News | Stents Drug Eluting | October 16, 2020

Shorter DAPT With Xience Stent is Noninferior to Standard DAPT

Results from the XIENCE 90/28 trials reported at TCT Connect show safety of shortened dual anti-platelet therapy following stent implant

The Abbott Vascular Xience Sierra drug eluting stent (DES). The XIENCE 28 and XIENCE 90 studies presented at TCT 2020 showed the stent can be used safely with only one month of dual antiplatelet therapy (DAPT). #TCT #TCTconnect #TCT2020

October 16, 2020 – Results from the XIENCE 90/28 clinical trials have shown that a shorter course of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was noninferior to standard DAPT up to 12 months. Findings were reported today at 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual symposium of the Cardiovascular Research Foundation (CRF). 

The trial adds more validity to shortening DAPT in patients who are at higher risk for bleeding. It comes on the heels of the U.S. FDA approving the first shortened DAPT indication for the Medtronic Resolute Onyx drug-eluting stent (DES) for one-month of DAPT.

Extended duration of DAPT after PCI increases the risk of bleeding, which is associated with worse outcomes and quality of life, especially among patients at high bleeding risk (HBR). Recent clinical trials on newer generation drug-eluting stents have shown an acceptable safety profile with a short course of DAPT. However, the optimal DAPT duration in HBR patients undergoing PCI remains unknown.

The XIENCE 28 and XIENCE 90 trials were prospective, single-arm, multicenter, open-label nonrandomized trials conducted to evaluate the safety of one-month (28) or three-month (90) DAPT in HBR patients undergoing PCI with the XIENCE everolimus-eluting stent. The primary endpoint evaluated safety (all-cause death or myocardial infarction) of a short DAPT regimen (one or three months) compared to DAPT up to 12 months. The secondary endpoints were the incidence of clinically relevant bleeding (BARC 2-5) and stent thrombosis (definite/probable) against a performance goal (only for XIENCE 90). The XIENCE V USA post-approval study served as the historical control group through a propensity score stratified analysis.

“Among high bleeding risk patients undergoing PCI with the XIENCE stent, a short DAPT regimen of one or three months compared with standard DAPT up to 12 months resulted in non-inferior ischemic outcomes and similar rates of clinically relevant (BARC 2-5) bleeding, with a significant reduction in major (BARC 3-5) bleeding. Additionally, there was a very low incidence of stent thrombosis.” said Roxana Mehran, M.D. She is The Mount Sinai professor of clinical research and outcomes, professor of medicine (cardiology), population health science and policy, Icahn School of Medicine at Mount Sinai and director of interventional cardiovascular research and clinical trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai. 

After successful PCI, enrolled patients in XIENCE 28 were prescribed one month of DAPT while patients in XIENCE 90 were prescribed three months of DAPT. Those who were free from ischemic events and adhered to the antiplatelet regimen during the first one month or three months received “one-month” or “three-month” clear assessments. Clear subjects were eligible to be placed on antiplatelet monotherapy (aspirin) from one or three months to 12 months.

The XIENCE 90 study demonstrated similar rates of all death or MI between three and 12 months in the test group versus the control (5.4% vs. 5.4%, one-sided 97.5% UCL: 2.23%, p non-inferiority=0.0063). XIENCE 28 also demonstrated non-inferiority of death or MI in the test group between one and six months (3.5% vs.4.3%, one-sided 97.5% UCL: 0.97%, p non-inferiority = 0.0005). For the secondary endpoint, the incidence of bleeding (BARC 2-5) was 5.1% vs. 7.0% (p superiority=0.0687 in XIENCE 90 and 4.9% vs. 5.9% (p superiority=0.19) in XIENCE 28. Major bleeding (BARC 3-5) was significantly reduced in both trials (XIENCE 90: 2.2% vs. 6.3%, p superiority<0.0001; XIENCE 28: 2.2% vs. 4.5%, p superiority=0.0156).

The XIENCE 90-28 trials were funded by Abbott.

