User:Mxp635

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Clinical trials relevant for PCI practice. Page collated by M Protty


Mechanical circulatory support

  • IABP-SHOCK II (2012): IABP in MI and cardiogenic shock
    • NOTE, the ESC ACS Guidelines 2023 list IABP as a Class III (Harmful) indication for cardiogenic shock, and only reserve it to mechanical complications of AMI (eg VSD)


PCI in Stable Angina

  • COURAGE (2007): PCI vs. medical therapy in CAD
  • ISCHEMIA (2020): PCI/CABG vs. medical therapy in stable CAD
  • ORBITA (2017): PCI vs. sham procedure on optimal medical therapy in stable angina
  • ORBITA-2 (2023): PCI vs sham procedure on no/minimal medical therapy in stable angina
    • Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia (FFR/iFR), PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death.

PCI in ACS

  • CULPRIT-SHOCK (2017): Culprit-only vs. multivessel PCI in cardiogenic shock: In patients with acute MI complicated by cardiogenic shock found to have multivessel CAD on coronary angiography, culprit-only PCI is associated with 9.5% absolute reduction in the rate of death or renal replacement therapy at 30 days. This was driven primarily by a 7.3% absolute reduction in all-cause mortality with culprit-lesion only PCI.
  • CvLPRIT (2015): Culprit lesion-only vs. complete revascularization: Among patients undergoing PCI for STEMI and found to have multivessel disease on angiography, complete revascularization is associated with an 11% absolute reduction in major adverse cardiovascular outcomes (MACE) at 12 months compared to culprit lesion-only revascularization, driven by symmetric modest reductions in each component of the primary composite outcome.

Complete Revasc

Previous to COMPLETE, smaller randomized trials including the PRAMI, CvLPRIT and DANAMI-3 PRIMULTI trials, comparing complete and culprit-only revascularization have been mostly been supportive of complete revascularization but had various limitations. Criticisms included having composite outcomes driven by repeat revascularization or refractory angina, as well as having a small number of total events. The COMPLETE trial, therefore, aimed to address the need for a large randomized trial with hard clinical endpoints.

  • DANAMI-3 PRIMULTI
  • CvLPRIT
  • PRAMI (2013): PCI to high-risk non-infarct arteries in STEMI
  • COMPLETE (2019) - Complete Revascularization with Multivessel PCI for Myocardial Infarction". The New England Journal of Medicine. 2019. 381(15):1411-1421.

All the above was in a STEMI setting.

Interestingly, the FIRE trial 2023 looked at complete revasc vs culprit only in NSTEACS patients >75 years old, showing "Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion–only PCI. "

CABG vs PCI

  • STICH (2011): CABG in ischemic HFrEF
  • STICHES (2016): This is the 10 year follow up of STICH. In a cohort of patients with ischemic cardiomyopathy, the rates of death from any cause, death from cardiovascular causes, and death from any cause or hospitalization for cardiovascular causes were significantly lower over 10 years among patients who underwent CABG in addition to receiving medical therapy than among those who received medical therapy alone.
  • SYNTAX (2009): PCI vs. CABG in severe CAD

PCI in LMS

  • SYNTAX 2014 (Circulation. 2014;129:2388–2394) analysis of 5 year outcomes suggest that in patients with low SYNTAX score (<33), LMS PCI (Taxus stents) had similar mortality outcomes to CABG
  • EXCEL (2016): CABG vs. PCI in left main CAD with low SYNTAX - No difference in mortality/MACE
  • NOBLE (2016): CABG vs. PCI in left main CAD with low SYNTAX - No difference in mortality (MACE was higher with PCI, but the difference was driven by higher periprocedural MI, the definition of which was different to EXCEL)
  • DK-CRUSH V (2017): DK-Crush was superior to provisional in LMS-PCI
  • EBC-MAIN (2021): Provisional with step wise layered approach was superior to upfront (any) 2-stent techniques (BUT, the use of DK Crush in the 2-stent arm was only 5%).
    • There were differences between DK-CRUSH V and EBC-MAIN, one being the EBC-MAIN under utilised DKC technique (53% was culotte), and the other is that the DK-CRUSH V population had worse disease (16mm side branch disease compared with 7mm in EBC-MAIN, higher SYNTAX score) but higher operator experience (>300 PCI/yr and >20 LMS) and >98% use of POT (compared to 85% in EBC-MAIN)


