Добавил:
kiopkiopkiop18@yandex.ru t.me/Prokururor I Вовсе не секретарь, но почту проверяю Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз: Предмет: Файл:

Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3840_Библиотеки_им_академика_М_И_Перельмана

.pdf
Скачиваний:
1
Добавлен:
15.09.2026
Размер:
13 Мб
Скачать
☆
110
(A) (B)
Figure 23 (A) Double curve of the tip of the guidewire. (B) The distal tip engages the SB ostium while the primary curve guarantees good back support to reenter the SB.
FAVERO ET AL.
This step can be technically demanding and time-consuming, and failure to perform it is a common reason for the lack of performance of final kissing balloon inflation by operators who are not familiar with the technique.
An optimal wire tip shape, double curve with long primary curve larger than the MB diameter and a short distal tip curve, is an essential element to rewire the SB. The
distal tip engages the SB ostium, whereas the primary curve guarantees adequate
support, by pushing against the MB wall, to re-enter the SB (Fig. 23).
Often, the SB can be recrossed through the stent using nonhydrophilic guidewires such as BMW and Balance Universal (Abbott Vascular Devices). It is essential that one attempts to recross into the SB through the MB stent struts at the distal aspect of the SB orifice. In cases where
rewiring of the SB fails after multiple attempts using nonhydrophilic guidewires and multiple angiographic projections, we suggest using hydrophilic guidewires (Choice PT, Boston Scientific Corporation; Pilot 50 and Pilot 150, Abbott Vascular Devices)or stiff tapered-tip guidewires (Miracle Bros, Abbott Vascular Devices). It is extremely important to point out that these guidewirescan easilydissect theSB ifnot usedcarefully andexpertly. Ifall attemptedwires fail to recross into the SB, a fixed wire-balloon system can be attempted. In case of persistent inability to rewire the SB, postdilatation of the MB stent with noncompliant balloon could lead to more favorable stent strut geometry, allowing subsequent reentry of the wire into the SB.
Stent Deployment Optimization
General Guidelines
Final kissing balloon inflation using noncompliant balloons is a key element to optimize the results in all EDS techniques. Except for the V-stent and kissing stent techniques, the SB balloon needs to traverse the MB stent struts. This step can be difficult and time-consuming, especially in the presence of multiple stent layers such as the case with the crush and culotte techniques. We suggest that a low-profile monorail balloon (1.0 or 1.5. mm) is used first to predilate the struts. If the balloon does not cross, inflation of the balloon at high pressure while pushing it against resistance may help open theintrastrut spaceand allow the subsequentpassage of a new low profile balloon. In case of persistent failure to cross the stent with a balloon, the operator should consider repositioning the wire and crossing the stent at another site. It is important to point out that in every instance where there are persistent difficulties in recrossing the MB stent with the balloon, the operator should make certain that there is no wire crisscrossing or that the
ELECTIVE DOUBLE STENTING FOR NON–LEFT MAIN CORONARY ARTERY BIFURCATION LESIONS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
111
SB wire has not traversed under the proximal MB stent. Ifin doubt, it is advisable to retrieve the wire from the SB and try to recross the stent toward the SB at the distal aspect of the SB orifice.
After dilatation of the MB stent struts toward the SB with a small balloon, the next step should be postdilatation of the SB with a noncompliant balloon at high pressure guarantee
complete stent apposition and expansion. This is followed by final kissing balloon
(≥16 atm)
to
inflation usingtwo noncompliantballoons with sizes similar tothe respectivestents atmoderate inflation pressure.
Care should be taken not to extend the balloons beyond the proximal edge
of the MB stent to avoid dissections.
Optimization of results during EDS techniques cannot be realized onthe basis of angiogra­phy alone. As ithas beendemonstrated withnonbifurcation lesions,IVUS often provideinsights that cannot be elucidated by angiography alone, irrespective of the experience of the operator.
Role of IVUS
Suboptimal stent deployment in bifurcation lesions, particularly with EDS techniques, increase the risk of stent thrombosis and restenosis (particularly at the SB ostium) (16,32). As it has been discussed in Chapter 2, IVUS interrogation before intervention can inform technical decision making regarding true vessel size and plaque burden/composition, which may lead to better lesion preparation and stent sizing (especially in the SB). Postprocedure IVUS assessment of stent expansion and apposition,particularly atthe carina level,is alsoimportant toguide optimal dilatation of the SB ostium and kissing-balloon dilatation. Although IVUS catheteradvancement through stent struts into the SB can be challenging, particularly in severely angulated SBs, this can be accomplished in many patients with appropriate technique.
