascular Research Foundation: Transcatheter Cardiovascular Therapeutics (TCT)
Longer duration of triple therapy confers no benefit, trial suggests
Credit: Sage Ross
WASHINGTON, DC—Six weeks of triple anticoagulant therapy may be sufficient in patients who have received a drug-eluting stent.
Results of the ISAR-TRIPLE trial revealed no significant differences in net clinical outcomes for patients who received 6 weeks of triple anticoagulant therapy and those who received 6 months of the therapy.
Nikolaus Sarafoff, MD, of Deutsches Herzzentrum Munich and Klinikum der Universität Munich in Germany, presented these results at TCT 2014.
“The shortening of triple therapy neither reduced the incidence of TIMI major bleeding nor increased the incidence of the composite of ischemic events,” Dr Sarafoff said. “These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy.”
For the ISAR-TRIPLE trial, Dr Sarafoff and his colleagues randomized 614 patients in a 1:1 fashion to either 6 weeks or 6 months of clopidogrel therapy, in addition to aspirin plus an oral anticoagulant (phenprocoumon or warfarin).
The primary endpoint was a composite of death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months.
As secondary endpoints, the researchers assessed TIMI major bleeding separately from a composite endpoint of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke.
The primary endpoint occurred in 9.8% of patients in the 6-week treatment group and 8.8% of patients in the 6-month group (P=0.63.)
The composite of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke occurred at a similar rate in both the 6-week and 6-month groups—4.0% and 4.3%, respectively (P=0.87).
And the same was true for TIMI major bleeding, which occurred in 5.3% of patients in the 6-week group and 4.0% in the 6-month group (P=0.44).
This trial was funded by Deutsches Herzzentrum München. Dr Sarafoff reported fees for lectures or traveling from Lilly/Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare, Boston Scientific, Biotronik, and Medtronic. 
Credit: Sage Ross
WASHINGTON, DC—Six weeks of triple anticoagulant therapy may be sufficient in patients who have received a drug-eluting stent.
Results of the ISAR-TRIPLE trial revealed no significant differences in net clinical outcomes for patients who received 6 weeks of triple anticoagulant therapy and those who received 6 months of the therapy.
Nikolaus Sarafoff, MD, of Deutsches Herzzentrum Munich and Klinikum der Universität Munich in Germany, presented these results at TCT 2014.
“The shortening of triple therapy neither reduced the incidence of TIMI major bleeding nor increased the incidence of the composite of ischemic events,” Dr Sarafoff said. “These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy.”
For the ISAR-TRIPLE trial, Dr Sarafoff and his colleagues randomized 614 patients in a 1:1 fashion to either 6 weeks or 6 months of clopidogrel therapy, in addition to aspirin plus an oral anticoagulant (phenprocoumon or warfarin).
The primary endpoint was a composite of death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months.
As secondary endpoints, the researchers assessed TIMI major bleeding separately from a composite endpoint of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke.
The primary endpoint occurred in 9.8% of patients in the 6-week treatment group and 8.8% of patients in the 6-month group (P=0.63.)
The composite of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke occurred at a similar rate in both the 6-week and 6-month groups—4.0% and 4.3%, respectively (P=0.87).
And the same was true for TIMI major bleeding, which occurred in 5.3% of patients in the 6-week group and 4.0% in the 6-month group (P=0.44).
This trial was funded by Deutsches Herzzentrum München. Dr Sarafoff reported fees for lectures or traveling from Lilly/Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare, Boston Scientific, Biotronik, and Medtronic.
Credit: Sage Ross
WASHINGTON, DC—Six weeks of triple anticoagulant therapy may be sufficient in patients who have received a drug-eluting stent.
Results of the ISAR-TRIPLE trial revealed no significant differences in net clinical outcomes for patients who received 6 weeks of triple anticoagulant therapy and those who received 6 months of the therapy.
Nikolaus Sarafoff, MD, of Deutsches Herzzentrum Munich and Klinikum der Universität Munich in Germany, presented these results at TCT 2014.
