Table 4.
Clinical events.
| No. | Group | Target segment | FFR of target lesion | Time after randomisation | Event | MACE | Target lesion related |
|---|---|---|---|---|---|---|---|
| 1 (1) | BVS | LAD-mid (7) | 0.82 | During BVS implant | Cardiac arrest due to pulseless electrical activity during BVS implantation, for which chest compressions were performed for 1 minute and atropine was given, after which return of spontaneous circulation occurred. No mechanical complication was seen. Postprocedural troponin values were not elevated. Episode was attributed to a vagal reaction. | No | Yes |
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| 1 (2) | BVS | LAD-mid (7) | 0.82 | 6 months | Elective PCI of proximal and distal RCA (in-stent restenosis distal RCA) because of progressive angina. No pre-intervention FFR was performed because stenosis in distal RCA was 90%. | No | No |
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| 2 | BVS | LAD-mid (7) | 0.81 | 4 months | Cardiac arrest due to ventricular fibrillation. ICA shows left main coronary artery occlusion, for which PCI was performed. OCT shows good patency of BVS in the mid LAD. | Yes | No |
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| 3 | BVS | LAD-mid (7) | 0.84 | 24 months | Non-cardiac death due to obstruction hydrocephalus caused by metastasized lung carcinoma. | Yes | No |
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| 4 | BVS | RCA-prox (1) | 0.93 | 23 months | Elective PCI of LAD-mid because of stable angina. | No | No |
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| 5 | BVS | LAD-mid (7) | 0.86 | 8 days | Infected hematoma of the femoral puncture site/closure device. | No | No |
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| 6 | BVS | Cx-mid (13) | 0.95 | 15 months | STEMI with PCI of distal RCA (culprit). Additional occlusion of a small MO2 branch. This occlusion was not intervened upon as patient was free of complaints after PCI of the RCA. BVS in the mid-Cx was patent. | Yes | No |
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| 7 | OMT | LAD-mid (7) | 0.87 | 12 months | Non-cardiac death due to aspiration pneumonia in patient with lymphoma and metastasized squamous cell carcinoma. | Yes | No |
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| 8 | OMT | Cx-mid (13) | 1.00 | 24 months | Hospital admission with chest pain and slightly elevated cardiac troponin levels without rise/fall. ICA showed no obstructive coronary artery disease. Complaints were attributed to hypertension. | No | No |
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| 9 | OMT | Cx-prox (1) | 0.83 | 22 months | Lobectomy for newly diagnosed lung carcinoma. | No | No |
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| 10 | OMT | MO1 (12) | 0.97 | Same day as randomisation | Transient binocular diplopia after ICA. | No | No |
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| 11 | OMT | LAD-mid (7) | 0.89 | 24 months | Elective PCI of the mid LAD (target segment) and proximal RCA due to stable angina and optimisation for esophageal cancer-related chemotherapy. No pre-intervention FFR was performed because the wire could not pass the mid-LAD. | No | Yes |
BVS, bioresorbable vascular scaffold, Cx, circumflex artery, FFR, fractional flow reserve, ICA, invasive coronary angiography, LAD, left anterior descending artery, MACE, major adverse cardiac event, MLA, minimal lumen area, MO, obtuse marginal artery, OCT, optical coherence tomography, OMT, optimal medicinal therapy, PCI, percutaneous coronary intervention, RCA, right coronary artery, STEMI, ST-elevation myocardial infarction.