CHAMGAP
APPROVEDReviewed and approved by the Chamgap Editorial Team (2026-08-01). The draft was written by AI, the existence of all 3 cited sources was verified at the original page, and the verdict passed blind grading and adversarial audit. Methodology v0.6.
Verdict No. 1918 · Search date 2026-08-01 · Methodology v0.6

IABP,
does it really help with Reduced 30-day mortality in acute myocardial infarction with cardiogenic shock undergoing early revascularization?

30-Second Summary
D
Evidence Grade D · 30 · Safety caution
The large trial found no mortality reduction but did not completely exclude substantial benefit
Intra-aortic placement requires specialist monitoring for bleeding, limb ischemia, vascular injury, and infection. Major bleeding and peripheral ischemic complications were not significantly increased in the pivotal trial.
What the
research shows
The grade is D. IABP-SHOCK II randomized 600 patients and analyzed 598 for the primary outcome. Thirty-day mortality was 119/300 (39.7%) versus 123/298 (41.3%), RR 0.96 (95% CI 0.79 to 1.17), P=0.69. One- and six-year follow-up also found no benefit, but the 30-day interval retained up to a 21% relative benefit, so this is D rather than F, with 30 points.
What the
ads claim
Mechanical counterpulsation can support hemodynamics, but that physical action is not evidence of longer survival. Survival improvement was not established in this population.
*

Useful facts when choosing a product

  • IABP-SHOCK II enrolled patients with acute myocardial infarction, cardiogenic shock, and planned early revascularization.
  • The investigator-initiated trial combined public and academic funding with unrestricted grants from Maquet and Teleflex; the companies reportedly had no trial role.
  • No existing verdict for the same IABP and myocardial-infarction shock mortality combination was identified.
Gap Measurement · Verdict 1918 · D 30
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

IABP-SHOCK II assigned 301 to IABP and 299 to control; the primary analysis included 300 versus 298. Treatment was open label, but mortality was objective and centrally adjudicated by a masked committee. At 12 months mortality was 52% versus 51%, RR 1.01 (95% CI 0.86 to 1.18), and at six years 66.3% versus 67.0%, RR 0.99 (0.88 to 1.11). These are follow-ups of the same cohort, not independent replication. An earlier 40-patient randomized trial focused on hemodynamics and lacked power to confirm mortality; its interval did not exclude the large-trial estimate, so it is not conflicting evidence either.

02

Why this is classified as D (30)

The large hard-outcome trial and follow-up were null, but the 30-day interval retained meaningful relative benefit, giving D with 30 points.

Counterpoint. A null result does not prove zero possible benefit; this interval did not close a 21% relative reduction.

Rejudgment record. Cross-check applied — The large 600-patient trial failed on 30-day mortality and long-term follow-up was null, but the pivotal interval retained a possible 21% relative benefit

Scoring profile behind this grade
EndpointHHard endpoint - actual events such as death
ReplicationR1Single confirmatory trial
IndependenceI1Mixed funding sources
Effect sizeE0Null
PrecisionC0The confidence interval leaves room for benefit

The scoring table and the verdict agree (D).

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
Reduced 30-day mortalityDRR 0.96 (95% CI 0.79 to 1.17) was null and retained meaningful benefit.
Reduced 12-month mortalityDMortality was 52% versus 51%, RR 1.01 (95% CI 0.86 to 1.18).
Reduced six-year mortalityDMortality was 66.3% versus 67.0%, RR 0.99 (95% CI 0.88 to 1.11).

Cross-check — Codex and Claude

This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Study 1Multicenter randomized open-label controlled trial with masked central outcome adjudication298German public and academic funding plus unrestricted Maquet and Teleflex grants; manufacturers had no trial involvementPrimary all-cause mortality at 30 days119/300 (39.7%) versus 123/298 (41.3%), RR 0.96 (95% CI 0.79 to 1.17), P=0.69.Pivotal large hard-outcome trial
Study 2Long-term follow-up of the same randomized cohort591Same mixed funding as the original trialAll-cause mortality at 12 months and six yearsAt 12 months, 52% versus 51%, RR 1.01 (0.86 to 1.18); at six years, 66.3% versus 67.0%, RR 0.99 (0.88 to 1.11).Same-cohort follow-up showing persistent null results
§

Receipt — 3 References

All 3 cited sources were verified for existence at the original page (as of 2026-08-01).

Thiele H, Zeymer U, Neumann FJ, et al. Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock. N Engl J Med. 2012;367:1287-1296. PMID: 22920912. DOI: 10.1056/NEJMoa1208410.
checked
Thiele H, Zeymer U, Neumann FJ, et al. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: final 12 month results. Lancet. 2013;382:1638-1645. PMID: 24011548. DOI: 10.1016/S0140-6736(13)61783-3.
checked
Thiele H, Zeymer U, Thelemann N, et al. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome. Circulation. 2019;139:395-403. PMID: 30586721. DOI: 10.1161/CIRCULATIONAHA.118.038201.
checked
Draft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-01 · Corrections: none

Cite this verdict

IABP x mortality reduction in myocardial-infarction cardiogenic shock Evidence Grade D card
[Chamgap] IABP x mortality reduction in myocardial-infarction cardiogenic shock — Evidence Grade D·30. 3 cited sources checked. Source: https://chamgap.com/en/verdicts/heart/iabp-acute-myocardial-infarction-cardiogenic-shock-mortality/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

!

What this document does and does not do

Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.