“The shortening of triple therapy neither reduced the incidence of TIMI major bleeding nor increased the incidence of the composite of ischemic events,” Dr Sarafoff said. “These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy.”
For the ISAR-TRIPLE trial, Dr Sarafoff and his colleagues randomized 614 patients in a 1:1 fashion to either 6 weeks or 6 months of clopidogrel therapy, in addition to aspirin plus an oral anticoagulant (phenprocoumon or warfarin).
The primary endpoint was a composite of death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months.
As secondary endpoints, the researchers assessed TIMI major bleeding separately from a composite endpoint of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke.
The primary endpoint occurred in 9.8% of patients in the 6-week treatment group and 8.8% of patients in the 6-month group (P=0.63.)
The composite of cardiac death, myocardial infarction, stent thrombosis, or ischemic stroke occurred at a similar rate in both the 6-week and 6-month groups—4.0% and 4.3%, respectively (P=0.87).
And the same was true for TIMI major bleeding, which occurred in 5.3% of patients in the 6-week group and 4.0% in the 6-month group (P=0.44).
This trial was funded by Deutsches Herzzentrum München. Dr Sarafoff reported fees for lectures or traveling from Lilly/Daiichi Sankyo, Boehringer Ingelheim, Bayer Healthcare, Boston Scientific, Biotronik, and Medtronic.
Shorter duration of DAPT appears safe
Credit: Andre E.X. Brown
WASHINGTON, DC—New research indicates that patients may only need 6 months of dual antiplatelet therapy (DAPT) after receiving a second-generation drug-eluting stent.
Results of the SECURITY trial showed that patients had similar outcomes whether they received DAPT for 6 months or a full year.
The proportion of patients who met a composite endpoint of cardiac, thrombotic, and bleeding events was low among both treatment groups at the 12- and 24-month time points.
Antonio Colombo, MD, of San Raffaele Scientific Institute in Milan, Italy, and his colleagues reported these findings at TCT 2014 and in the Journal of the American College of Cardiology.
SECURITY was a randomized, multicenter study that aimed to address the need for prolonged use of DAPT following the implantation of a second-generation drug-eluting stent for patients without high-risk acute coronary syndromes.
Patients with a diagnosis of stable or unstable angina or documented silent ischemia undergoing revascularization with at least 1 second-generation drug-eluting stent were eligible for the study. The stents used were the Endeavor Resolute (Medtronic), Xience (Abbott), Promus (Boston Scientific), Nobori (Terumo Corporation), and the Biomatrix (Biosensors Europe SA).
Of 1399 patients, 682 were randomized to 6 months of DAPT, and 717 were randomized to 12 months of treatment. They received clopidogrel at 75 mg per day for at least 3 days before the procedure or a pre-procedural loading dose of a minimum of 300 mg of clopidogrel, if they were not on chronic clopidogrel therapy.
In the post-procedure period, patients received 75 mg of clopidogrel for 6 or 12 months, according to randomization. They also received aspirin indefinitely. And once the new antiplatelet compounds prasugrel and ticagrelor hit the market, they were allowed as treatment options in a protocol amendment.
At 12 months, the incidence of the primary endpoint—the composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or BARC type 3 or 5 bleeding—was 4.5% in the 6-month DAPT group and 3.7% in the 12-month DAPT group (P=0.469).
After 24 months, the 6-month and 12-month groups still showed similar incidences of cardiac death (0.9% vs 0.8%, P=0.925), MI (3.1% vs 2.6%, P=0.636), stroke (0.9% vs 0.4%, P=0.636), stent thrombosis (0.4% vs 0.4%, P=0.951), and BARC 3 or 5 bleeding (0.7% vs 1.1%, P=0.496).
Rates of the secondary endpoint—a composite of cardiac death, spontaneous MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months—were also similar among the 6-month and 12-month treatment groups.
At 12 months, the incidence of the secondary composite endpoint was 5.3% in the 6-month group and 4.0% in the 12-month group (P=0.273). In the year that followed, both groups had lower incidences of secondary composite endpoints—1.5% and 2.2%, respectively (P=0.289).
