Guidelines on the Management of Stable Angina Pectoris ... - Cardio

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40 ESC <strong>Guidelines</strong>therapy, angina plus ischaemia-guided drug therapy, andrevascularization by PCI or CABG surgery. At 2 years offollow-up, death or MI had occurred in 4.7% of the revascularizationpatients when compared with 8.8% of theischaemia-guided group and 12.1% of the angina-guidedgroup (P , 0.01 for the revascularized group comparedwith ischaemia or angina-guided groups). The results ofthe ACIP trial indicate that higher-risk patients who areasymptomatic or have minimal symptoms but demonstrableischaemia and significant CAD may have a better outcomewith revascularization with either CABG or PCI comparedwith those managed medically.A Swiss study (TIME) 588 in elderly patients (mean age 80years) with severe angina randomized participants toimmediate invasive or continued medical therapy. Of thoserandomized to invasive therapy, 52% received PCI and 21%had CABG. Invasive therapy was associated with a statisticallysignificant improvement in symptoms at 6 months,but the difference was not maintained at 1 year, partlydue to a 48% delayed revascularization rate in the medicallytreated arm. Death and MI were not significantly differentbetween the two treatment strategies. Investigators in theMedicine, Angioplasty or Surgery Study (MASS) 589 randomizedpatients with stable angina and isolated disease ofthe left descending coronary artery to medical treatmentor PCI (including stenting) or CABG using a combined endpointof cardiac death, MI, and refractory angina requiringrepeat revascularization by surgery. At 3 years of follow-up,this combined endpoint occurred in 24% of PCI patients, in17% of medical patients, and in 3% of surgical patients.Importantly, there was no significant difference in overallsurvival in the three groups. Death or MI occurred in 1% ofthe CABG group, 2% of the PCI group, and 1.4% of themedically treated group.PCI vs. surgeryA large number of clinical trials have compared PCI withsurgery in order to establish the choice of revascularizationtechnique, both before and subsequent to the introductionof stenting, 562,597,598 and in multi-vessel as well as onevesseldisease. Meta-analysis of trials conducted before1995, 599 when coronary stenting was rare, revealed no significantdifferences in the treatment strategies for eitherdeath and the combined endpoint of death and MI.Mortality during the initial hospitalization for the procedureoccurred in 1.3% of the CABG group and 1% of the PCI group.The need for subsequent revascularization was significantlyhigher in the PCI group, and although patients weresignificantly less likely to have angina 1 year after bypasssurgery than after PCI, by 3 years this difference was nolonger statistically significant. Results from the BARI study,the largest single randomized trial of PCI vs. surgery,not included in this meta-analysis, were nonethelessconsistent with these findings, although a survival advantagewith bypass surgery was observed in the diabeticsubgroup. 590More recent trials, such as the ARTS 600 and SOS trials, 597have incorporated the use of stents as part of PCI. TheARTS 1 trial 600 compared the strategy of multiple-stentimplantation with the aim of complete revascularizationvs. bypass surgery in patients with multi-vessel disease.However, this trial was not exclusively among patientswith stable angina; 37 and 35%, respectively, in both armshad unstable angina, 57 and 60%, respectively, had stableangina, and 6 and 5%, respectively, had silent ischaemia.As in previous analyses of balloon angioplasty, at 1 year,there was no difference between the two groups in termsof rate of death, stroke, or MI. Among patients who survivedwithout stroke or MI, 16.8% of those in the stenting groupunderwent a second revascularization, when comparedwith 3.5% of those in the surgery group. The rate of eventfreesurvival at 1 year was 73.8 percent among the patientswho received stents and 87.8 percent among those whounderwent bypass surgery. As measured 1 year after theprocedure, coronary stenting for multi-vessel disease inselected patients offered a similar outcome in terms ofdeath, stroke, and MI as bypass surgery. However, stentingwas associated with a greater need for repeatedrevascularization.A meta-analysis including trials of stents 560 suggests a mortalitybenefit with CABG compared with PCI at 5 years whichcontinued to 8 years in