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Year : 2016  |  Volume : 4  |  Issue : 1  |  Page : 38-40

Journal watch

Department of Cardiology, Heritage Hospital, Varanasi, Uttar Pradesh, India

Date of Web Publication4-Mar-2016

Correspondence Address:
Alok Kumar Singh
Department of Cardiology, Heritage Hospital, Varanasi - 221 005, Uttar Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2321-449X.178114

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How to cite this article:
Singh AK. Journal watch. Heart India 2016;4:38-40

How to cite this URL:
Singh AK. Journal watch. Heart India [serial online] 2016 [cited 2022 Jan 21];4:38-40. Available from: https://www.heartindia.net/text.asp?2016/4/1/38/178114

Dear readers, from this first issue of “Heart India” 2016 we are starting a regular column, namely, Journal Watch. In this segment we will discuss the salient findings of recent studies, which will impact future clinical practice.

The fair trial: Drug-coated balloon for superficial femoral artery (SFA) in-stent restenosis

Randomized trials have already established the superiority of drug-coated balloon angioplasty for femoropopliteal lesions over standard balloon angioplasty but no randomized trials comparing drug-coated balloon angioplasty with standard balloon angioplasty has been performed in-stent restenosis till date. The femoral artery in-stent restenosis (FAIR) study compared the drug-coated balloon with the standard balloon for SFA in-stent restenosis.

The study enrolled a total of 119 patients with SFA in-stent restenosis and randomized them to drug-coated balloon angioplasty (n = 62) or standard balloon angioplasty (n = 57). The study had a nonblinded design. The mean lesion length was 82.2 ± 68.4 mm. The restenotic segment was totally occluded in 28.6% of the patients and was moderately or heavily calcified in 25.2%. The primary endpoint of recurrent in-stent restenosis evaluated by ultrasound at 6 months occurred in 15.4% (8 of 52) of the drug-coated balloon group versus 44.7% (21 of 47) of the standard balloon group (P = 0.002). The rate of recurrent restenosis at 12 months was 29.5% (13 of 44 patients) in the drug-coated balloon group versus 62.5% (25 of 40 patients) in the standard balloon group (P = 0.004). Accordingly, freedom from target lesion revascularization at 12 months was significantly higher with drug-coated balloon angioplasty compared with standard balloon angioplasty (90.8% vs 52.6%; P< 0.0001). Clinical improvement was also better with the drug-coated balloon. Safety outcomes were similar in the two groups.

The COURAGE trial:[2] Extended follow-up data of 15 years

The COURAGE trial is a landmark study comparing percutaneous coronary intervention with medical therapy in patients with stable ischemic heart disease. The COURAGE trial did not find a significant difference between the treatment groups in the rate of all-cause death, hospitalization for acute coronary syndrome, and death from any cause/nonfatal myocardial infarction during a median follow-up period of 4.6 years. This paper reported the rate of survival among the patients who were followed up to 15 years. The COURAGE trial included 2,287 patients (1,355 from the US and 932 from Canada) with chronic stable angina or silent ischemia who had at least 70% stenosis of an epicardial coronary artery. Patients were randomized to optimal medical therapy (n = 1138) or PCI plus optimal medical therapy (n = 1,149). Extended follow-up data were available for 1,211 patients (53%), of whom 598 were in the medical therapy group and 613 were in the PCI group. The median follow-up duration in the original trial was 4.6 years and the median follow-up duration for patients with extended follow-up was 11.9 years (mean: 10.5; 0-15.3 years). None of the baseline characteristics differed significantly between the medical therapy group and the PCI group among those with extended follow-up. The rate of death was 25% in the PCI group and 24% in the medical therapy group (P = 0.77). In the cohort of patients with extended follow-up, the rate of death was 41% in the PCI group and 42% in the medical therapy group (P = 0.53). In the original COURAGE trial, 32.6% of the patients in the medical therapy group had undergone revascularization. The rate of revascularization during the extended follow-up period was unknown. In the original COURAGE trial, there was separation of survival curves at 5 years in favor of PCI but this was not confirmed in the extended follow-up. In conclusion, this extended follow-up study of the COURAGE trial showed that PCI is not superior to medical therapy in stable ischemic heart disease.

The DANAMI-3-PRIMULTI trial:[3] Complete revascularization during the index admission in ST-elevation myocardial infarction

Approximately 50% of the patients with acute ST-elevation myocardial infarction (STEMI) have multivessel disease. The DANAMI-3-PRIMULTI trial investigated the effect of complete revascularization guided by fractional flow reserve (FFR) measurements before the discharge of patients with STEMI. The study enrolled 627 patients between 2011 and 2014 and randomized to FFR-guided complete revascularization (n = 314) or no further invasive treatment after primary PCI of the infarct-related artery only (n = 313). Among patients assigned to complete revascularization, 31% had FFR values >0.80 and these individuals did not have any further invasive treatment. FFR-guided complete revascularization was performed after a median of 2 days [interquartile range (IQR) 2-4) after hospitalization. The primary endpoint was a composite of all-cause mortality, nonfatal reinfarction, and ischemia-driven revascularization of lesions in non-infarct related artery (IRA). During a median follow-up of 27 months, the primary endpoint events occurred in 13% of the patients who had complete revascularization and in 22% of patients who had PCI of the infarct-related artery only [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.38-0.83, P = 0.004]. When the clinical events comprising the primary endpoint were individually assessed, the HRs were 1.40 (0.63-3.00, P = 0.43) for all-cause mortality, 0.94 (0.47-1.90, P = 0.87) for non-fatal myocardial infarction (MI), and 0.31 (0.18-0.53, P< 0.0001) for revascularization. Thus, the superiority of complete revascularization was driven by a reduction in the need for repeat revascularizations but all-cause mortality was more in the complete revascularization group.

