Intraaortic balloon support in ACS with early revascularization
- Included 598 patients acute coronary syndrome patients (70% STEMI) with cardiogenic shock and planned early revascularization (PCI or CABG)
- Randomized to intraaortic balloon pump (IABP) or no IABP (control)
- Primary endpoint (30-day all-cause mortality) was not different between IABP and control (39.7% vs. 41.3%, p=O.96)
- SAPS II scores were improved on days 2 and 3 with IABP, but there was no difference by day 4
- There was no difference in measures of tissue oxygenation and inflammation (serum lactate and C-reactive protein)
- There were no differences in any safety endpoints, including stroke, bleeding, sepsis, or peripheral ischemic complications
- The vast majority of patients underwent PCI (96%), with only 3.5% receiving emergent CABG
- Crossover rate from control to IABP was generally low (10%)
- The trial was underpowered (designed for a control mortality rate of 56%), thus being at-risk for a type II error
In patients with acute coronary syndromes and cardiogenic shock with planned early revascularization, the use of an intraaortic balloon pump did not improve 30-day mortality or tissue oxygenation.
Intensive vs. standard blood pressure in intracerebral hemorrhage
- Included 2839 patients with a spontaneous intracerebral hemorrhage and a systolic BP between 150-220 mmHg within 6 hours of symptom onset.
- The study excluded those with a low Glasgow coma score (GCS 3-5) on the basis of an expected poor outcome.
- Randomized patients to “intensive” BP treatment (goal SBP < 140 mmHg within 1 hour) or “standard” BP treatment (goal SBP < 180 mmHg).
- Specific antihypertensive treatment was recommended based on a study protocol and site-specific formularies.
- After 7 days, all patients were assigned to a SBP goal of < 140 mmHg.
- Primary endpoint (90-day death or major disability based on a modified Rankin scale) was not different between intensive and standard therapy (52% vs. 55.6%, p=O.06)
- An ordinal analysis (comparing each of the 7 Rankin scores rather than comparing a dichotomous “favorable” versus “unfavorable” score) did demonstrate a favorable shift in scores with intensive therapy (OR for a higher score 0.87 [95% Cl 0.77-
- Quality of life at 90-days (as measured by EQ-5D between 0 [death] and 1 [perfect health]) was more favorable with intensive therapy (mean score 0.6 vs. 0.55 , 0=0.002)
- There was no difference in all-cause mortality or ICH-related mortality between the two groups
- No safety outcome (including severe hypotension, stroke, and neurologic deterioration) was different between the two groups
- There was no difference in 24-hour hematoma expansion between the two groups
- There were no differences in any subgroup analysis, including those with baseline hypertension
- The mean blood pressure prior to randomization was about 180/100 mmHg. At 1 hour, intensive patients had a lower SBP than standard patients (150 vs. 164 mmHg, p<0.001)
- Of note, the study only included spontaneous parenchymal hemorrhage (intracerebral). It did not include other types of intracranial hemorrhage such as subarachnoid, traumatic, aneurysmal, or subdural.
- The majority of the patients were from China and many received an antihypertensive drug called urapidil (not available in the US) — this may limit study external validity
- Although use of a variety of antihypertensives makes this a very pragmatic trial, there is concern that only certain antihypertensives may have contributed benefit in the trial (eg, through non-blood-pressure pleiotropic effects)
- Many patients received mannitol but ICP monitoring data was not provided.
- Because patients with elevated ICP may benefit from a higher blood pressure (to maintain cerebral perfusion pressure), it is not clear whether an “intensive” goal is appropriate for these patients.
- Given the results of ATACH-II (a similar trial published in 2016) showing no benefit with intensive BP control within the first 24 hours and the fact that INTERACT 2 did not demonstrate benefit in the primary endpoint, the ordinal analysis showing benefit in this trial should be interpreted with caution
Among patients with a spontaneous intracerebral hemorrhage, a lower blood pressure goal may have benefit for long-term disability outcomes and quality of life.
Clipping vs. coiling for aneurysmal subarachnoid hemorrhage
- Included 2143 patients with subarachnoid hemorrhage due to a ruptured intracranial aneurysm that would be anatomically suitable for either endovascular or neurosurgical treatment
- Randomized patients to endovascular platinum coiling or neurosurgical clipping. All other elements of care were left to the discretion of the treating clinicians.
- Primary endpoint (death or dependence at 1 year based on the modified Rankin scale) was reduced in patients with endovascular treatment compared to neurosurgery (23.5% vs. 30.9%, p=O.0001, NNT 14)
- The benefit of endovascular treatment for the primary endpoint was significant for at least 7 years (Log- rank p=0.03)
- Pre-specified subgroups related to age, severity, and anatomical location were underpowered and either neutral or favored endovascular therapy
- Early rebleeding (within 30 days) was slightly more common with endovascular treatment (1.9% vs. 0.7%, RR 1.09-5.57). The long-term rebleeding risk was no different between the two groups (Log-rank p=O.22).
- Post-procedure in-hospital seizures were more common with neurosurgery (1.5% vs. 3.1%, RR 0.37-0.74)
- A significant number of patients (69% of those evaluated) were excluded because the anatomical location of the aneurysm was not equally appropriate for both procedures (usually not appropriate for coiling)
- Critics of the ISAT trial highlight that the study only included a specific segment of aneurysmal SAH patients and that the decision to pursue coiling or clipping involves many patient-specific factors that the study was not powered to evaluate
Among a very select group of patients with aneurysmal subarachnoid hemorrhage, endovascular coiling reduced death or disability compared to neurosurgery.