Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk.

Valgimigli, M.; Frigoli, E.; Heg, D.; Tijssen, Jan; Jüni, Peter; Vranckx, Pascal; Ozaki, Yukio; Morice, Marie-Claude; Chevalier, Bernard; Onuma, Yoshinobu; Windecker, S.; Tonino, Pim A L; Roffi, Marco; Lesiak, Maciej; Mahfoud, Felix; Bartunek, Jozef; Hildick-Smith, David; Colombo, Antonio; Stanković, Goran; Iñiguez, Andrés; ... (2021). Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. New England journal of medicine NEJM, 385(18), pp. 1643-1655. Massachusetts Medical Society MMS 10.1056/NEJMoa2108749

[img] Text
Valgimigli_NEnglJMed_2021_epub.pdf - Published Version
Restricted to registered users only until 1 March 2022.
Available under License Publisher holds Copyright.

Download (574kB) | Request a copy

BACKGROUND

The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.

METHODS

One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.

RESULTS

Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority).

CONCLUSIONS

One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020.).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Frigoli, Enrico; Heg, Dierik Hans and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

07 Sep 2021 15:32

Last Modified:

29 Oct 2021 00:12

Publisher DOI:

10.1056/NEJMoa2108749

PubMed ID:

34449185

BORIS DOI:

10.48350/159124

URI:

https://boris.unibe.ch/id/eprint/159124

Actions (login required)

Edit item Edit item
Provide Feedback