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The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed. The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.
The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not. The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF). The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).
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| Measure | Description | Time Frame |
|---|---|---|
| Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery | Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy | 3 months |
| Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery | Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with prior percutaneous coronary intervention (PCI) with stent implantation undergoing urgent or elective surgical/endoscopic procedures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Rossini, MD, PhD | Contact | 347 2548176 | +39 | roberta.rossini2@gmail.com |
| Dominick Angiolillo, MD, PhD | Contact | 904-244-3378 | +1 | dominick.angiolillo@jax.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Musumeci, MD | A.O. Santa Croce e Carle di Cuneo, 26 - 12100 - Cuneo (CN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. Santa Croce e Carle di Cuneo | Cuneo | CN | 12100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22179539 | Background | Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. | |
| 20562067 |
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It is not yet known if there will be a plan to make Individual Participant Data available
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2017 | Jan 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Istituto Clinico Humanitas | Rozzano | MI | 20089 | Italy |
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| Istituto Clinico Humanitas | Rozzano | MI | 20089 | Italy |
|
| Ospedale degli Infermi | Rivoli | TO | 10098 | Italy |
|
| A.O. di Cosenza | Cosenza | Italy |
|
| Università Campus Bio-Medico di Roma | Roma | 00128 | Italy |
|
| Background |
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