Early Aspirin Discontinuation Following Acute Coronary Syndrome or Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Abstract
:1. Introduction
2. Materials and Methods
2.1. Research Strategy and Selection Criteria
2.2. Data Extraction
2.3. Statistical Analysis
3. Results
3.1. Systematic Review
3.2. Safety Endpoints
3.3. Efficacy Endpoints
3.4. Sensitivity Analyses and Bias Assessment
4. Discussion
Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Conflicts of Interest
References
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Study Publication Year Clinicaltrials.gov ID | Study Design | Main Inclusion Criteria | Main Exclusion Criteria | Sample Size | Follow Up | Early Aspirin Discontinuation | Standard of Care | Primary Outcomes | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Duration of Aspirin Therapy after Randomization | P2Y12 Inhibitors Use (Dosage) | OAC Agent | DAPT Duration | Antiplatelet Agents | OAC Agent | |||||||
WOEST [11] 2013 NCT00769938 | Randomized, open label, multicentric, superiority, controlled trial | Indication for oral anticoagulation and PCI | >80 years, Prior ICH, cardiogenic shock recent major bleeding, thrombocytopenia | 563 | 12 months | None after randomization | Clopidogrel 100% (75 mg) | VKA | 1 to 12 months | Aspirin 80–100 mg; and Clopidogrel 75 mg | VKA | Safety: Any episode of bleeding (defined by TIMI, GUSTO or BARC classification |
PIONEER AF-PCI [12] 2016 NCT01830543 | Randomized, open label, multicentric, controlled trial | Non-valvular AF PCI with coronary stent implantation | Prior stroke/TIA, recent GI bleeding, severe CKD, anemia increase risk of bleeding contra-indication for OAC Active malignancy | 2124 | 12 months | None after randomization | Clopidogrel 93.1% (75 mg), Ticagrelor 5.2% (90 mg bid), Prasugrel 1.7% (10 mg) | Rivaroxaban 15 mg or 10 mg | 1, 6 or 12 months | Aspirin 75–100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg | VKA or Rivaroxaban 2.5 mg | Safety: Composite of: Major and minor TIMI bleeding and bleeding requiring medical attention |
REDUAL-PCI [13] 2017 NCT02164864 | Phase IIIb, randomized, open label, multicentric, non-inferiority, controlled trial | Non valvular AF Successful PCI < 120 h | Prosthetic heart valves, severe CKD, recent stroke, major surgery or GI bleeding | 2725 | 14 months * | None after randomization | Clopidogrel 86.6% (75 mg), Ticagrelor 12.4% (90 mg bid) | Dabigatran 150 or 110 mg bid | 1 month (BMS) 3 months (DES) | Aspirin < 100 mg and Clopidogrel 75 mg, Ticagrelor 90 mg bid | VKA | Safety: Time to event analysis of first major or clinically relevant non major ISTH bleeding |
GLOBAL LEADERS [14] 2018 NCT01813435 | Randomized, open label, multicentric, superiority, controlled trial | Clinical indication of PCI | Need for OAC, planned surgery, recent stroke, prior major bleeding | 15,968 | 24 months | 30 days | Ticagrelor 100% (90 mg bid) | N.A. | 12 months | Aspirin 75-100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid | N.A. | Efficacy: Composite of all-cause death or non-fatal, new Q-wave myocardial infarction. |
