BMS vs. DES vs. CABG
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1 A Collaborative Systemic Review and Meta-Analysis of A Results from 3976 Patients: BMS vs. DES vs. CABG Overall Safety and Efficacy Issues of Left Main Intervention Duk-Woo Park, MD, PhD University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
2 Background Left main coronary artery (LMCA) disease is associated with a poor prognosis when treated medically, and its presence is indicated for coronary artery bypass surgery (CABG). Several registries data show promising results of percutaneous coronary intervention (PCI) with stent implantation in terms of safety and feasibility for patients with LMCA disease.
3 Background Despite the favorable outcomes after bare-metal stents (BMS) or drug-eluting stents (DES), subsequent restenosis or possible stent thrombosis limited the widespread use of PCI in LMCA disease. Also, previous studies about LMCA intervention were hampered by small numbers of patients, limited duration of follow-up or an retrospective observational study design.
4 Objective Despite the existence of multiple observational studies comparing DES, BMS, or CABG, none of them was individually powered to assess the comparative efficacy of each revascularization strategies in LMCA disease. Therefore, by aggregating all available registry data, we performed a collaborative systemic review and meta-analysis to assess the risk-benefit balance of PCI, in itself and in comparison with each PCI intervention (BMS vs. DES) and CABG.
5 Literature search and study selection We searched PUBMED, MEDLINE, EMBASE, and SCOPUS and Websites dedicated to dissemination of results from cardiovascular studies ( for relevant full reports in any language (from inception to June 2007). In addition, we hand searched reference lists and checked relevant reviews and book chapters.
6 Literature search and study selection Two investigators (DWP, SCY) independently assessed reports for eligibility. To be included in the analysis, data had to be clinical studies in individuals with symptoms or signs of myocardial ischemia due to LMCA disease, comparing DES with BMS or DES with CABG, or reporting DES or BMS only for unprotected LMCA disease. Studies had to have 30 patients and at least 6 months clinical follow-up duration. Duplicate publication, only PCI with balloon PTCA or DCA, only high-risk patients, only protected LMCA, ongoing/unpublished studies, and incomplete data reporting for analysis were excluded.
7 Pre-Specified End Points Study end points - Overall mortality - Myocardial infarction (MI), including Q-wave or Non-Q-wave MI - Target vessel revascularization (TVR) - MACE: composite of death, MI, or TVR In studies with non-availability of rates of TVR, we used rates of target lesion revascularization as a proxy measure. The number of patients experiencing an event and the overall number of patients at risk were recorded separately two time period (within 1 months & within 1 year).
8 Statistical Analysis The rates of mortality, MI, and TVR, as defined in each study, were pooled, and Pearson chi-square values were calculated for each of these individual end points. For MACE, there was no double counting of events. Generalized linear mixed effect model (GLMM) was used to combine each result of individual treatment modality and overall. Pooled estimates of relative risk (RR) were obtained by calculating the weighted average of the logarithm of RR. Breslow-Day test was used to address the heterogeneity among the registries.
9 Results
