Coronary Drug-eluting Stents
Table 2: SINTAX Trial: Results from the Left Main Subgroup Analysis
PCI n=358
One-year Clinical Outcomes Death (%) Stroke (%) MI (%)
Revascularisation (%) ST or graft occlusion (%) Overall MACCE (%)
MACCE, low SYNTAX score (0–17)
MACCE intermediate SYNTAX score (23–32)
MACCE high SYNTAX score (≥33)
Three-year Clinical Outcomes Death (%) Stroke (%) MI (%)
Revascularisation (%) ST or graft occlusion (%) Overall MACCE (%)
MACCE low SYNTAX score (0–17)
MACCE intermediate SYNTAX score (23–32)
MACCE high SYNTAX score (≥33)
4.2 0.3 4.3 12
2.7 15.8 7.7 12.6 25.3
7.3 1.2 6.9 20
4.1 26.8 18 23.4 37.3
CABG n=357
4.4 2.7 4.1 6.7 3.7
13.6 13 15.5 12.9
8.4 4
4.1
11.7 3.7
22.3 23 23.4 21.2 p 0.88
0.0009 0.97 0.02 0.49 0.44
0.19 0.54 0.008
0.64 0.02 0.14
0.004 0.80 0.20
0.33 0.90 0.003
CABG = coronary artery bypass graft; MACCE = major adverse cerebrovascular events; MI = myocardial infarction; PCI = percutaneous coronary intervention; ST = definite/probable stent thrombosis.
Table 3: Clinical and Lesion Characteristics Influencing the Choice of Stenting Versus Coronary Artery Bypass Grafting in Unprotected Left Main Coronary Artery Disease in Everyday Clinical Practice
Pro Stenting
Isolated (ostial or midshaft) lesion or ULMCA plus 1 vessel disease (SYNTAX score <32)
Isolated (distal) lesion or ULMCA (distal) plus 1 vessel disease anatomically suitable for stenting (SYNTAX score <32)
No contraindications for prolonged dual antiplatelet therapy High-surgical risk comorbidities: advanced age; chronic lung disease; limited life expectancy, etc Patient refusal of surgery
Pro Bypass Surgery
Complex coronary anatomy (SYNTAX score ≥33 due to ULMCA lesion associated with severe multi-vessel coronary disease, total occlusions of ≥2 major coronary epicardial vessels, severe calcifications or tortuosity) Diabetes
Renal dysfunction
Severe compromised left ventricular systolic function Severe peripheral vascular disease unsuitable for catheterization Contraindication to antiplatelet therapy (allergy or intolerance to aspirin, clopidogrel, ticlopidine, high bleeding risk)
ULMCA = unprotected left main coronary artery.
The Revascularization for unprotected left main coronary artery stenosis: comparison of percutaneous coronary angioplasty versus surgical revascularization (MAIN-COMPARE) registry was the first multicentre non-randomised study comparing long-term outcome
46 following PCI with stenting versus CABG in ULMCA disease.25 This
registry involved 2,240 patients with ULMCA stenosis who underwent stenting (DES n=784; BMS n=318) or CABG (n=1138). Patients in the PCI cohort were less likely to have diabetes or multivessel coronary artery disease; however, a propensity scoring model found that treatment with DES was associated with a significantly lower rate of freedom from repeat revascularisation versus CABG at three-year follow-up (90.7 versus 98.4%; p<0.001). Of note, no significant differences in safety end-points including freedom from death (DES 91% versus CABG 93.1%; p=0.26) or the composite end-point of death, myocardial infarction (MI) or stroke were identified.25
The five-year risk of death (HR 1.13, 95% CI 0.88–1.44; p=0.35) and the combined risk of death, Q-wave MI or stroke (HR 1.07, 95% CI 0.84–1.37; p=0.59) were not significantly different between the PCI and the CABG group, whereas the target vessel revascularisation (TVR) rate was significantly higher in the PCI group (HR 5.11, 95% CI 3.52–7.42; p<0.001).61
Similar results were found even when follow-up was extended to five years.61
Consistent with this finding, a non-randomised comparison from our group showed no difference between PCI with DES implantation (107 patients) and CABG (142 patients) in the occurrence of cardiac death (adjusted OR 0.502, 95% CI 0.162–1.461; p=0.24), although the PCI group showed a trend towards a lower occurrence of the composite end-point of cardiac death and MI (adjusted OR 0.408, 95% CI 0.146–1.061; p=0.06). However, CABG was correlated with a lower TVR rate (adjusted OR 4.411, 95% CI 1.825–11.371; p=0.0004), and no difference was detected in the occurrence of MACCE (adjusted OR 1.578, 95% CI 0.825–3.054; p=0.18) at five-year clinical follow-up.62
The randomised SYNTAX trial compared PCI with paclitaxel-eluting stent (PES) implantation versus CABG for left main/multivessel CAD.41
Recently, the three-year results of the ULMCA subgroup from the SYNTAX trial (PCI arm 348 patients versus CABG arm 357 patients) were presented by Serruys at Transcatheter Cardiovascular Therapeutics 2010. PCI with PES implantation (348 patients) resulted in equivalent three-year overall MACCE to CABG (22.3% CABG versus 26.8% PCI; p=0.20). Notably, the MACCE rate was similar between the groups for patients with low (23% CABG versus 18% PCI; p=0.33) and intermediate (23.4% CABG versus 23.4% PCI; p=0.90) SYNTAX score, but was significantly higher in the PCI arm in the high SYNTAX score group (21.2% CABG versus 37.3% PCI; p=0.003). Even the overall safety outcomes (death/cerebrovascular event [CVE]/MI) were similar between the two groups (14.3% CABG versus 13% PCI; p=NS).
As reported at one-year follow-up,42 there was a higher
revascularisation rate in the PCI group (11.7% CABG versus 20% PCI, p=0.004) and a higher rate of CVE in the CABG group (4% CABG versus 1.2% PCI, p=0.2) even at three-year follow-up (see Table 2) Moreover, favourable results of PCI for ULMCA disease treatment were also reported in a gender subanalysis.43
Although the
encouraging results for PCI, especially in cases with anatomically simple LMCA disease (isolated LMCA ostial or mid-shaft disease or non-distal LMCA plus single-vessel disease), because of the hypothesis-generating nature of subgroup analysis, results from adequately powered trials for patients with ULMCA disease are needed. Table 3 shows the variables influencing revascularisation strategy in clinical practice.
INTERVENTIONAL CARDIOLOGY
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