RISK SCORES in Revasc

  • SYNTAX (as above)
  • GRACE Score (outcomes of ACS)
  • CRUSADE Score (bleeding risk in ACS)
  • EuroScore and STS Score (surgical risk)
  • BCIS-1 Jeopardy Score

Pressure wires

  • DEFER
  • FAME (2009): FFR-guided PCI in stable CAD
  • FAME 2 (2012): FFR-guided PCI vs. OMT in CAD
  • FAMOUS-NSTEMI
  • FAME 3
  • IFR-SWEDEHEART (2017): iFR vs. FFR for PCI
  • FLOWER-MI 2021: The FLOWER-MI trial failed to show that FFR-guided complete revascularization was superior to angiography-guided complete revascularization. The goal of the trial was to evaluate complete revascularization guided by fractional flow reserve (FFR) versus angiography among patients with ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI) of their culprit vessel.
  • RIPCORD2 2022: The RIPCORD 2 trial was an 1100 patient prospective, multicentre, randomized trial that compared a strategy of coronary angiography alone versus coronary angiography + routine FFR assessment of all epicardial vessels of sufficient size amenable to revascularization to determine whether the latter strategy was associated with more effective resource utilization, improved quality of life, and better clinical outcome. The study thus concluded that routine FFR at the stage of diagnostic angiography is not associated with reduction in cost or improvement in quality of life.


[Image to summarise studies on FFR]

PCI in LV dysfunction

  • REVIVED 2022 - PCI in LV dysfunction

The benefits of coronary revascularization in patients with significant left ventricular systolic dysfunction remains uncertain. A survival benefit in patients undergoing CABG in this population became apparent only after 10 years in the STICH trial. The REVIVED investigators examined whether coronary revascularization with PCI in addition to guideline directed optimal medical therapy (OMT) (n=347) as compared to OMT alone (n=353) improved event-free survival in patients with left ventricular ejection fraction (LVEF) ≤ 35%, extensive coronary artery disease (BCIS jeopardy score ≥ 6) and myocardial viability in at least four dysfunctional segments amenable to revascularization with PCI. No difference in The primary composite outcome of death from any cause or hospitalization for heart failure over a minimum follow-up period of 24 months.

Viability and Revasc

  • Neither STICHES (CABG) nor REVIVED (PCI) showed the revascularisation in viable myocardium improved LVEF (function) or outcome. So this makes testing for viability less useful, although identifying scar as part of viability testing was associated with higher risk of arrhythmic death according to REVIVED substudy (presented ESC 2023).


P2Y12 inhibitors

CTCA in CABG

  • BYPASS-CTCA : randomized 688 patients with previous CABG to undergo computerized tomography coronary angiography (CTCA) prior to ICA or ICA alone. The primary endpoints were procedural duration, patient satisfaction scores post ICA, and the amount of contrast-induce nephropathy. Results showed a 66% relative reduction in procedural duration (17.4 vs. 39.5 minutes) with CCTA prior to ICA, as well as 92% relative risk reduction in the incidence of contrast-induced nephropathy (3.2% vs. 27.9%) and a 40% relative improvement in patient satisfaction (1.49 vs. 2.54). There was also an 80% reduction in procedural complications, such as heart attack, bleeding or stroke, (10.8% vs. 2.4%) and a 7.7% improvement in quality of life at 12 months.


OOHCA

  • MIRACLE2 score was created based on a single-center study of 373 patients. Predictors of poor outcome (CPC 3–5) at 6 months were unwitnessed arrest, non-shockable rhythm, non-reactivity of pupils, age, changing intra-arrest rhythm, low pH (<7.2), and higher amount of epinephrine administration.
  • COACT trial: investigated the impact of immediate versus delayed CAG and PCI in 522 OHCA patients without ST elevation on post-ROSC ECG. The primary outcome of 90-day survival was not significantly different between the two groups. ONLY SHOCKABLE RHYTHMS
  • TOMAHAWK trial: Among patients with resuscitated out-of-hospital cardiac arrest without ST-segment elevation, a strategy of performing immediate angiography provided no benefit over a delayed or selective strategy with respect to the 30-day risk of death from any cause. ALL RHYTHMS

The evidence for STE on post ROSC ECG is well established from registry work


Pros and Cons of PCI In TAVI


Evidence base for CTO PCI

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