Stent thrombosis incidence in bare metal stents
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editors-In-Chief: Smita Kohli, M.D.; Varun Kumar, M.B.B.S.; Lakshmi Gopalakrishnan, M.B.B.S.
Overview
Multiple contemporary studies involving single center and multi center experience suggests an overall lifetime incidence of stent thrombosis is 0.5 % - 2.5 %.[1] [2] [3] [4][5] There is some variation of these numbers with the definitions used. For instance, in a recent study of 8847 patients who received a BMS, a cumulative incidence of definite, probable or possible stent thrombosis (ST) over 15 months was 2.15% and that for definite ST was 0.61%.[1] In a study involving serial angiography after sirolimus-eluting stent (SES) and BMS implantation at 4, 11, and 21.2 ± 2.2 months, no BMS developed thrombus, however SES demonstrated the presence of thrombi and yellow plaques even as much as 2 years after implantation.[6]
Incidence in Bare Metal Stents
Incidence of Early ST in BMS
For purposes of discussion this group would include:
- Intra-procedural ST
- Acute ST: up to 24 hrs
- Subacute ST: 24 hrs to 30 days
Supportive Trial Data
- In study of 7484 patients with (intra vascular ultrasound study) IVUS before and after stenting, incidence of ST was 0.4% up to a week. The median time of ST was 24 hours and the minimum time was 1 hour.[7]
- In a retrospective analysis 4509 patients the rate of subacute ST was 0.51%.[8]
Higher Incidence of Subacute ST in Special Patient Populations
- In a group of 40 patients who underwent non cardiac surgery following BMS, the incidence of ST while on two antiplatelet agents appeared to be 2.5 % (one patient out of 40).[9]
- Incidence of ST in patients with acute coronary syndrome(ACS) are higher than those with stable angina as demonstrated by ACUITY and TRITON-TIMI 38 trial databases.[10] [11]
- The incident rates of early ST in ACS i.e STEMI and NSTEMI have shown to be 1.4 - 1.6%, and 0 - 2.9% respectively while ST incidence in patients with stable angina is 0 - 0.5%.[12]
Incidence of ST from 30 days up to 3 years or longer
This would include:
- Late ST: 30 days to one year
- Very late ST: more than one year, but generally less than 3 years
- Later than 3 years
The reported incidence in this group ranges between 0-0.5%. Given the paucity of data only assumptions can be made for the group beyond 1-3 years.
Incidence of Late-ST
- The incidence of late ST with BMS was 0.28% in a meta-analysis of 14 trials looking at 6675 patients.[13]
- Long term aspirin therapy is necessary to reduce the incidence of late ST in patients with BMS.[14] [15]
- Late ST is uncommon in patients who are on dual anti-platelet therapy(DAT).[16] [15][17]
- With the use of second generation BMS, and current antithrombotic regimens (aspirin and thienopyridine) the 30 days ST incidence range from 0.5-2.5% in high risk patients.[2] [3] The incidence is higher if aspirin is used alone or when warfarin is used along with aspirin without thienopyridine.[2]
Incidence of Very Late-ST
- It appears that ST in the very late group is exceedingly rare.
- In a meta-analysis of 14 trials looking at 6675 patients no patient presented with very late ST of BMS. However regular follow up of most patients confined to one year or less.[13]
References
- ↑ 1.0 1.1 Jensen LO, Maeng M, Kaltoft A, Thayssen P, Hansen HH, Bottcher M; et al. (2007). "Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions". J Am Coll Cardiol. 50 (5): 463–70. doi:10.1016/j.jacc.2007.06.002. PMID 17662400.
- ↑ 2.0 2.1 2.2 Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK; et al. (1998). "A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators". N Engl J Med. 339 (23): 1665–71. doi:10.1056/NEJM199812033392303. PMID 9834303.
- ↑ 3.0 3.1 Moreno R, Fernández C, Hernández R, Alfonso F, Angiolillo DJ, Sabaté M; et al. (2005). "Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies". J Am Coll Cardiol. 45 (6): 954–9. doi:10.1016/j.jacc.2004.11.065. PMID 15766835.