AUGUSTUS [15] 2019 NCT02415400 | Multicentric, randomized with two-two factorial design, double blinded, non-inferiority, controlled trial | AF and recent PCI or ACS with planned used of at least 6 months of P2Y12 | Other indication for OAC, severe CKD, prior ICH, coagulopathy, planned CABG | 4614 | 6 months | None after randomization | Clopidogrel 93.2% (75 mg) Ticagrelor 5.9% (90 mg bid) Prasugrel 0.9% (10 mg) | Apixaban 5 mg or 2.5 mg bid or VKA | 6 months | Aspirin 81 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg | Apixaban 5 mg or 2.5 mg bid or VKA | Safety: major or clinically relevant non-major ISTH bleeding |
STOPDAPT-2 [16] 2019 NCT02619760 | Randomized, open label, multicentric, non inferiority, controlled trial | PCI with CoCr-EES without periprocedural complication | Need for OAC, prior ICH, use of other stents | 3009 | 12 months | 1 month | During 1st month Clopidogrel 60.2% (75 mg) Prasugrel 39.6% (10 mg) After 1st month Clopidogrel 100% (75 mg) | N.A. | 12 months | Aspirin 81 to 200 mg and Clopidogrel 75 mg or Prasugrel 10 mg before 1 month, Followed by Clopidogrel 75 mg | N.A. | Safety and efficacy: Composite of cardiovascular death, MI, definite stent thrombosis, stroke and TIMI major and minor bleeding |
SMART CHOICE [17] 2019 NCT02079194 | Randomized, open label, multicentric, non inferiority, controlled trial | PCI with DES for ACS or stable CAD | Hemodynamic instability; active bleeding; recent DES implantation | 2993 | 12 months | 3 months | Clopidogrel 76.9% (75 mg) Ticagrelor 6.5% (90 mg bid) Prasugrel 0.7% (10 mg) | investigators choice | 12 months | Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg | investigators choice | Efficacy: Composite of all-cause mortality, MI, stroke |
ENTRUST-AF PCI [18] 2019 NCT02866175 | Phase IIIb, Randomized, open label, multicentric, controlled trial | Non valvular AF and PCI procedure for stable CAD or ACS with success | Valvular or reversible AF, mechanical heart valve, severe CKD, major surgery planned, recent ischemic stroke, high bleeding risk | 1506 | 12 months | None after randomization | Clopidogrel 92.7% (75 mg) Ticagrelor 6.5% (90 mg bid) Prasugrel 0.7% (5 or 10 mg) | Edoxaban 60 mg or 30 mg VKA | 1 to 12 months | Aspirin 100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 5 or 10 mg | VKA | Safety: Composite of ISTH major and clinically relevant non-major bleeding Efficacy: Composite of CV death, stroke, systemic embolic event, MI and definite ST |
TWILIGHT [19] 2019 NCT02270242 | Phase IV, randomized, blinded-label, multicentric, superiority controlled trial | High risk patients with complex PCI † | Contraindication to aspirin or ticagrelor, STEMI as index event, need for chronic OAC, prior stroke, planned surgery or coronary revascularization | 7119 | 12 months | None after randomization | Ticagrelor (100%) | N.A. | 12 months | Aspirin 81–100 mg and Ticagrelor 90 mg bid | N.A. | Safety: Composite of BARC types 2, 3 or 5 bleeding |
Study | Male Sex | Age (Years) * | Prior MI | Prior Coronary Revascularization | Diabetes Mellitus | Systemic Hypertension | Dyslipidemia | Active Smoking | ACS as iIdex Rvent | Type of Stent Used |
---|---|---|---|---|---|---|---|---|---|---|
WOEST | 448 (79.6%) | EAD: 70.3 ± 7.0 DAPT: 69.5 ± 8.0 | 196 (34.8%) | PCI: 187 (33.2%) CABG: 130 (23.1%) | 140 (24.9%) | 386 (68.6%) | 396 (70.3%) | 102 (18.1%) | 155 (27.5%) | None: 9 (1.6%) DES: 364 (64.6%) BMS: 175 (31.1%) Both: 14 (2.5%) |