Few studies have provided valuable insights into the problems and solutions associated with EDS techniques in bifurcation lesions. In an analysis of postprocedure IVUS in 25 patients undergoing EDS (crush technique) (Fig. 24) using sirolimus-eluting stent, Costa et al. (14) reported high frequency of localization of minimum stent area (MSA) at the SB ostium (68%)
5 mm
Ostium
Proximal
stent
Crush
Distal
stent
Figure 24 A schematic diagram of the in-stent segmental approach to intravascular ultrasound analysis after crush stenting.
Abbreviations
: MV, main vessel; SB, side branch.
Distal
stent
Source
: Adapted from Ref. 14.
112
FAVERO ET AL.
4.0
r=0.551, p <0.001
3.5
3.0
2.5
2.0
QCA MLD (mm) –– main vessel
1.5
3.5
1.5
2.0
IVUS MLD (mm) –– main vessel
Figure 25 Intravascular ultrasound(IVUS) minimum lumen diameter (MLD) versus quantitative coronary angiog­raphy (QCA). MLD in the main vessel (
2.5
3.0
4.0
left
) and side branch (SB) ostium (
3.5
r =0.532, p<0.006
3.0
2.5
2.0
1.5
QCA MLD (mm) –– ostium of the SB
1.0
1.0
1.5
IVUS MLD (mm) –– ostium of the SB
2.5
2.0
right).Source
: Adapted from Ref. 14.
3.0
3.5
[SB-MSA <5.00 mm2 and <4.00 mm2 in 76% and 44% of patients, respectively] with significant SB stent under expansion compared to the MV. Only a moderate correlation between IVUS and quantitative angiography minimum lumen diameter was found both in the MV and in the SB (Fig. 25). Despite a good angiographic appearance after crush stenting, incomplete crush was noted in the majority of cases (>60%) (Fig. 26). In this study, incomplete crush was associated with lower postdilatation balloon inflation pressure in the SB and SB stent under expansion.
The aboveobservations werealso corroboratedin alarger study whereserial IVUSanalysis (Figs. 27 and 28) was performed postprocedure and at nine-month follow-up in 73 bifurcation lesions (42% LMCA) treatedwith the TAP technique (33). This study also demonstratedthat the postprocedureMSA was locatedat the SB ostiumin 42% of lesions andthat there was significant SB stent under expansion compared to the MV. In addition, the SB ostiumwas not fully covered by stent struts in 8.2% of patients in whom a majority (5 of 6 lesions) had a distal angle <60 degrees. At follow-up, SB restenosis was found in 12.3% of patients and involvedmainly the SB ostium (8 out of 9 lesions). The optimal cut-off value of postprocedure MSA at the SB ostium to predict “adequate” follow-up minimum lumen area (MLA) (>4.0 mm
2
) was 4.83 mm2.
Of course, larger body of evidence is needed to establish whether routine IVUS guidance
(A) (B) (C)
Figure 26 (A) Intravascular ultrasound image showing complete crush (apposition) of the sidebranch (SB) stent;
arrows
indicate the three layers of stent struts. (B and C) Intravascular ultrasound images showing incomplete
crush (apposition) of the SB stent struts (
arrows).Source
: Adapted from Ref. 14.
ELECTIVE DOUBLE STENTING FOR NON–LEFT MAIN CORONARY ARTERY BIFURCATION LESIONS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
113
5 mm
(45%)
(MV)
distal
41
(58%)
33
Main vessel
(MV)
Side branch
(SB)
Figure 27 Schematic diagram of intravascular ultrasound analysis and location of postprocedural minimum stent area in the main vessel (MV) and the side branch (SB).
Source
: Adapted from Ref. 33.
(MV)
proximal
ostium
SB
middle
(44%)
(55%)
5 mm
distal
(MV)
32
40
SB
used whenever in doubt regarding the adequacy of the results because relying on angiography alone to determine optimal stent deployment is almost always inadequate.
IS THERE AN EVIDENCE-BASE FOR CHOOSING AN OPTIMAL EDS TECHNIQUE?
