Coronary Figure 1: STEMI of the Anterior Wall: Single Vessel Disease and Multivessel Disease
A, B: Coronary angiography documented a single vessel disease with a subtotal proximal occlusion of the LAD with TIMI I flow in a 75-year-old patient. C, D: Anterior wall STEMI showing a long segment 95 % stenosis of the proximal LAD (culprit lesion). Coronary angiography documented additional lesions (*) of 50–70 % in the ostial LAD, 70–90 % in the mid and distal LCx, 90 % in the mid RCA and 50–70 % in the distal segment of RCA. LAD = left anterior descending; TIMI = thrombolysis in myocardial infarction; STEMI = ST elevation myocardial infarction; LCx = left circumflex; RCA = right coronary artery.
Procedure time, fluoroscopy dose and contrast volume increased in these patients, thereby not affecting complications like procedurerelated stroke, bleeding and CIN. However, this trial was not designed to address the question of immediate versus staged preventive PCI in STEMI multivessel disease.10 In The Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease (DANAMI-3 PRIMULTI), 627 STEMI patients with MVCD were randomly assigned to undergo PPCI of the culprit vessel only (n=313) or staged complete fractional flow reserve (FFR) guided PCI (n=314) before discharge. A FFR value ≤0.80 was considered haemodynamically significant and complete revascularisation was performed a median of 2 days after initial PCI.11 After a median FUP of 27 months the primary combined endpoint of all-cause mortality, re-infarction and ischaemia-driven revascularisation was significantly reduced in the staged FFR-guided complete revascularisation group (HR: 0.56, 95 % CI: 0.38–0.83, 0=0.004). This was mainly driven by a 69 % reduction of repeat revascularisation of the N-IRA (HR: 0.31, 95 % CI: 0.18–0.53, p<0.0001). This effect was more pronounced in young men with anterior MI. However, these subgroups were too small to draw firm conclusions. There was no difference concerning all-cause mortality and non-fatal re-infarction. Furthermore, there were no significant differences of procedure-related complications (MI, bleeding requiring transfusion, stroke or CIN). This trial failed to show differences in hard clinical endpoints like mortality and re-infarction because of a lack of power and like PRAMI, it did not address the question of optimal timing of preventive multivessel PCI.11 Another RCT focusing on preventive MVPCI in STEMI is the Complete versus Lesion-only Primary PCI (CvLPRIT) trial, including 306 patients
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for IRA PCI only (n=146) or complete revascularisation (n=150) during hospital stay, either during PPCI (recommended, 64 %) or staged before discharge. The primary outcome of MACE (all-cause mortality, recurrent MI, heart failure, ischaemia-driven revascularisation) was significantly reduced in favour of preventive PCI (10 % versus 21.2 %, HR 0.45, 95 % CI 0.24–0.84, p=0.009), leading to a 55 % relative risk reduction in the primary endpoint.12 The individual components of the primary outcome were lower in the complete revascularisation arm, although not statistically significant. Again, Kaplan–Meier curves showed early divergence, with a continuing separation of groups during FUP. There were no differences in the occurrence of serious adverse events between the two groups. Similar to PRAMI and DANAMI-3 PRIMULTI, this trial was not powered to show significant differences in hard clinical endpoints. Furthermore, as almost two thirds of patients were revascularised during initial PCI, timing of preventive revascularisations remains unclear. Like in PRAMI, the CvLPRIT trial did not evaluate the role of FFR for MVPCI.12 Finally, the most recent RCT to address this issue was the Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients with MVD (COMPARE-ACUTE) trial, which enrolled 885 patients. Patients were randomly assigned in a 2:1 fashion to receive either FFR-guided complete revascularisation (n=295) or culprit-only revascularisation (n=590).13 Complete revascularisation was performed in 83.4 % of patients during PPCI in lesions with FFR ≤0.80. The primary endpoint was a composite of all-cause mortality, non-fatal MI, any revascularisation, and cerebrovascular events (MACCE) at 12 months. In COMPARE-ACUTE, MACCE was significantly reduced in preventive FFR guided PCI (23 versus 121 patients, HR: 0.35, 95 %: CI 0.22–0.55, p<0.001), an effect which was mainly driven by a decreased need for revascularisation (HR 0.32, 95 % CI 0.20–0.54, p<0.001). The other components of the primary endpoint did not differ significantly. As there were no significant differences in bleeding, cerebrovascular events and stent thrombosis, this study showed that FFR could be safely performed in PPCI. However, also this trial was not powered to show differences in hard clinical end points.13
Timing of Revascularisation So far, four different strategies of revascularisation are possible for treatment of MVCD in STEMI: (1) complete revascularisation at the index procedure; (2) complete revascularisation as a staged procedure before discharge; (3) complete revascularisation as a staged procedure after discharge but within a few weeks (not symptom driven); and (4) culprit vessel only PCI. Of the aforementioned RCTs, none included both staged and immediate complete revascularisation and analysed them separately. Politi et al. conducted a small RCT earlier, randomising 214 patients to IRA PCI only (n=81), complete revascularisation during index procedure (n=65), or staged 2 months after index procedure (n=65).14 Patients undergoing staged or immediate procedures had a 63 % (p=0.003) and a 60 % (p=0.002) risk reduction of MACE after a median FUP of 2.5 years, mainly driven by a lower incidence of in-hospital death, re-PCI and re-hospitalisation. There was no significant difference between the two different MVPCI strategies concerning MACE and the safety outcomes (length of hospital stay, CIN). Primarily this study suffered from a small sample size.14 A post-hoc analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, originally designed to compare bivalirudin to heparin plus GbIIb/IIIa inhibitors during primary P-PCI, retrospectively evaluated 275 patients
INTERVENTIONAL CARDIOLOGY REVIEW
06/09/2018 22:54