A multivariable analysis showed that an age of 75 years or older, the type of stent used, the mean number of stents implanted, the mean stent length, and the mean stent size were all significant independent predictors of the primary endpoint.
The SECURITY trial was funded by grants from Medtronic and Terumo, makers of 2 brands of drug-eluting stents used in the study.
Credit: Andre E.X. Brown
WASHINGTON, DC—New research indicates that patients may only need 6 months of dual antiplatelet therapy (DAPT) after receiving a second-generation drug-eluting stent.
Results of the SECURITY trial showed that patients had similar outcomes whether they received DAPT for 6 months or a full year.
The proportion of patients who met a composite endpoint of cardiac, thrombotic, and bleeding events was low among both treatment groups at the 12- and 24-month time points.
Antonio Colombo, MD, of San Raffaele Scientific Institute in Milan, Italy, and his colleagues reported these findings at TCT 2014 and in the Journal of the American College of Cardiology.
SECURITY was a randomized, multicenter study that aimed to address the need for prolonged use of DAPT following the implantation of a second-generation drug-eluting stent for patients without high-risk acute coronary syndromes.
Patients with a diagnosis of stable or unstable angina or documented silent ischemia undergoing revascularization with at least 1 second-generation drug-eluting stent were eligible for the study. The stents used were the Endeavor Resolute (Medtronic), Xience (Abbott), Promus (Boston Scientific), Nobori (Terumo Corporation), and the Biomatrix (Biosensors Europe SA).
Of 1399 patients, 682 were randomized to 6 months of DAPT, and 717 were randomized to 12 months of treatment. They received clopidogrel at 75 mg per day for at least 3 days before the procedure or a pre-procedural loading dose of a minimum of 300 mg of clopidogrel, if they were not on chronic clopidogrel therapy.
In the post-procedure period, patients received 75 mg of clopidogrel for 6 or 12 months, according to randomization. They also received aspirin indefinitely. And once the new antiplatelet compounds prasugrel and ticagrelor hit the market, they were allowed as treatment options in a protocol amendment.
At 12 months, the incidence of the primary endpoint—the composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or BARC type 3 or 5 bleeding—was 4.5% in the 6-month DAPT group and 3.7% in the 12-month DAPT group (P=0.469).
After 24 months, the 6-month and 12-month groups still showed similar incidences of cardiac death (0.9% vs 0.8%, P=0.925), MI (3.1% vs 2.6%, P=0.636), stroke (0.9% vs 0.4%, P=0.636), stent thrombosis (0.4% vs 0.4%, P=0.951), and BARC 3 or 5 bleeding (0.7% vs 1.1%, P=0.496).
Rates of the secondary endpoint—a composite of cardiac death, spontaneous MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months—were also similar among the 6-month and 12-month treatment groups.
At 12 months, the incidence of the secondary composite endpoint was 5.3% in the 6-month group and 4.0% in the 12-month group (P=0.273). In the year that followed, both groups had lower incidences of secondary composite endpoints—1.5% and 2.2%, respectively (P=0.289).
A multivariable analysis showed that an age of 75 years or older, the type of stent used, the mean number of stents implanted, the mean stent length, and the mean stent size were all significant independent predictors of the primary endpoint.
The SECURITY trial was funded by grants from Medtronic and Terumo, makers of 2 brands of drug-eluting stents used in the study.
Credit: Andre E.X. Brown
WASHINGTON, DC—New research indicates that patients may only need 6 months of dual antiplatelet therapy (DAPT) after receiving a second-generation drug-eluting stent.
Results of the SECURITY trial showed that patients had similar outcomes whether they received DAPT for 6 months or a full year.
The proportion of patients who met a composite endpoint of cardiac, thrombotic, and bleeding events was low among both treatment groups at the 12- and 24-month time points.
Antonio Colombo, MD, of San Raffaele Scientific Institute in Milan, Italy, and his colleagues reported these findings at TCT 2014 and in the Journal of the American College of Cardiology.
SECURITY was a randomized, multicenter study that aimed to address the need for prolonged use of DAPT following the implantation of a second-generation drug-eluting stent for patients without high-risk acute coronary syndromes.