Therehas beenonly oneRCT thatcompared one EDS techniquewith another, namely, Stent Technique Study
(34). In this study, 424 out of 2292 eligible patients with a bifurcation
the Nordic
lesion were selected for randomization to crush (n = 209) and culotte (n = 215) stenting. At six-month follow-up, there were no significant differences in major adverse cardiac events rates between the groups (crush 4.3%, culotte 3.7%, p = 0.87). Procedure and fluoroscopy times and contrast volumes were similar in the two groups. The rates of procedure-related increase in biomarkers of myocardial injury were 15.5% in crush versus 8.8% in culotte group (p = 0.08). A total of 324 patients had a quantitative coronary assessment at the index procedure and after
Figure 28 The neocarina was observed, and the side branch (SB) stent was slightly pulled back into the main vessel. The SB ostium was fully covered, and stents were well apposed against the vessel wall. D1, first diagonal branch; LAD, left anterior descending artery.
Source
: Adapted from Ref. 33.
Abbreviations
:
114
FAVERO ET AL.
8 months. The angiographic end-points of in-segment and in-stent restenosis of main vessel and/or side branch after 8 months were found in 12.1% versus 6.6% (p = 0.10) and in 10.5% versus 4.5% (p = 0.046) in the crush and culotte groups, respectively.
Although this is an important study that demonstrates the safety and efficacy of the tested techniques, several major limitations limit its generalizability to unselected patientswith bifurcation lesions. The most important of these limitations is that only 18% of eligible patients with bifurcation lesions were recruited into this trial. Although the reasons for this selection are not clear, themost plausiblescenario is thatoperators excluded patients whom theybelieve were not good candidates for one of the techniques. This issue is of prime importance in treatment of bifurcation lesions because the various EDS techniques are not interchangeable (i.e., it is unlikely that one technique is better than allother techniques in all lesions and acrossall ranges of operator experience). For the time being, the choice of technique should be driven by the bifurcation morphology and operator experience.
REFERENCES
1. Colombo A, Moses JW, Morice MC, et al. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation 2004; 109:1244–1249.
2. Steigen TK, Maeng M, Wiseth R, et al. Randomized study on simple versus complex stenting of coronary bifurcation lesions: The Nordic Bifurcation Study. Circulation 2006; 114:1955–1961.
3. Colombo A, Bramucci E, Sacc`a S, et al. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation 2009; 119(1):71–78.
4. Ferenc M, Gick M, Kienzle RP, et al. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J 2008; 29:2859–2867.
5. Guidelines for Percutaneous Coronary Interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005; 26(8):804–847.
6. Medina A, Suarez de Lezo J, Pan M. A new classification of coronary bifurcation lesions [in Spanish]. Rev Esp Cardiol 2006; 59:183.
7. Furukawa E, Hibi K, Kosuge M, et al. Intravascular ultrasound predictors of side branch occlusion in bifurcation lesions after percutaneous coronary intervention. Cir J 2005; 69:325–330.
8. Carrie D, Elbaz M, Dambrin G, et al. Coronary stenting of bifurcation lesions using “T” or “reverse Y” configuration with Wiktor stent. Am J Cardiol 1998; 82(11):1418–1421, A8.
9. Kobayashi Y, Colombo A, Akiyama T, et al. Modified “T” stenting. A technique for kissing stents in bifurcational coronary lesion. Catheter Cardiovasc Diagn 1998; 43:323–326.
10. Colombo A, Stankovic G, Orlic D, et al. Modified T-stenting technique with crushing for bifurcation lesions: immediate results and 30-day outcome. Catheter Cardiovasc Interv 2003; 60:145–151.
11. Burzotta F, Gwon HC, Hahn JY, et al. Modified T-stenting with intentional protrusion of the side­branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: the T-stenting and small protrusion technique (TAP-stenting). Report ofbench testing andfirst clinical Italian-Korean two-centre experience. Catheter Cardiovasc Diagn 2007; 70(1):75–82.
12. Ge L, Airoldi F, Iakovou I, et al. Clinical and angiographic outcome after implantation of drug-eluting stents in bifurcation lesions with the crush stent technique: importance of final kissing balloon post­dilation. J Am Coll Cardiol 2005; 46(4):613–620.
13. Ormiston JA, Currie E, Webster MW, et al. Drug-eluting stents for coronary bifurcations: insights into crush technique. Catheter Cardiovasc Interv 2004; 63:332–336.
14. Costa RA, Mintz GS, Carlier SG, et al. Bifurcation coronary lesions treated with the “crush”technique: an intervascular ultrasound analysis. J Am Coll Cardiol 2005; 46:599–605.
