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Interventional Cardiology: Bare Metal Stent vs. Drug-Eluting Stent
Transcript of Interventional Cardiology: Bare Metal Stent vs. Drug-Eluting Stent
someone died from heart disease or stroke." "Heart disease is one of the three leading cause of deaths in Canada." Interuption of blood supply
to a part of the heart CABG PCI Mechanically widening a narrowed or
obstructed blood vessel History of PCI 1717 Hales conducted the first heart catherization of a horse using brass pipes 1929 First documented human heart
catherization perforned by
Dr. Werner in Germany 1977 First cath lab on an awake patient
and all PTCA data is entered
to the worldwide registry 1997 Over one million angioplasties will be performed worldwide, making angioplasty the most common medical intervention in the world Problem with Angioplasy? "In-stent restenosis continues to occur in 15% to 20% of ideal coronary lesions and 30% to 60% of patients with more challenging characteristics..."
(Mehran et al., 1999) Therefore, drug-eluting stents are invented Bare Metal Stent
(BMS) Drug-Eluting Stent
(DES) Restenosis Thrombosis Which one is better? ? Part 1: Restenosis
Part 2: Thrombosis
Part 3: Antiplatelet Therapy Part 1: Restenosis Reoccurance of narrowing of a blood vessel, leading to restricted blood flow Morice et al.
2002 Methods Randomized, double-blinded
Duration: 1 year (Aug 2000 - Aug 2001)
Age: 18 to 85 years
N = 238 at 19 medical centres
Endpoints 1. In-stent late luminal loss
2. Percentage of in-stent restenosis
3. Death, MI, revascularization Conclusion Drug-Eluting stent shows considerable promise for the prevention of restenosis and associated clinical events Result 1 The percentage of stenosis at six months is essentially the same as that immediately after the procedure and in all cases are less than 35% Result 2 The rate of event-free survival was significantly higher in the drug-eluting stent than in the standard-stent group Moses et al.
2003 Methods Randomized, double blinded
Duration: 270 days
N = 1058 at 53 centres Endpoints 1. Death
2. Myocardial infarction
3. Revascularization Result 1 Results 2 Conclusion Drug-eluting stent significantly reduces the risk of restenosis. The rate of failure of the target vessel was reduced from 21% with a standard stent to 8.6% with a drug-eluting stent Part 2: Thrombosis Fromulation of blood clots inside a blood vessel, obstructing the flow of blood "Cumulative incidence of stent thrombosis with DES at 9 to 12 months has ranged from 0.5% to 0.7% compared to the BMS"
(Tung et al., 2006) "24% of stent thrombosis cases presented as death, 60% as non-fatal MI, and 7% unstable angina"
(Iakovou et al., 2005) "In a series of patient presented with ACS and has had angiographically proven ST after DES implantation, 6-month mortality is 31%"
(Kuchulakanti et al., 2006) Bavry et al.
2006 Methods Meta analysis on 14 trials that randomized 6675 patients to DES compared with BMS Endpoints Stent thrombosis i) Early thrombosis (within 30 days)
ii) Late thrombosis (> 30 days) a) > 30 days
b) > 6 months
c) > 1 year Result 1 Result 4 Result 2 Result 3 Conclusion Although the incidence of very late thrombosis more than 1 year of coronary revascularization is low, DES appear to increase the risk of LATE thrombosis Slottow et al.
2008 Methods Retrospective analysis
Duration: April 2003 to July 2007
N = 8402 Endpoints Stent Thrombosis i) 30 days
ii) 6 months
iii) 1 year
iv) 2 years Result 1 Conclusion ST after DES implantation continues to occur from 30 days to 2 years at a rate of > 0.36%/year and is associated with high rates of morbidity and mortality. Jensen et al.
2007 Methods Endpoints N = 12,395
Duration: Jan 2002 to June 2005 with a 15-month followup 1. Stent thrombosis
2. All-cause mortality, death, MI Result 1 (ST) Result 2 (Mortality) Result 3 (MI) Conclusion Results 1. BMS and DES treatments are associated with low rates of cardiac events
2. Study found no significant difference between the 2 groups in cardiac and non-cardiac mortality during the 15 month follow-up Study concludes that minor risk of ST and MI after implantation of DES seems unlikely to outweigh the benefit of these stents Part 3: Antiplatelet Therapy Compliance to Antiplatelet Therapy Medications that decrease platelet aggregation and inhibit thrombus formation Antiplatelet
Drugs Clopidogrel (PLAVIX) Acetylsalicylic Acid (ASPIRIN) "Recommend that patients to receive aspirin indefinitely plus a minimum of 3 or 6 months of Plavix with therapy extended to 12 months in patients at a low risk of bleeding."
(Smith et al., 2005) Eisenstein et al.
