Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Disease
Bibliographic record
Abstract
Belley-Cote et al. question the noninferiority margin in the EXCEL trial. The margin should be selected to support a reasonable conclusion of therapeutic interchangeability between the test and control treatments,1 and in an active controlled trial, the margin may be based on a putative placebo or expert consensus of the minimal clinically important difference.2 Trial feasibility often necessitates composite end points. The cardiology and surgical leadership in the EXCEL trial unanimously agreed that death, stroke, and large MI are clinically important end points and that a margin of 4.2 percentage points was acceptable. An examination of the absolute 95% confidence intervals of the 3-year difference with respect to the primary end point in the EXCEL trial (which accounts for the number of patients enrolled) shows that PCI may range from 2.7 percentage points better to 4.0 percentage points worse than CABG for treatment of left main disease, with a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). Both Belley-Cote et al. and Christiansen et al. question the appropriateness of the EXCEL protocol definition of MI. Our MI definition represents extensive myonecrosis, which has been strongly associated with subsequent death in patients who underwent PCI and patients who underwent CABG3 and avoids ascertainment bias. Periprocedural MI, as defined in the EXCEL trial, was significantly associated with death at 3 years in patients who underwent PCI (hazard ratio, 3.04; 95% confidence interval [CI], 1.39 to 6.63) and in patients who underwent CABG (hazard ratio, 2.44; 95% CI, 1.10 to 5.40), which justifies its inclusion in the composite outcome. We disagree with Christiansen et al. that repeat revascularization (which favored CABG) deserves equality with death, stroke, and large MI as a primary end-point event. Repeat revascularization is of no greater clinical consequence than many other adverse outcomes that favored PCI, such as major bleeding, renal failure, arrhythmia, or serious infection. Comparisons between the EXCEL trial and NOBLE4 are problematic because a relatively thick-strut stainless steel stent was used in NOBLE; the rate of thrombosis among the patient who received this stent in NOBLE was 4 times as high as that among the patients who received the everolimus-eluting stent used in the EXCEL trial. Moreover, in NOBLE, periprocedural MI was not routinely assessed, and a higher rate of stroke was observed in association with PCI than with CABG, which could not be explained. Finally, Belley-Cote et al. implicate undue industry influence in the design of the EXCEL trial. Our hypotheses and end points were developed by a large group of practicing interventional cardiologists and cardiac surgeons (with guidance from the Food and Drug Administration) and were not prejudiced by the sponsor.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.035 | 0.114 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.006 |
| Insufficient payload (model declined to judge) | 0.005 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".