What Type of Stent Should Be Used to Treat Patients With STEMI? Part II: Second-generation Drug-eluting Stent is the Gold Standard Treatment for ST-elevation Myocardial Infarction

Oct 26, 2015   |  Manel Sabate, MD; Giuseppe Giacchi, MD

Expert Analysis

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Editor's Note: This is Part II of a two-part Expert Analysis. Go to Part I.

Primary percutaneous coronary intervention (PCI) is the elective treatment for ST-elevation myocardial infarction (STEMI). Although primary PCI has been routinely performed for many years, there is still some controversy on which type of stent should be used in this challenging clinical scenario. Although drug-eluting stents (DES) are known to have lower rate of target lesion revascularization (TLR) than bare metal stents (BMS)1, the relative safety of DES and BMS in patients with STEMI continues to be debated. Some concerns raised about DES thrombosis rate, especially with first-generation ones2,3. In popular perception, DES thrombogenicity is caused either by the eluted drug or by the polymer coating. However, Kolandaivelu et al demonstrated that coating of current second-generation DES was, in fact, more thromboresistant than the absence of coating. Besides, the pro-thrombotic properties of stents were mainly associated with strut dimensions and malapposition4. Therefore, it could be hypothesized that second-generation DES, with low struts-profile, and co-polymeric fluorinated coating may carry less thrombogenic risk than BMS.

Several clinical trials have demonstrated a better clinical performance of second-generation DES than of BMS in STEMI5-10. Palmerini et al5 demonstrated a reduction in the rates of cardiac death, myocardial infarction and stent thrombosis at 1 year with the use of new-generation DES. DES also had improved definite and definite/probable stent thrombosis rates at 30-days, 1-year and 2-years. COMFORTABLE AMI and EXAMINATION trials are the two multi-center studies that evaluated the performance of second-generation DES vs BMS in STEMI6,7. When results of these two trials were pooled together, rates of target vessel re-infarction, TLR and stent thrombosis were reduced in the DES arm8. This benefit was extended up to 2-year follow-up in both trials9,10.

Clinical implications of the observed reduction in repeat revascularization by DES implantation in STEMI can be drawn from the analysis of the 3-year follow-up of the HORIZONS-AMI population11. In this analysis, BMS implantation appeared as an independent predictor of TVR, which in turn, was an independent predictor of myocardial infarction, stent thrombosis and major bleeding11.

Furthermore, DES appeared to improve clinical outcomes not only at early- and mid-term, but also at long-term follow-up. Indeed, the 5-year follow-up of EXAMINATION trial demonstrated a reduction in the patient-oriented (DES 21.2% BMS 25.7%, HR 0.80, 95% CI 0.65–0.98, p=0.033) and in the device-oriented endpoints (DES 11.7% BMS 15.1%, HR 0.75, 95% CI 0.57–0.99, p=0.043) with DES, with the absence of very late hazards in terms of definite/probable stent thromboses rates (DES 2.0% BMS 3.1%, HR 0.64, 95% CI 0.33 –1.24, p =0.18)12.

The evidence emanated from these trials supported the IA indication for second-generation DES in STEMI in the 2014 myocardial revascularization European guidelines13. Consequently, BMS should be used only in patients with a clear contraindication to DES use, such as patients who need chronic oral anticoagulation or urgent major surgery.

One possible drawback of new generation DES could be the price, as in many countries they usually are more expensive than BMS. Therefore cost-effectiveness was assessed in two studies. The EVASTENT study analyzed a matched cohort of patients undergoing PCI with second-generation DES or BMS. It demonstrated that new DES were more cost-effective than BMS, both in diabetic and in non diabetic patients, and also both in single vessel disease and in multivessel disease patients14. In addition, a sub-analysis of the SPIRIT-IV trial (that compared clinical outcomes between everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) in patients with up to three native de novo coronary artery lesions) showed that at 2-year follow-up, EES (second-generation DES) was economically more attractive than PES (first-generation DES), reducing cardiovascular costs by $ 273/patient15.

