Mini-CAT                                                                                    

 

RT6-WK1 PICO Expanded to Mini-CAT

 

Clinical Scenario:

65 year old male with long-standing history of coronary artery disease is experiencing symptoms that interfere with daily activities despite medical management. The patient is told he is a candidate for surgical revascularization and is presented with two options, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). The patient is curious about which option has lower mortality and risk of adverse events such as revascularization, myocardial infarction or stroke.

PICO Question:

In elderly patients with coronary artery disease requiring revascularization, does percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) result in lower mortality and decreased risk of adverse events such as revascularization, stroke or myocardial infarction?

Question Type:

☐Prevalence                           ☐Screening                 ☐Diagnosis

☐Prognosis                             ☒Treatment                ☐Harms

Assuming that the highest level of evidence to answer your question will be meta-analysis or systematic review, what other types of study might you include if these are not available (or if there is a much more current study of another type)? Please explain your choices.

– If meta-analysis or systematic review are not available, randomized controlled clinical trials will also offer great supporting evidence as they are carefully planned experiments, reduce the potential for bias, and allow for comparison between intervention and control groups.

– Cohort studies could also be used since they allow to follow the patients who have already received a particular treatment forward over time. This is not as reliable as randomized controlled clinical trials since patients might differ in ways other than in the variable that is being observed.

Search terms:

P	I	C	O
Elderly patient	Percutaneous coronary intervention	Coronary artery bypass graft	Decreased mortality
Coronary artery disease	PCI	CABG	Decreased adverse events
Elderly with CAD			Repeat revascularization
Coronary artery stenosis			Stroke
			Myocardial infarction

Results found:

PubMed:

Coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft, mortality (2,032)

Coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft, mortality, elderly, 10 years (802)

Coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft, mortality, elderly, 10 years, systematic review/meta-analysis (21)

Google Scholar:

Percutaneous coronary intervention, coronary artery bypass graft, mortality (181,000)

Percutaneous coronary intervention, coronary artery bypass graft, mortality, 10 years (18,900)

Elderly, PCI, CABG, systematic review/meta-analysis, 10 years (14,400)

Elderly, PCI, CABG, mortality, systematic review/meta-analysis, myocardial infarction, stroke, 10 years (12,500)

Medline Complete:

Percutaneous coronary intervention, coronary artery bypass graft, mortality (2,524)

Elderly with CAD, Percutaneous coronary intervention, coronary artery bypass graft, mortality (4)

Cochrane Library:

Coronary artery disease, percutaneous coronary intervention, coronary artery bypass graft (14)

A lot of research on this topic was done within the last decade and includes many different types of studies. I was able to find many articles and among them many meta-analyses and systematic reviews from the past decade. I narrowed down search results by limiting research to 10 years and only systematic reviews and meta-analyses. I was able to gather great articles with these limits and they each addressed my question well. Most of my articles were from PubMed and Medline, as Google Scholar yielded too many results even with many filters, and Cochrane library did not produce many articles at all.

Articles chosen for inclusion:

Citation: Gaudino M, Hameed I, Farkouh ME, Rahouma M, Naik A, Robinson NB, Ruan Y, Demetres M, Biondi-Zoccai G, Angiolillo DJ, Bagiella E, Charlson ME, Benedetto U, Ruel M, Taggart DP, Girardi LN, Bhatt DL, Fremes SE. Overall and Cause-Specific Mortality in Randomized Clinical Trials Comparing Percutaneous Interventions With Coronary Bypass Surgery: A Meta-analysis. JAMA Intern Med. 2020 Dec 1;180(12):1638-1646. doi: 10.1001/jamainternmed.2020.4748. PMID: 33044497; PMCID: PMC7551235.