patients with multi-vessel disease, aswell as significantly less angina and less need for repeatrevascularization. Subgroup analysis of trials with andwithout stents indicated significant heterogeneity betweenthe two groups, with trials performed pre-stents showing atrend towards reduced mortality favouring CABG which wasnot evident in the trials with stents. A more recentmeta-analysis of four randomized controlled trials of percutaneousintervention with stents compared with bypasssurgery (n ¼ 3051) showed no significant differencebetween the treatment strategies in the primary endpointof death, MI, or stroke at 1 year. 601 However, observationaldata with 3-year follow-up on .60 000 patients from theNew York cardiac registry indicated that for patients withtwo or more diseased coronary arteries, CABG was associatedwith higher adjusted rates of long-term survival thanstenting. 602To summarize, the trial evidence suggests that, outside ofthe population with high-risk indicators which have beenproven to benefit prognostically from surgery, either PCI orsurgery may be considered as an effective option for thetreatment of symptoms. After an initial pharmacologicalapproach, revascularization may be recommended forpatients with suitable anatomy who do not respond adequatelyto medical therapy or for the individual patientwho, regardless of age, wishes to remain physically active(performing regular physical exercise).In non-diabetic patients with 1–2-vessel disease withouthigh grade stenosis of the proximal LAD in whom angioplastyof one or more lesions has a high likelihood of initial success,PCI is generally the preferred initial approach, influenced byfactors such as the less invasive nature and lower initial riskof the initial procedure and the absence of survivaladvantage of CABG in lower risk subgroups. The individualcircumstances and preferences of each patient mustbe considered carefully when planning the treatmentstrategy.In asymptomatic patients, revascularization cannotimprove symptoms and the only appropriate indication forrevascularization with PCI would be to reduce the likelihoodof ischaemic complications in the future. Evidence tosupport this strategy is limited only to those patients withobjective evidence of extensive ischaemia, in whom revascularization(either PCI or CABG) may reduce the likelihoodof mortality relative to an angina-guided strategy (ACIP). 70
ESC <strong>Guidelines</strong> 41PCI may be considered for mildly symptomatic patients inthe category of higher-risk ischaemia and severe anatomicCAD only if there is a high likelihood of success and a lowrisk of morbidity or mortality.Specific patient and lesion subsetsPatients with severely depressed LV function and/or highsurgical risk. Patients in whom surgical risk is prohibitivelyhigh may benefit from revascularization by PCI, particularlywhen residual viability can be demonstrated in the dysfunctioningmyocardium perfused by the target vessel(s). Thisissue is currently addressed in two large randomizedstudies, the STICH 603 and the HEART UK 604 trials.Unprotected LM disease. The LM stem is referred to asunprotected when the distal coronary arteries do notreceive circulation from a bypass graft. Several observationalreports 605,606 indicate the feasibility of PCI in LMstem disease. More recently, an observational registry hasshown improved results with drug eluting compared withbare metal stents 607 holding promise for the use of PCI inLM stem disease in the future. However, surgery shouldremain the preferred approach until the outcome offurther trials are known.Multi-vessel disease in patients with diabetes. Aformaltrialcomparing the effect of PCI vs. CABG in diabetics is not yetavailable; however, post hoc subgroup analyses of randomizedtrials comparing these treatment strategies have shownreduced mortality with bypass surgery compared withPCI. 608,609 The BARI trial was the largest of these trials andthe only in which a statistical difference in mortality wasdetected between the treatment groups in the diabetics. 