Patients with a diagnosis of stable or unstable angina or documented silent ischemia undergoing revascularization with at least 1 second-generation drug-eluting stent were eligible for the study. The stents used were the Endeavor Resolute (Medtronic), Xience (Abbott), Promus (Boston Scientific), Nobori (Terumo Corporation), and the Biomatrix (Biosensors Europe SA).
Of 1399 patients, 682 were randomized to 6 months of DAPT, and 717 were randomized to 12 months of treatment. They received clopidogrel at 75 mg per day for at least 3 days before the procedure or a pre-procedural loading dose of a minimum of 300 mg of clopidogrel, if they were not on chronic clopidogrel therapy.
In the post-procedure period, patients received 75 mg of clopidogrel for 6 or 12 months, according to randomization. They also received aspirin indefinitely. And once the new antiplatelet compounds prasugrel and ticagrelor hit the market, they were allowed as treatment options in a protocol amendment.
At 12 months, the incidence of the primary endpoint—the composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or BARC type 3 or 5 bleeding—was 4.5% in the 6-month DAPT group and 3.7% in the 12-month DAPT group (P=0.469).
After 24 months, the 6-month and 12-month groups still showed similar incidences of cardiac death (0.9% vs 0.8%, P=0.925), MI (3.1% vs 2.6%, P=0.636), stroke (0.9% vs 0.4%, P=0.636), stent thrombosis (0.4% vs 0.4%, P=0.951), and BARC 3 or 5 bleeding (0.7% vs 1.1%, P=0.496).
Rates of the secondary endpoint—a composite of cardiac death, spontaneous MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months—were also similar among the 6-month and 12-month treatment groups.
At 12 months, the incidence of the secondary composite endpoint was 5.3% in the 6-month group and 4.0% in the 12-month group (P=0.273). In the year that followed, both groups had lower incidences of secondary composite endpoints—1.5% and 2.2%, respectively (P=0.289).
A multivariable analysis showed that an age of 75 years or older, the type of stent used, the mean number of stents implanted, the mean stent length, and the mean stent size were all significant independent predictors of the primary endpoint.
The SECURITY trial was funded by grants from Medtronic and Terumo, makers of 2 brands of drug-eluting stents used in the study.
Bivalirudin bests heparin in BRIGHT trial
Credit: Bill Branson
WASHINGTON, DC—The latest results from the BRIGHT trial suggest bivalirudin confers benefits over heparin monotherapy and heparin plus tirofiban for patients with acute myocardial infarction undergoing percutaneous coronary intervention.
Patients who received bivalirudin had a significantly lower incidence of net adverse clinical events (NACE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, stroke, or any bleeding, both at 30 days and at 1 year.
Bivalirudin conferred a lower risk of bleeding at both time points as well.
However, there were no significant differences between the treatment arms with regard to stent thrombosis or major adverse cardiac and cerebral events (MACCE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, or stroke.
Yaling Han, MD, of the General Hospital of Shenyang Military Region in China, presented these data at TCT 2014.
The BRIGHT trial included 2194 patients who had acute myocardial infarction and were eligible for emergency percutaneous coronary intervention. They were randomized to receive bivalirudin alone (n=735), heparin alone (n=729), or heparin plus tirofiban (n=730).
The primary endpoint was NACE at 30 days. Secondary endpoints were NACE at 1 year, any bleeding at 30 days and 1 year, and MACCE at 30 days and 1 year. Safety endpoints were thrombocytopenia at 30 days and stent thrombosis at 30 days and 1 year.
Bivalirudin was superior to both heparin monotherapy and heparin plus tirofiban in reducing the primary composite endpoint. At 30 days, NACE had occurred in 8.8%, 13.2%, and 17.0% of patients, respectively (P<0.001).
Bivalirudin was also superior with regard to bleeding at 30 days. Bleeding occurred in 4.1% of patients in the bivalirudin arm, 7.5% in the heparin arm, and 12.3% in the heparin-tirofiban arm (P<0.001).