Type of article: Meta-analysis

Abstract: Importance: Mortality is a common outcome in trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG). Controversy exists regarding whether all-cause mortality or cardiac mortality is preferred as a study end point, because noncardiac mortality should be unrelated to the treatment.Objective: To evaluate the difference in all-cause and cause-specific mortality in randomized clinical trials (RCTs) comparing PCI with CABG for the treatment of patients with coronary artery disease. Data Sources: MEDLINE (1946 to the present), Embase (1974 to the present), and the Cochrane Library (1992 to the present) databases were searched on November 24, 2019. Reference lists of included articles were also searched, and additional studies were included if appropriate. Study Selection: Articles were considered for inclusion if they were in English, were RCTs comparing PCI with drug-eluting or bare-metal stents and CABG for the treatment of coronary artery disease, and reported mortality and/or cause-specific mortality. Trials of PCI involving angioplasty without stenting were excluded. For each included trial, the publication with the longest follow-up duration for each outcome was selected. Data Extraction and Synthesis: For data extraction, all studies were reviewed by 2 independent investigators, and disagreements were resolved by a third investigator in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline. Data were pooled using fixed- and random-effects models. Main Outcomes and Measures: The primary outcomes were all-cause and cause-specific (cardiac vs noncardiac) mortality. Subgroup analyses were performed for PCI trials using drug-eluting vs bare-metal stents and for trials involving patients with left main disease. Results: Twenty-three unique trials were included involving 13 620 unique patients (6829 undergoing PCI and 6791 undergoing CABG; men, 39.9%-99.0% of study populations; mean age range, 60.0-71.0 years). The weighted mean (SD) follow-up was 5.3 (3.6) years. Compared with CABG, PCI was associated with a higher rate of all-cause (incidence rate ratio, 1.17; 95% CI, 1.05-1.29) and cardiac (incidence rate ratio, 1.24; 95% CI, 1.05-1.45) mortality but also noncardiac mortality (incidence rate ratio, 1.19; 95% CI, 1.00-1.41). Conclusions and Relevance: Percutaneous coronary intervention was associated with higher all-cause, cardiac, and noncardiac mortality compared with CABG at 5 years. The significantly higher noncardiac mortality associated with PCI suggests that even noncardiac deaths after PCI may be procedure related and supports the use of all-cause mortality as the end point for myocardial revascularization trials.

Gaudino

Citation: Head, S. J., Milojevic, M., Daemen, J., Ahn, J.-M., Boersma, E., Christiansen, E. H., … Kappetein, A. P. (2018). Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. The Lancet, 391(10124), 939–948. Doi:10.1016/s0140-6736(18)30423-9.

Type of article: Systematic review

Abstract: Background: Numerous randomized trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularization strategies.Methods: We did a systematic review up to July 19, 2017, to identify randomized clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics. Findings: We included 11 randomized trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06–1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09–1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19–1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86–1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87–1·33; p=0·52), regardless of diabetes status and SYNTAX score. Interpretation: CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularization strategies.

head2018

Citation: Giacoppo D, Colleran R, Cassese S, et al. Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting in Patients With Left Main Coronary Artery Stenosis: A Systematic Review and Meta-analysis. JAMA Cardiol. 2017;2(10):1079-1088. Doi:10.1001/jamacardio.2017.2895

Type of article: Systematic review and meta-analysis

Abstract: Importance: In patients with left main coronary artery (LMCA) stenosis, coronary artery bypass grafting (CABG) has been the standard therapy for several decades. However, some studies suggest that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative.Objective: To compare the long-term safety of PCI with drug-eluting stent vs CABG in patients with LMCA stenosis. Data Sources: PubMed, Scopus, EMBASE, Web of Knowledge, and Science Direct databases were searched from December 18, 2001, to February 1, 2017. Inclusion criteria were randomized clinical trial, patients with LMCA stenosis, PCI vs CABG, exclusive use of drug-eluting stents, and clinical follow-up of 3 or more years. Data Extraction and Synthesis: Trial-level hazard ratios (HRs )and95%Ciswerepooledby fixed-effect and random-effects models with inverse variance weighting. Time-to-event individual patient data for the primary end point were reconstructed. Sensitivity analyses according to drug-eluting stent generation and coronary artery disease complexity were performed. Main Outcomes and Measures: The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at long-term follow-up. Secondary end points included repeat revascularization and a composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at long-term follow-up. Results: A total of 4randomized clinical trials were pooled; 4394 patients were included in the analysis. Of these, 3371 (76.7%) were men; pooled mean age was 65.4 years. According to Grading of Recommendations, Assessment, Development and Evaluation, evidence quality with respect to the primary composite end point was high. Percutaneous coronary intervention and CABG were associated with a comparable risk of all-cause death, myocardial infarction, or stroke both by fixed-effect (HR, 1.06; 95% CI, 0.90-1.24; P = .48) and random-effects (HR, 1.06; 95% CI, 0.85-1.32; P = .60) analysis. Sensitivity analyses according to low to intermediate Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score (random-effects: HR, 1.02; 95% CI, 0.74-1.41; P = .89) and drug-eluting stent generation (first generation: HR, 0.90; 95% CI, 0.68-1.20; P = .49; second generation: HR, 1.19; 95% CI, 0.82-1.73; P = .36) were consistent. Kaplan-Meier curve reconstruction did not show significant variations over time between the techniques, with a 5-year incidence of all-cause death, myocardial infarction, or stroke of 18.3% (319 events) in patients treated with PCI and 16.9% (292 events) in patients treated with CABG. However, repeat revascularization after PCI was increased (HR, 1.70; 95% CI, 1.42-2.05; P < .001). Other individual secondary end points did not differ significantly between groups. Finally, pooled estimates of trials with LMCA stenosis tended overall to differ significantly from those of trials with multivessel coronary artery disease without left main LMCA stenosis. Conclusion and Relevance: Percutaneous coronary intervention and CABG show comparable safety in patients with LMCA stenosis and low to intermediate–complexity coronary artery disease. However, repeat revascularization is more common after PCI.

