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GLASSY: Long-term ticagrelor monotherapy noninferior to DAPT after PCI

Marco Valgimigli
Marco Valgimigli

NEW ORLEANS — One month of dual antiplatelet therapy followed by ticagrelor monotherapy was noninferior to conventional DAPT to prevent nonfatal MI, all-cause death, nonfatal stroke or urgent target vessel revascularization at 2 years in patients who underwent PCI with a drug-eluting stent, according to data presented at the American College of Cardiology Scientific Session.

In the GLASSY study, Marco Valgimigli, MD, associate professor of cardiology and senior interventional cardiologist at Inselspital Universitätsspital Bern in Switzerland, and colleagues assessed data from 7,585 patients (mean age, 65 years; 24% women) from the GLOBAL LEADERS study to determine the effectiveness of the experimental treatment strategy compared with conventional DAPT for 12 months followed by aspirin.

As Cardiology Today’s Intervention previously reported, 1 month of combination ticagrelor (Brilinta, AstraZeneca) and aspirin followed by ticagrelor alone was not superior to 1-year standard dual antiplatelet followed by 1-year aspirin monotherapy for reducing deaths or MI over 2 years in patients who underwent PCI. In addition, among patients who had PCI with a DES, 1 month of combination ticagrelor and aspirin therapy followed by ticagrelor alone conferred better bleeding outcomes at 2 years than 1-year clopidogrel plus aspirin followed by 1-year aspirin monotherapy in patients with ACS.

The primary efficacy endpoint was adjudicated all-cause death, nonfatal stroke, nonfatal MI or urgent TVR. The primary safety endpoint was adjudicated Bleeding Academic Research Consortium 3 or 5 bleeding.

Two years after PCI, the primary efficacy endpoint occurred in fewer patients in the experimental arm vs. those in the conventional arm (7.14% vs. 8.41%; rate ratio = 0.85; 95% CI, 0.72-0.99; P for noninferiority < .001; P for superiority = .0465).

Compared with conventional treatment, experimental treatment did not significantly affect death (experimental, 2.93%; conventional, 3.6%; P = .11), cardiac death (experimental, 1.82%; conventional, 2.32%: P = .13), the composite of cardiac death and MI (experimental, 4.51%; conventional, 5.41%: P = .081), MI alone (experimental, 2.85%; conventional, 3.56%; P = .085), stroke (1.16% in both groups; P = .99) or definite stent thrombosis (experimental, 0.71%; conventional, 1%; P = .17).

The rate of urgent TVR was lower in patients assigned the experimental treatment compared with those assigned the conventional treatment (1.87% vs. 2.72%; rate ratio = 0.69; 95% CI, 0.51-0.93; P = .015).

When the researchers compared 1 year of DAPT with 1 month of DAPT followed by ticagrelor for 11 months, there was no signal that stopping aspirin at 30 days exposed patients to a higher ischemic risk.

The experimental group had a numerical reduction in MI compared with the conventional group at 1 year (rate ratio = 0.93; 95% CI, 0.69-1.26) and a significant reduction at 2 years (rate ratio = 0.54; 95% CI, 0.33-0.88; P for interaction = .062). This was also seen for definite stent thrombosis at 1 year (rate ratio = 1.04; 95% CI, 0.59-1.83) and 2 years (rate ratio = 0.14; 95% CI, 0.03-0.63; P for interaction = .007).

The primary safety endpoint occurred in 2.46% of patients in each of the groups at 2 years. There was a trend towards an excess of bleeding complications at 30 days in patients assigned the experimental treatment (rate ratio = 1.54; 95% CI, 0.92-2.58; P = .095), which was followed by an opposite trend from 30 days to 2 years (rate ratio = 0.82; 95% CI, 0.58-1.16; P = .26; P for interaction = .043). At 1 year, there was no signal that ticagrelor monotherapy was increasing risk for BARC 3 or 5 bleeding vs. aspirin monotherapy.

“Our results provide new evidence that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischemic risk as compared to a standard DAPT for 1 year and actually may reduce the rates of MI and stent thrombosis as compared to aspirin alone,” Valgimigli said during the presentation. “Furthermore, the experimental treatment did not increase the risk of major bleeding complications.” – by Darlene Dobkowski

Reference:

Valgimigli M, et al. Featured Clinical Research II: Interventional. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.

Disclosures: The GLOBAL LEADERS study was sponsored by the European Cardiovascular Research Institute with grants from AstraZeneca, Biosensors and The Medicines Company. Valgimigli reports he received grants from Abbott, AstraZeneca, Medicure and Terumo and personal fees from Abbott, Alvimedica, Amgen, AstraZeneca, Bayer, Biosensors, Chiesi, Daiichi Sankyo, Idorsia and Terumo.