15. Moussa I, Costa R, Lasic Z, et al. A prospective registry to evaluate sirolimus-eluting stentsimplanted at coronary bifurcation lesions using the “crush technique.” Am J Cardiol 2006; 97(9):1317–1321.
16. Hoye A, Iakovou I, Ge L, et al. Long-term outcomes after stenting of bifurcation lesions with the “crush” technique: predictors of an adverse outcome. J Am Coll Cardiol 2006; 47(10):1949–1958.
17. Collins N, Dzavik V. Amodified balloon crush approach improves side branchaccess and side branch stent apposition during crush stenting of coronary bifurcation lesions. Catheter Cardiovasc Interv 2006; 68:365–371.
18. Jim MH, Ho HH, Miu R, et al. Modified crush technique with double kissing balloon inflation (sleeve technique): a novel technique for coronary bifurcation lesions. Catheter Cardiovasc Interv 2006; 67(3):403–409.
19. Chevalier B, Glatt B, Royer T, et al.Placement of coronary stents in bifurcation lesions by the “culotte” technique. Am J Cardiol 1998; 82:943–949.
ELECTIVE DOUBLE STENTING FOR NON–LEFT MAIN CORONARY ARTERY BIFURCATION LESIONS
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
115
20. Schampaert E, Fort S, Adelman AG, et al. The V-stent: a novel technique for coronary bifurcation stenting. Catheter Cardiovasc Diagn 1996; 39:320–326.
21. Sharma SK. Simultaneous kissing drug-eluting stent technique for percutaneous treatment of bifurca­tion lesions in large-size vessels. Catheter Cardiovasc Interv 2005; 65:10–16.
22. Roy P, Torguson R, Okabe T, et al. Angiographic and procedural correlates of stent thrombosis after intracoronary implantation of drug-eluting stents. J Interv Cardiol 2007; 20(5):307–313.
23. Kuchulakanti PK, Chu WW, Torguson R, etal. Correlates andlong-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation 2006; 113(8):1108–
1113.
24. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005; 293(17):2126–2130.
25. Moussa I, Di Mario C, Moses JW, et al. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation 1997; 96(1):128–136.
26. Ozaki Y, SuzukiT,Yamaguchi T, etal. Canintravascular ultrasoundguided cuttingballoon angioplasty before stenting be a substitute for drug eluting stent? Final results of the prospective randomized multicenter trial comparing cutting balloon with balloon angioplasty before stenting (Reduce III). J Am Coll Cardiol 2004; 43:(Suppl A):1138.
27. Al Suwadi J, Berger PB, Rihal CS, et al. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am coll Cardiol 2000; 35:929–936.
28. Yamashita T, NishidaT Adamian MG,et al. Bifurcation lesions: twostents versus one stent: immediate and follow-up results. J Am Coll Cardiol 2000; 35:1145–1151.
29. Latib A, Cosgrave J, Godino C, et al. Sirolimus-eluting and paclitaxel-eluting stents for the treatment of coronary bifurcations. Am Heart J 2008; 156(4):745–750.
30. Colombo A, Stankovic G. Ostial and bifurcation lesions. In: Topol EJ, ed. Textbook of Interventional Cardiology, Vol. 20. Philadelphia, PA: Saunders Elsevier, 2008:349–375.
31. Louvard Y, Lefevre T. Bifurcation lesion stenting. In: Colombo A, Stankovic G, eds. Problem Oriented Approach in Interventional Cardiology, Vol 4. London, U.K.: Informa Healthcare, 2007:37–57.
32. Costa RA, Mintz GS, Carlier SG, et al. Impact of final lumen dimensions on restenosis after crush drug-eluting stent implantation for bifurcation lesions. J Am Coll Cardiol 2005; 45:3A.
33. Hahn JY, Song YB, Lee SY, et al. Serial intravascular ultrasound analysis of the main and side branches in bifurcation lesions treated with the T-stenting technique. J Am Coll Cardiol 2009; 54(2):110–117.
34. Erglis A, Kumsars I, Niemela M, et al.; For the Nordic PCISG. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic Stent Technique Study. Circ Cardiovasc Intervent 2009; 2:27–34.
6
Coronary Revascularization for Patients with Unprotected Left Main Coronary Artery Disease: Making Clinical Decisions in the Absence of Definitive Evidence
Issam D. Moussa
Cardiac Catheterization Laboratory, New York Presbyterian Hospital–Weill Medical College of Cornell University, New York, New York, U.S.A.