However, there was no significant difference between the arms for the incidence of MACCE at 30 days—5.0%, 5.8%, and 4.9%, respectively (P=0.74). Likewise, there was no significant difference in the rate of stent thrombosis at 30 days—0.6%, 0.9%, and 0.7%, respectively (P=0.77).
There were differences between the arms in the 30-day thrombocytopenia rate, which was 0.1% in the bivalirudin arm, 0.7% in the heparin arm, and 1.1% in the heparin-tirofiban arm (P=0.04 for bivalirudin vs pooled heparin, P=0.12 for bivalirudin vs heparin, P=0.02 for bivalirudin vs heparin-tirofiban).
The differences between the treatment arms at 1 year were similar to those observed at the 30-day mark. Bivalirudin remained significantly superior when it came to NACE and bleeding, but there were no significant differences with regard to MACCE and stent thrombosis.
At 1-year, NACE had occurred in 12.8% of patients in the bivalirudin arm, 16.5% in the heparin arm, and 20.5% in the heparin-tirofiban arm (P<0.001). Bleeding had occurred in 6.3%, 9.9%, and 14.2% of patients, respectively (P<0.001).
The incidence of MACCE was 6.7% in the bivalirudin arm, 7.3% in the heparin arm, and 6.8%, in the heparin-tirofiban arm. And stent thrombosis had occurred in 1.2%, 1.9%, and 1.2% of patients, respectively.
This research was funded by Salubris Pharmaceutical Co. Ltd, makers of bivalirudin, and the National Key Science and Technology R&D project of the 12th Five-Year Plan.
Credit: Bill Branson
WASHINGTON, DC—The latest results from the BRIGHT trial suggest bivalirudin confers benefits over heparin monotherapy and heparin plus tirofiban for patients with acute myocardial infarction undergoing percutaneous coronary intervention.
Patients who received bivalirudin had a significantly lower incidence of net adverse clinical events (NACE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, stroke, or any bleeding, both at 30 days and at 1 year.
Bivalirudin conferred a lower risk of bleeding at both time points as well.
However, there were no significant differences between the treatment arms with regard to stent thrombosis or major adverse cardiac and cerebral events (MACCE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, or stroke.
Yaling Han, MD, of the General Hospital of Shenyang Military Region in China, presented these data at TCT 2014.
The BRIGHT trial included 2194 patients who had acute myocardial infarction and were eligible for emergency percutaneous coronary intervention. They were randomized to receive bivalirudin alone (n=735), heparin alone (n=729), or heparin plus tirofiban (n=730).
The primary endpoint was NACE at 30 days. Secondary endpoints were NACE at 1 year, any bleeding at 30 days and 1 year, and MACCE at 30 days and 1 year. Safety endpoints were thrombocytopenia at 30 days and stent thrombosis at 30 days and 1 year.
Bivalirudin was superior to both heparin monotherapy and heparin plus tirofiban in reducing the primary composite endpoint. At 30 days, NACE had occurred in 8.8%, 13.2%, and 17.0% of patients, respectively (P<0.001).
Bivalirudin was also superior with regard to bleeding at 30 days. Bleeding occurred in 4.1% of patients in the bivalirudin arm, 7.5% in the heparin arm, and 12.3% in the heparin-tirofiban arm (P<0.001).
However, there was no significant difference between the arms for the incidence of MACCE at 30 days—5.0%, 5.8%, and 4.9%, respectively (P=0.74). Likewise, there was no significant difference in the rate of stent thrombosis at 30 days—0.6%, 0.9%, and 0.7%, respectively (P=0.77).
There were differences between the arms in the 30-day thrombocytopenia rate, which was 0.1% in the bivalirudin arm, 0.7% in the heparin arm, and 1.1% in the heparin-tirofiban arm (P=0.04 for bivalirudin vs pooled heparin, P=0.12 for bivalirudin vs heparin, P=0.02 for bivalirudin vs heparin-tirofiban).
The differences between the treatment arms at 1 year were similar to those observed at the 30-day mark. Bivalirudin remained significantly superior when it came to NACE and bleeding, but there were no significant differences with regard to MACCE and stent thrombosis.
