In a nutshell: The hottest developments in the field of cardiology in 2020. Section 5. Coronary artery disease - Page 4
7. HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of coronary artery diseases-comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients) trial
After 1 month of regular-dose DAPT, reduced-dose prasugrel (5 mg) is superior to regular-dose prasugrel (10 mg) when used along with low-dose aspirin for ACS PCI.
Patients were randomized in a 2x2 factorial design to: a) either prasugrel 5 mg daily or 10 mg daily, or b) durable polymer (DP) vs. bioabsorbable polymer (BP) drug-eluting stent (DES). Patients were stratified according to CHADS2 score (2 points or ≥3 points).
The recommended protocol was that all patients receive 300 mg aspirin and a loading dose of 60 mg prasugrel before PCI. After PCI, all patients in both groups were given aspirin 100 mg daily with 10 mg of maintenance prasugrel until the 1-month follow-up.
The results of this trial indicate that reduced-dose prasugrel (5 mg) is superior to regular-dose prasugrel (10 mg) when used along with low-dose aspirin for ACS PCI after 1 month of procedure.
In addition, BP-DES met the primary criteria for noninferiority compared with DP-DES, but device-related endpoints, including the need for repeat procedures, were lower in the DP-DES arm.
Source: Lancet journal: Kim HS, Kang J, Hwang D, et al. Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial. Lancet 2020; Aug 31 https://doi.org/10.1016/S0140-6736(20)31791-8
PCI with sirolimus-eluting stents was noninferior to CABG among patients with severe left main disease.
Patients with unprotected left main coronary artery stenosis were randomized to PCI with sirolimus-eluting stents (n = 300) versus CABG (n = 300).
Major adverse cardiac and cerebrovascular events (MACCE) were similar between the groups at 10 years.
During extended follow-up, there was possible effect modification for MACCE, favoring CABG versus PCI for left main plus three-vessel disease.
This is consistent with other lines of evidence, which revealed that CABG is likely preferential to PCI among patients with high SYNTAX score.
This study was conducted exclusively in Koreans and might be less applicable to other populations.
While CABG is still considered the standard of care for revascularization of left main coronary stenosis, accumulating data support the use of PCI for select patients.
So how near we are to solving the riddle between CABG and PCI in Left main disease?
This 10-year follow-up of the randomised PRECOMBAT trial adds to the already published long-term randomised comparisons of PCI vs. CABG for LM disease, including the data from SYNTAX (10 years), EXCEL (5 years) and NOBLE (5 years) trials.
At large, these trials seem to convey a similar set of messages. First, all-cause mortality appears to be similar in the long term, with the only exception being the EXCEL trial, while all trials (including EXCEL) showed no difference in terms of cardiac mortality.
Second, CABG is consistently associated with a reduction in repeat revascularisations, which given recent data connecting repeat revascularisations with mortality, may impact clinical decision making. Third, the reported inconsistencies in the effect of CABG vs. PCI on the incidence of MI may largely be dependent on the trial’s MI definition.
When interpreting the totality of evidence from these trials, at least the following two sets of potential effect modifiers may need to be kept in mind. First, the extent of the underlying coronary artery disease is of importance, as CABG seems to be associated with better results compared with PCI in cases of a more diffuse disease.
Second, variations in the PCI arm such as the distal LM bifurcation stenting technique, use of intracoronary imaging and the operator’s LM PCI-specific expertise could have an impact on the overall results.
In summary, as interventionalists are gaining more widespread experience with LM PCI, careful patient (lesion) selection and standardised improvements in PCI technique remain paramount.
Source: Circulation: Park SJ, Park DW, Ahn JM, et al. Extended Follow-Up of the PRECOMBAT Trial. Circulation 2020; Mar 30
Coronary artery disease (CAD) management id undoubtedly the most impactful arena of interventional cardiology. This year we witnessed several important trials that redefined the drug management as well as interventions for CAD. There was ATPCI trial that explored the benefit of trimetazidine in post PCI setup, Tailor PCI, TICO, TWILIGHT COMPLEX, ALPHEUS and COMPARE CRUSH trials will serve as landmarks for future guidelines for antiplatelet therapy in CAD.
The extended outcome of PRECOMBAT trial sheds more light on ever-debatable CABG vs. PCI for left main disease while DEFINITION II has supported DK crush for complex PCI lesions. Finally, COMPARE ACUTE supported the role of FFR in complete revascularisation during the index procedure in STEMI setting.
Page 1: ATPCI and TAILOR-PCI trials
Page 2. TICO and TWILIGHT COMPLEX trials
Page 3. ALPHEUS and COMPARE-CRUSH trials
Page 4. HOST REDUCE POLYTECH ACS and PRECOMBAT trials
Page 5. DEFINITION II, COMPARE ACUTE and ONTIME 3 trials
Long term trimetazidine is safe but not preventative of angina or adverse outcome after PCI.
The ATPCI trial followed 6007 patients receiving either trimetazidine or a placebo, following successful percutaneous coronary intervention (PCI). After a median follow-up of 47.5 months, trimetazidine did not improve either the outcome or the occurrence of angina.
The event rate in this trial was lower than expected and may have contributed to the null finding.
"It is the first study to test the value of increasing the energy status of the ischemic myocyte with trimetazidine in terms of hard end points such as cardiac death and hospitalization. This is particularly relevant considering that a recent study with ranolazine (RIVER-PCI trial), another piperazine derivative, in a similar patient setting failed to show a benefit" noted Roberto Ferrari, MD Department of Cardiology and LTTA Centre University Hospital of Ferrara ITALY (study author).
Source: The Lancet Journal: Ferrari R, Ford I, Fox K, et al. Efficacy and safety of trimetazidine after percutaneous coronary intervention (ATPCI): Lancet 2020;396:830-8.
2. The Tailor PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention) trial
A genotype-guided strategy was not superior at reducing adverse cardiovascular events compared with standard therapy after PCI.
Patients undergoing primary PCI for stable or unstable coronary artery disease were randomized to a genotype-guided strategy (n = 2,652) versus standard therapy (n = 2,650).
The primary analysis was between 903 subjects with a loss of function allele (*2 or *3) in the genotype-guided group compared with 946 subjects in the standard therapy group with a loss of function allele.
Among patients who underwent PCI for stable or unstable coronary artery disease, a genotype-guided strategy was not beneficial compared to standard therapy. The primary outcome of major adverse cardiovascular events and bleeding were similar between treatment groups at 12 months.
"Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one-third fewer adverse events in the patients who received genetically guided treatment compared with those who did not," said Naveen L. Pereira, MD, of Mayo Clinic, Rochester, Minnesota, co-principal investigator of the study, who presented the results.
Source: JAMA cardiology: Pereira NL, Farkouh ME, So D, et al. The TAILOR-PCI Randomized Clinical Trial. JAMA 2020;324:761-71