Ted Feldman
Cardiac Catheterization Laboratory, Cardiology Division, Evanston Hospital, Evanston, Illinois, U.S.A.
INTRODUCTION
A 63-year-old patient with progressive exertional angina on maximal medical therapy and no prior revascularization is admitted to your service. Coronary angiography demonstrated a 75% lesion in the distal unprotected left main coronary artery (ULMCA) extending to the ostium of the left anterior descending artery. The left circumflex and right coronary arteries were free of obstructive disease. Theleft ventricular systolic function wasnormal. Thepatient was otherwise healthy.
How should this patient be treated? In the United States, the majority of cardiologists would affirmthat this patient should undergocoronary artery bypassgraft (CABG) surgery. On the other hand, if this patient was in South Korea, Italy, or Germany, it is likely that his treating physician would recommend PCI. Who is right? Is someone wrong?
Supporters of the CABG recommendation would argue that CABG is the “standard of care” and is endorsed by Guidelines as a class I recommendation (1), whereas PCI is considered a class III recommendation (2). On the other hand, supporters of the PCI recommendationwould argue that the underlying evidence for the practice guidelines recommendations is both weak and outdated, and that the emerging evidence does not support the superiority of CABG over PCI withrespect to irreversible clinical endpoints. From this vantage point,physician judgment, expertise, and patient preference should drive clinical decision making on a case-by-case basis.
The purpose of thischapter is to critically reevaluate current state of the artwith respect to coronary revascularization of patients with ULMCAD who are acceptable surgical candidates. In doing so, we will
1. briefly discuss the divergence between clinical practice guidelines and clinical decision
making.
2. critically appraise the “evidence” underlying the current practice guidelines recommenda-
tions.
3. review the emerging data regarding utility of CABG versus PCI in patients with ULMCAD.
4. Discuss the elements of a contemporary approach to clinical decision making in light of the
current state of knowledge.
CLINICAL PRACTICE GUIDELINES AND CLINICAL JUDGMENT
In principle, the process of clinical practice guidelines development should be straightfor­ward when “unequivocal evidence” is available. So why then do different physicians come out with different interpretations after scrutinizing the same “evidence?” The simple truth is that “unequivocal evidence” in the practice of medicine is rarely achievable. The word “evidence” has been overused to include not only randomized clinical trials (RCT)and well-organized reg­istries but also almost any peer-reviewed publication. Although categorization of “evidence” to different classes (A, B, C) has been used to express its quality, this step has not been effective
CORONARY REVASCULARIZATION FOR PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
117
in reflecting the extent of uncertainty in the literature because at the end it is still promoted as “evidence.” Although it is true that RCTs are often the best we can do to increase scientific certainty, and do to an extent,the applicability of these trials,and by extension the clinical prac­tice guidelines, to individual patients is fraught with uncertainty. This uncertainty stems from whether the patient was adequately represented in the trial, whether the choice of endpoints weighs eventsproportionally toits impact on patientwell-being, whether the underlying power calculation assumptions reflect reality, andfinally whether the technology and expertise usedin the trialare similar tothose at thetime of patient’sencounter. Inbrief, despite theadmirable role of clinical practice guidelines in attempting to provide a sense of certainty in making clinical decisions, we continue to practice medicine in an environment of inescapable uncertainty. This assertion is not meant to suggest that guidelines have no practical value in clinical decision making, but rather that the process has to allow for clinical and scientific judgment to be used by those who ultimately put the recommendations into clinical practice. In other words, fram­ing a clinical decision as “evidence-based” does not absolve the physician from using clinical judgment. There are disclaimers in the guidelines that try to convey this sentiment, but are lost in the translation from print documents into practice.
THE “EVIDENCE” UNDERLYING THE CURRENT CLINICAL PRACTICE GUIDELINES
The American College of Cardiology/American Heart Association (ACC/AHA/SCAI) 2004 guidelines categorize the use of CABG surgery for ULMCAD as a class IA recommendation (1) while the 2006 guidelines categorize the use of PCI as class III recommendation (class IIb for patients with US/NSTEMI with hemodynamic instability) (1,2). The recently proposed appropriateness criteria for coronary revascularization reflect these recommendations (3). In the forthcoming discussion we will review the evidence underlying these recommendations and evaluate the extent of uncertainty of this “evidence” in light of current knowledge.