Data supporting the use of second-generation DES in STEMI are unbeatable. The use of DES provides improved early clinical outcomes, long-term benefit without the occurrence of very late hazards and is cost-effective as compared to either first generation DES or BMS. Their use should be routine in STEMI patients requiring primary intervention.

References

  1. Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370:937-48.
  2. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998-1008.
  3. Kalesan B, Pilgrim T, Heinimann K, Räber L, Stefanini GG, Valgimigli M, da Costa BR, Mach F, Lüscher TF, Meier B, Windecker S, Jüni P. Comparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012;33:977-87.
  4. Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011;123:1400-9.
  5. Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Sabaté M, Valgimigli M, Frati G, Kedhi E, Smits PC, Kaiser C, Genereux P, Galatius S, Kirtane AJ, Stone GW. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2013;62:496-504.
  6. Räber L, Kelbæk H, Ostojic M, Baumbach A, Heg D, Tüller D, von Birgelen C, Roffi M, Moschovitis A, Khattab AA, Wenaweser P, Bonvini R, Pedrazzini G, Kornowski R, Weber K, Trelle S, Lüscher TF, Taniwaki M, Matter CM, Meier B, Jüni P, Windecker S; COMFORTABLE AMI Trial Investigators. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA. 2012;308:777-87.
  7. Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012;380:1482-90.
  8. Sabaté M, Räber L, Heg D, Brugaletta S, Kelbaek H, Cequier A, Ostojic M, Iñiguez A, Tüller D, Serra A, Baumbach A, von Birgelen C, Hernandez-Antolin R, Roffi M, Mainar V, Valgimigli M, Serruys PW, Jüni P, Windecker S. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials. JACC Cardiovasc Interv. 2014;7:55-63.
  9. Räber L, Kelbæk H, Taniwaki M, Ostojic M, Heg D, Baumbach A, von Birgelen C, Roffi M, Tüller D, Engstrøm T, Moschovitis A, Pedrazzini G, Wenaweser P, Kornowski R, Weber K, Lüscher TF, Matter CM, Meier B, Jüni P, Windecker S; COMFORTABLE AMI Trial Investigators. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circ Cardiovasc Interv. 2014;7:355-64.
  10. Sabaté M, Brugaletta S, Cequier A, Iñiguez A, Serra A, Hernádez-Antolín R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vázquez N, Backx B, Serruys PW. The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial. JACC Cardiovasc Interv. 2014;7:64-71.
  11. Brener SJ, Ertelt K, Mehran R, Genereux P, Xu K, Witzenbichler B, Brodie BR, Guagliumi G, Stone GW. Predictors and impact of target vessel revascularization after stent implantation for acute ST-segment elevation myocardial infarction: lessons from HORIZONS-AMI. Am Heart J. 2015;169:242-8.
  12. Sabate M, et al. Long-term Clinical Outcomes of Everolimus-Eluting Stent vs Bare-Metal Stent in ST-segment Elevation Myocardial Infarction. Five-year results of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) randomised trial. Lancet 2015 (in press).
  13. Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35:2541-619.
  14. Barone-Rochette G, Machecourt J, Vanzetto G, Foote A, Quesada JL, Castelli C, Danchin N, Combescure C; EVASTENT Investigators. The favorable price evolution between bare metal stents and drug eluting stents increases the cost effectiveness of drug eluting stents. Int J Cardiol. 2013;168:1466-71.
  15. Amin AP, Reynolds MR, Lei Y, Magnuson EA, Vilain K, Durtschi AJ, Simonton CA, Stone GW, Cohen DJ. Cost-effectiveness of everolimus- versus paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization (from the SPIRIT-IV Trial). Am J Cardiol. 2012;110:765-70.

Keywords: Acute Coronary Syndrome, Coronary Vessels, Diabetes Mellitus, Drug-Eluting Stents, Follow-Up Studies, Infarction, Myocardial Infarction, Metals, Myocardial Revascularization, Paclitaxel, Percutaneous Coronary Intervention, Polymers, Sirolimus, Stents, Thrombosis


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