Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry.

The registry reports 3-year safety and clinical performance of the ultrathin strut (60 µm) biodegradable polymer-coated Tetrilimus, an everolimus-eluting stent (EES) (Sahajanand Medical Technologies Limited, India), in 'real-world' patients with coronary artery disease. A total of 815 Tetrilimus EES were implanted in 735 lesions in 594 patients. At 3-year follow-up, primary endpoint (target lesion failure, TLF) was reported in 8.6 % patients, including 2.6 % cardiac deaths, 3.5 % myocardial infarction and 2.6 % target lesion revascularization. At three-year, no cases of definite stent thrombosis were reported. The final three-year results of PERFORM-EVER registry endorse the continuous safety and effectiveness Tetrilimus EES.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

Post market surveillance registry (PIONEER) of the Yukon Choice PC-Elite Coronary Stent System for percutaneous coronary intervention in Indian acute coronary syndrome population.

AIM: The aim of this study was to assess the safety and efficacy profile of a newer generation biodegradable DES, the Yukon Choice PC Elite with a temperature controlling mechanism, in patients with acute coronary syndrome (ACS). METHODS: This prospective multi-center study (PIONEER Registry) was conducted in an Indian ACS population, therefore providing data in real world clinical practice. Patients with ACS underwent DES implantation in de novo native-vessel coronary lesions with the Yukon Choice PC Elite biodegradable polymer DES and were followed up for a year. RESULTS: A total 999 patients were evaluated. The majority of patients were male (79.2%). A total of 6.7% of the patients had a history of prior myocardial infarction (MI) and 2.7% of patients had a history of previous coronary artery bypass graft. The clinical presentations of the patients included: unstable angina pectoris (UA) (46.4%), ST-segment elevation MI (STEMI) (38.1%), and Non-ST-segment elevation MI (NSTEMI) (15.4%). Implantation of the device was successful in 99.9% of cases. The median stent length and stent size were 21.0 mm (Range: 8.0-40.0 mm) and 2.8 mm (Range 2.0-4.0 mm), respectively. Through to one-year clinical follow-up after percutaneous coronary intervention, all-cause death occurred in 4 of 999 patients (Crude Percentage: 0.4%). Cardiac death, MI, TLR, and stent thrombosis were occurred in 1 (0.1%), 8 (0.8%), 12 (1.2%) and 1 (0.1%) patients, respectively. CONCLUSION: The results of this post marketing surveillance registry suggest favorable safety and efficacy outcomes associated with the Yukon Choice PC Elite biodegradable DES in a real world Indian ACS population.

Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in "Real-World" Patients: A Multicenter Registry (PERFORM-EVER).

BACKGROUND: Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt-chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in "real-world" clinical practice. METHODS: The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimuseluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All "real-world" patients who had received Tetrilimus everolimuseluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint. RESULTS: During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/ patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up. CONCLUSION: Low incidences of target lesion failure and stent thrombosis at 1-year followup indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.

Guiding Principles for the Clinical Use and Selection of Microcatheters in Complex Coronary Interventions.

The use of microcatheters as a coronary interventional tool for a therapeutic approach to complex coronary interventions like bifurcation lesions, ostial location, tortuous anatomy, angled takeoffs, coronary calcification, and chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is growing among cardiologists across the country. During the treatment of such complex lesions, microcatheters play an essential part of the tool kit with both single-lumen and double-lumen microcatheters (DLMs) having their specific niche areas. The selection of microcatheters involves a detailed understanding of the microcatheter specification, lesion anatomy, lesion location, vessel tortuosity and trajectory, and crossing techniques. The selection of appropriate crossing techniques with different microcatheters increases success rates of PCI, reduces procedural time and contrast use, and lowers the radiation. However, the use of microcatheters and their technicalities have not yet fully realized by many operators and their true scope has not been fully explored. This article discusses and summarizes the thoughts and key opinions of experts in this field.

A randomized placebo-controlled trial with amiodarone for persistent atrial fibrillation in rheumatic mitral stenosis after successful balloon mitral valvuloplasty.

OBJECTIVE: Atrial fibrillation is the most common sustained arrhythmia in patients with rheumatic heart disease (RHD). This study was conducted to determine the maintenance of sinus rhythm with amiodarone therapy following DC cardioversion (DCCV), early after successful balloon mitral valvuloplasty (BMV). METHODS: Patients were randomized to amiodarone group and placebo group and their baseline characteristics were recorded. DCCV was done 48h after BMV. After cardioversion, oral amiodarone was started initially 200mg three times a day for 2 weeks, then 200mg twice daily for two weeks followed by 200mg once daily for 12 months. Patients in placebo group received DCCV alone without preloading amiodarone. After DCCV, they were given placebo for 12 months. RESULTS: The 3 months follow-up period was completed by 77 patients (95%). Of them, 31 (77.5%) patients in amiodarone group and 14 (34.1%) in placebo group remained in sinus rhythm (SR). The 12 months follow-up period was completed by 73 patients (90.1%). Of them, 22 (55%) patients in amiodarone group and 7 (17.1%) in placebo group remained in SR. CONCLUSION: We conclude that amiodarone is more effective than placebo in maintenance of SR at the end of 3 months following successful cardioversion and more patients continued to remain in SR even at the end of 12 months without major serious adverse effects.

Bioresorbable vascular scaffolds for LMCA with double vessel disease under IVUS guidance.

An 80-year-old male patient, presented with chest pain. ECG showed ST elevation in leads V2 to V4 and T wave inversion in leads V2-V6. Check angiogram revealed ostial LMCA 70% lesion & mid-LAD 90% lesion and LCX proximal 80% lesion. Predilatation of LMCA lesion was done with 2.0 × 12 mm NC Trek balloon and the LAD lesion with 2.0 × 12 mm and 2.5 × 08 mm (NC Trek balloons). Prestenting IVUS (Intravascular ultrasound) was done with Atlantis SR pro 40 MHz 3.6 Fr catheter. IVUS showed the LAD to have a minimal lumen area of 2.6 sq mm with 90% fibrotic plaque and a vessel size of 2.5mm and the LMCA to have a minimal lumen area of 8.8 sq mm with 70% fibrotic plaque and vessel size of 3.8mm. Mid-LAD stenting was done with 2.5 × 28 mm Absorb Stent (BVS). Predilatation of LCX lesion was done with 2.5 × 08 mm NC Trek balloon. Then stenting was performed with 3.0 × 28 mm Absorb Stent (BVS). Check angiogram showed edge dissection proximal to the BVS Stent which was covered with 3.0 × 12 mm Xience Xpedtion Stent (DES). Then LMCA Stenting was done with 3.5 × 12 mm Absorb Stent. Post dilatation was done with 4.0 × 08 mm NC Trek balloon. Post Stenting LMCA - LAD IVUS was done. LMCA and LAD Stents were well opposed without any dissection or residual stenosis. TIMI III Flow was achieved in the final results.