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particular with respect to lower risks of stent thrombosis and recur-
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particular with respect to lower risks of stent thrombosis and recur- rent MI. In two recent trials—the Effect of biolimus-eluting stents with biodegradable polymer vs. bare-metal stents on cardiovascular events among patients with AMI (COMFORTABLE AMI) trial 149 and the Everolimus-Eluting Stents Versus Bare-Metal Stents in ST- Segment Elevation Myocardial Infarction (EXAMINATION) trial 150 —new-generation DES have been shown to be superior to BMS in patients with AMI, mostly in terms of need for reintervention. In the latter trial, the recently released 5 year follow-up results showed a reduction in all-cause mortality by DES as compared to BMS. 151 In the Norwegian Coronary Stent (NORSTENT) trial, 152 9013 patients undergoing PCI (26% with STEMI) were randomized to DES or BMS. There were no differences in the incidence of the pri- mary endpoint (composite of death from any cause or non-fatal spontaneous MI) after a median follow-up of 5 years. However, DES were associated with lower rates of definite stent thrombosis (0.8% vs. 1.2%; P = 0.0498) and of target lesion and any repeat revasculariza- tion (16.5% vs. 19.8%; P < 0.001). 152 Deferring stenting in primary PCI has been investigated as an option to reduce microvascular obstruction (MVO) and preserve microcirculatory function. Two small studies recently found opposite results in the effect of deferred stenting on cardiac magnetic reso- nance (CMR) imaging-measured MVO. 153 , 154 In the larger DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction – Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarc- tion (DANAMI 3-DEFER) trial, 155 in 1215 STEMI patients, deferred stenting (48 h after the index procedure) had no effect on the pri- mary clinical outcome (composite of all-cause mortality, non-fatal MI, or ischaemia-driven revascularization of non-IRA lesions). Routine deferred stenting was associated with a higher need for target vessel revascularization. Based on these findings, routine use of deferred stenting is not recommended. 5.2.1.3 Thrombus aspiration A number of small-scale or single-centre studies and one meta-analysis of 11 small trials 156 suggested that there could be benefits from routine manual thrombus aspiration during primary PCI. Recently, two large (>10 000 and >7000 patients) randomized controlled trials, which were adequately powered to detect superiority of routine manual thrombus aspiration versus conventional PCI, showed no benefit on clinical outcomes of routine aspiration strategy overall. 157 – 160 A safety concern emerged in the Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) trial (n = 10 732), with an increase in the risk of stroke. 161 In the subgroup with high thrombus burden [TIMI (Thrombolysis in Myocardial Infarction) thrombus grade 3], thrombus aspiration was associated with fewer cardiovascular deaths [170 (2.5%) vs. 205 (3.1%); hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.65–0.98; P = 0.03] and with more strokes or transient ischaemic attacks [55 (0.9%) vs. 34 (0.5%); odds Table 5 Summary of important time targets ECG = electrocardiogram; FMC = first medical contact; PCI = percutaneous cor- onary intervention; STEMI = ST-segment elevation myocardial infarction a ECG should be interpreted immediately. 134 ESC Guidelines Downloaded from https://academic.oup.com/eurheartj/article-abstract/39/2/119/4095042 by E-Library Insel user on 07 February 2018 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . ratio 1.56, 95% CI 1.02–2.42, P =0.04]. However, the interaction P val- ues were 0.32 and 0.34, respectively. 162 In the Taste 157 and TOTAL trials 159 , 1–5% of randomized patients crossed over from PCI alone to thrombus aspiration. Based on these data and the results of a recent meta-analysis, 162 routine thrombus aspiration is not recommended, but in cases of large residual throm- bus burden after opening the vessel with a guide wire or a balloon, thrombus aspiration may be considered. 5.2.1.4 Multivessel coronary revascularization Multivessel disease is common (in approximately 50%) in patients with STEMI. 163 , 164 While it is recommended to always treat the IRA, evidence supporting immediate (preventive) revascularization of additional significant coronary stenoses is conflicting. It has been reported that patients with extensive CAD in vessels remote from the IRA have lower rates of ST-segment recovery and an adverse prognosis following primary PCI. 163 Data from the US National Cardiovascular Data Registry and New York State’s Percutaneous Coronary Interventions Reporting System suggested an increase in adverse events, including mortality, in patients treated with immedi- ate multivessel revascularization versus IRA PCI only, while patients in cardiogenic shock were excluded from the analysis. 165 , 166 Randomized clinical trials addressing this issue have been small (each of them included from 69 to 885 patients). One study allocated 214 STEMI patients with multivessel disease to three arms: IRA angioplasty- only, simultaneous treatment of non-IRA lesions, and staged revascula- rization of the non-IRA. At a mean follow-up of 2.5 years, patients allo- cated to IRA angioplasty-only had more major adverse cardiac events (MACE) (i.e. death, reinfarction, rehospitalization for ACS, and repeat coronary revascularization) than the patients treated with other strat- egies. 167 After this study, four randomized clinical trials have compared PCI of the IRA only vs. complete revascularization: the Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial (n = 465, 23 months follow-up), 168 the Complete Versus Lesion-Only Primary PCI Trial (CvLPRIT) (n = 296, 12 months follow-up), 169 the Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel dis- ease (DANAMI-3–PRIMULTI) trial (n = 627, 27 months follow-up), 170 and the Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With Multivessel dis- ease (Compare-Acute, n = 885, 12 months follow-up) trial. 