10 Identification of eligible studies potentially eligible reports Identified and and screened for for retrieval reports retrieved for for detailed evaluation reports included :: DES DES vs. vs. BMS (5 (5 reports) DES DES vs. vs. CABG (4 (4 reports) DES DES only only (9 (9 reports) BMS only only (13 (13 reports) reports reports excluded excluded :: review review analyses analyses case-reports case-reports mainly mainly balloon balloon angioplasty angioplasty Incomplete Incomplete data data reports reports excluded excluded :: repetitive repetitive data data from from same same center center 9 protected protected LMCA LMCA only only high high surgical surgical risk risk only only less less than than patients patients
11 Study Framework (Total 3976 patients) 5 Comparisons DES (N=1573) 9 Studies 4 Comparisons BMS (N=1739) 13 Studies 0 Comparisons CABG (N=664)
12 5 Comparison Studies: DES vs. BMS Study Pt (n) Gr (n) In. for PCI Age (mean) Male DM HTN ACS EF Bifurcation Park et al (2005) 223 BMS (121) DES (102) Stable UA AMI Cheiffo et al. (2005) 149 BMS (64) DES (85) SA UA Valgimili et al. (2005) 216 BMS (86) DES (95) SA UA AMI Erglis et al. (2007) 103 BMS (50) DES (53) SA UA Ya-ling et al. (2006) 210 BMS (34) DES (176) SA UA AMI Total 866 BMS (355) DES (511)
13 4 Comparison Studies: DES vs. CABG Study Pt (n) Gr (n) In. for PCI Age (mean) Male DM HTN ACS EF Bifurcation Chieffo et al (2006) 209 DES (107) CABG (102) Stable UA AMI Lee et al. (2006) 173 DES (50) CABG (123) SA UA AMI Palmerini et al. (2006) 311 DES (157) CABG (154) SA UA AMI Sanmartin et al. (2007) 341 DES (96) CABG (245) SA UA AMI Total 1034 DES (410) CABG (624)
14 9 Studies reporting DES results Study Center (n) Pt (n) In. for PCI Age (mean) Male DM HTN ACS EF Bifurcation Khattab et al. (2007) SA/UA/AMI Lei et al. (2007) 1 70 SA/UA Morton et al. (2007) 1 30 SA/UA/AMI Cheng et al. (2007) SA/UA/NSTEMI Sanmartin et al. (2007) SA/UA/AMI Migliorini et al. (2006) SA/UA/AMI Price et al. (2006) 1 50 SA/UA/AMI Lee et al. (2005) 5 54 SA/UA/MI De Lezo et al. (2004) 2 52 SA/UA Total
15 13 Studies reporting BMS results Study Pt (n) In. for PCI Age (mean) Male DM HTN ACS EF Bifurcation Run-lin et al.. (2006) 224 SA/UA Peszek et al. (2006) 62 SA/UA Carrie et al. (2005) 57 SA/UA/AMI Marti et al. (2004) 38 UA/AMI ZiaKas et al. (2004) 80 SA/UA/AMI Kelley et al. (2003) 43 SA/UA/AMI Brueren et al. (2003) 71 SA/UA Tan et al. (2001) 279 SA/UA/AMI Black et al. (2001) 92 SA/UA/AMI De Lezo et al. (2001) 155 SA/UA/AMI Silvestri et al. (2000) 140 SA/UA Wong et al. (1999) 55 SA/UA Korowski et al SA/UA Total
16 5 Comparison Studies: DES vs. BMS Mortality (within 1 year) Park et al. RR: NA (no event) Chieffo et al. RR: 3.98 ( ) Valgimili et al. RR: 1.19 ( ) Erglis et al. RR: 1.06 ( ) Ya-ling et al. RR: 1.73 ( ) Overall BMS Better DES Better RR: 1.62 ( ) P (Overall Effect) = P (Heterogeneity) = 0.484
17 5 Comparison Studies: DES vs. BMS MI (within 1 year) Park et al. RR: NA (no event) Chieffo et al. RR: 1.11 ( ) Valgimili et al. RR: 2.76 ( ) Erglis et al. RR: 1.48 ( ) Ya-ling et al. Overall BMS Better DES Better RR: 2.59 ( ) RR: 1.11 ( ) P (Overall Effect) = P (Heterogeneity) = 0.697
18 5 Comparison Studies: DES vs. BMS TVR (within 1 year) Park et al. RR: 8.85 ( ) Chieffo et al. RR: 1.58 ( ) Valgimili et al. RR: 3.68 ( ) Erglis et al. RR: 8.48 ( ) Ya-ling et al. RR: 2.88 ( ) Overall BMS Better DES Better RR: 2.05 ( ) P (Overall Effect) = P (Heterogeneity) = 0.157
19 5 Comparison Studies: DES vs. BMS MACE (within 1 year) : Death, MI, or TVR Park et al. RR: 8.85 ( ) Chieffo et al. RR: 1.80 ( ) Valgimili et al. RR: 1.87 ( ) Erglis et al. RR: 2.27 ( ) Ya-ling et al. RR: 2.33 ( ) Overall BMS Better DES Better RR: 2.19 ( ) P (Overall Effect) = P (Heterogeneity) = 0.414
20 4 Comparison Studies: DES vs. CABG Mortality (within 1 year) Chieffo et al. RR: 3.01 ( ) Lee et al. RR: 2.64 ( ) Palmerini et al. RR: 0.91 ( ) Sanmartin et al. RR: 1.57 ( ) Overall CABG Better DES Better RR: 1.34 ( ) P (Overall Effect) = P (Heterogeneity) = 0.227
21 4 Comparison Studies: DES vs. CABG MI (within 1 year) Chieffo et al. RR: 2.67 ( ) Lee et al. RR: NA Palmerini et al. RR: 0.54 ( ) Sanmartin et al. RR: NA Overall RR: 1.70 ( ) CABG Better DES Better P (Overall Effect) = P (Heterogeneity) = 0.012
