*3.1.4.1. Baseline characteristics*

In general population the mean age was 59 ± 10.6 (31–88) years; 92 (67.2%) were men. The inci‐ dence of diabetes mellitus in study cohort was 22.1%. The MS primary group included 67 patients, and the MS staged group 69 patients. The elective procedure in the MS staged group was performed on average 10.1 ± 5.1 days after the primary PCI. We evaluated the results in two study groups (MS primary vs. MS staged).

**Table 1** shows the baseline clinical and demographic characteristics in study groups. Patients of MS primary and MS staged group were comparable for all clinical and demographic char‐ acteristics. The majority of patients in both groups were male, had hypertension and acute heart failure Killip 1.

**Table 2** shows the baseline angiographic characteristics and special features of PCI. Mean SYNTAX score in the groups did not exceed 19 points, which corresponds to an intermediate


**Table 1.** Patient clinical and demographic characteristics.


**Table 2.** Baseline angiographic characteristics and special features of procedures.

severity of coronary lesions. About half of the patients in each group had 3‐vessel CAD. Total mean stent length in each group exceeded 57 mm. There were no statistically significant differences between angiographic characteristics in the groups.

#### *3.1.4.2. Events*

Follow‐up was completed in 100% of patients. Over the 12‐month observation, there were no significant differences in frequency of adverse cardiovascular events among groups. After a follow‐up of 12 months, there was only one noncardiac death in MS staged group (colon can‐ cer). At the same time, fatality outcomes in the groups did not exceed 3% (**Table 3**). Survival free of MI and re‐PCI was 62 (92.5%) patients in MS primary group and 67 (97.1%) in MS staged group (p>0.05).


*of them within 30 days* 0 0 1 100 –

*of them within 30 days* 1 25 2 100 –

4 5.9 3 4.3 0.7

4 5.9 2 2.9 0.7

**Table 3.** 12‐month outcomes.

**Combined endpoint (cardiac** 

**Stent thrombosis (on the number of patients)**

**death + MI + TVR)**

#### *3.1.5. Discussion*

severity of coronary lesions. About half of the patients in each group had 3‐vessel CAD. Total mean stent length in each group exceeded 57 mm. There were no statistically significant

**Variables MS primary (n = 67) MS staged (n = 69) Р**

**Variables MS primary (n = 67) MS staged (n = 69) Р**

**Age, years** 58.6 ± 10.2 59.1 ± 11.1 0.6 **Male** 48 71.6 43 62.3 0.3 **LVEF, %** 50.7 ± 9.2 51.8 ± 7.3 0.5 **Hypertension** 64 94 61 88.4 0.4 **Diabetes mellitus** 16 23.9 14 20.3 0.8 **Peripheral artery disease** 13 19.4 20 29 0.3 **Previous MI** 10 14.9 4 5.8 0.2 **Previous stroke** 0 0 2 2.9 0.5 **Acute heart failure (Killip II)** 10 14.9 8 11.6 0.8

**Three‐vessel disease** 32 47.8 31 44.9 0.9 **SYNTAX score** 19.1 ± 7.9 18.6 ± 7.1 0.9 **SYNTAX score ≥23 points** 18 26.9 16 23.2 0.8 **Contrast medium, ml** 325.8 ± 110.2 373 ± 154.5 0.06 **Mean number of stents** 2.6 ± 0.5 2.7 ± 0.6 0.7 **Total mean stent length, mm** 57.5 ± 13.4 58 ± 16.2 0.6 **Mean stent diameter, mm** 3.3 ± 0.4 3.3 ± 0.5 0.3

**n % n %**

**n % n %**

Follow‐up was completed in 100% of patients. Over the 12‐month observation, there were no significant differences in frequency of adverse cardiovascular events among groups. After a follow‐up of 12 months, there was only one noncardiac death in MS staged group (colon can‐ cer). At the same time, fatality outcomes in the groups did not exceed 3% (**Table 3**). Survival free of MI and re‐PCI was 62 (92.5%) patients in MS primary group and 67 (97.1%) in MS

differences between angiographic characteristics in the groups.

**Table 2.** Baseline angiographic characteristics and special features of procedures.

**Table 1.** Patient clinical and demographic characteristics.

*3.1.4.2. Events*

22 Interventional Cardiology

staged group (p>0.05).

