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. 2021 Sep 15;18(3):207–217. doi: 10.2217/fca-2021-0057

Table 3. . Clinical studies with COBRA-PzF.

Study Publication year Study participants Follow-up duration Study design End point findings Ref.
Maillard et al. 2017 100 patients (38% with ACS); 151 lesions 1 year Single-center study Primary end point:
target vessel failure 12%, including 2% mortality, 5% periprocedural MI and 5% target lesion revascularization
[35]
Cutlip et al. 2017 296 patients (31% with ACS); 300 lesions 9 months Multi-center study Primary end point:
target vessel failure 11.5%, including 0.3% cardiac death, 7.0% MI (1% spontaneous MI), 5.9% target vessel revascularization
Secondary end point:
angiographic in-stent late lumen loss 0.84 ± 0.48 mm
[40]
Maillard et al. 2020 940 patients (47% with ACS; 62% with high bleeding risk); 1229 lesions 1 year Multi-center study Primary end point:
Major adverse cardiac event rate of 9.0%, including 3.7% cardiac death, 4.8% MI, 4.3% target lesion revascularization
Secondary end point:
definite stent thrombosis in 0.7%
[41]
Maillard et al. 2020 77 patients with high bleeding risk (18.2% with ACS); 120 lesions 1 year Single-center study Primary end point:
treatment with clopidogrel for 1 month, followed by aspirin monotherapy did not result in stent thrombosis
Secondary end point:
major adverse cardiac events rate of 3.8%, including 0% cardiac death, 0% MI, 3.8% target lesion revascularization
[42]

ACS: Acute coronary syndrome; MI: Myocardial infarction.