590,610Among treated diabetics (n ¼ 353), there was an absolutesurvival advantage of 15% for CABG at 5 years (P ¼ 0.003).The rate of repeat revascularization was also higher with PCIin diabetics in BARI and was evident too even withstent-assisted PCI (41 vs. 8.4%) in the ARTS study.A limitation of these trials is that they were conductedbefore the widespread use of drug-eluting stents or adjuvantperi-procedural antiplatelet therapy. Drug-eluting stentshave reduced the rate of restenosis in diabetic as in nondiabeticpatients 585,586,611 but the impact of this reductionon mortality in diabetic patients, particularly in multi-vesselPCI, is unknown. Two major trials are underway to addressthis important issue, BARI 2 Diabetes (BARI 2D) andFREEDOM (Future Revascularisation Evaluation in Patientswith Diabetes Mellitus). However, for the present, due considerationshould be given to the evidence available and PCIshould be used with reservation in diabetics with multivesseldisease until the results of further trials are known.Patients with previous bypass graft surgery. There are norandomized controlled trials comparing treatment optionsin patients with previous bypass surgery. Observationaldata suggest that patients with late stenoses of vein graftshave a high mortality rate, 612 and re-operation improvedthe outcome of these patients in one observational comparison.613 Redo surgery may be undertaken on symptomaticgrounds where the anatomy is suitable. However, the operativerisk of redo bypass surgery is as high as three-foldgreater than initial surgery, 614 and for those with a patentITA graft, there is the additional risk of damage to thisgraft during surgery.In contrast, PCI can be performed following previous surgicalrevascularization, either in the vein graft or arterialgraft, or the native coronary tree beyond the graft whichis not revascularized, and may provide a useful alternativeto redo surgery for symptomatic relief. Protective filterdevices may be employed to reduce particulate debrisfrom embolizing downstream and causing peri-proceduralmyocardial damage (SAFER) 615 when dilating old saphenousvein grafts.Chronic total occlusions. Chronic total occlusions still representthe most frequent mode of failure of PCI. When theocclusion can be crossed with a guide-wire and the distallumen has been reached, satisfactory results are obtainablewith stent implantation, as shown by several trials, 616–618albeit at the expense of high restenosis rate ranging from32 to 55%. The value of drug-eluting stents in this respectis currently under evaluation. In patients with multi-vesseldisease, failure to treat chronic total occlusions will resultin incomplete revascularization, which could be avoidedwhen the patient is referred for bypass surgery.Indications for revascularizationIn general, patients who have indications for coronary arteriographyand in whom catheterization reveals severe coronaryartery stenosis are also potential candidates formyocardial revascularization. In addition, a patient is potentiallyeligible for revascularization if:(1) medical therapy is unsuccessful in controlling symptomsto the patient’s satisfaction(2) non-invasive tests reveal a substantial area of myocardiumat risk(3) there is a high likelihood of success and acceptable riskof morbidity and mortality(4) the patient prefers an interventional rather than amedical approach and is fully informed of the risks ofthis route of therapy in their individual caseAn adequate response to therapy must be judged in consultationwith the patient. For some, Class I symptoms(angina only on strenuous exertion but not during ordinaryactivity) are acceptable, but others may wish for completeabolition of their symptoms. Recommendations for revascularizationon symptomatic grounds, as summarized in Table 8or below, have taken into account the range of symptomaticgrades for which evidence is available and should be construedin this fashion rather than as a directive to performrevascularization across the entire range of symtomatology.What is an acceptable risk of morbidity and mortality shouldalso be considered on an individual basis for each patient.Ideally, patients should not be advised to have a procedurefor which the procedural mortality exceeds their estimatedannual mortality unless there is evidence of substantialprognostic benefit in the longer term or symptoms arehaving a serious impact on their quality of life, despiteappropriate medical therapy.Selection of the method of revascularization should bebased on:(1) risk of peri-procedural morbidity and morbidity(2) likelihood of success, including factors such as technicalsuitability of lesions for angioplasty or surgicalbypass(3) risk of restenosis or graft occlusion
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Guidelines on the Management of Stable Angina Pectoris ... - Cardio

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