The main finding of the present randomized study is that after a follow‐up of 12 months, in STEMI patients with multiple coronary lesions treated with multivessel PCI (primary and staged (10.1 ± 5.1 days)) with second‐generation DES (Resolute Integrity), revascularization had satisfactory outcomes in two different strategies of PCI despite the initial severity of patients, including a high frequency of occurrence of diabetes (22.1%) and the average length of the stented segment 57.8 ± 14.6 mm.

According to previous guidelines, PCI should be performed only in IRA, at least in patients without cardiogenic shock [25]. This recommendation was based on the hypothesis that single‐vessel PCI has a more favorable benefit‐to‐risk ratio and better financial implications. Some studies suggest that the more conservative strategy of treating only the IRA could avoid complications arising from longer procedures, such as the larger use of contrast medium with a potentially increased risk of contrast‐induced nephropathy, the increased administration of radiation, as well as the danger of ischemia in noninfarcted myocardial regions [15, 18].

There is no randomized data to definitely answer the issues about the specific scientific merits of any of the approaches (multivessel stenting in primary PCI or staged PCI) [26]. And there is no evidence base for second‐generation DES in STEMI patients with multivessel CAD, but in recent years, with the development of new advanced devices the outcome of multivessel PCI has markedly improved [17, 19].

However, the results of recent randomized trials challenged these recommendations [1, 4, 27]. The approach to the choice of revascularization strategy in patients with STEMI and MVCAD was detailed in 2014 ESC/EACTS Guidelines on myocardial revascular‐ ization [4]. The basic position of the recommendations is that the primary percutaneous coronary intervention (PCI) should be limited to infarct‐related artery (IRA) (excepting car‐ diogenic shock or persistent ischemia, IIa class, level of evidence B) [4]. However, in patients with ischemia in noninfarct area primary PCI should be also performed for nonculprit lesions up to one week after admission (evidence grade IIa, Level B). Moreover, it is possible to carry out revascularization of nonculprit lesions at the time of primary PCI (evidence IIb class, level B) [20]. These standards came with the publication of the data from a random‐ ized trial describing the preventive importance of PCI in nonculprit lesions (PRAMI) [1]. Nevertheless, the PRAMI trial does not respond to a key question—in which cases do we need to perform MS?

To the best of our knowledge the present study is the first that estimates throughout a follow‐up the multivessel stenting during primary PCI and multivessel staged (10.1 ± 5.1 days) PCI with second‐generation DES in STEMI patients with multivessel disease. We found that aggressive approach (multivessel stenting at the time of primary PCI or staged PCI) in STEMI patients with Resolute Integrity stents is associated with low risk of MACE in 12‐month follow‐up period. It is clear when compared with the published data. Twelve‐month incidence of MACE in STEMI patients with multivessel disease in general cohort (BMS and DES) is 23.9–28%, re‐MI 1.6–8.8%, death 3.3–6.3%, ST 1.8–4.3% [12, 15, 18]. In our study, we observed 12‐month MACE, re‐MI, death, and ST in 5.1, 5.1, 2.9, and 4.4% of patients, respectively.

Indeed, the inflammatory reaction arising during acute coronary syndromes and responsi‐ ble for plaque instability is not limited to the culprit lesion, but involves the entire coronary tree [28]. Our results suggest that the multivessel approach (primary and staged) with second‐ generation DES is safe and possibly less expensive than an incomplete approach by reducing the probability of further unplanned procedures. We suppose that multivessel revasculariza‐ tion could decrease the risks and discomfort for patients associated with new unscheduled procedures. This hypothesis was also confirmed in the PRAMI trial. In PRAMI trial it was shown that in patients with STEMI and multivessel coronary artery disease undergoing infarct artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery [20].

In two other randomized trials, investigators have specifically assessed the value of preven‐ tive PCI in patients with acute STEMI undergoing PCI in the infarct artery. In one study, 69 patients were randomly assigned (in a 3:1 ratio) to preventive PCI (52 patients) or no pre‐ ventive PCI (17 patients) [29]. At 1 year, in the preventive‐PCI group, there were nonsignifi‐ cant reductions in the rates of repeat revascularization (17 and 35%, respectively) and cardiac death or myocardial infarction (4 and 6%, respectively). In the other trial, 214 patients were randomly assigned to one of three groups: no preventive PCI (84 patients), immediate pre‐ ventive PCI (65 patients), and staged preventive PCI performed during a second procedure about 40 days later (65 patients) [17]. At 2.5 years, the rate of repeat revascularization was less frequent in the immediate—and staged—preventive‐PCI groups combined, as compared with the group receiving no preventive PCI (11 and 33%, respectively), and there was a non‐ significant decrease in the rate of cardiac death (5 and 12%, respectively). The results of these studies are consistent with those of our study.