Giacoppo

Citation: Sharma, S. P., Dahal, K., Khatra, J., Rosenfeld, A., & Lee, J. (2017). Percutaneous coronary intervention vs coronary artery bypass grafting for left main coronary artery disease? A systematic review and meta-analysis of randomized controlled trials. Cardiovascular Therapeutics, 35(3), e12260. Doi:10.1111/1755-5922.12260.

Type of article: Systematic review and meta-analysis

Abstract: Background: It is not clear whether Percutaneous Coronary Intervention (PCI) is as effective and safe as Coronary Artery Bypass Grafting (CABG) for left main coronary artery disease. We aimed to perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) that compared PCI and CABG in left main coronary disease.Methods: We searched PubMed, EMBASE, Cochrane, Scopus and relevant references for RCTs (inception through, November 20, 2016 without language restrictions) and performed meta- analysis using random effects model. All-cause mortality, Myocardial infarction, revascularization rate, stroke, , major adverse cardiac and cerebrovascular events (MACCE) were the measured outcomes. Results: 6 RCTs with a total population of 4700 were analyzed. There was no difference in all- cause mortality at 30-day, 1-year and 5-year (1.8% vs. 1.1%; OR 0.60; 95%CI 0.26- 1.39;P=0.23;I2=9%) follow up between PCI and CABG. CABG group had less MI at 5-year follow up than PCI (5% vs. 2.5%; OR 2.04; CI 1.30-3.19; P=0.002;I2=1%). Revascularization rate favored CABG in 1-year (8.6% vs 4.5%; OR 2; CI 1.46-2.73; P<0.0001;I2=45%) and 5-year (15.9% vs. 9.9%;OR 1.73; CI 1.36-2.20; P<00001;I2=0%)follow up. Though stroke rate was lower in PCI group at 1-year there was no difference in longer follow up. MACCE at 5-year favored CABG (24% vs. 18%; OR 1.45; CI 1.19-1.76; P=00001;I2=0%). On subgroup analysis, MAACE was not different between two groups in low to intermediate Syntax group while it was higher for PCI group with high Syntax group. Conclusion: PCI could be as safe and effective as CABG in a select group of left main coronary artery disease patients.

sharma2017

Citation: Chang M, Lee CW, Ahn JM, Cavalcante R, Sotomi Y, Onuma Y, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Serruys PW, Park SJ. Outcomes of Coronary Artery Bypass Graft Surgery Versus Drug-Eluting Stents in Older Adults. J Am Geriatr Soc. 2017 Mar;65(3):625-630. doi: 10.1111/jgs.14780. Epub 2017 Feb 6. PMID: 28165613.

Type of article: Meta-analysis

Abstract: Objectives: Little data are available to compare coronary artery bypass graft surgery (CABG) vs percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in older adults. We evaluate the long-term outcomes of CABG vs PCI with DES in older adults with left main or multivessel coronary artery disease (CAD). Design: Individual patient-level meta-analysis. Settings: Databases from the BEST, PRECOMBAT, and SYNTAX trials were combined. Participants: A total 1,079 adults aged 70 to 89 years were pooled. Measurements: The primary outcome was a composite of death from any causes, myocardial infarction, stroke, or repeat revascularization. Results: During a total of 6.3 (median, 4.9) years of follow-up, the primary composite outcome of all-cause mortality, myocardial infarction, stroke, or repeat revascularization occurred in 26% (141/550) and 34% (179/529) of patients in the CABG and PCI groups, respectively (hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.60-0.94; P = .012). CABG was associated with fewer myocardial infarction (4% vs 8% for PCI; HR, 0.48; 95% CI, 0.29-0.80; P = .037); and repeat revascularizations (8% vs 17% for PCI; HR, 044; 95% CI, 0.31-0.64; P < .001), but had little association with all-cause mortality or stroke. Conclusion: Older adults age 70 to 89 years with left main or multivessel CAD who participated in the BEST, PRECOMBAT, and SYNTAX trials; compared to PCI, CABG was associated with lower risk of primary outcome which was mostly driven by lower risk of myocardial infarction.

chang2017

Summary of the evidence:

Author and Date	Level of Evidence	Sample/Setting (# of subjects/studies, cohort, etc.)	Outcomes Studied	Key Findings	Limitations and Biases
Gaudino, et al.   2020	Meta-analysis	Articles were considered for inclusion if they were in English and were RCTs comparing PCI with bare-metal or drug-eluting stents and CABG for the treatment of coronary artery disease and reported mortality and/or cause-specific mortality.   Trials of PCI involving angioplasty without stenting were excluded. For each included trial, the publication with the longest follow-up duration for each outcome was selected.   A total of 425 citations were evaluated, of which 23 trials in 24 studies met the eligibility criteria and were included in the final meta-analysis.   A total of 13,620 patients were included (6829 undergoing PCI and 6791 undergoing CABG).   The number of patients in the individual trials ranged from 44 to 1905.   The mean follow-up duration of the individual studies was 4.5 years (range, 0.5-11.4 years).   The mean age of patients ranged from 60.0 to 71.0 years.	The primary outcomes were all-cause and cause-specific (cardiac vs noncardiac) mortality.   Subgroup analyses were performed for trials comparing PCI using bare-metal or drug- eluting stents vs CABG and for trials comparing PCI with CABG in patients with left main disease.	Compared with CABG, PCI was associated with a higher rate of all-cause mortality, cardiac mortality, and noncardiac mortality.   Sensitivity analyses confirmed the solidity of the primary analysis.   In the analysis by anatomical extent of coronary disease, the IRR was 1.11 for studies including patients with left main disease vs 1.19  for the others.	Differences in procedural aspects, post-procedural management, and follow-up protocol may have existed between trials   Exact causes of non-cardiac mortality were not reported by several trials and couldn’t be independently compared between PCI and CABG
Head et al.   2018	Systematic review	11 trials included with 11,518 patients, randomly assigned to CABG (n=5765) or to PCI (n=5753).   PCI was done with bare-metal stents in 1490 patients in four trials (n=3051), with first-generation drug-eluting stents in 2199 patients in four trials (n=4498), and with newer-generation drug- eluting stents in 1920 patients in three trials (n=3969; table 1).   CABG was done with a left internal mammary artery in 4574 patients in nine trials (n=4753), with a bilateral internal mammary artery in 771 patients in seven trials (n=4122), and off-pump in 1085 patients in seven trials (n=3945).	All-cause mortality was the primary endpoint of this study, with analyses planned in all patients and separately in patients with multivessel disease or left main disease.	5-year all-cause mortality was 11·2% (539 events) after PCI and 9·2% (437 events) after CABG.   At 30 days’ follow-up, all-cause mortality was 1·3% (76 events) after PCI and 1·4% (78 events) after CABG.   Between 31 days’ and 5 years’ follow-up, all-cause mortality was 10·0% (463 events) after PCI and 8·0% (359 events) after CABG.   A time-dependent model showed that the risk of mortality was similar for PCI and CABG during the first year of follow-up, but in favor of CABG beyond 1 year.   5 year all-cause mortality was 16·5% (71 events) after PCI versus 13·4% (51 events) after CABG in the subgroup of patients with left main disease who had diabetes, and 8·8% (103 events) after PCI versus 9·6% (107 events) after CABG in the subgroup of patients without diabetes.	All included trials assumed clinical equipoise between CABG and PCI   Inclusion and exclusion criteria led to significant heterogeneity in baseline characteristics of patients from different trials   Definitions and reporting of patient characteristics might have slightly differed between trials, which could have affected the results of the subgroup analyses.
Giacoppo et al.   2017	Systematic review and meta-analysis	4 randomized clinical trials were included in the primary analysis.   A total of 4394 patients were included.   76.7% were men with average age of 65.4.	The primary end point was a composite of all-cause death, myocardial infarction, or stroke at the longest available follow- up.   The secondary end points were repeat revascularization, individual components of the primary end point, cardiac death, stent or graft occlusion, and a composite of all-cause death, myocardial infarction, stroke, or repeat revascularization at the longest available follow-up.	Percutaneous coronary intervention and CABG showed comparable outcomes both by fixed-effect and by random-effects models.   Kaplan-Meier analysis did not show significant differences between treatments over time, with a cumulative incidence of 18.3% (319 events) in the PCI group and 16.9% (292 events) in the CABG group at 5-year follow-up.   Within the first 2 years, PCI exhibited a numeric advantage over CABG; however, from 3 to 5 years, CABG showed a nonsignificant advantage over PCI.   Risk estimation by a shared frailty model showed similar safety of the techniques.   With respect to repeat revascularization, PCI was associated with a significantly higher risk compared with CABG.   A total of 313 events occurred in the PCI group and 184 events occurred in the CABG group.   There was a comparable risk of death between PCI and CABG in both all-cause and cardiac death.	Qualitative assessment showed overall low risk of bias.   According to GRADE, evidence quality with respect to the primary composite end point and repeat revascularization was high, evidence quality for death was moderate, and evidence quality for myocardial infarction, stroke, and stent or graft occlusion was low.   Absence of individual patient data didn’t permit stratification of patients according to every SYNTAX score tercile.   One trial provided only 3 years of follow up, while the rest had 5 years of follow-up.
Sharma et al.   2017	Systematic review and meta-analysis	Authors included studies that met all the of the following criteria- 1) randomized controlled studies comparing PCI and CABG for the revascularization of left main coronary disease; 2) a minimum follow up period of one year; 3) report of at least two of the outcomes of interest 8 studies were included with a total of 4,700 patients   Analyses were done at 30 days, 1 year, and 5 year follow-ups   All the patients included in the meta-analysis had unprotected left main coronary artery disease.   PCI arm consisted of 2349 and CABG arm consisted of 2351 left main disease patients.   Of the total, 2594 had 5 years of follow-up.   Males constituted more than 70% of population.	Primary outcome was all-cause mortality   Secondary outcomes were myocardial infarction, stroke, revascularization, major adverse cardiac or cerebrovascular events, and adverse events in PCI and CABG	There was no difference in all-cause mortality between PCI and CABG arm at 30-day (1.8% vs. 1.1%), one year (2.3% vs. 3.5% and five year (7.8% vs.8.3%) follow-up   There was no difference in rate of MI between revascularization strategies by PCI and CABG at 30-day (3.5% vs. 4.6%) and one year of follow up (2.4% vs. 2.2%)   However, at 5-year follow up revascularization with CABG was associated with low rate of MI (5% vs. 2.5%) 30-day revascularization rate was not different between PCI and CABG group (0.9% vs. 1)   CABG showed better outcome at 1-year (8.6% vs. 4.5) and 5-year (15.9% vs. 9.9)   CABG was associated with low revascularization rate at ≥3years follow up as well   CABG had more adverse events than PCI. Increased incidence of major bleeding, renal failure, post procedure arrhythmia, infection and surgical site complication was seen in CABG arm.	High risk of performance bias was identified as blinding of study participants and personnel were not possible.   Other biases were identified to be low risk.   Limitations included heterogeneity in definitions of myocardial infarction by individual studies, small number of RCTs, absence of blinding of treatment assignments, and variable rate of follow-up.   Variable rate of antiplatelet use between the two options may have affected clinical outcomes.
Chang et al.   2017	Meta-analysis	Three trials were used in this meta-analysis   All of the trials were multicenter   SYNTAX recruited 1,800 patients (mean age 65) with 3-vessel or left main CAD from Europe and the United States.   PRECOMBAT trial enrolled 600 patients (mean age 62) with left main CAD from Korea   BEST recruited 880 patients (mean age 64) with 2- or 3-vessel CAD from Asia   In all of these trials, patients who were eligible for both PCI and CABG were randomly assigned to receive either strategy.   Among these patients, we identified 1,079 adults (32.9% of total cohort) with age 70 to 89 years, 3 comprising the study population.   Baseline characteristics were matched between the two study populations	Primary outcomes were all-cause mortality, myocardial infarction, stroke, or repeat revascularization.	The primary outcome occurred in 141 (25.6%) patients in the CABG group and 179 (33.8%) patients in the PCI group     Death from any causes occurred in 77 (14.0%) patients in the CABG group and 95 (18.0%) patients in the PCI group and a similar trend was observed regarding death from cardiac causes   The rate of myocardial infarction was significantly lower in the CABG group compared with the PCI group   There were more strokes among CABG patients than among PCI patients   The need for repeat revascularization was remarkably less common in the CABG group than in the PCI group	Results of study are mainly affected by the BEST trial despite well-founded statistical method   Optimal medical therapy was less likely used after CABG than after PCI which may disadvantage patients regarding cardiovascular events following CABG   The analysis addresses primarily age and coronary anatomical factors as risk factors and predictors of outcome

Conclusions:

Article 1 (Gaudino): This meta-analysis found that percutaneous coronary intervention was associated with higher all-cause, cardiac, and non-cardiac mortality compared to CABG. The significantly higher non-cardiac mortality associated with PCI suggests that even non-cardiac deaths after PCI may be related to the procedure and/or subsequent management, and the data strongly supports use of all-cause mortality as the most comprehensive and unbiased end point for myocardial revascularization trials.

Article 2 (Head): 5 year mortality was significantly lower after CABG than after PCI. In particular, the benefit of CABG over PCI was shown in patients with multivessel disease and diabetes, but not in patients with multivessel disease without diabetes. Also, no benefit was seen between CABG and PCI in left main disease.

Article 3 (Giacoppo): In patients undergoing revascularization of left main coronary artery (LMCA) stenosis, the PCI and CABG techniques are associated with a comparable risk of a composite of all-cause death, myocardial infarction, or stroke at long-term follow-up. However, patients treated with PCI present a higher risk of repeat revascularization compared with those who undergo CABG. Evidence quality with respect to both of these end points was high. Risk of death— both all-cause and cardiac—was comparable between the 2 strategies, and only numeric differences in myocardial infarction and stroke were observed. The group of trials including patients with CAD involving LMCA stenosis tended to show diverging results from the group of trials including patients with multi vessel CAD without LMCA stenosis. These findings suggest that, in patients with significant stenosis of the LMCA and overall low to intermediate CAD complexity, both PCI and CABG are valid approaches to revascularization.

Article 4 (Sharma): The study shows that PCI can be a feasible and safe option for revascularization of LMCA patients with low to intermediate Syntax score. The decision about appropriate revascularization for LMCA patients should be individualized factoring into their clinical and angiographic risk factors and their preference. The meta-analysis provides the important understanding of the expected outcome of PCI or CABG for revascularization in LMCA patients.

Article 5 (Chang): CABG compared to PCI may reduce risk of major adverse cardiac and cerebrovascular events in older adults with left main or multivessel CAD.

Overall Conclusion: The studies appear to have produced mixed findings on CABG vs PCI for coronary artery disease. Most studies found that CABG is beneficial over PCI in terms of long-term adverse effects and mortality, but PCI appears more advantageous in the short-term. PCI has a higher revascularization rate and greater incidence of myocardial infarction and stroke but is less likely to result in major bleeding or procedure complications.

Clinical Bottom Line:

The choice between percutaneous coronary intervention and coronary artery bypass graft is a tough one for many patients. While PCI offers the advantages of being less invasive, having a shorter recovery time and much less intra-procedural complications, the long-term benefits are questionable compared to CABG. On the other hand, CABG is an incredibly invasive procedure and has many possible procedural complications but is known as the better option long-term.

I decided to ask this question in order to assess the real long-term outcomes and mortality between the two procedures. The studies by Gaudino and Head concluded that CABG was associated with a lower 5-year mortality rate than PCI. The study by Giacoppo found that while CABG was associated with a lower 5-year mortality rate, it was not statistically significant. However, the same study also found less adverse effects early on with PCI but more adverse effects occurring at longer follow-up. PCI was also associated with a higher risk of revascularization. The study by Sharma found that there was essentially no difference between PCI and CABG regarding all-cause mortality, myocardial infarction, and stroke at long-term follow-up but the high risk of bias and shorter follow-up time makes this finding less reliable.

Looking at the evidence as a whole, I believe CABG is the better choice for the patient in my clinical scenario. For a 65-year-old, CABG provides less adverse outcomes long-term according to these studies. CABG is also associated with the same mortality rate as PCI according to two studies and a lower mortality according to the other two studies. At the bare minimum, the mortality rate is similar, but the long-term adverse outcomes are lower with CABG. However, for patients that are older and are looking for less short-term adverse effects and not weighing the long-term as heavily, PCI appears to be the better choice according to the research compiled above.

Weight of Evidence:

I weighed the study by Gaudino, et al. (article 1) in first place as it’s a large-scale study with over 13,000 patients and is the most recent study I found, being done in 2020. The study is a meta-analysis making it a high level of evidence. The average follow-up time was found to be 4.5 years, allowing for adequate monitoring of adverse effects and long-term complications. The study also reported low bias and very few limitations. Overall, the study design along with the previously mentioned characteristics makes this the most reliable and heavily weighed study.

I weighed the study by Head, et al. (article 2) in second place as it’s a recently done systematic review from 2018 and it included 11,518 patients. The large sample size and high level of evidence makes this a reliable study. The study reported only slight bias and limitations. I especially appreciated that the study included information regarding different types of stents used in PCI and different arteries used in CABG, as well as off-pump CABG results.

I weighed the study by Giacoppo, et al. (article 3) in third as it is both a systematic review and meta-analysis that was done fairly recently in 2017. This study included 4,394 patients, which is a decent sample size. The study had a 5-year follow-up period, allowing for adequate monitoring of outcomes and complications. The authors also reported low risk of bias and limitations, making this study reliable.

I weighed the study by Sharma, et al. (article 4) in fourth place mainly due to the limitations and bias reported by the authors. This was a recent systematic review and meta-analysis dating to 2017, with 4,700 patients and a 3-year follow-up period. While these characteristics make this a well-designed study, the reported high risk of performance bias and slight limitations make this study less reliable than the others.

I weighed the study by Chang, et al. in last, mostly due to the fact that it only included three trials. This was a meta-analysis done in 2017 with 3,479 patients. While fairly recent, the authors reported that one of the trials included affected the results the most. With results that may have been skewed by one trial in particular, the findings of this study may not be reliable.

Magnitude of Effects:

Gaudino (Article 1): Compared with CABG, PCI was associated with a higher rate of all-cause mortality (IRR, 1.17; 95% CI, 1.05-1.29), cardiac mortality (IRR, 1.24; 95% CI, 1.05-1.45), and noncardiac mortality (IRR, 1.19; 95% CI, 1.00-1.41). The pooled IRR for all-cause mortality was 1.22 (95% CI, 1.09- 1.38) for studies including drug-eluting stents vs 1.04 (95% CI, 0.84-1.29) for studies including bare-metal stents (P = .19 for subgroups). The pooled IRR for cardiac mortality was 1.31 (95% CI, 1.09- 1.58) for studies including drug-eluting stents vs 1.04 (95% CI, 0.76-1.43) for studies including bare-metal stents (P = .21 for subgroups). The pooled IRR for noncardiac mortality was 1.28 (95% CI, 1.04-1.57) for studies including drug-eluting stents vs 1.02 (95% CI, 0.75-1.38) for studies including bare-metal stents (P = .22 for subgroups). The pooled IRR was 1.41 (95% CI, 1.05-1.89) for studies including patients with left main disease vs 1.09 (95% CI, 0.88-1.34) for the others (P = .15 for subgroups).

Head (article 2): 5 year all-cause mortality was 11·2% (539 events) after PCI and 9·2% (437 events) after CABG (HR 1·20, 95% CI 1·06–1·37; p=0·0038). At 30 days’ follow-up, all-cause mortality was 1·3% (76 events) after PCI and 1·4% (78 events) after CABG (0·97, 0·71–1·33; p=0·84). Between 31 days’ and 5 years’ follow-up, all- cause mortality was 10·0% (463 events) after PCI and 8·0% (359 events) after CABG (1·26, 1·09–1·44; p=0·0009). A time-dependent model showed that the risk of mortality was similar for PCI and CABG during the first year of follow-up (0∙97, 0∙80–1∙19; p=0·80), but in favor of CABG beyond 1 year (1·39,1·17–1·62;p<0·0001). The estimate of the frailty parameter for heterogeneity was significant (θ=0·39, p<0·0001). The difference in 5 year mortality between PCI and CABG was consistent when analyzing the 4300 patients in the trials using first- generation drug-eluting stents (13·2% [254 events] after PCI vs 11·1% [201 events] after CABG; HR 1·21, 95% CI 1·01–1·46; p=0·0415) and the 3969 patients in the trials using newer-generation drug-eluting stents (10·3% [136 events] after PCI vs 7·9% [106 events] after CABG; 1·27, 0·98–1·64; p=0·0658; pinteraction=0·78).

Giacoppo (Article 3): Percutaneous coronary intervention and CABG showed comparable outcomes both by fixed-effect (HR, 1.06; 95% CI, 0.90-1.24; P = .48) and by random-effects (HR, 1.06; 95% CI, 0.85-1.32, P = .60) models. The EXCEL trial had the highest relative weight (35.9%). There was a moderate degree of heterogeneity (I2 = 42.5%, P = .16). Kaplan-Meier analysis did not show significant differences between treatments over time, with a cumulative incidence of 18.3% (319 events) in the PCI group and 16.9% (292 events) in the CABG group at 5-year follow-up. Within the first 2 years, PCI exhibited a numeric advantage over CABG; however, from 3 to 5 years, CABG showed a nonsignificant advantage over PCI. Risk estimation by a shared frailty model showed similar safety of the techniques (HR, 1.05; 95% CI, 0.90-1.23; P = .53).
Influence analysis showed that heterogeneity was mainly due to the NOBLE trial, which was the only trial favoring CABG (omitting NOBLE: HR, 0.96; 95% CI, 0.80- 1.15; P = .66; I2 = 0%). After including only patients with SYNTAX scores of 1 to 32, the results remained consistent (random effects: HR, 1.02; 95% CI, 0.74-1.41; P = .89). The grouping of trials according to DES generation did not show significant differences (Figure 1B), with comparable pooled estimates (first-generation: HR, 0.90; 95% CI, 0.68-1.20; P = .49; second-generation: HR, 1.19; 95% CI, 0.82- 1.73; P = .36). Effect size was uniform within the first- generation DES group (I2 = 0%, P = .95), while the second- generation DES group showed high heterogeneity (I2 = 71.4%, P = .06) as an expression of the contrasting results of the EXCEL and NOBLE trials.

