A 66-year-old man presents to the emergency department with a 2-day history of intermittent and exertional substernal chest pain radiating to the left arm. His symptoms have not improved with over-the-counter pain killers and antacids. He has a history of hypertension and hyperlipidemia and smoked a pack of cigarette a day for the past 30 years. He takes amlodipine 10 mg once daily, lisinopril 20 mg once daily, and rosuvastatin 10 mg once daily.
On examination, his temperature is 97.4 degrees F, heart rate is 88 bpm, blood pressure is 128/74 mmHg, respiratory rate is 14, oxygen saturation is 86% on room air, and body mass index is 32 kg/m2. The remainder of his exam is unremarkable. He has no murmurs on auscultation. Electrocardiography is normal. Echocardiography demonstrates normal left ventricular ejection fraction with hypokinesis of the inferolateral myocardium. His troponin-I levels return back elevated at 4.2 ng/ml. Cardiac catheterization revealed severe 90% discrete obstruction of the mid-segment of the right coronary artery with mild disease in the left anterior descending artery and the left circumflex artery. A 3.5 mm x 12 mm permanent polymer-based everolimus-eluting stent was deployed in the right coronary artery with good angiographic result.
Which of the following statements is NOT true regarding newer-generation drug-eluting stents (DES)?
The correct answer is: D. Early-generation DES have comparable late definite stent thrombosis compared with newer-generation DES.
The ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4) randomized trial1,2 evaluated the efficacy and safety of new-generation DES compared with early-generation DES. The study compared a new-generation biodegradable polymer-based sirolimus-eluting stent (Yukon Choice PC [Translumina Therapeutics; New Delhi, India]) and a new-generation permanent polymer-based everolimus-eluting stent (Xience [Abbott Vascular; Green Oaks, IL]) with an early-generation permanent polymer sirolimus-eluting stent (Cypher [Cordis Corporation; Baar, Switzerland]). At 10-year follow-up, a difference was observed in definite stent thrombosis in favor of patients treated with new-generation DES (Yukon Choice PC and Xience) compared with early-generation DES (Cypher). These findings are in line with results from previous randomized trials reported for both biodegradable polymer DES and permanent polymer DES.3
The main finding of the 10-year follow-up study of the ISAR-TEST 4 trial was a significant reduction of overall major adverse cardiac events (composite of death, myocardial infarction, or target lesion revascularization) with the newer-generation stents (~47%) compared with early DES (55%) (answer A). The difference is driven by significantly lower all cause-mortality after implantation of newer DES (answer C). Another important finding was that the outcomes of the two new-generation DES do not seem to be impacted by whether the polymer is of biodegradable or permanent nature (answer B), which is consistent with observations from prior trials.4,5
Kufner S, Joner M, Thannheimer A, et al. Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease. Circulation 2019;139:325-33.
Kufner S, Byrne RA, Valeskini M, et al. Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial. Eurointervention 2016;11:1372-9.
Jensen LO, Thayssen P, Christiansen EH, et al. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. J Am Coll Cardiol 2016;67:751-62.
Natsuaki M, Kozuma K, Morimoto T, et al. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovascular Interv 2015;8:e002817.
Vlachojannis GJ, Smits PC, Hofma SH, et al. Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent). JACC Cardiovasc Interv 2017;10:1215-21.