22 4 Comparison Studies: DES vs. CABG TVR (within 1 year) Chieffo et al. RR: 0.29 ( ) Lee et al. RR: 0.14 ( ) Palmerini et al. RR: 0.10 ( ) Sanmartin et al. RR: 0.16 ( ) Overall RR: 0.17 ( ) CABG Better DES Better P (Overall Effect) = P (Heterogeneity) = 0.409
23 4 Comparison Studies: DES vs. CABG MACE (within 1 year) : Death, MI, or TVR Chieffo et al. RR: 1.27 ( ) Lee et al. RR: 1.22 ( ) Palmerini et al. RR: 1.11 ( ) Sanmartin et al. RR: 0.98 ( ) Overall CABG Better DES Better RR: 1.21 ( ) P (Overall Effect) = P (Heterogeneity) = 0.745
24 Early outcomes (overall patients) 1 Month Death Treatment Group DES BMS CABG Comparison Estimated incidence 2.2 ( ) 2.1 ( ) 2.0 ( ) RR with 95% CI P value for difference BMS vs. DES 0.94 ( ) CABG vs. DES CABG vs. BMS 2.16 ( ) 2.30 ( )
25 Early outcomes (overall patients) 1 Month MI Treatment Group DES BMS CABG Comparison Estimated incidence 2.1 ( ) 3.0 ( ) 4.2 ( ) RR with 95% CI P value for difference BMS vs. DES 1.41 ( ) CABG vs. DES CABG vs. BMS 2.03 ( ) 1.43 ( )
26 Early outcomes (overall patients) 1 Month TVR Treatment Group DES BMS CABG Comparison Estimated incidence 0.3 ( ) 0.7 ( ) 1.1 ( ) RR with 95% CI P value for difference BMS vs. DES 2.79 ( ) CABG vs. DES CABG vs. BMS 4.24 ( ) 1.52 ( )
27 Early outcomes (overall patients) 1 Month MACE (Death, MI, TVR) Treatment Group DES BMS CABG Comparison Estimated incidence 4.9 ( ) 6.5 ( ) 11.1 ( ) RR with 95% CI P value for difference BMS vs. DES 1.34 ( ) CABG vs. DES CABG vs. BMS 2.28 ( ) 1.70 ( )
28 Late outcomes (overall patients) 1 Year Death Treatment Group DES BMS CABG Comparison Estimated incidence 5.2 ( ) 7.4 ( ) 7.4 ( ) RR with 95% CI P value for difference BMS vs. DES 1.45 ( ) CABG vs. DES CABG vs. BMS 1.44 ( ) 0.99 ( )
29 Late outcomes (overall patients) 1 Year MI Treatment Group DES BMS CABG Comparison Estimated incidence 2.7 ( ) 4.5 ( ) 4.6 ( ) RR with 95% CI P value for difference BMS vs. DES 1.64 ( ) CABG vs. DES CABG vs. BMS 1.67 ( ) 1.02 ( )
30 Late outcomes (overall patients) 1 Year TVR Treatment Group DES BMS CABG Comparison Estimated incidence 8.2 ( ) 19.7 ( ) 1.4 ( ) RR with 95% CI P value for difference < BMS vs. DES 2.39 ( ) CABG vs. DES CABG vs. BMS 0.17 ( ) 0.07 ( ) <0.0001
31 Late outcomes (overall patients) 1 Year MACE Treatment Group DES BMS CABG Comparison Estimated incidence 14.7 ( ) 29.7 ( ) 17.7 ( ) RR with 95% CI P value for difference BMS vs. DES 2.02 ( ) CABG vs. DES CABG vs. BMS 1.21 ( ) 0.60 ( )
32 DES vs. BMS Clinical Events (within 1 year) Death MI TVR MACE RR: 1.45 ( ) RR: 1.64 ( ) RR: 2.39 ( ) RR: 2.02 ( ) P = P = P = P = BMS Better DES Better
33 DES vs. CABG Clinical Events (within 1 year) Death MI TVR MACE RR: 1.44 ( ) RR: 1.67 ( ) RR: 0.17 ( ) RR: 1.21 ( ) P = P = P = P = CABG Better 10 DES Better
34 BMS vs. CABG Clinical Events (within 1 year) Death MI TVR MACE RR: 0.99 ( ) RR: 1.02 ( ) RR: 0.17 ( ) RR: 0.60 ( ) P = P = P < P = CABG Better 10 BMS Better
35 Conclusions Percutaneous intervention for LMCA disease with DES or BMS was feasible and safe with comparable early mortality and morbidity to bypass surgery. Mortality and MI incidence within 1 year was similar between patients treated with BMS, DES, and CABG. Incidence of TVR was significantly lower in CABG patients compared to BMS patients or DES patients. BMS patients showed a higher incidence of TVR compared to DES patients.
36 Conclusions The incidence of MACE (composite of death, MI, or TVR) was significantly higher in BMS patients in comparison with DES patients or CABG patients. However, DES patients showed the comparable incidence of MACE to bypass surgery. The long-term safety and efficacy of DES for unprotected LMCA needs to be ascertained in large, randomized trials.
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