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Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DES-std group | Active Comparator | (DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage. |
|
| DES-slow group | Experimental | (DES: drug-eluting stent). Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS. |
|
| BVS group | Experimental | (Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioresorbable Vascular Scaffolds (BVS) | Device | Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IMR between baseline and post-stent/scaffold implantation. | IMR: index of microvascular resistance | During procedure |
| Change in CFR between baseline and post-stent/scaffold implantation. | CFR: coronary flow reserve | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of troponin elevation post-PCI (MI4a). | Measuring serum troponin I levels by blood test | Measured 6 hours after stent insertion |
| Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Duckworth | Papworth NHS Foundation Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital NHS Foundation Trust | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39044651 | Derived | Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Chiu YD, Duckworth M, Khialani B, Kyranis S, Bennett MR, West NEJ, Hoole SP. Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison. Catheter Cardiovasc Interv. 2024 Sep;104(3):462-471. doi: 10.1002/ccd.31155. Epub 2024 Jul 24. | |
| 35470686 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| Drug-Eluting Stent (DES) - slow | Device | Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS. |
|
|
| Drug-Eluting Stent (DES) - standard(std) | Device | Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage. |
|
|
IMR: index of microvascular resistance
| 3 months follow up |
| Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up. | Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared | Up to 12 months |
| Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis. | OCT analysis of stent struts done quantitatively | During index procedure and at 3 month follow up |
| Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis. | OCT analysis of stent struts done quantitatively | During index procedure and at 3 month follow up |
| Nature/phenotype of underlying target lesion plaque by OCT analysis. | OCT analysis of lesion characteristics done quantitatively | During index procedure and at 3 month follow up |
| Adverse events | Adverse event assessed by clinical history and medical notes | At time points 1, 3, 6 & 12 months post-PCI |
| Serious adverse events | Serious adverse event assessed by clinical history and medical notes | At time points 1, 3, 6 & 12 months post-PCI |
| Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Khialani B, Kyranis S, Braganza DM, Clarke SC, Bennett MR, West NEJ, Hoole SP. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios. J Am Heart Assoc. 2022 May 3;11(9):e023554. doi: 10.1161/JAHA.121.023554. Epub 2022 Apr 26. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |