Vol.48 - Número 3, Julio/Septiembre 2019 Imprimir sólo la columna central

Percutaneous coronary intervention and coronary artery
bypass surgery in patients with trunk disease

MIRTHA LÓPEZ RAMÍREZ, MANUEL NAFEH ABI-RESK, ABEL LEYVA QUERT,
TAMARGO BARBEITO; TEDDY OSMIN; HIDALGO GARCÉS, IVANIA DOMITILA,
JOHN KAROL RAMÍREZ, DAYMIR LÓPEZ RAMÍREZ, NOEL PEÑA FERNÁNDEZ
Hospital Hermanos Ameijeiras. La Habana, Cuba
E-mail
Recibido 06-MAY-19 – ACEPTADO después de revisión el 21-JUNIO-2019.
There are no conflicts of interest to disclose.

 

ABSTRACT

It is important to know the evolution of patients with left main coronary artery disease after a percutaneous intervention or myocardial revascularization surgery. Objective: To describe the results of myocardial revascularization and percutaneous coronary intervention in patients with left main coronary artery disease in the "Hermanos Ameijeiras" hospital.
Method: A comparative longitudinal descriptive observational research was conducted with retrospective data collected with a total of 138 patients; 41 patients with left main coronary artery disease who underwent percutaneous coronary intervention in the period of time 2010-2016 and 97 treated by coronary artery bypass grafting 2012-2016, in the Cardiology and Cardiovascular Surgery service of the Cardiocentro of the Hermanos Ameijeiras Surgical Clinical Hospital.
Results: Acute periprocedural myocardial infarction was more frequent in the presence of coronary artery bypass grafting (p = 0.028). Previous myocardial infarction and dyslipidemia were more frequent variables in percutaneous coronary intervention. The need for revascularization of the target vessel once a year was more frequent in patients treated by intervention (9.8%) compared to surgery (2.1%) (p = 0.043).
Conclusions: The majority of patients treated with percutaneous coronary intervention presented less anatomical complexity and complications. Acute periprocedural myocardial infarction occurred more frequently in patients treated with coronary artery bypass grafting. The need for new revascularization was greater in patients treated by percutaneous intervention. There were no differences in overall survival and patients were free of adverse events according to the type of revascularization procedure.
Key words: Left main coronary artery disease. Myocardial revascularization surgery. Coronary artery bypass grafting. Percutaneous coronary intervention.

 

INTRODUCTION
The treatment of ischemic heart disease is based on three fundamental pillars: pharmacological treatment, percutaneous coronary intervention and heart surgery [1]. Within the framework of coronary artery disease requiring revascularization procedures, there is left main coronary artery disease (LMCAD).

LMCAD is a reduction greater than 50% in the left main coronary artery diameter. Present in 4 to 6% of coronary angiographies, it is usually associated to multivessel disease (70-80% of cases). Ostial LMCA lesions are 17.9% of trunk lesions and are more frequent in women [2]. It has a poor prognosis with pharmacological treatment, with a high mortality close to 50% in three years, and is considered the most advanced manifestation of coronary atherosclerosis.

LMCA is the origin of the anterior descending and circumflex arteries irrigating the left ventricular myocardium. Total occlusion of this segment is incompatible with life [3].

Since the 1980s, myocardial revascularization (MRV) presents benefits in survival and improvement in clinical symptoms, placing it as the standard therapy for these patients and has been considered the best therapeutic option for this disease, essentially based on the CASS registry results [4,5].

There are characteristics that negatively influence the success of percutaneous coronary intervention (PCI) in LMCA lesions: in 80% of cases, LMCAD affects the bifurcation, which presents more risk of restenosis, and 80% of patients also have multivessel CAD (MCAD). It has been proven that intervention could be efficient in the cases LMCA compromise that is not anatomically unfavorable for angioplasty, assessed by low or intermediate SYNTAX score [6,7].

Several comparative studies on surgical revascularization against percutaneous coronary intervention [1,6,8] have shown that both strategies separately cannot solve the whole range of patients with CAD, including LMCA. It should be taken into account that MRV displays a higher percentage of full revascularization in comparison to percutaneous coronary intervention (PCI); and that in MRV, the complexity of proximal coronary lesions influences results less.

Studies comparing PCI against MRV on LMCA [9,10,11] are constituted by heterogeneous populations and clinical scenarios (protected and unprotected LMCA, elective, urgent, diabetic, nondiabetic, drug-eluting of different generations), reflecting the existing practice, but makes the analysis of results difficult, besides emphasizing the fact that they were conducted in different contexts to this investigation. The percutaneous treatment of these lesions is still one of greatest challenges for interventionist cardiology currently.