The Evidence for CABG Vs. Medical Therapy in Patients with ULMCAD
When one is asked about the role of CABG surgery in treatment of patients with ULMCAD, the most likely answer is that the superiority of CABG surgery over medical therapy was established overa quarter century ago byrandomized controlledtrials (4)! Along thesame lines, the current ACC/AHA/SCAI guidelines state, “the benefit of surgery over medical treatment in patients with significant ULMCAD (greater than 50%) is little argued” (1). In the face of this unquestionable certainty one could raise eyebrows by “revisiting” the topic! Why waste time and discuss well-established facts? The reason is that the alleged “evidence” is not so certain, and it does merita critical reviewsince the standardsfor “evidence” today are notthose of three decades ago.
The evidence supporting CABG over medical therapy for treatment of patients with ULMCAD
does notmeet today’s standards andis outdated:
a
single dedicated prospective RCT that compared CABG to medical therapy for patients with
ULMCAD. The current guidelines are based primarily on a meta-analysis (5) that summarized
In fact,it may be surprisingto many that there is not
the results of four small and three moderate-sized trials of patients with stable angina and significant CAD conducted in the 1970s. Altogether, 2649 patients were randomized to CABG or to an initial strategy of medical therapy. Of note, patients with ULMCAD made up only 6.6% (150 patients) of the study population and the presence of ULMCAD was not a prespecified element for analysis. In this analysis, there was a significant relative risk reduction in mortality with CABG of about 66% at 5 years with the benefit extending to 10 years.
However, this isnot the wholestory.One of themore frequently quoted studiesin support of CABG over medical therapy is the CASS (Coronary Artery Surgery Study). CASS enrolled asymptomatic orminimally symptomatic patients. Inthis registry, 1484 patientswith ULMCAD underwent CABG (n =1153) or medical therapy (n = 331) and were followed for up to 16 years (6). Patients undergoing medical therapy in this registry were at higher risk than those under­going CABG, and in this older era, CABG surgery may have been denied surgery due to older age and increased surgical risk. Although the overall median survival for CABG patients was
13.3 years versus 6.6 years for patients undergoing medical therapy, several subgroups did not have survival benefit from CABG. Patients who did not benefitfrom CABG included those with preserved systolic LV function, with nonobstructive RCA disease, and with ULMCAD between
118
MOUSSA ET AL.
50% and 59%. The survival benefit of CABG extended only to the higher-risk subgroups of patients with symptomatic multivessel coronary disease and left ventricular dysfunction.
Furthermore, both the medical therapy and surgical techniques used in these studies are outdated by today’s standards. In patients undergoing CABG, the internal mammary artery (IMA) grafts were used in less than 10% of patients. More importantly, pharmacological agents proven to reduce long-term mortality were not used in the medically treated patients. Specifi­cally, only66.1% of thepatients in the medically treated arm were on aB-blocker, and only 18.8% were taking aspirin. Statins and angiotensin-converting enzyme inhibitors were not used at all. Whether the impact of an IMA graft on survival is as important as statins, ACEI, and aspirin is unknown. Nonetheless, the current guidelines advocate offering CABG to all patients with ULMCAD. The purpose of this discussion is not to suggest that CABG surgery is not beneficial to patients with ULMCAD but to highlight that there are many questions and uncertainties about this recommendation, which is considered by our guidelines as an undebatable gold standard!
The “Evidence” for CABG Surgery Vs. PCI in Patients with ULMCAD
Current Guidelines
The most updated ACC/AHA/SCAI clinical practice guidelines for revascularization of patients with ULMCAD who are candidates for surgery categorize CABG surgery as a class IA (1) and PCI as a class III indication (class IIb for patients with US/NSTEMI with hemodynamic instability) (2,7). According to these guidelines, elective stent implantation in a patient with ULMCAD who is a candidate for CABG surgery would be considered harmful. Let us review the evidence underlying these recommendations.
Is PCI for ULMCAD Harmful?
The evidence that was used to suggest that PCI is harmful at the time of guidelines synthesis consisted of the published literature between 1997 and 2005 (2). Discussion of the details of these studies is beyond the scope of this review, but its substance can be characterized by the following observations:
1. All these studies were retrospective and none included a comparative CABG arm.
2. All these studies were small and included a high proportion of high-risk surgical patients
or surgical “turn-downs” (i.e., patients who have bad prognosis irrespective of the revascu­larization modality.)