The ABSORB III trial: [4] Bioresorbable vascular scaffold versus cobalt-chromium everolimus-eluting stent

The ABSORB III trial compared the safety and effectiveness of bioresorbable vascular scaffolds (BVS) with cobalt-chromium everolimus-eluting stent (CoCr-EES) in a large group of patients with coronary artery disease. ABSORB III study included 2008 patients with stable or unstable angina and one or two lesions no more than 24 mm in length with a reference-vessel diameter of 2.5-3.75 mm. The patients were randomized in a 2:1 ratio to receive an everolimus-eluting BVS (n = 1322) or an everolimus-eluting CoCr-EES (n = 686). Patients with acute myocardial infarction and complex lesions were excluded. The primary endpoint was the composite of cardiac death, target-vessel MI, or ischemia-driven target-lesion revascularization at 1 year. It was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority. The study was single-blinded.

The primary endpoint at 1 year occurred in 7.8% of the patients in the BVS group and in 6.1% of the patients in the CoCr-EES group (risk difference, 1.7 percentage points; 95% CI, -0.5 to 3.9; P = 0.007 for noninferiority and P = 0.16 for superiority). The BVS group and the CoCr-EES group had similar rates of cardiac death (0.6% vs 0.1%; P = 0.29), target-vessel MI (6.0% vs 4.6%; P = 0.18), or ischemia-driven target-lesion revascularization (3.0% vs 2.5%; P = 0.50). Stent thrombosis occurred in 1.5% of the BVS group and in 0.7% of the CoCr-EES group (P = 0.13). Although not statistically significant, the rate of thrombosis was higher in the BVS group. The study included noncomplex coronary lesions. In conclusion, BVS was noninferior to CoCr-EES but the upper limit of 95% CI (3.9 percentage points) was very close to 4.5 percentage points, the criteria for noninferiority. Further long-term outcome studies are needed before the widespread use of BVSs.

LEADLESS II study:[5] Data of the First 300 Leadless Pacemaker Implantations

Recently, leadless permanent pacemakers have been developed. It is placed directly within the right ventricle. Leadless II (safety and efficacy of a leadless pacemaker) study investigated the efficacy and safety of the Nanostim leadless permanent pacemaker. This publication reported the efficacy and safety in the initial 300 patients who were followed up to 6 months (the primary cohort) and outcomes for all 526 patients who were enrolled as of June 2015 (the total cohort).

The composite primary efficacy endpoint was both a pacing capture threshold of ≤2.0 V at 0.4 ms and a sensing amplitude (R wave) of ≥5.0 mV, or a value equal to or greater than the value at implantation through 6 months. The primary safety endpoint was freedom from device-related serious adverse events during the initial 6 months after implantation and it was compared with the rates obtained from historical data.

In the first 300 patients, implant success was 96.3%. The primary efficacy endpoint was 90%, which met the prespecified performance goal of 85% (P = 0.007). The safety outcome was 93.3%, which met the prespecified performance goal of 86% (P< 0.001). Device-related serious adverse events were observed in 6.7% of the patients, device dislodgment with retrieval in 1.7%, cardiac perforation in 1.3%, pacing-threshold elevation requiring retrieval and device replacement in 1.3%. Estimated device life was calculated as 15 ± 6.7 years.

In the total cohort, implant success was 95.8%, and the primary safety endpoint was 93.5%. The average follow-up of the total cohort was 6.9 ± 4.2 months. A total of 28 deaths occurred in this cohort during follow-up. Two deaths were classified by the clinical events committee as procedure-related. Overall, device-related serious adverse events occurred in approximately one in 15 patients.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Krankenberg H, Tübler T, Ingwersen M, Schlüter M, Scheinert D, Blessing E, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. Circulation 2015;132:2230-6.   Back to cited text no. 1
Sedlis SP, Hartigan PM, Teo KK, Maron DJ, Spertus JA, Mancini GB, et al.; COURAGE Trial Investigators. Effect of PCI on long-term survival in patients with stable ischemic heart disease. N Engl J Med 2015;373:1937-46.   Back to cited text no. 2
Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, et al.; DANAMI-3--PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3--PRIMULTI): An open-label, randomised controlled trial. Lancet 2015;386:665-71.  Back to cited text no. 3
Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al.; ABSORB III Investigators. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 2015;373:1905-15.   Back to cited text no. 4
Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, et al.; LEADLESS II Study Investigators. Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med 2015;373:1125-35.  Back to cited text no. 5


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