Clinical practice guidelines advise first, MRV in the treatment of severe LMCAD, although PCI is equaled to MRV (class I A) in LMCAD with SYNTAX ≤22, and in 3-vessel disease in non-diabetic patients with SYNTAX ≤22 [1]. Percutaneous treatment of LMCA is a fact, and the arrival of drug-eluting stents (DES) has achieved similar results to those of surgery [6].

It is necessary to analyze and enhance, in each health care center, some significant aspects such as the percentage of peri-procedure ictus (probably more frequent in patients treated with MRV), and the evolution in the long term even with the use of “first-generation” DES, as the last-generation ones are not always available because of their high cost. Therefore, it is valuable to compare MRV and PCI results in patients with LMCAD, both in the short and long term, in the Hospital Hermanos Ameijeiras.

 

MATERIAL AND METHODS
An observational, descriptive, longitudinal, comparative study was made with data gathered retrospectively between years 2010 and 2016 and other prospective data from year 2012 to 2017, in the service of Cardiology and Cardiovascular Surgery of the Cardiocenter of the Hospital Clínico Quirúrgico Hermanos Ameijeiras.

Patients were excluded when presenting history of previous heart surgery, clinical diagnosis of cardiogenic shock, combined MRV and living patients in whom follow-up could not be conducted, or who wouldn’t cooperate with the study.

The sample was constituted by a total of 138 patients; 41 with (unprotected) LMCAD, in whom PCI was conducted with first-generation DES (paclitaxel) in the term from January 2010 to December 2016, and 97 treated by MRV from January 2012 to December 2017, in the Service of Cardiology and Cardiovascular Surgery of the Cardiocenter of the Hospital Clínico Quirúrgico Hermanos Ameijeiras.

In both methods, the patients presented a one-year follow-up. The following variables were taken into account: age, gender, body mass index (BMI), history of AMI, clinical diagnosis, functional class (FC) of angina (according to the CCS), HTN, diabetes, dyslipidemia, smoking, left ventricular ejection fraction (LVEF), co-morbidities, SYNTAX score, complications, angiographic variables, and immediate and mediate major adverse cardiac events. Data was collected during the hospital stay before surgery, in the post-operative care ward, hemodynamic lab, and in the cardiology ward; through questions, clinical history, coronary angiography reports from the hemodynamics department of the Cardiocenter in the Hospital Hermanos Ameijeiras, and death certificates. All patients had a clinical follow-up of a visit at one month, six months and one year after revascularization. The occurrence of major adverse cardiac events is documented by an interview in person or by phone, or contact with attending physicians; in the cases in which the information was obtained by phone, the patient was requested to visit to confirm the presence of the event. The data of patients were included in a worksheet prepared by the authors of the investigation.

Statistical analysis: As summary measures, absolute rate and percentage for qualitative variables were used; quantitative variables were expressed as mean±standard deviation (SD). Overall survival and survival according to adverse events by groups was estimated with the Kaplan-Meier test and the curves were compared by the Breslow test. In all hypothesis tests, a significance level of 0.05 was set.

Ethical aspects: The investigation was made following the Nuremberg Code (International Military Tribunal at Nuremberg, 1947) and the Declaration of Helsinki (18th WMA General Assembly, 1964, 1975, 1983, 1989, 2001), taking as principles respecting the anonymity of patients, their autonomy and self-determination. The patients were explained the aim of the study during the interview in their visit, and their written informed and signed consent was taken into account to include them in the research. The filing department and the Service of Hemodynamics and Cardiovascular Surgery of the Cardiocenter of the Hospital Hermanos Ameijeiras were requested their authorization to obtain access to clinical histories, under the responsibility and obligation of not divulging the information gathered.

 

RESULTS
This investigation had a sample of 138 patients, a group of 97 patients in whom MRV was conducted, and 41 who underwent PCI. In the patients treated by PCI, the average age was 64.2±10.1, similar to the patients treated by MRV, an average of 63.1±9.9. In patients treated by PCI, there was a predominance of the female gender that represented 70.7%; while in those treated by MRV, the male gender was predominant; this result was significant, p<0.001. Previous myocardial infarction was present in 32 patients treated by PCI for 78.0% and in 45 patients for 46.4% of those treated by MRV (p=0.001). Patients with percutaneous revascularization presented less sick vessels (1.6/3.0) than those treated by MRV (3.0/1.0) (p<0.001); and showed a low SYNTAX score with an average of 19.5±6.7 points; while those with surgical revascularization presented a high SYNTAX score (36.0±9.9), very significant results p<0.001. The percentage of complications was greater in patients revascularized by surgery (62.5%) in comparison to those with PCI (7.3%). In patients treated by PCI functional class I predominated (48.8%); while in those treated by surgical revascularization, functional class IV predominated for 48.5% (p<0.001) (Table 1).

Table 1. Distribution of patients with left main coronary artery disease
  Clinical and angiographic characteristics Revascularization p
Percutaneous(n=41) Surgical (n=97)
  Age (mean ± SD years) 64,2 ± 10,1 63,1 ± 9,9 0,854a
  Gender
• Male
• Female

12 (29,3%)
29 (70,7 %)

79 (81,4 %)
18 (18,6 %)
<0,001b
  BMI (mean ± SD Kg/m2) 26,6 ± 3,6 26,8 ± 4,0 0,852 a
  Previous infarction 32 (78,0 %) 45 (46,4 %) 0,001b
  Previous clinical diagnosis
• Chronic stable angina
• NSTEACS
• STEACS

22 (53,7 %)
10 (24,4 %)
7 (17,1 %)

44 (45,4 %)
9 (9,3 %)
44 (45,4 %)

*
  HTN 34(82,9%) 77(79,4%) 0,631b
  Diabetes mellitus 32 (78,0 %) 13(13,4%) 0,883b
  Dyslipidemia 18 (43,9 %) 16 (16,5 %) 0,001b
  LVEF (median/interquartile range) 58,8/4,0 60,8/15,0 0,129a
  Co-morbidities
• COPD
• Extracardiac arteriopathy
• Previous stroke
• CKD
• Thyroid disease

0 (0,0 %)
1 (2,4 %)
1 (2,4 %)
2 (4,9 %)
0 (0,0 %)

20 (20,6 %)
30 (30,9 %)
6 (6,2 %)
7 (7,2 %)
2 (2,1 %)
0,004b
0,001b
0,674c
1,000c
1,000c
  Previous coronary angioplasty 6 (14,6 %) 13 (13,4 %) 1,000b
  Classification of angina according to CCS
• I
• II
• III
• IV

20 (48,8 %)
14 (34,1 %)
3 (7,3 %)
4 (9,8 %)

0 (0,0 %)
8 (8,2 %)
42 (43,3 %)
47 (48,5 %)
<0,001d
  Number of sick vessels (median/IQR) 1,6/3,0 3,0/1,0 <0,001a
  SYNTAX score (mean ± SD) 19,5 ± 6,7 36,0 ± 9,9 <0,001a
  Complications 3 (7,3 %) 62 (63,9 %) <0,001a
  Location of lesion
• Ostial
• Bifurcation
• Body
15(36,6%)
17(41,5%)
9(22,0 %)
27(27,8%)
60(61,9 %)
10(10,3 %)
0,058d
  Classification according to the number of vessels
• Isolated LMCA
• LMCA + one vessel
• LMCA + two vessels
• LMCA + three vessels
11(26,8%)
8(19,5%)
(24,4%)
(29,3 %)
2(2,1%)
15(15,5%) 31(32,0 %)
49(50,5 %)
<0,001a
 

a: Mann-Whitney U test, b: Chi square test (c2) with correction
*Test not valid for 25% of frequencies expected lower than 5
c: Fisher’s exact test, d: Chi square test (c2)

 

In relation to the presence of immediate adverse events, 19 (19.6%) patients treated by surgical revascularization suffered perioperative acute myocardial infarction (pAMI); while in patients treated by PCI, only 2 suffered this event (4.9%). Thus, pAMI was significantly more frequent than MRV (p=0.028) (Table 2).

Table 2 . Distribution of patients with LMCAD according to the presence of immediate adverse events

  Immediate adverse events Revascularization p
Percutaneous (n=41) Surgical (n=97)
  Peri-procedure AMI 2(4,9%) 19 (19,6%) 0,028a
  Mortality 2 (4,9 %) 3 (3,1 %) 0,634
  HF 2 (4,9 %) 11 (11,3 %) 0,344b
  Stroke 0 (0,0 %) 5 (5,2 %) 0,322b
 

a: Chi square test (c2) with correction, b: Fisher’s exact test

 

As to mediate adverse events, only the need for a new target vessel revascularization presented with a significant difference in both methods (p=0.043), with new revascularization being more frequent at one year in patients treated by PCI (9.8%) in comparison to those treated by MRV (2.1%). The rest of the events had no significant differences between both methods (Table 3).

