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This is a multi-center, investigator initiated study that will prospectively and retrospectively examine treatment strategies and outcomes of patients who underwent percutaneous coronary interventions (PCI).
The goal of this multi-center, investigator initiated, registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing laser-assisted PCI among various participating centers. The study is a purely observational, chart review study and involves retrieval and compiling of data based on clinically indicated procedures and follow-up clinical and procedural outcomes.
The information collected will be used to determine the frequency of laser-assisted PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and subsequent) outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing laser-assisted PCI | Patients of VAMC centers who undergone laser-assisted percutaneous coronary interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser-assisted percutaneous coronary interventions | Procedure | Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success of the PCI | Procedural success is defined as achievement of technical success with no in-hospital major adverse cardiac events (MACE). In-hospital MACE includes any of the following adverse events prior to hospital discharge: death from any cause, myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke. | through hospital discharge post-PCI procedure, approximately 24 hours, but variable based on patient recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of the PCI | Technical success of the PCI was defined as successful revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow. | through end of PCI of procedure, approximately 5 minutes after end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Potential subjects may or may not be patients of each site investigator and they will have undergone clinically indicated laser-assisted PCI at the investigator's site.
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| Name | Affiliation | Role |
|---|---|---|
| Bavana Rangan, BDS, MPH | UT Southwestern Medical Center/ Dallas VA Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24142769 | Background | Jeroudi OM, Alomar ME, Michael TT, El Sabbagh A, Patel VG, Mogabgab O, Fuh E, Sherbet D, Lo N, Roesle M, Rangan BV, Abdullah SM, Hastings JL, Grodin J, Banerjee S, Brilakis ES. Prevalence and management of coronary chronic total occlusions in a tertiary Veterans Affairs hospital. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):637-43. doi: 10.1002/ccd.25264. Epub 2013 Nov 13. | |
| 15842978 |
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| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
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| major adverse cardiovascular events |
In-hospital major adverse cardiovascular events (MACE) include any of the following adverse events prior to hospital discharge: death from any cause, myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke. MACE during clinical follow-up include death, myocardial infarction, target lesion and target vessel revascularization. |
| through hospital discharge post-PCI procedure,approximately 24 hours, but variable based on patient recovery. |
| Background |
| Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065. |
| 19626394 | Background | Boatman DM, Saeed B, Varghese I, Peters CT, Daye J, Haider A, Roesle M, Banerjee S, Brilakis ES. Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events. Heart Vessels. 2009 Jul;24(4):241-6. doi: 10.1007/s00380-008-1114-1. Epub 2009 Jul 22. |
| 23993124 | Background | Niccoli G, Belloni F, Cosentino N, Fracassi F, Falcioni E, Roberto M, Panico RA, Mongiardo R, Porto I, Leone AM, Burzotta F, Trani C, Crea F. Case-control registry of excimer laser coronary angioplasty versus distal protection devices in patients with acute coronary syndromes due to saphenous vein graft disease. Am J Cardiol. 2013 Nov 15;112(10):1586-91. doi: 10.1016/j.amjcard.2013.07.015. Epub 2013 Aug 30. |
| 23454891 | Background | Fernandez JP, Hobson AR, McKenzie D, Shah N, Sinha MK, Wells TA, Levy TM, Swallow RA, Talwar S, O'Kane PD. Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions. EuroIntervention. 2013 Jun 22;9(2):243-50. doi: 10.4244/EIJV9I2A40. |
| 23332778 | Background | Badr S, Ben-Dor I, Dvir D, Barbash IM, Kitabata H, Minha S, Pendyala LK, Loh JP, Torguson R, Pichard AD, Waksman R. The state of the excimer laser for coronary intervention in the drug-eluting stent era. Cardiovasc Revasc Med. 2013 Mar-Apr;14(2):93-8. doi: 10.1016/j.carrev.2012.12.008. Epub 2013 Jan 16. |
| 17296821 | Background | Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007 Mar 8;356(10):1020-9. doi: 10.1056/NEJMoa067731. Epub 2007 Feb 12. |
| 17470709 | Background | Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313. |
| 17951284 | Background | Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction; Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernandez-Aviles F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available. |
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |