Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease

Stone, Gregg W.; Kappetein, Arie Pieter; Sabik, Joseph F.; Pocock, Stuart J.; Morice, Marie‐Claude; Puskas, John D.; Kandzari, David E.; Karmpaliotis, Dimitri; Brown, W. Morris; Lembo, Nicholas; Banning, Adrian P.; Merkely, Béla; Horkay, Ferenc; Boonstra, Piet W.; Boven, Ad J. van; Ungi, Imre; Bogáts, Gábor; Mansour, Samer; Noiseux, Nicolas; Sabaté, Manel; Pomar, José L.; Hickey, Mark; Gershlick, Anthony; Buszman, Paweł; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Modolo, Rodrigo; Gregson, John; Simonton, Charles A.; Mehran, Roxana; Kosmidou, Ioanna; Généreux, Philippe; Crowley, Aaron; Dressler, Ovidiu; Serruys, Patrick W.

doi:10.1056/nejmoa1909406

Cited by 563 publications

(422 citation statements)

References 28 publications

Supporting

Mentioning

377

Contrasting

Unclassified

Order By: Relevance

“…Three other works were suggestive of a significant BACO in which the RR of the composite outcome was towards nullity compared to the RR of mortality. 29,30,35 These works Regarding the positive controls, the CAPRICORN study showed that carvedilol, compared with placebo, was not significantly associated with the composite outcome (RR = 0.94; 95% CI: 0.84 to 1.06) but was associated with a 22% reduction in mortality (BACO index: 0.24; 95% CI: -0.15 to 0.64). On the other hand, in the EXPEDITION study, the use of cariporide was associated with an 18% lower incidence of the composite outcome, but with a 53% higher mortality, compared with placebo (BACO index: -0.48; 95% CI: -1.03 to 0.08).…”

Section: Resultsmentioning

confidence: 99%

Estimating and Testing an Index of Bias Attributable to Composite Outcomes in Comparative Studies

Díaz-Quijano

2020

Preprint

View full text Add to dashboard Cite

Background: Little guidance is available on how composite outcomes should be interpreted, especially in situations of varied direction in the association across the event subtypes. I proposed an index to evaluate the bias attributable to composite outcomes (BACO) and applied it in recently published clinical trials.Methods: I defined the BACO index as the ratio between logarithms of the association measures of both a composite outcome and its most relevant component (e.g., any-cause mortality). By using the non-linear combination of parameters, based on the delta method, I calculated the confidence intervals and performed Wald-type tests for the null hypotheses (BACO index = 1). I applied this method in systematically selected clinical trials, and in two other preselected trials which I considered "positive controls". These last trials have been recognized as examples of primary composite outcomes that were disregarded because of inconsistency with the treatment effect on mortality.Results: BACO index values different from one were classified according to whether the use of composite outcomes overestimated (BACO index >1), underestimated (BACO index between zero and <1), or inverted (BACO index <0) the association between exposure and prognosis. In three of 23 clinical trials and the two positive controls, the BACO indices were significantly lower than one (using p <0.005 as a preset cutoff).Conclusion: Based on the BACO index testing, researchers could predefined rules to make impartial decisions about maintaining a composite outcome as the primary endpoint or to state cautions regarding its interpretation.

show abstract

Section: Resultsmentioning

confidence: 99%

Estimating and Testing an Index of Bias Attributable to Composite Outcomes in Comparative Studies

Díaz-Quijano

2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Five-year data of 2 highly anticipated trials of PCI vs CABG for left main coronary disease provided contrasting results. In EXCEL [8], which studied low to intermediate left main complexity, the incidence of death, stroke, or MI (including periprocedural MI) was similar in the PCI and CABG cohorts (22.0% vs 19.2%; 95% CI, -0.9 to 6.5; P = 0.13). Conversely, in the NOBLE study [9], which studied all-comer left main complexity, the incidence of death, MI (excluding peri-procedural MI), repeat revascularisation, and stroke was higher for PCI (28% vs 19%; p = 0.0002).…”

Section: Dear Readersmentioning

confidence: 96%

Cardiology and Therapy: A Summary of 2019 and Key Areas of Emerging Research in 2020

2020

View full text Add to dashboard Cite

“…These trials led to the conclusion that both therapies remain important for the treatment of left main/multivessel disease, but with bearing in mind that a heart team discussion is of outmost importance when managing these difficult cases. Their most important data is marked in Table 2 ( Mäkikallio et al, 2016;Stone et al, 2016Stone et al, , 2019.…”

Section: ''The Era To Excel In Noble Trials'' (Des2 Trials)mentioning

confidence: 99%

“…On 28 September 2019 was published the 5-year follow-up for EXCEL trial, with essentially the same results: the frequency of cardiovascular death and myocardial infarction were not statistically different, with a similar incidence of stroke in both groups and with less numerous cerebrovascular events following angioplasty than after CABG (a total difference of 1.9%); moreover, there was no compelling disparity between PCI and CABG at 5 years when taking into consideration the rate of the composite outcome (stroke, myocardial infarction and death). At the end of the trial, death from any cause was more often identified in the angioplasty group than in the CABG arm, with a crucial difference of 3.1% (Table 2) (Stone et al, 2019).…”

Section: ''The Era To Excel In Noble Trials'' (Des2 Trials)mentioning

confidence: 99%

Coronary artery bypass graft surgery versus percutaneous coronary intervention in unprotected left main coronary artery disease: A systematic review

Macovei

Magopet²,

Tanasa

et al. 2020

Reviews in Cardiovascular Medicine

View full text Add to dashboard Cite

Critical lesion of the unprotected left main coronary disease carries a tremendous mortality burden, often associated with a diabetes status or multivessel disease, with coronary artery bypass grafting being the standard treatment for over 40 years. Percutaneous coronary intervention with drug eluting stents should be taken into consideration and could be a better option for patients with low SYNTAX score as validated by the recently published studies. This review summarizes the major randomized clinical trials and meta-analyses concerning the debate regarding percutaneous coronary intervention with drug eluting stents versus coronary artery bypass grafting for unprotected left main coronary disease, along with the latest European and American revascularization guidelines and tries to shed light on this matter. The most results advocate that there is no convincing difference in survival rate for both therapies, especially in patients with isolated left main disease but with fewer major ischemic events for coronary artery bypass grafting when compared with percutaneous coronary intervention in multivessel coronary artery disease, at the rate of a higher stroke incidence. The gaps in evidence are also highlighted, especially the lack of randomized clinical trials with new generation drug eluting stents versus coronary artery bypass grafting or those regarding the best revascularization strategy for an acute coronary syndrome when unprotected left main coronary disease is involved.

show abstract

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease

Cited by 563 publications

References 28 publications

Estimating and Testing an Index of Bias Attributable to Composite Outcomes in Comparative Studies

Estimating and Testing an Index of Bias Attributable to Composite Outcomes in Comparative Studies

Cardiology and Therapy: A Summary of 2019 and Key Areas of Emerging Research in 2020

Coronary artery bypass graft surgery versus percutaneous coronary intervention in unprotected left main coronary artery disease: A systematic review

Contact Info

Product

Resources

About