Ali Alghamdi

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Background Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave‐free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. Methods We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR‐guided or FFR‐guided coronary revascularization. The primary end point was the 1‐year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. Results At 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, ‐0.2 percentage points; 95% confidence interval [CI], ‐2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P=0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P=0.001). Conclusions Coronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. (Funded by Philips Volcano; DEFINE‐FLAIR ClinicalTrials.gov number, NCT02053038.)

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

OBJECTIVESnThe aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS).nnnBACKGROUNDnAssessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization.nnnMETHODSnThe safety of deferral of coronary revascularization in the pooled per-protocol population (nxa0= 4,486) ofxa0thexa0DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year.nnnRESULTSnCoronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (pxa0< 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; pxa0= 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; pxa0= 0.04).nnnCONCLUSIONSnOverall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate ofxa0about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. Inxa0deferredxa0patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.

23. Does the maximum allowable contrast dose (MACD) predict the risk of contrast induced nephropathy (CIN) in patients with chronic kidney disease (CKD)

Background CIN is associated with high in-hospital mortality. Some studies recommend the utilization of the MACD formula to guide safe contrast dosing, however the evidence supporting use of this measure is limited. Objective The purpose of this study was to determine if MACD is helpful in predicting the risk of CIN in patients with CKD. Methods 8670 patients who underwent coronary angiography in our center with or without Percutaneous Coronary Intervention (PCI) (2008–2013) were included. Patients with CKD ( n xa0=xa0144) were selected. Patients in shock, on intra aortic balloon pump, on prophylactic hemofiltration or on dialysis were excluded. Creatinine was measured 48–72xa0h post procedure. T-test, Chi-Square and multiple regression were used to compare those patients who developed CIN and those who did not develop CIN. CIN was defined as an increase in serum creatinine by ⩾25% or 0.5mg/dL from baseline within 48–72xa0h after contrast exposure. Results CIN occurred in 28 patients (19.4%). Only 8 (5.6%) of the 144 patients exceeded MACD and 2 of these patients developed CIN. The use of biplane angiography explains the lower contrast dose. For this reason the impact of exceeding MACD could not be evaluated. Primary PCI was associated with CIN ( p xa0=xa00.012; OR 5.1)). Conclusion Overall it is best to limit contrast dose to the extent possible as this is a known risk factor, however MACD is not a useful variable in a risk model for predicting CIN in our population. Primary PCI was the only predictor of CIN in our population.

Drug eluted balloon has the potential to treat in-stent restenosis and small vessels disease

Background In-stent restenosis still a major problem after percutanous coronary intervention. One-quarter of DESs can result in restenosis, paclitaxel-coated coronary balloons showed an advantage in patients with in-stent restenosis in different clinical studies, small vessels disease is a challenge in coronary intervention Methods Single center study in our cath lab between Jan 2010–Oct 2011, a total of 36 patients, with either in-stent restenosis more than 50%, or small vessel disease, under went balloon angioplasty using a Dior Eurocor, Drug Eluted Balloon to treat those lesions. And patients were prepared in the same way of regular PCI, given heparin and clopidogrel loading and maintenance dose accordingly. We are planning to f/u the patients clinically for 6 months to 2 years. Results Total of 36 patients, 10 (28%) patients had in-stent restenosis treated by DEB. 26 (72%) patients had a small vessels disease, diameter Conclusion The vast majority of our patients are diabetic and this technique could resolve the PCI limitations in those patients even after DES implantation.