171 PCI of non-IRA was done either during the index procedure (PRAMI and Compare-Acute), staged during hospital admission (DANAMI- 3–PRIMULTI), or any time before discharge (immediate or staged) (CVLPRIT). Indication for PCI in non-IRA was angiography-guided in lesions with 50% stenosis (PRAMI), >70% stenosis (CVLPRIT), or fractional flow reserve (FFR)-guided (DANAMI-3–PRIMULTI and Compare-Acute). Primary outcome (composite of different end- points) was significantly reduced in the complete revascularization group in all four trials. Total mortality was not statistically different in any of the four trials. Repeat revascularization was significantly reduced in the complete revascularization arm in the PRAMI, DANAMI- 3–PRIMULTI, and Compare-Acute trials. Non-fatal MI was reduced in the non-IRA PCI group only in PRAMI. The lack of significant treatment effect of non-IRA lesion intervention on death or MI was confirmed by three meta-analyses 172 – 174 (none of these meta-analyses included the Compare-Acute trial, and one 173 did not include the DANAMI-3–PRIMULTI). Based on these data, revascularization of non-IRA lesions should be considered in STEMI patients with multives- sel disease before hospital discharge. As the optimal timing of revascu- larization (immediate vs. staged) has not been adequately investigated, no recommendation in favour of immediate vs. staged multivessel PCI can be formulated. 5.2.1.5 Intra-aortic balloon pump The Counterpulsation to Reduce Infarct Size Pre-PCI-Acute Myocar- dial Infarction (CRISP AMI) trial showed no benefit from a routine intra-aortic balloon pump (IABP) in anterior MI without shock, 175 but there was increased bleeding, which is consistent with previous data regarding the role of IABP in high-risk STEMI without cardiogenic shock. 176 In addition, a recent randomized trial showed that IABP did not improve outcomes in MI with cardiogenic shock. 177 Haemody- namic support in patients with cardiogenic shock is discussed in Chapter 8. Procedural aspects of the primary percutaneous cor- onary intervention strategy Recommendations Class a Level b IRA strategy Primary PCI of the IRA is indicated. 114 , 116 , 139 , 140 I A New coronary angiography with PCI if indicated is recommended in patients with symptoms or signs of recurrent or remaining ischaemia after primary PCI. I C IRA technique Stenting is recommended (over balloon angio- plasty) for primary PCI. 146 , 147 I A Stenting with new-generation DES is recom- mended over BMS for primary PCI. 148 – 151 , 178 , 179 I A Radial access is recommended over femoral access if performed by an experienced radial operator. 143 – 145 , 180 I A Routine use of thrombus aspiration is not recommended. 157 , 159 III A Routine use of deferred stenting is not recommended. 153 – 155 III B Non-IRA strategy Routine revascularization of non-IRA lesions should be considered in STEMI patients with mul- tivessel disease before hospital discharge. 167 – 173 IIa A Non-IRA PCI during the index procedure should be considered in patients with cardiogenic shock. IIa C CABG should be considered in patients with ongoing ischaemia and large areas of jeopardized myocardium if PCI of the IRA cannot be performed. IIa C CABG = coronary artery bypass graft surgery; DES = drug-eluting stent; IRA = infarct-related artery; PCI = percutaneous coronary intervention; STEMI = ST- segment elevation myocardial infarction. a Class of recommendation. b Level of evidence. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . ESC Guidelines 135 Downloaded from https://academic.oup.com/eurheartj/article-abstract/39/2/119/4095042 by E-Library Insel user on 07 February 2018 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 5.2.2 Periprocedural pharmacotherapy 5.2.2.1 Platelet inhibition Patients undergoing primary PCI should receive DAPT, a combina- tion of aspirin and a P2Y 12 inhibitor, and a parenteral anticoagulant. Aspirin can be given orally including chewing, or i.v. to ensure com- plete inhibition of thromboxane A2-dependent platelet aggregation. The oral dose of plain aspirin (non-enteric-coated formulation) should preferably be 150–300 mg. There are few clinical data on the optimal i.v. dosage. Given a 50% oral bioavailability of oral aspirin, a corresponding dose is 75–150 mg. Pharmacological data suggest that this lower dose range avoids inhibition of cyclooxygenase-2- dependent prostacyclin. A recent randomized study showed that a single dose of 250 or 500 mg acetylsalicylic acid i.v. compared to 300 mg orally was associated with a faster and more complete inhibi- tion of thromboxane generation and platelet aggregation at 5 min, with comparable rates of bleeding complications. 181 There is limited evidence with respect to when the P2Y 12 inhibitor should be initiated in STEMI patients. The Administration of Ticagrelor in the Cath Lab or in the Ambulance for New ST Elevation Myocardial Infarction to Open the Coronary Artery (ATLANTIC) trial 182 is the only randomized study testing the safety and efficacy of different timings of P2Y 12 inhibitor initiation in STEMI. In this trial, patients were randomized to receive ticagrelor either during transfer to a primary PCI centre or immediately before angiography. 182 The median difference between the two tested loading treatment strat- egies was only 31 min. This study failed to meet the pre-specified pri- mary endpoint in terms of improved ST-segment elevation resolution or TIMI flow before intervention. Rates of major and minor bleeding events were identical in both treatment arms. While the evidence of a clinical benefit of P2Y 12 inhibitor pre-treatment in this setting is lacking, early initiation of a P2Y 12 inhibitor while the patient is being transported to a primary PCI centre is common prac- tice in Europe and is consistent with the pharmacokinetic data. Furthermore, early treatment with high-dose clopidogrel was supe- rior to in-catheterization laboratory treatment in observational stud- ies and one small randomized trial. 183 – 185 In all, the data suggest that the earliest administration may be preferable to achieve early efficacy, tải về 4.91 Mb. Chia sẻ với bạn bè của bạn:
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