Table 3. Distribution of patients with LMCAD treated by PCI and MRV
according to the presence of mediate adverse events

    Events Revascularization p
Percutaneous (n=41) Surgical (n=97)
  Mediate AMI 1(2,4 %) 11(11,3 %) 0,090a
  Mediate HF 7(17,1%) 12(12,4%) 0,464a
  Mediate recurrence of chest angina 10(24,4%) 18(18,6 %) 0,436a
  Readmission 3 (7,3 %) 9 (9,3%) 1,000b
  Mediate stroke 1(2,4 %) 1(1,0 %) 0,527a
  New revascularization 4(9,8 %) 2(2,1 %) 0,043a
  Mediate death 4 (9,8 %) 4 (4,1 %) 0,125b
 

a: Chi square test (2) with correction, b: Fisher’s exact test

 

About overall survival, there were no significant differences between both groups (p=0.340) (Table 4). As shown in Table 5, there were no significant differences between both groups in terms of survival free from events (p=0.243), but the chance of events increased as time passed in both groups, and was greater in those with PCI, as well as the chance of survival being higher in those with surgical revascularization.

Table 4. Overall survival according to revascularization type (PCI vs MRV).
    Time PCI   MRV   p*
Prob of death Prob of survival Prob of death Prob of survival
  3 months 2,5 97,5 3,1 96,9 0,340
  6 months 4,5 95,5 4,1 95,9
  9 months 7,5 92,5 6,3 93,7
  12 months 16,2 83,8 6,3 93,7
  * Breslow test


Table 5. Survival for events according to revascularization type
    Time PCI   MRV   p*
Probability
of events
Probability
of survival
Probability
of events
Probability
of survival
  3 months*     3,1 96,9 0,243
  6 months*     7,2 92,8
  9 months 7,6 92,4 8,3 91,7
  12 months 21,5 78,5 17,3 82,7
 

* Breslow test, *A patient presented event on the same day as the procedure and the other occurred after 3 months, approximately at 5 months, and at six months there were no events

 

DISCUSSION
The characteristics of the sample in terms of age, agree with what is stated by different authors [12,13]. Medical literature poses that the age group in highest risk for CAD is between those older than 60 years. Absolute risk of CAD increases with age due to coronary atherosclerosis progression [14].

Men usually present greater extension and severity of CAD in regard to women, and require MRV more frequently, while in women estrogens are capable of delaying atherosclerosis [15]. Women treated with MRV constitute a population in higher risk than men because of the coexistence of factors, such as advanced age, diabetes, HTN, less body surface, smaller coronary arteries or urgent intervention, which favor recurrence of angina in the long term.

On the other hand, using both mammary arteries, mainly in diabetic women, is accompanied by a greater risk of infection by sternal ischemia; and the radial artery could be small to guarantee permeability, so sometimes it is not possible to perform full arterial revascularization [16,17,18].

Taymur et al [19], in their study, showed a predominance of the female gender, significantly greater than in patients with isolated LMCA in comparison to those with LMCA compromise plus another sick vessel. However, in a study made in Argentina by Fernández-Pereira et al [20], in 281 patients with unprotected LMCAD, a predominance of the male gender (77.2%) was reported in patients with PCI, differing from this investigation.

Bollati et al [21], in a series of 197 patients with unprotected LMCAD referred to PCI, identified 10.2% with LVEF ≤40%, results different from this study. Although history of previous MI was significant in this investigation, it was more frequent in patients treated by MRV. These findings are similar to those of Liu C et al [22], who documented previous MI in a large percentage of patients. In this investigation, the patients that presented SYNTAX score <23 were referred to PCI and those presenting SYNTAX score greater than 32 points to MRV.

In a study [23] on 158 patients with unprotected LMCAD treated with PCI, 65% of cases with SYNTAX score >32 were reported, which differs from this investigation. MRV is the revascularization technique of choice in patients with LMCAD with level of evidence IA; but PCI may be considered when SYNTAX score is low (<22), level of evidence IA; when SYNTAX score is intermediate (23-32), the recommendation is II with level of evidence of A [10,24,25].