At 1-year, NACE had occurred in 12.8% of patients in the bivalirudin arm, 16.5% in the heparin arm, and 20.5% in the heparin-tirofiban arm (P<0.001). Bleeding had occurred in 6.3%, 9.9%, and 14.2% of patients, respectively (P<0.001).
The incidence of MACCE was 6.7% in the bivalirudin arm, 7.3% in the heparin arm, and 6.8%, in the heparin-tirofiban arm. And stent thrombosis had occurred in 1.2%, 1.9%, and 1.2% of patients, respectively.
This research was funded by Salubris Pharmaceutical Co. Ltd, makers of bivalirudin, and the National Key Science and Technology R&D project of the 12th Five-Year Plan.
Credit: Bill Branson
WASHINGTON, DC—The latest results from the BRIGHT trial suggest bivalirudin confers benefits over heparin monotherapy and heparin plus tirofiban for patients with acute myocardial infarction undergoing percutaneous coronary intervention.
Patients who received bivalirudin had a significantly lower incidence of net adverse clinical events (NACE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, stroke, or any bleeding, both at 30 days and at 1 year.
Bivalirudin conferred a lower risk of bleeding at both time points as well.
However, there were no significant differences between the treatment arms with regard to stent thrombosis or major adverse cardiac and cerebral events (MACCE), a composite of death from any cause, reinfarction, ischemia-driven target vessel revascularization, or stroke.
Yaling Han, MD, of the General Hospital of Shenyang Military Region in China, presented these data at TCT 2014.
The BRIGHT trial included 2194 patients who had acute myocardial infarction and were eligible for emergency percutaneous coronary intervention. They were randomized to receive bivalirudin alone (n=735), heparin alone (n=729), or heparin plus tirofiban (n=730).
The primary endpoint was NACE at 30 days. Secondary endpoints were NACE at 1 year, any bleeding at 30 days and 1 year, and MACCE at 30 days and 1 year. Safety endpoints were thrombocytopenia at 30 days and stent thrombosis at 30 days and 1 year.
Bivalirudin was superior to both heparin monotherapy and heparin plus tirofiban in reducing the primary composite endpoint. At 30 days, NACE had occurred in 8.8%, 13.2%, and 17.0% of patients, respectively (P<0.001).
Bivalirudin was also superior with regard to bleeding at 30 days. Bleeding occurred in 4.1% of patients in the bivalirudin arm, 7.5% in the heparin arm, and 12.3% in the heparin-tirofiban arm (P<0.001).
However, there was no significant difference between the arms for the incidence of MACCE at 30 days—5.0%, 5.8%, and 4.9%, respectively (P=0.74). Likewise, there was no significant difference in the rate of stent thrombosis at 30 days—0.6%, 0.9%, and 0.7%, respectively (P=0.77).
There were differences between the arms in the 30-day thrombocytopenia rate, which was 0.1% in the bivalirudin arm, 0.7% in the heparin arm, and 1.1% in the heparin-tirofiban arm (P=0.04 for bivalirudin vs pooled heparin, P=0.12 for bivalirudin vs heparin, P=0.02 for bivalirudin vs heparin-tirofiban).
The differences between the treatment arms at 1 year were similar to those observed at the 30-day mark. Bivalirudin remained significantly superior when it came to NACE and bleeding, but there were no significant differences with regard to MACCE and stent thrombosis.
At 1-year, NACE had occurred in 12.8% of patients in the bivalirudin arm, 16.5% in the heparin arm, and 20.5% in the heparin-tirofiban arm (P<0.001). Bleeding had occurred in 6.3%, 9.9%, and 14.2% of patients, respectively (P<0.001).
The incidence of MACCE was 6.7% in the bivalirudin arm, 7.3% in the heparin arm, and 6.8%, in the heparin-tirofiban arm. And stent thrombosis had occurred in 1.2%, 1.9%, and 1.2% of patients, respectively.
This research was funded by Salubris Pharmaceutical Co. Ltd, makers of bivalirudin, and the National Key Science and Technology R&D project of the 12th Five-Year Plan.