#### *3.1.6. Conclusions*

However, the results of recent randomized trials challenged these recommendations [1, 4, 27]. The approach to the choice of revascularization strategy in patients with STEMI and MVCAD was detailed in 2014 ESC/EACTS Guidelines on myocardial revascular‐ ization [4]. The basic position of the recommendations is that the primary percutaneous coronary intervention (PCI) should be limited to infarct‐related artery (IRA) (excepting car‐ diogenic shock or persistent ischemia, IIa class, level of evidence B) [4]. However, in patients with ischemia in noninfarct area primary PCI should be also performed for nonculprit lesions up to one week after admission (evidence grade IIa, Level B). Moreover, it is possible to carry out revascularization of nonculprit lesions at the time of primary PCI (evidence IIb class, level B) [20]. These standards came with the publication of the data from a random‐ ized trial describing the preventive importance of PCI in nonculprit lesions (PRAMI) [1]. Nevertheless, the PRAMI trial does not respond to a key question—in which cases do we

To the best of our knowledge the present study is the first that estimates throughout a follow‐up the multivessel stenting during primary PCI and multivessel staged (10.1 ± 5.1 days) PCI with second‐generation DES in STEMI patients with multivessel disease. We found that aggressive approach (multivessel stenting at the time of primary PCI or staged PCI) in STEMI patients with Resolute Integrity stents is associated with low risk of MACE in 12‐month follow‐up period. It is clear when compared with the published data. Twelve‐month incidence of MACE in STEMI patients with multivessel disease in general cohort (BMS and DES) is 23.9–28%, re‐MI 1.6–8.8%, death 3.3–6.3%, ST 1.8–4.3% [12, 15, 18]. In our study, we observed 12‐month MACE, re‐MI,

Indeed, the inflammatory reaction arising during acute coronary syndromes and responsi‐ ble for plaque instability is not limited to the culprit lesion, but involves the entire coronary tree [28]. Our results suggest that the multivessel approach (primary and staged) with second‐ generation DES is safe and possibly less expensive than an incomplete approach by reducing the probability of further unplanned procedures. We suppose that multivessel revasculariza‐ tion could decrease the risks and discomfort for patients associated with new unscheduled procedures. This hypothesis was also confirmed in the PRAMI trial. In PRAMI trial it was shown that in patients with STEMI and multivessel coronary artery disease undergoing infarct artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct

In two other randomized trials, investigators have specifically assessed the value of preven‐ tive PCI in patients with acute STEMI undergoing PCI in the infarct artery. In one study, 69 patients were randomly assigned (in a 3:1 ratio) to preventive PCI (52 patients) or no pre‐ ventive PCI (17 patients) [29]. At 1 year, in the preventive‐PCI group, there were nonsignifi‐ cant reductions in the rates of repeat revascularization (17 and 35%, respectively) and cardiac death or myocardial infarction (4 and 6%, respectively). In the other trial, 214 patients were randomly assigned to one of three groups: no preventive PCI (84 patients), immediate pre‐ ventive PCI (65 patients), and staged preventive PCI performed during a second procedure about 40 days later (65 patients) [17]. At 2.5 years, the rate of repeat revascularization was

death, and ST in 5.1, 5.1, 2.9, and 4.4% of patients, respectively.

need to perform MS?

24 Interventional Cardiology

artery [20].

There is no doubt about the fact that the results of revascularization in STEMI patients with multivessel CAD may be improved by using the latest generation of DES (Resolute Integrity™ Stent, Medtronic). It is clear that further research in this area should be directed to the search criteria according to which it would be possible to choose a strategy of revascularization for PCI differentiated. Also important is to have an objective angiographic criteria indicat‐ ing sufficient volume of revascularization performed in the hospital period with primary or staged multivessel stenting. In this context, in the next section of this chapter will be pre‐ sented the relevant data of our own study—prognostic role of initial and residual SYNTAX score in STEMI patients after primary PCI.