Predominance of both functional class IV, and NSTEACS, is due to the inclusion of patients in a very high coronary risk who have reached the therapeutic phase of MRV. These results are similar to those shown by Rodríguez [26], where 45.7% of patients presented unstable angina and most had functional class IV and post-infarction angina.

In this investigation, coronary angiography was made on patients in functional class I and II, who suffered NSTEMI or presented chronic stable angina, in whom noninvasive tests yielded high-risk results with indication of coronary angiography, which detected LMCAD.  

During heart surgery, the heart may suffer ischemia and reperfusion, mainly with extracorporeal circulation. This may lead to complications such as pAMI. Morlans [27], shows an incidence of pAMI of 14.9%, although with a higher number of cases. These results are also similar to those of the EXCEL study [6], which involved countries from North and South America, Europe and Asia, where the rate of early myocardial infarction and major adverse peri-procedure events was significantly lower in the group with PCI than in the one with MRV (3.9% vs 6.2% and 8.1% vs 23%, respectively). Immediate mortality was greater in MRV than in PCI; mortality in PCI was caused by acute stent thrombosis.

In the study made by Sánchez González [28], on 250 patients, an in-hospital cardiac mortality was observed of 0.4%, with overall in-hospital mortality being 2.0%. After a mean follow-up of 19.6±14.6 months, an overall incidence of adverse events of 18.4% was observed, including an incidence of AMI of 2.0%, new revascularization of 6.8% and mortality by cardiac cause of 9.6%. Most of the cardiac mortality observed was due to myocardial ischemia. The need for new revascularization in follow-up was 17.6%, and the incidence of all-cause mortality reached 16.8%. These results differ on the incidence of adverse events and the rate of death by cardiovascular cause of the Hospital Hermanos Ameijeiras.

The results of this study in relation to adverse events during the follow-up year coincide with those shown in a meta-analysis [2,29,30], that included five randomized studies (PRECOMBAT, SYNTAX, NOBLE, EXCEL and the study conducted by Boudriot et al) with a total of 4594 patients, on which the primary endpoint was a composite of all-cause mortality, infarction or stroke, and the secondary endpoint was a composite of all-cause mortality, infarction, stroke and revascularization. There were no differences in the primary endpoint between both strategies (OR 0.97; 95% CI, 0.79-1.17; p=0.73). The secondary endpoint was in favor of MRV due to major revascularization in the angioplasty group (OR 1.85; 95% CI, 1.53-2.23, p<0.001). There were no differences when considering each of the primary endpoints separately. All of which coincides with the results of this investigation.

Although new-generation of DES have been developed, which optimized the results of PCI, the greater need for revascularization in a long term is still a weak point for angioplasty.

In the ASAN-MAIN (ASAN Medical Centre-Left Main Revascularization) Registry [31], the results of patients with LMCAD treated with PCI were compared to those treated with MRV in two analyses; one of the results at 10 years from 100 patients treated with uncovered stents and 250 patients treated with MRV; and another result at 5 years from 176 patients treated with DES and 219 patients with MRV, mortality, AMI and/or ictus were not significantly different with none of the two strategies. MRV was associated with a decrease in the risk of new revascularization.

Mohr FW et al [8], in a report published on the SYNTAX trial, after a 5-year follow-up in 1800 patients treated by PCI or MRV, described an overall mortality of 13.9% for the PCI group, results above those of this investigation, where the follow-up lasted less (one year).

In relation to survival rate and the probability of events, the results are similar to those described in the SYNTAX study [32], where patients with 3-vessel disease or LMCAD, with percutaneous or surgical treatment, showed a similar safety profile in 12 months, with no differences in mortality or AMI. The subsequent need for new revascularization procedures in patients treated percutaneously (5.9% vs 13.7%; p<0.0001) made the total rate of events at 12 months to be greater (12.1 vs 17.8%, p=0.0015) in patients revascularized by PCI. Between the 705 patients included with LMCAD, surgical revascularization showed a lower rate of events; 13.7 vs 15.8%.

This study contributes knowledge and allows to outline strategies to select the best revascularization method in patients with LMCAD, according to the characteristics in each case and center.

 

CONCLUSIONS
The patients treated by PCI presented less anatomical complexity and a lower number of affected vessels and complications. Peri-procedure acute myocardial infarction was more frequent in patients treated by myocardial revascularization surgery. The need for new revascularization was greater in patients treated by percutaneous coronary interventionism. There were no differences in overall survival and free from events between both revascularization methods.

 

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Publication: September 2019



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