Marco Valgimigli
Marco Valgimigli

NEW ORLEANS — One month of dual antiplatelet therapy followed by ticagrelor monotherapy was noninferior to conventional DAPT to prevent nonfatal MI, all-cause death, nonfatal stroke or urgent target vessel revascularization at 2 years in patients who underwent PCI with a drug-eluting stent, according to data presented at the American College of Cardiology Scientific Session.

In the GLASSY study, Marco Valgimigli, MD, associate professor of cardiology and senior interventional cardiologist at Inselspital Universitätsspital Bern in Switzerland, and colleagues assessed data from 7,585 patients (mean age, 65 years; 24% women) from the GLOBAL LEADERS study to determine the effectiveness of the experimental treatment strategy compared with conventional DAPT for 12 months followed by aspirin.

As Cardiology Today’s Intervention previously reported, 1 month of combination ticagrelor (Brilinta, AstraZeneca) and aspirin followed by ticagrelor alone was not superior to 1-year standard dual antiplatelet followed by 1-year aspirin monotherapy for reducing deaths or MI over 2 years in patients who underwent PCI. In addition, among patients who had PCI with a DES, 1 month of combination ticagrelor and aspirin therapy followed by ticagrelor alone conferred better bleeding outcomes at 2 years than 1-year clopidogrel plus aspirin followed by 1-year aspirin monotherapy in patients with ACS.

The primary efficacy endpoint was adjudicated all-cause death, nonfatal stroke, nonfatal MI or urgent TVR. The primary safety endpoint was adjudicated Bleeding Academic Research Consortium 3 or 5 bleeding.

Two years after PCI, the primary efficacy endpoint occurred in fewer patients in the experimental arm vs. those in the conventional arm (7.14% vs. 8.41%; rate ratio = 0.85; 95% CI, 0.72-0.99; P for noninferiority < .001; P for superiority = .0465).

Compared with conventional treatment, experimental treatment did not significantly affect death (experimental, 2.93%; conventional, 3.6%; P = .11), cardiac death (experimental, 1.82%; conventional, 2.32%: P = .13), the composite of cardiac death and MI (experimental, 4.51%; conventional, 5.41%: P = .081), MI alone (experimental, 2.85%; conventional, 3.56%; P = .085), stroke (1.16% in both groups; P = .99) or definite stent thrombosis (experimental, 0.71%; conventional, 1%; P = .17).

The rate of urgent TVR was lower in patients assigned the experimental treatment compared with those assigned the conventional treatment (1.87% vs. 2.72%; rate ratio = 0.69; 95% CI, 0.51-0.93; P = .015).

When the researchers compared 1 year of DAPT with 1 month of DAPT followed by ticagrelor for 11 months, there was no signal that stopping aspirin at 30 days exposed patients to a higher ischemic risk.

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The experimental group had a numerical reduction in MI compared with the conventional group at 1 year (rate ratio = 0.93; 95% CI, 0.69-1.26) and a significant reduction at 2 years (rate ratio = 0.54; 95% CI, 0.33-0.88; P for interaction = .062). This was also seen for definite stent thrombosis at 1 year (rate ratio = 1.04; 95% CI, 0.59-1.83) and 2 years (rate ratio = 0.14; 95% CI, 0.03-0.63; P for interaction = .007).

The primary safety endpoint occurred in 2.46% of patients in each of the groups at 2 years. There was a trend towards an excess of bleeding complications at 30 days in patients assigned the experimental treatment (rate ratio = 1.54; 95% CI, 0.92-2.58; P = .095), which was followed by an opposite trend from 30 days to 2 years (rate ratio = 0.82; 95% CI, 0.58-1.16; P = .26; P for interaction = .043). At 1 year, there was no signal that ticagrelor monotherapy was increasing risk for BARC 3 or 5 bleeding vs. aspirin monotherapy.

“Our results provide new evidence that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischemic risk as compared to a standard DAPT for 1 year and actually may reduce the rates of MI and stent thrombosis as compared to aspirin alone,” Valgimigli said during the presentation. “Furthermore, the experimental treatment did not increase the risk of major bleeding complications.” – by Darlene Dobkowski

Reference:

Valgimigli M, et al. Featured Clinical Research II: Interventional. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.

Disclosures: The GLOBAL LEADERS study was sponsored by the European Cardiovascular Research Institute with grants from AstraZeneca, Biosensors and The Medicines Company. Valgimigli reports he received grants from Abbott, AstraZeneca, Medicure and Terumo and personal fees from Abbott, Alvimedica, Amgen, AstraZeneca, Bayer, Biosensors, Chiesi, Daiichi Sankyo, Idorsia and Terumo.

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