2007 Methods Observational Study
Duration: Jan 2000 to July 2005
N = 3165 Endpoints 1. Death
2. Nonfatal MI
3. Composite of death or MI Results Conclusion Extended use of Plavix in patients with DES may be associated with a reduced risk of death or MI
Safe to state that anti-platelet therapy compliance contributes greatly to the incidence of stent thrombosis after stent implantation Stent Thrombosis Time Frames Early thrombosis < 30 days
Late thrombosis > 30 days
Very late thrombosis > 1 year
(Holmes et al., 2007) Final Note DES does hold promise in reducing in-stent restenosis but with a possible increased stent thrombosis rate
Special population must also be taken into consideration when analyzing stent types (i.e. Diabetic, elders, and obesity).
Present findings unfold an increased stent thrombosis rate resulting in cautious use of DES which may suggest that BMS is the preferred choice of stent at the present moment PROMUS® Everolimus-Eluting Coronary Stent Flexibility
More effective drug coating Morice et al.
2002 Morice et al.
2002 Angioplasty Procedure Table 3, Moses et al., NEJM, 2003 Figure 1, Moses et al., NEJM, 2003 Figure 1, Morice et al., NEJM, 2002 Figure 2, Morice et al., NEJM, 2002 Figure 1, Bavry et al., AMJMED, 2006 Figure 2, Bavry et al., AMJMED, 2006 Figure 3, Bavry et al., AMJMED, 2006 Figure 4, Bavry et al., AMJMED, 2006 Figure 1, Slottow et al., AMJCard, 2008 Figure 1, Jensen et al., JACC, 2007 Figure 1, Jensen et al., JACC, 2007 Figure 1, Jensen et al., JACC, 2007 Figure 4, Eisenstein et al., JAMA, 2007 Boston Scientific, PROMUS® Boston Scientific, PROMUS® Boston Scientific, PRMUS® Boston Scientific, PROMUS® Boston Scientific, PROMUS® Boston Scientific, PROMUS® Boston Scientific, PROMUS® Boston Scientific, PRMUS® Retrived from:
http: //www.youtube.com/watch?v=4Qf8XC1QlJk Retrieved from:
http: //www.ptca.org/history_timeline.html Retrieved from:
http: //www.ptca.org/history_timeline.html Retrieved from:
http: //www.ptca.org/history_timeline.html Boston Scientific, PROMUS® Interventional Cardiology:
Bare Metal Stent vs. Drug-Eluting Stent By: Timothy Yam Boston Scientific, PROMUS® Retrieved img from AHA Retrieved img from ACC Retrieved img from SCAI Retrieved img from Boston Scientific Retrieved from:
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm Retrieved from:
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm 2002 25th Anniversary of the first angioplasty performed in an awake patient Recommendations Examine closely to the optimal dosage of Plavix and the duration of anti-platelet therapy
Patient’s characteristics for pre-procedure assessment between BMS and DES Boston Scientific, PROMUS® Bavry, A. A. , Kumbhani, D. J. , Helton, T. J. , Borek, P. P. , & Mood, G. R. , Mood, G. R. , Bhatt, D. L. . (2006). Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. The American Journal of Cardiology, 119, 1056-1061.
Eisenstein, E. L. , Anstrom, K. J. , & Kong , D. F. . (2007). Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA, 297, 159-168.
Iakovou, I. , Schmidt, T. , Bonizzoni, E. (2005). Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA, 293, 2126-2130.
Jensen, L. O. , Maeng, M. , Kaltoft, A. , Thayssen, P. , & Hansen, H. H. T. , Bottcher, M. , Lassen, J. F. , Krussel, L. R. , Rasmussen, K. , Hansen, K. N. , Pedersen, L. , Johnsen, S. P. , Soerensen, H. T. , Thuesen, L. . (2007). Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. Journal of American College of Cardiology, 50(5), 463-470.
Mehran, R. , Dangas, G. , & Abizaid, A. S. . (1999). Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation, 100, 1872-1878.
Morice, M., Serruys, P. W. , Barragan, P. , Bode, C. , & Van Es, G. , Stoll, H. , Snead, D. , Mauri, L. , Cutlip, D. E. , Sousa, E. (2007). Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the ravel trial. Journal of American College of Cardiology, 50(14), 1299-1304.
Moses , J. W. , Leon, M. B. , & Popma, J. J. . (2003). Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med, 349, 1315-1323. Park, S. J., Shim, W. H. , & Ho, D. S. . (2003). A Paclitaxel-eluting stent for the prevention of coronary restenosis. N Engl J Med, 348, 1537-1545.
Slottow, T. L. P., Steinberg, D. H. , Roy, P. K. , Buch, A. N. , & Okabe, T. , Xue, Z. , Kaneshige, K. , Torguson, R. , Linsay, J. , Pichard, A. D. , Satler, L. F. , Suddath, W. O. , Kent, K. M. , Waksman, R. . (2008). Observations and outcomes of definite and probable drug-eluting stent thrombosis seen at a single hospital in a four-year period. The American Journal of Cardiology, 102, 298-303. References Retrieved from:
http://www.bostonscientific.com/interventional-cardiology/products.html?#productDetailPage%2810127891%29; Coronary Artery Disease (CAD) ECG
Coronary Angiogram / Heart Catherization