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coronary stent/coronary stenting

Use of a prosthetic metal device (coronary stert) to provide & maintain an enlarged coronary lumen at the side of an obstructive atherosclerotic plaque. Used in conjection with (PCI/PTCA). Indications: - acute coronary syndrome - myocardial infarction - inserted during percutaneous coronary intervention - reduction in coronary restinosis - reperfusion of coronary stenosis within 12 hours of ST segment elevation myocardial infarction (STEMI)* * reduction of infarct size if performed with 48 hours of STEMI [5] Contraindications: - of no benefit for stable ischemic heart disease due to coronary artery disease (myocardial ischemia)* [52] - stable angina pectoris with severe coronary artery stenosis [70] * also see percutaneous coronary intervention (PCI) Benefit/risk: - coronary artery disease without acute coronary syndrome - no mortality benefit [46] - number needed to harm: 50 (complication of coronary artery catheterization) [46] Procedure: - insertion of a 15-30 mm expandable tube across a lesion opened by balloon angioplasty during PTCA may diminish the rate of restenosis (2-7%) [2] Clinical significance: 1) drug-eluting stents inhibit regrowth of endothelial cells that quickly conver bare metal stents 2) overgrowth of endothelial cells can clog stents while exposure of the stent increases risk of clots 3) everolimus-eluting stents superior to paclitaxel-eluting stents dincluding patients with type 2 diabetes [50] 4) bioresorbable scaffolds with everolimus-eluting stents - not ready for 1st line use [51] - no benefit, potential risks [60] 5) no difference in mortality or myocardial infarction or in quality of life after drug-eluting stent vs bare-metal stent; however, restenosis & stent thrombosis less frequent with drug-eluting stent [56] 6) all-cause mortality, myocardial infarction, stroke, & ischemia-driven target-lesion revascularization more frequent with bare-metal stent than drug-eluting stent (16% vs 12%) [71] Laboratory: - platelet function testing to adjust antiplatelet therapy of no benefit [55] Complications: 1) severe to moderate bleeding 2) stent thrombosis most likely to occur within 6 months of stent placement - late thrombosis weeks to months after stent placement more common in patients with drug-eluting stents [11,14] - clopidogrel may need to be continued for 18 months [11] - early stent thrombosis days after stent placement - 1.1% with placement of sirolumus-eluting stent, then 0.6%/year thereafter [14] 3) stent restenosis occurs with progressive endothelialization of stent - occurs weeks to months after stent placement [86] - stenosis gradually worsens resulting in progressive exertional angina 4) 3 or more coronary stents associated with higher rates of subsequent ischemic events, but not bleeding events [76] 5) late incomplete stent apposition & delayed endothelialization are mechanistic factors in late drug-eluting stent thrombosis [16] 6) coronary aneurysm after drug-eluting stent (rare) [24] 7) patients with atrial fibrillation requiring warfarin plus clopidogrel plus aspirin at high risk of hemorrhage [35] 8) migration of stent - migration of left main coronary artery stent into aorta [53] 9) delay in filling prescriptions for clopidogrel after receiving stents, puts patients at increased risk for early stent thrombosis, death or myocardial infarction in subsequent months & years [4] Management: 1) dual antiplatelet therapy (DAPT), P2Y12 inhibitor + aspirin 81 mg a) short-term DAPT (< 6 months) not for STEMI or NSTEMI [57] - 12 months minumum duration of DAPT after STEMI or NSTEMI (NEJM) - 6 months minumum duration of DAPT if placed to stable ischemic heart disease - may interrupt at 6 months for elective surgery - 3-6 months of dual antiplatelet therapy (DAPT) after PCI with drug-eluting stent; 6 months of DAPT (MKSAP) [1] - associated with less bleeding with no difference in ischemia or thrombosis relative to 12 months of therapy [47] - high-risk patients may discontinue aspirin after 3 months [81] - > 6 months of dual antiplatelet therapy (DAPT) is associated with fewer MIs but more bleeding & more deaths relative to < 6 months of therapy, but absolute risk is low (0.03% for MI) [49] - 1-3 months of DAPT sufficient [79,89] - lower bleeding risk with 3 months DAPT than 6 months in elderly without difference in major cardiovascular events [89] - continue P2Y12 inhibitor alone for 6-12 months [72] - 1 month of DAPT after PCI with biodegradable-polymer sirolimus-eluting coronary stent may be sufficient in high-risk patients [85] - 1 month of DAPT after PCI with drug-eluting coronary stent followed by 12 months of ticagrelor with less bleeding & no difference in major cardiovascular events vs DAPT [90] - bare metal stents & polymer-free umirolimus-coated stents (DCS; BioFreedom) safe with only 1 month of DAPT [82] b) standard DAPT (6-12 months) - minimimum of 12 months of DAPT after drug-eluting stent for STEMI or NSTEMI [1] - 6 months of DAPT after drug-eluting stent for STEMI reportedly non-inferior to 12 months of DAPT [74] - clopidogrel 75-150 mg QD, ticagrelor or prasugrel indicated for 6-12 months following placement of stent* [1,8,28,37,44] - prasugrel contraindicated in patients with history of stroke [1] - ticagrelor with similar risks of major cardiovascular events as clopidogrel with greater safety risks (12 months of therapy) [83] - 6-12 months of DAPT for stable CAD followed by aspirin monotherapy [72] - need for BID dosing with ticagrelor & its much greater cost than aspirin argues for 6-12 months of DAPT, followed by aspirin monotherapy [72] - 12 months of DAPT for acute coronary syndrome followed by aspirin monotherapy [72] - 12 months of dual antiplatelet therapy (DAPT) does not decrease risk of myocardial infarction, cardiac death or stent thrombosis & increases risk of bleeding relative to 6 months of therapy with or without type 2 diabetes [59,80] c) long-term DAPT (> 12 months) - long-term DAPT (> 12 months) associated with decreased risks for myocardial infarction & stent thrombosis but increased risks for noncardiac death &major bleeding relative to short-term DAPT (< 6 months) [80] - DAPT for 30 months lowers risk for stent thrombosis (0.4% vs 1.4%), MI (2.1% vs 4.1%), & death, MI or stroke (4.3% vs 5.9%) at the cost of increased risk of moderate-to-severe bleeding (2.5% vs 1.6%) & increased non-cardiovascular mortality (1.0% vs 0.5%) relative to 12 months of DAPT with continued low-dose (81 mg) aspirin [44] - long-term DAPT with newer-generation stents associated with increased risks for all-cause mortality & major bleeding [80 - dual antiplatelet therapy (DAPT) for 24 months results in similar risks for all-cause & cardiovascular mortality (RR =1.05 & 1.01, respectively) compared with 12 months of DAPT [45] - may offer greatest benefits to those at low risk for bleeding [76] d) other recommendations for duration of therapy* - at least 1 month (11-30 days) for bare metal stent [1] - at least 3 months for sirolilus-eluting stent - at least 6 months for paclitaxel-eluting stent - at least 3 months for zotarolimus-eluting stent (dual therapy with aspirin) [40] - low-dose aspirin is recommended for prevention of cardiovascular events & should be continued indefinetly 2) clopidogrel generally given with 81 mg of aspirin QD [28,37,44] a) 1-3 months of dual anti-platelet therapy sufficient [79] b) addition of cilostazol 100 mg QD may enhance platelet inhibition [27] c) esomeprazole more effective than famotidine in preventing GI bleed [30] d) interruption of dual therapy (median of 1 week) not associated with adverse outcomes [34] 3) ticagrelor (Brilinta) is more effective clopidogrel with similar bleeding risk [31] 4) patients with atrial fibrillation, venous thromboembolism or mechanical heart value [25] a) PGY12 inhibitor + aspirin 81 mg to prevent white clot + warfarin or direct oral anticoagulant (DOAC) to prevent red clot (triple therapy) - clopidogrel over prasugrel [75] - PGY12 inhibitor + warfarin or DOAC (dual therapy) [75] - clopidogrel + apixaban without aspirin [77] - lower rates for major & minor bleeding with PGY12 inhibitor + DOAC (without aspirin) - no increased risk for death, cardiovascular death, myocardial infarction, or stent thrombosis if aspirin excluded [84] b) bare metal stent requires shorter antiplatelet therapy duration than drug-eluting stent (4 weeks vs 1 year) c) polymer-free umirolimus-coated stents (DCS; BioFreedom) safe with only 1 month of DAPT [82] d) no difference in triple therapy for 6 weeks vs 6 months in patients with atrial fibrillation also on warfarin [48] - discontinue PGY12 inhibitor at 6 weeks, continue warfarin + aspirin [48] e) low-dose rivaroxaban (15 mg QD) + P2Y12 inhibitor [61] f) dabigatran 110 mg BID + clopidogrel or ticagrelor [66] (no aspirin) noninferior to triple therapy with respect to thromboembolic events with lower