3. The majority of patients in these studies were treated with bare metal stents (BMS), though
several studies reported patient outcomes after DES implantation.
One of the studies often quoted to highlight the shortcomings of PCI in patients with ULMCAD is the ULTIMA (Unprotected Left Main Trunk Intervention Multicenter Assessment) registry (8). This registry suggested a high early mortality (2% per month among hospital survivors over the first six monthsafter hospital discharge). What is conspicuously absent from discussion ofthis study is the factthat 65% of patients were at high riskfor surgeryor inoperable and stents were only used in ∼50% of patients.
So, how are these data relevant to clinical decision making for patients with ULMCAD, who are good surgical candidates, contemplatingthe choice betweenCABG surgery and stents? The answer is simple and clear. These data are not relevant because these patients were not represented in the above studies. Therefore, these data constitute an “absence of evidence” and it cannot form an evidence-base for recommendations for management of patients with ULMCAD and no special risks for either surgery or PCI. Absence of evidence should not be used to formulate “evidence” of harm, which a class III recommendation does.
The “Evidence” Beyond the Current Guidelines
Since the publication of the 2006 ACC/AHA/SCAI guidelines, many more publications on the topic of coronary revascularization in patients with ULMCAD have become available. The objective of this discussion is to review a representative number of these studies. These studies
CORONARY REVASCULARIZATION FOR PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
Tab le 1 Studies of DES Vs. BMS in Patients with ULMCAD
Cumulative long-term events
Cardiac
death (%),
DES/ BMS
MI (%),
DES/ BMS
b
Study
Registry
Ta mb u r in o
a
et al.
Patient
no.,
DES/
BMS
611/238 60/79 NR 68/60 3 13/17 4.8/11.8
(9)
High surgical risk (%),
DES/
BMS
Urgent
intervention
(%), DES/
BMS
Distal
location
(%), DES/
BMS FU (yr)
RCT
Erglis
et al. (10)
High surgical risk defined by a Euroscore >6 or a parsonnet score >13–15.
a
Patients with acute coronary syndromes (long-term events are reported in the matched population of DES vs. BMS).
b
p
< 0.05.
Abbreviation
53/50 0 0 68/81 0.5 2/0 9/14 2/16
: NR, not reported.
119
TVR (%),
DES/ BMS
8.6/19.3
b
b
include registries of BMS or DES without a CABG arm for comparison, registries with a CABG comparison, and randomized trials of PCI compared to CABG:
Studies of DES and BMS Without a Comparative CABG Arm
Table 1lists few of themost recentstudies that comparedDES to BMSin patientswith ULMCAD (9,10). The only randomized trial that compared DES to BMS in good-surgical candidates (10) included small number of patients and reported only six-month follow-up data. These studies indicate that (i) the short- tointermediate-term cardiac death and nonfatalMI inpatients receiv­ing DES is similar, or lower, than that in patients receiving BMS; (ii) the short- to intermediate­term rate of repeat intervention is lower in patients receiving DES compared to BMS; ( iii)there are no special procedure risks of death or MI for LM PCI; and ( iv) the risk of mortality due to stent thrombosis is low.
Table 2 lists studies that reported on the use of DES in patients with ULMCAD (11–14). These studies share the limitations of previous reports in that they included high proportion of high-risk surgical patients and patients undergoing urgent interventions, thereby, limiting generalizability to good-risk surgical patients. Nonetheless, several noteworthy observations can be made:
(
a) When DES implantation is performed electively in patients with ULMCAD, it is associ-
ated with low rates of cardiac death (∼2–3% annually) and myocardial infarction (∼2–3% annually).
(b) There is awide variation inthe rate of repeat intervention afterDES implantation due tothe
multitude of factors that influence this event such as systematic angiographic follow-up,
Tab le 2 Studies of DES in Patients with ULMCAD
Patient
no.
Price
et al. (11)
Chieffo
et al. (12)
SanMartin
et al. (13)
DELFT (14) 358 50 20 74 3 9.2 8.6 21.4
High surgical risk defined by a Euroscore >6 or a parsonnet score >13–15.
a
Angiographically driven TVR.
50 58 34 94 0.8 2 10 38
147 39 0 0 2.4 3.4 3.4 5.4
100 46 19 53 1 7.0 6 3.7
High surgical risk (%)
Urgent
intervention
(%)
Distal LM
location
(%)
FU (yr)
mean
Cardiac
death (%) MI (%) TVR (%)
Cumulative long-term events
a