PIONEER AF-PCI | 1581 (74.4%) | EAD: 70.4 ± 9.1 DAPT: 70.0 ± 9.1 and 69.9 ± 8.7 | 477 (22.5%) | - | 624 (29.4%) | 1571 (74.0%) | 913 (43.0%) | 141 (6.6%) | 1096 (51.6%) | DES: 1403 (66.0%) BMS: 675 (31.8%) Both: 40 (1.9%) |
REDUAL-PCI | 2070 (76.0%) | EAD: 71.5 ± 8.9 and 68.6 ± 7.7 DAPT: 71.7 ± 8.9 | 699 (25.6%) | PCI: 912 (33.5%) CABG: 287 (10.5%) | 993 (36.4%) | - | - | - | 1375 (50.5%) | DES: 2251 (82.8%) BMS: 404 (14.9%) Both: 41 (1.5%) Other: 21 (0.8%) |
GLOBAL LEADERS | 12,254 (76.7%) | EAD: 64.5 ± 10.3 DAPT: 64.6 ± 10.3 | 3710 (23.2%) | PCI: 5,221 (32.7%) CABG: 943 (5.9%) | 4038 (25.3%) | 11,715 (73.4%) | 10,768 (67.4%) | 4169 (26.1%) | 7487 (46.9%) | Biolimus A9-eluting stent: 94.6% of lesions; other stent in 6.5% of lesions |
AUGUSTUS | 3277 (71.0%) | EAD: 70.8 (64.4–77.3) DAPT: 70.6 (63.8–77.2) | - | - | 1678 (36.4%) | 4073 (88.3%) | - | - | 2811 (60.2%) | - |
STOPDAPT-2 | 2337 (77.7%) | EAD: 68.1 ± 10.9 DAPT: 69.1 ± 10.4 | 406 (13.5%) | PCI: 1032 (34.3%) CABG: 59 (2.0%) | 1159 (38.5%) | 2221 (73.8%) | 2244 (74.6%) | 710 (23.6%) | 1148 (38.2%) | CoCr-EES |
SMART CHOICE | 2198 (73.4%) | EAD: 64.6 ± 10.7 DAPT:64.4 ± 10.7 | 127 (4.2%) | 349 (11.7%) | 1122 (37.5%) | 1840 (61.5%) | 1352 (45.2%) | 791 (26.4%) | 1741 (58.2%) | CoCr-EES: 1051 (35.1%) PtCr-EES: 967 (32.3%) BP-SES: 972 (32.5%) |
ENTRUST-AF PCI | 1120 (74.4%) | EAD: 69 (63–77) DAPT: 70 (64–77) | 365 (24.2%) | PCI: 394 (26.2%) CABG: 95 (6.3%) | 517 (34.3%) | 1361 (90.4%) | 981 (65.1%) | - | 777 (51.6 %) | - |
TWILIGHT | 5421 (76.1%) | EAD: 65.2 ± 10.3 DAPT: 65.1 ± 10.4 | 2040 (28.7%) | PCI: 2998 (42.1%) CABG: 710 (10.0%) | 2620 (36.8%) | 5154 (72.4%) | 4303 (60.4%) | 1548 (21.8%) | 4614 (64.8%) | Locally approved DES |
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Guedeney, P.; Mesnier, J.; Sorrentino, S.; Abcha, F.; Zeitouni, M.; Lattuca, B.; Silvain, J.; De Rosa, S.; Indolfi, C.; Collet, J.-P.; et al. Early Aspirin Discontinuation Following Acute Coronary Syndrome or Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J. Clin. Med. 2020, 9, 680. https://doi.org/10.3390/jcm9030680
Guedeney P, Mesnier J, Sorrentino S, Abcha F, Zeitouni M, Lattuca B, Silvain J, De Rosa S, Indolfi C, Collet J-P, et al. Early Aspirin Discontinuation Following Acute Coronary Syndrome or Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Clinical Medicine. 2020; 9(3):680. https://doi.org/10.3390/jcm9030680
Chicago/Turabian StyleGuedeney, Paul, Jules Mesnier, Sabato Sorrentino, Farouk Abcha, Michel Zeitouni, Benoit Lattuca, Johanne Silvain, Salvatore De Rosa, Ciro Indolfi, Jean-Philippe Collet, and et al. 2020. "Early Aspirin Discontinuation Following Acute Coronary Syndrome or Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials" Journal of Clinical Medicine 9, no. 3: 680. https://doi.org/10.3390/jcm9030680
APA StyleGuedeney, P., Mesnier, J., Sorrentino, S., Abcha, F., Zeitouni, M., Lattuca, B., Silvain, J., De Rosa, S., Indolfi, C., Collet, J.-P., Kerneis, M., & Montalescot, G. (2020). Early Aspirin Discontinuation Following Acute Coronary Syndrome or Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Clinical Medicine, 9(3), 680. https://doi.org/10.3390/jcm9030680