Dr. Mehran reported the followings disclosures: consultant/advisory/speaking engagements for Abbott Laboratories (to institution), Abiomed (spouse), Boston Scientific, Idorsia Pharmaceuticals Ltd. (no fee), Janssen, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences Inc., Sanofi, Siemens Medical Solutions, Regeneron Pharmaceuticals (no fee), Spectranetics/Philips/Volcano Corp. (to institution), and The Medicines Company (spouse); research funding to institution from Abbott,
Abiomed, AstraZeneca, Bayer, Beth Israel Deaconess, BMS, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis, and OrbusNeich; Scientific Advisory Board from Bristol Myers Squibb (to institute), Medtelligence (Janssen Scientific Affairs), and Merck (spouse); equity (less than 1%) from Claret Medical and Elixir Medical; DSMB membership paid to institution from Watermark Research Partners; and associate editor at ACC and AMA.

Dr. Valgimigli reported the following disclosures: grant/research support from Daiichi Sankyo, Medicure, Terumo, and CoreFLOW; and consulting fees/honoraria from Abbott, Alvimedica/CID, AstraZeneca, Bayer, CoreFLOW, Chiesi, IDORSIA, Bristol Myers Squib SA, Medscape, Vesalio, and Universität Basel Dept. Klinische Forschung. 

For more information: www.tctconference.com

Find additional TCT 2020 news, video and late-breaking studies

 

Related Shorten DAPT Content:

Medtronic Resolute Onyx Drug Eluting Stent First to Receive One-Month DAPT Indication - October 1, 2020

VIDEO: Overview of Short DAPT in High-risk Bleeding Patients Who Receive Stents — Interview with Robert Harrington, M.D.

6 Hot Topics in Interventional Cardiology at TCT 2019

VIDEO: Early Discontinuation of DAPT in High Bleeding Risk Patients With the Synergy Stent. — Interview with Ajay Kirtane, M.D.

 VIDEO: TWILIGHT Trial Shows Benefit to Ticagrelor Monotherapy After Stent Implantation — Interview with Roxana Mehran, M.D.

Resolute Onyx Drug-Eluting Stent Noninferior to Polymer-Free Drug-Coated Stent With One-Month DAPT

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study

TWILIGHT Trial Substudy Examines Bioabsorbable Polymer vs. Durable Polymer Drug-Eluting Stents in High-Risk PCI

Related Content

The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images #ACC #ACC21 #ACC2021

The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in patients with pre-existing cardiovascular disease who were taking 81 milligrams (mg) baby aspirin, versus 325 mg of daily aspirin. Getty Images

News | Antiplatelet and Anticoagulation Therapies | May 15, 2021
May 15, 2021 — The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in pat
A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

A Chinese registry study found there are higher event rates in patients with shorter dual-antiplatelet therapy (DAPT) after PCI procedures. There has been a lot of movement toward using shorter duration DAPT with newer generation drug-eluting stent technologies, but this study reinforces the need longer DAPT in many patients. The findings were presented as a late-breaking trial at SCAI 2021 today. 

News | Antiplatelet and Anticoagulation Therapies | April 28, 2021
April 28, 2021 — An analysis of the prospective Chinese Fuwai PCI Registry, confirms long-term,...
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis, and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Clotting Prevention in COVID-19 Patients, Thrombosis Prevention in COVID-19 Patients, Preventing blood clots in COVID-19 patients

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) can potentiate all 3 sides of Virchow’s Triad of coagulopathy, including endothelial dysfunction, blood flow stasis and hypercoagulability. Angiotensin-converting enzyme-2 (ACE-2)–dependent viral entry and the virus-induced inflammatory response can lead to endothelial dysfunction. Additional figure included in the JACC article.

Feature | Antiplatelet and Anticoagulation Therapies | March 22, 2021 | By Dave Fornell, Editor
A comprehensive review or more than 80 randomized controlled trials (RCTs) investigating how to best manage optimal a
Tailor PCI trial showed genetic testing may play a role in personalizing antiplatelet therapy after PCI.
News | Antiplatelet and Anticoagulation Therapies | September 02, 2020
September 2, 2020 — An international, first-of-its-kind cardiology trial used personalized genetic testing to reduce
Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. #ACC20 #ACC2020

Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. 

News | Antiplatelet and Anticoagulation Therapies | March 28, 2020
March 28, 2020 — The TAILOR-PCI trial that used genetic testing to guide which antiplatelet medication was given to p
The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban).

The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban).

Feature | Antiplatelet and Anticoagulation Therapies | December 27, 2019
December 27, 2019 — The U.S.