- ↑ Cutlip DE, Baim DS, Ho KK, Popma JJ, Lansky AJ, Cohen DJ; et al. (2001). "Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials". Circulation. 103 (15): 1967–71. PMID 11306525.
- ↑ Schühlen H, Kastrati A, Pache J, Dirschinger J, Schömig A (2001). "Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen". J Am Coll Cardiol. 37 (8): 2066–73. PMID 11419889.
- ↑ Awata M, Kotani J, Uematsu M, Morozumi T, Watanabe T, Onishi T; et al. (2007). "Serial angioscopic evidence of incomplete neointimal coverage after sirolimus-eluting stent implantation: comparison with bare-metal stents". Circulation. 116 (8): 910–6. doi:10.1161/CIRCULATIONAHA.105.609057. PMID 17684153.
- ↑ Cheneau E, Leborgne L, Mintz GS, Kotani J, Pichard AD, Satler LF; et al. (2003). "Predictors of subacute stent thrombosis: results of a systematic intravascular ultrasound study". Circulation. 108 (1): 43–7. doi:10.1161/01.CIR.0000078636.71728.40. PMID 12821553.
- ↑ Orford JL, Lennon R, Melby S, Fasseas P, Bell MR, Rihal CS; et al. (2002). "Frequency and correlates of coronary stent thrombosis in the modern era: analysis of a single center registry". J Am Coll Cardiol. 40 (9): 1567–72. PMID 12427407.
- ↑ Kałuza GL, Joseph J, Lee JR, Raizner ME, Raizner AE (2000). "Catastrophic outcomes of noncardiac surgery soon after coronary stenting". J Am Coll Cardiol. 35 (5): 1288–94. PMID 10758971.
- ↑ Aoki J, Lansky AJ, Mehran R, Moses J, Bertrand ME, McLaurin BT; et al. (2009). "Early stent thrombosis in patients with acute coronary syndromes treated with drug-eluting and bare metal stents: the Acute Catheterization and Urgent Intervention Triage Strategy trial". Circulation. 119 (5): 687–98. doi:10.1161/CIRCULATIONAHA.108.804203. PMID 19171852.
- ↑ Cook S, Windecker S (2009). "Early stent thrombosis: past, present, and future". Circulation. 119 (5): 657–9. doi:10.1161/CIRCULATIONAHA.108.842757. PMID 19204315.
- ↑ Wiviott SD, Braunwald E, McCabe CH, Horvath I, Keltai M, Herrman JP; et al. (2008). "Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial". Lancet. 371 (9621): 1353–63. doi:10.1016/S0140-6736(08)60422-5. PMID 18377975. Review in: ACP J Club. 2008 Sep 16;149(3):12
- ↑ 13.0 13.1 Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL (2006). "Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials". Am J Med. 119 (12): 1056–61. doi:10.1016/j.amjmed.2006.01.023. PMID 17145250.
- ↑ Moussa I, Di Mario C, Reimers B, Akiyama T, Tobis J, Colombo A (1997). "Subacute stent thrombosis in the era of intravascular ultrasound-guided coronary stenting without anticoagulation: frequency, predictors and clinical outcome". J Am Coll Cardiol. 29 (1): 6–12. PMID 8996288.
- ↑ 15.0 15.1 Ferrari E, Benhamou M, Cerboni P, Marcel B (2005). "Coronary syndromes following aspirin withdrawal: a special risk for late stent thrombosis". J Am Coll Cardiol. 45 (3): 456–9. doi:10.1016/j.jacc.2004.11.041. PMID 15680728.
- ↑ van Werkum JW, Heestermans AA, Zomer AC, Kelder JC, Suttorp MJ, Rensing BJ; et al. (2009). "Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry". J Am Coll Cardiol. 53 (16): 1399–409. doi:10.1016/j.jacc.2008.12.055. PMID 19371823.
- ↑ Ellis SG, Colombo A, Grube E, Popma J, Koglin J, Dawkins KD; et al. (2007). "Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years". J Am Coll Cardiol. 49 (10): 1043–51. doi:10.1016/j.jacc.2007.01.015. PMID 17349883.