Sharma (Article 4): There was no difference in all-cause mortality between PCI and CABG arm at 30-day (1.8% vs. 1.1%; OR 0.60;95%CI 0.26-1.39;P=0.23;I2=9%), one year (2.3% vs. 3.5%; OR 0.67;CI 0.43- 1.06; P=0.09;I2=0%) and five year (7.8% vs.8.3%;OR0.92;CI 0.69-1.24; P=0.6;I2=9%). There was no difference in rate of MI between revascularization strategies by PCI and CABG 30-day (3.5% vs. 4.6%; OR 0.75;CI 0.53-1.06; P=0.1;I2=0%) and one year of follow up (2.4% vs. 2.2%;OR 1.10;CI 0.67-1.82; P=0.71;I2=0%). However, at 5-year follow up revascularization with CABG was associated with low rate of MI (5% vs. 2.5%; OR 2.04;CI 1.30-3.19; P=0.002;I2=1%). 30-day revascularization rate was not different between PCI and CABG group (0.9% vs. 1%;OR 0.65; CI 0.35-1.21; P=0.17;I2=0%). CABG showed better outcome at 1-year (8.6% vs. 4.5%;OR 2; CI 1.46-2.73; P<0.0001;I2=45%) and 5-year (15.9% vs. 9.9%;OR 1.73; CI 1.36- 2.20; P<00001;I2=0%). Revascularization by PCI was associated with low stroke rate at 30-day (0.3% vs. 1.1%; OR 0.40; CI0.16-0.98; P=0.05; I2=0%) and 1-year (0.2% vs. 1.3%; OR 0.21;CI 0.07-0.63; P=0.005;I2=0%).

Chang (Article 5): The primary outcome occurred in 141 (25.6%) patients in the CABG group and 179 (33.8%) patients in the PCI group (hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.60–0.94; P = .012). In patients with low SYN- TAX scores (<23), the rate of primary outcome tended to be higher with CABG than with PCI (HR, 1.19; 95% CI, 0.78– 1.83; P = .418). Conversely, in those individuals with intermediate SYNTAX scores (23–32), it tended to be lower with CABG than with PCI (HR, 0.76; 95% CI, 0.53– 1.09; P = .137). For patients with high SYNTAX scores (≥33), however, the rate of primary outcome was significantly lower with CABG than with PCI (HR, 0.49; 95% CI, 0.34–0.72; P < .001). By multi-variate analysis, revascularization strategy (CABG vs PCI with DES), peripheral artery disease, completeness of revascularization, SYNTAX scores, and EuroSCORE were independent predictors of primary outcome. Death from any causes occurred in 77 (14.0%) patients in the CABG group and 95 (18.0%) patients in the PCI group (HR, 0.80; 95% CI, 0.60–1.09; P = .153). A similar trend was observed regarding death from cardiac causes. The rate of myocardial infarction was significantly lower in the CABG group compared with the PCI group (HR, 0.48; 95% CI, 0.29– 0.80; P = .037). Likewise, the composite outcome of death from any causes or myocardial infarction significantly favored CABG over PCI. There were numerically more strokes among CABG patients than among PCI patients (HR, 1.49; 95% CI, 0.76–2.92; P = .252). Conversely, the need for repeat revascularization was remarkably less common in the CABG group than in the PCI group (HR, 044; 95% CI, 0.31–0.64; P < .001).

Clinical Significance:

Percutaneous coronary intervention has gained more support for treatment of coronary artery disease over the years due to it being a simpler and less expensive procedure than coronary artery bypass graft surgery. PCI involves a catheter and stenting, while CABG involves cutting the breastbone, stopping the heart, and reattaching an excised vein or artery to bypass non-functional coronary arteries. The two options are vastly different, and many studies have attempted to assess their impact on mortality, adverse events, and quality of life. When faced with the decision between PCI and CABG, many patients prefer PCI due to its less invasive nature. The major factor to consider, however, is how effective the procedure really is in treatment of coronary artery disease in the long-term. The findings in these studies have shown CABG to be more effective long-term, which is a suitable choice for younger patients seeking long-term health with less likelihood of myocardial infarction, stroke, or revascularization. PCI was determined to have less adverse events short-term, which appears to be the better option for patients that are older and may not be able to withstand an open-heart surgery. With PCI showing higher mortality rates in some studies and equal mortality rates in other studies, the cost-effectiveness and minimally invasive nature of the procedure may be the choice option for more patients going forward if the short-term complications could be better expected and managed. PCI could also be the optimal option for treatment due to its less invasive nature and cost effectiveness. The lower mortality rate, lower risk of long-term major adverse events, and lower rate of revascularization seen with CABG is more favorable for patients that are interested in long-term effects, while others weigh the lower risk of short-term complications as a more favorable outcome.

Other Considerations:

More studies should be conducted on the effectiveness of both PCI and CABG in several comorbidities, not just diabetes. Another aspect to consider is standardizing medical management post-procedure, as PCI often involves different choices of medications than CABG after the procedure. These are both areas that the authors of the above studies have indicated need to be addressed and studied further.