eTable 1a. Expanded overview of studies of VKA-based triple therapy.
| WOEST study (29) | ISAR-TRIPLE (30) | PIONEER-AF-PCI (31) | |||||
| Treatment regimen | VKA + Clopi. 1 × 75 mg | Triple ther. with ASA und VKA + | VKA + | Riva. 1 × 15 mg + | Riva. 2 × 2.5 mg + | ||
| Clopi. 1 × 75 mg + | Clopi. 1 × 75 mg | Clopi. 1 × 75 mg + | |||||
| ASA 80–100 mg | Placebo | 6 weeks clopi. | 6 months clopi. | ASA 1 × 75–100 mg | ASA 1 × 75–100 mg | ||
| Indication for oral anticoagulation: atrial fibrillation (69%), mechanical valve prosthesis (11%), other (30%) | After termination of prespecified triple ther., riva. 1 × 15 mg + low-dose ASA until the end of the 12th month | ||||||
| No. of patients randomized | 573 | 614 | 2 124 | ||||
| Dose reduction | None | None | Riva. 1 × 10 mg if GFR <50 ml/min | ||||
| GFR exclusion | None | <30 ml/min | <30 ml/min | ||||
| Time to randomization | Up to 4 h after PCI | No stated | 3 days | ||||
| Duration of triple ther. | 12 months (66.5% of patients with triple ther. had ASA after 12 months) | 6 weeks vs. 6 months | 1, 6, or 12 months | ||||
| Study design | Open | Open | Open | ||||
| Follow-up | 12 months | 9 months | 12 months | ||||
| CHADS-VASc score | Not reported | 95.3% >2 | 92.7% >2 | 3.7 ± 1.6 | |||
| HAS-BLED score | Not reported | Not reported | 3.0 ± 0.9 | ||||
| PCI with ACS/CCS/non-PCI ACS | 30% ACS | 25% ACS | 33.2% ACS | 30.9% ACS | N/STEMI: 17.8%/10.7%; 18.5%/12.3%; 18.3%/13.8% | ||
| Other P2Y12 inhibitors apart from clopidogrel,% | 0 | 3.7 | 6.9 | 6.4 | |||
| TTR | Not reported | Not reported | 65% | ||||
| Bleeding endpoint | Any bleeds | Secondary bleeding endpoint: major bleeds (TIMI classification) | Major or minor bleeds (TIMI classification) or bleeds requiring treatment | ||||
| 44.4% | 19.4% | 5.3% | 4% | 26.7% | 16.8% | 18% | |
| Major bleeds (TIMI) | |||||||
| 5.6% | 3.2% | 5.3% | 4% | 3.3% | 2.1% | 1.9% | |
| Composite efficacy endpoint | Death, stroke, myocardial infarction, stent thrombosis, target vessel revascularization | Secondary composite ischemia endpoint made up of cardiac death, myocardial infarction, definitive stent thrombosis, and ischemic stroke | Cardiovascular death, myocardial infarction, stroke | ||||
| 17.6% | 11.1% | 4% | 4.3% | 6% | 6.5% | 5.6% | |
| Myocardial infarction | 4.6% | 3.2% | 2% | 0% | 3.5% | 3% | 2.7% |
| Overall mortality | 6.3% | 2.5% | 4% | 5.2% | 3.2% | 2.9% | 3.1% |
ACS, acute coronary syndrome; ASA, acetylsalicylic acid; BMS, bare metal stent; CCS, chronic coronary syndrome; clopi., clopidogrel; GFR, glomerular filtration rate; PCI, percutaneous coronary intervention; riva., rivaroxaban; STEMI, ST-elevation myocardial infarction; triple ther., triple therapy (with VKA, ASA, and P2Y12 inhibitors, mainly clopidogrel); TTR, time [of INR] in therapeutic range; VKA, vitamin K antagonist.