Page 209 - fbkCardioDiabetes_2017
P. 209
Cardio Diabetes Medicine 2017 185
dial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months) occurred in 10.0% of
the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45;
95% confidence interval: 0.24 to 0.84; p=0.009), though statistically not signficant. A trend toward benefit
was seen early after complete revascularization (p=0.055 at 30 days). There was no reduction in ischemic
burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced
nephropathy, or stroke between the groups.
Both these trials were not in line with the current practice of physiological (FFR) or histopathological (IVUS/
OCT) assessment of coronary stenosis and angiographic assessment was used as criteria for non-culprit
PCI. uncertainty remains about whether PCI of noninfarct- related vessels should be done during primary
PCI (as was done in the PRAMI trial) or as a staged procedure, either during the index admission or within
2 months of primary PCI, which most large registries indicate.
Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarc-
tion The PRImary PCI in MULTIvessel Disease (DANAMI3-PRIMULTI) trial compared a strategy of fractional
flow reserve (FFR)-guided complete revascularisation 2 days after initial PCI of the infarct-related artery with
one of no further invasive treatment after PCI[13]. Events comprising the primary endpoint were recorded in
68 (22%) patients who had PCI of the infarct-related artery only and in 40 (13%) patients who had complete
revascularisation (hazard ratio 0∙56, 95% CI 0∙38–0∙83; p=0∙004), this was driven by need for repeat revascu-
larisation. The use of FFR guidance changed the initial management plan substantially because, in almost a
third of patients allocated to complete revascularisation, FFR showed that the nonculprit-related lesions that
had appeared significant on angiography were non-significant led to fewer interventions. FFR was done 2
days after in index event to avoid the risk of invalid FFR measurements inferred from any acute changes in
macrovascular tone or microvascular flow obstruction.
In the PRAGUE-13 trial[14], 214 STEMI patients with double or triple vessel disease were randomly assigned to
culprit-lesion-only PCI or complete revascularization (non-culprit vessel PCI as a staged procedure within 3–40
days after the index event). Patients with stable angina for more than 1 month prior to the vent were excluded
from the trial. But the result indicate no significant difference between the two groups in hospitalization for
all-cause death, nonfatal MI and stroke, which occurred in 16% of patients in the multivessel PCI group vs.
13.9% in the conservative therapy group (HR = 1.35; 95% CI, 0.66-2.74) and unstable angina (P =0.193) or hos-
pitalization for HF (P =0.672), CV mortality (P =0.699) and revascularization for a noninfarct artery (P =0.089).
This study did not include ischaemia-driven revascularisation as part of the endpoint and was underpowered
to detect differences in hard endpoints. It is generally regarded as a trial of less significant non-IRA lesions.
Fig.4: Major randomized controlled trials comparing complete vs. culprit lesion only revascularization in pa-
tients presenting with ST-segment elevation myocardial infarction and multi-vessel coronary artery disease
These trials have led drastic changes in PCI recommendations by American and European societies[15,16],
modified the recommendation for non-culprit vessel PCI in case of hemodynamically stable MVD-STEMI
from class III (harmful) to Class IIb (might be considered), either at the time of primary PCI or as a planned,
staged procedure. The writing committee emphasizes that this change should not be interpreted as endors-
ing the routine performance of multivessel PCI in all patients with STEMI and multivessel disease. Rather,
when considering the indications for and timing of multivessel PCI, physicians should integrate clinical data,
lesion severity/complexity, and risk of contrast nephropathy to determine the optimal strategy. Guidelines
Cardio Diabetes Medicine

