Shorter Antiplatelet Tx After Stenting Safe

Major Finding: The rates of 12-month TVF were 4.7% for drug-eluting stent recipients given 6months of clopidogrel and aspirin and 4.4% for those given 12 months of antiplatelet therapy. By Kaplan-Meier analysis, the cumulative proportional estimate of target vessel failure at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen.

Data Source: A study of 1,443 patients receiving everolimus- or sirolimus-eluting stents and randomized to either 6 or 12 months of clopidogrel and aspirin.

Disclosures: Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Kaul has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the meeting.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6- and 12-month treatment duration groups for all-cause mortality, cardiac death, MI cerebrovascular accident, target vessel revascularization (TVR), stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

“At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months,” he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, questioned the researchers' use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, MI, or TVR. Dr. Gwon acknowledged that, saying “We recognize our study is hypothesis generating.”

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual-antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point “in a highly significant manner” (P = .0031; upper 1-sided 97.5% confidence interval 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetes patients receiving 6 months of dual-antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment.

There were no other significant subgroup differences.

Major Finding: The rates of 12-month TVF were 4.7% for drug-eluting stent recipients given 6months of clopidogrel and aspirin and 4.4% for those given 12 months of antiplatelet therapy. By Kaplan-Meier analysis, the cumulative proportional estimate of target vessel failure at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen.

Data Source: A study of 1,443 patients receiving everolimus- or sirolimus-eluting stents and randomized to either 6 or 12 months of clopidogrel and aspirin.

Disclosures: Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Kaul has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the meeting.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6- and 12-month treatment duration groups for all-cause mortality, cardiac death, MI cerebrovascular accident, target vessel revascularization (TVR), stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

“At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months,” he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, questioned the researchers' use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, MI, or TVR. Dr. Gwon acknowledged that, saying “We recognize our study is hypothesis generating.”

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual-antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point “in a highly significant manner” (P = .0031; upper 1-sided 97.5% confidence interval 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetes patients receiving 6 months of dual-antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment.

There were no other significant subgroup differences.

Major Finding: The rates of 12-month TVF were 4.7% for drug-eluting stent recipients given 6months of clopidogrel and aspirin and 4.4% for those given 12 months of antiplatelet therapy. By Kaplan-Meier analysis, the cumulative proportional estimate of target vessel failure at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen.

Data Source: A study of 1,443 patients receiving everolimus- or sirolimus-eluting stents and randomized to either 6 or 12 months of clopidogrel and aspirin.

Disclosures: Dr. Gwon reported consulting fees and honoraria from Cordis and Medtronic as well as research support from Abbott Korea and Medtronic Korea. Dr. Kaul has received consulting fees and honoraria from Novo Nordisk and Hoffman-LaRoche.

NEW ORLEANS – Short and standard durations of dual-antiplatelet therapy were equally protective against target vessel failure in drug-eluting stent recipients, Korean researchers reported at the meeting.

With the exception of patients who had diabetes, the overall 12-month clinical event rates were not different between 6- and 12-month treatment duration groups for all-cause mortality, cardiac death, MI cerebrovascular accident, target vessel revascularization (TVR), stent thrombosis, major bleeding, or various composites of the above end points, reported Dr. Hyeon-Cheol Gwon of Samsung Medical Center at Sungkyunkwan University in Seoul.

“At least in low-risk patients getting drug-eluting stents, that is, nondiabetics, maybe we can safely discontinue clopidogrel at 6 months,” he said. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism. Current guidelines recommend at least 12 months of anticoagulation to prevent venous thromboembolism.

Early discontinuation of antiplatelet therapy might be particularly relevant for patients at high risk of bleeding or those anticipating subsequent procedures, which are often delayed while the drugs are withdrawn.

But Dr. Sanjay Kaul of Cedars-Sinai Medical Center, Los Angeles, questioned the researchers' use of target vessel failure (TVF) as the primary study end point. TVF was defined as a composite of cardiac death, MI, or TVR. Dr. Gwon acknowledged that, saying “We recognize our study is hypothesis generating.”

The trial involved 1,443 patients with greater than 50% stenosis and evidence of myocardial ischemia. Patients receiving everolimus- or sirolimus-eluting stents were randomized to receive 6 or 12 months of dual-antiplatelet therapy with clopidogrel and aspirin.

The study found that discontinuing clopidogrel and aspirin after 6 months did not increase the rate of 12-month TVF. The rates were 4.7% for the 6-month group and 4.4% for the 12-month group. By Kaplan-Meier analysis, the cumulative proportional TVF estimate at 1 year was 5.2% for the 6-month regimen and 4.3% for the 12-month regimen, which met the noninferiority end point “in a highly significant manner” (P = .0031; upper 1-sided 97.5% confidence interval 0.9%-3.6%), Dr. Gwon said.

The cumulative incidence of major adverse cardiac or coronary events was 7.5% with 6-month therapy and 8.4% with 12-month therapy.

There was, however, a significantly higher risk for primary TVF with early discontinuation of antiplatelet therapy for patients with diabetes. Diabetes patients receiving 6 months of dual-antiplatelet therapy had a TVF rate of 8.9%, vs. 2.9% with 12 months of treatment.

There were no other significant subgroup differences.