risk of bleeding g) if aspirin monotherapy after appropriate DAPT & patient develops atrial fibrillation or DVT, discontinue aspirin & begin anticoagulation [1] 5) postpone MRI until 8 weeks after stent placement [8] 6) postpone elective surgery for: [20] a) 4-6 weeks for recipients of bare-metal stents - 14-30 days if stent placed for stable coronary artery disease [1] b) 6-12 months for recipients of drug-eluting stents [1,57,58], unless benefit of elective surgery outweighs risk - 3-6 months if stent placed for stable coronary artery disease [1] - AHA [57] & NEJM [88] recommend delay of at least 6 months - risk stabilizes after 6 months [39] c) no consensus on antiplatelet therapy (DAPT or single agent therary) & elective surgery in patients with coronary stents [65] 7) urgent surgery: [20] a) discontinue clopidogrel - no association between adverse events & continuation of antiplatelet therapy [39] b) continue aspirin unless significant risk of bleeding * no bleeding risk * MKSAP18 [1] recognizes dual anti-platelet therapy for at least 6 months except for bare metal stent placed after PCI in the absence of acute coronary syndrome; in that case duration is 1 month [1] Notes: 1) Drug-eluting stents: (2007) [15] - FDA has approved sirolimus-eluting stents to further diminish the rate of restenosis. [3,4] - sirolimus-eluting stents are better than paclitaxel-eluting stents [6,9,18] or bare stents [12,18,19] - superiority of sirolimus-eluting stent sustained for at least 5 years [23] - cost-effectiveness of drug-eluting stents in question [22] - sirolimus-eluting stents are better than zotarolimus- eluting stents [26] - cobalt-chromium everolimus-eluting stents (CoCr-EES) carry lower risks for thrombosis than other types of stents [28] - newer drug-eluting stents carry lowest risk of thrombosis, 1% at 1 & 3 years vs 2% for bare metal stents & older drug-eluting stents at 3 years [43] - drug-eluting stents are overused on patients at low risk for restenosis [32] - everolimus-eluting stents most effective for patients with diabetes mellitus [33] - zotarolimus-eluting stent - Xience is a thin-strut stent that elutes sirolimus months after the polymer coating is gone is noninferior to an already-marketed everolimus-eluting stent at 1 year [64] - biodegradable-polymer, ultrathin-strut (60-80 uM) sirolimus- eluting stent with similar 5 years outcomes to durable-polymer, thin-strut (81 uM) everolimus-eluting stent [73] - drug-eluting coronary stents have reduced rates of restenosis & repeat revascularization compared with bare-metal stents, but 1st-generation drug-eluting stents are associated with higher rates of stent thrombosis than bare metal stents [78] - 2nd-generation drug-eluting stents are safer than bare metal stents [78] 2) stent manufacturers - Taxus, Boston Scientific Corp. - Cypher, Johnson & Johnson's Cordis Corp. - Abbott XIENCE Xpedition [36,64] - Medtronic Comercial Ltd (zotarolimus-eluting stent) 3) resorbable stent to dissolve leaving nothing behind to trigger thrombosis, [17] contains Mg+2 - Absorb GT1 Bioresorbable Vascular Scaffold (FDA-approved March 2016 [54] - Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), releases everolimus to limit growth of scar tissue, is gradually absorbed by the body in ~3 years (FDA-approved July 2016) [54] - increased rates of device thrombosis with bioresorbable vascular scaffolds [63] - MiStent bioabsorbable polymer-based drug-eluting stent associated with with zero thrombosis at 5 years & a favorable long-term safety profile [69] - Absorb GT1 Bioresorbable Vascular Scaffold (BVS) associated with increased adverse cardiac events relative to metallic XIENCE drug-eluting stent [62] - BVS taken off the market by Abbott in Sept 2017 due to risks for major cardiac events & stent thrombosis [68] - thin-strut (60-um) polymer sirolimus-eluting stent reduces target-lesion failure at 1 year [67] - hybrid approach borrowing from both conventional metallic stents & fully absorbable scaffolds [87] 4) New stents in development: [15] a) a stent that elutes cbemotactic factor(s) for arterial repair b) a super-thin stent that uses a novel drug to prevent formation of scar tissue

Related

Arterial Revascularization Therapy Study (ARTS) percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI)/coronary stent vs CABG

General

vascular surgery cardiac surgery (heart surgery) vascular stent/vascular stenting

References

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