Ticagrelor monotherapy reduces bleeding risk after PCI regardless of DES platform
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Among patients who underwent PCI with a drug-eluting stent and were prescribed dual antiplatelet therapy for 3 months, subsequent ticagrelor monotherapy reduced bleeding risk compared with continued DAPT regardless of DES type, according to results from the TWILIGHT-SYNERGY study.
As Healio previously reported, in the main TWILIGHT results, ticagrelor (Brilinta, AstraZeneca) monotherapy begun 3 months after PCI lowered major bleeding risk by more than 40% compared with continued DAPT without raising ischemic risk. Cardiology Today Next Gen Innovator Usman Baber, MD, MS, who was assistant professor of medicine at Icahn School of Medicine at Mount Sinai at the time of the study and currently serves as director of interventional cardiology at the University of Oklahoma Health Sciences Center, presented data from the prespecified TWILIGHT-SYNERGY analysis comparing the treatment effect across different DES types at the virtual Society for Cardiovascular Angiography and Interventions Scientific Sessions.
The cohort (mean age, 66 years; 24% women; 63% with multivessel CAD) included 653 patients who received a very thin-strut biodegradable polymer everolimus-eluting stent (Synergy, Boston Scientific) and 6,404 patients who received a durable-polymer DES. Patients did not have STEMI or cardiogenic shock but did have at least one additional clinical risk factor and angiographic risk factor for bleeding or ischemic events. Choice of DES was left to the operator, Baber said during a press conference.
“Randomization was not stratified by DES type, and therefore we did observe several baseline imbalances in certain parameters,” he said. “But we did perform multivariable adjustment to examine results in select subgroups. We had limited power, so our point estimates are somewhat imprecise and type 2 error cannot be excluded. And we cannot generalize our results in patients with STEMI or in those without the high-risk features we studied in TWILIGHT.”
At 15 months, target lesion failure occurred in 6.4% of the biodegradable-polymer group and 6.1% of the durable-polymer group (adjusted HR = 0.93; 95% CI, 0.64-1.35), with no heterogeneity across subgroups, Baber said.
There were also no significant differences between the groups at 15 months in CV death or MI (biodegradable polymer, 3.5%; durable polymer, 5%; aHR = 0.64; 95% CI, 0.4-1.04), all-cause death (biodegradable polymer, 0.9%; durable polymer, 1.6%; aHR = 0.54; 95% CI, 0.22-1.33), target lesion revascularization (biodegradable polymer, 5.3%; durable polymer, 4.4%; aHR = 1.01; 95% CI, 0.67-1.53), definite or probable stent thrombosis (biodegradable polymer, 0.8%; durable polymer, 0.9%; aHR = 0.7; 95% CI, 0.25-1.94) or target vessel MI (biodegradable polymer, 1.6%; durable polymer, 2.2%; aHR = 0.73; 95% CI, 0.35-1.5), he said.
Assignment to ticagrelor monotherapy was associated with reduced major bleeding risk at 1 year compared with continued DAPT in both the biodegradable-polymer group (5.1% vs. 8.2%; aHR = 0.66; 95% CI, 0.32-1.37) and the durable-polymer group (4.1% vs. 6.7%; aHR = 0.6; 95% CI, 0.47-0.77), with no difference in treatment effect (P for interaction = .99), according to the researchers.
There was no difference in death/MI/stroke at 1-year DAPT in both the biodegradable-polymer group (monotherapy, 3.4%; DAPT, 3.3%; aHR = 1.27; 95% CI, 0.47-3.44) and the durable-polymer group (3.9% in both antiplatelet therapy groups; aHR = 0.99; 95% CI, 0.74-1.31), with no difference in treatment effect (P for interaction = .96), Baber said.
“We found that among high-risk patients undergoing PCI, Synergy bioabsorbable-polymer DES performed similar to that of durable-polymer DES with respect to target lesion failure at 15 months,” Baber said during the press conference. “We found a uniform effect of ticagrelor monotherapy without an apparent increase in thrombotic risk as compared with DAPT, irrespective of the DES platform received.”
The results were simultaneously published in Catheterization and Cardiovascular Interventions. – by Erik Swain
References:
Baber U, et al. Featured Clinical Research. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).
Baber U, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28995.
Disclosures: The main TWILIGHT study was supported by an investigator-initiated grant from AstraZeneca. The present analysis was supported in part by Boston Scientific. Baber reports he received advisory board/personal fees from Amgen, AstraZeneca and Boston Scientific and institutional research funding from AstraZeneca.
Perspective
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M. Chadi Alraies, MD, FACC
The main two objectives of this trial were to examine the safety and efficacy of the Synergy bioabsorbable-polymer DES vs. durable-polymer DES in high-risk patients undergoing PCI and to examine the effect of ticagrelor monotherapy compared with ticagrelor plus aspirin on clinically relevant bleeding and ischemic outcomes in relation to DES platform. This is a prespecified analysis of the TWILIGHT main trial.
This trial is unique since it included angiographic and clinical high-risk features compared with other difficulties. At 15 months, there was no difference in CV death, TLF, all-cause death, TLR, definite or probable stent thrombosis or MI between the two stent strategies. Although this is a prespecified analysis, the authors controlled for multiple baseline and clinical characteristics using multivariable adjustments. These findings gave more insight into the performance of biodegradable polymers in the high-risk population. Also, regardless of the polymer used for the deployed stent, it seems that 3 months of DAPT followed by ticagrelor alone is as good as 1 year of DAPT, with less bleeding and similar thrombosis risk. This is very helpful and practical information to know since we see more patients with more complex calcified lesions and more comorbidities that increase their risk for bleeding. We often see presented to the cath lab after being turned down from surgery patients with severely calcified lesions who require atherectomy and who often have chronic kidney disease, prior MI, prior stroke or anemia, for whom we feel hesitant to use long-term DAPT due to increased risk for bleeding. Therefore, this study adds guidance to manage these patients and their antiplatelet regimen.
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Baber U, et al. Featured Clinical Research. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).
Baber U, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28995.Read more about
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