Key Words Angioplasty Coronary artery disease Revascularization Stent drug eluting stent

Transcription

1 J Cardiol 26 Dec; 48 6 : mm : Initial and Mid-Term Effects of 3 mm Long Sirolimus-Eluting Stents in Patients With Diffuse Long Coronary Lesions: Comparison With Bare Metal Stents Abstract Yosuke Hisayuki Makoto Toshio Tetsuya Michiaki Akira Takeyuki Kamon NAKANO, MD OKADA, MD MUTO, MD HASUDA, MD ISHIKAWA, MD HIGASHITANI, MD ENDO, MD KUBOTA, MD IMAI, MD, FJCC Objectives and Methods. Sirolimus-eluting stents can reduce restenosis and reintervention compared with bare metal stents. However, the safety and efficacy of for diffuse long lesions remain unknown. This study compared the efficacy of and using the initial and mid-term outcomes of 124 patients with 13 long coronary lesions lengths 3 mm compared to 141 patients with 146 lesions treated with. Results. Quantitative coronary arteriography parameters and initial success rate were not significantly different between the two groups. Occurrence of stent thrombosis was not different between the groups 1 case,.7% in group vs case, % in group. Restenosis and major adverse cardiac event rates at 6 months were lower in the group than in the group 3.1% vs 34.2%, p.1, 3.8% vs 31.5%, p.1. Conclusions. Initial effects of sirolimus-eluting stents for diffuse long lesions are as useful and as safe as. The mid-term outcomes for are superior due to the lower rates of both restenosis and major adverse cardiac event. J Cardiol 26 Dec ; 48 6 : Key Words Angioplasty Coronary artery disease Revascularization Stent drug eluting stent bare metal stent : 1 sirolimus-eluting stent : : Department of Cardiology, Saitama Cardiovascular and Respiratory Center, Saitama Address for correspondence : NAKANO Y, MD, Department of Cardiology, Saitama Cardiovascular and Respiratory Center, Itai 1696, Konan-machi, Osato-gun, Saitama 36 15; k36993@pref.saitama.lg.jp Manuscript received July 2, 26; revised September 7 and October 6, 26 ; accepted October 16,

2 mm mm percutaneous coronary intervention : PCI PCI %DS 6 5mm 5% mm atm 6 intravascular ultrasound : IVUS 2 PCI 2 2mg mg PCI 2mg mg 2mg 4 2 mg 4 75 mg Pie Medical CASS for Windows QCA V4.1 4 StatView J-5. Student t 2 p.5 1. Table 1 2. Table 2 3. American Heart Association AHA type B 2 /C Table 3 4. IVUS Table 4 J Cardiol 26 Dec; 48 6 :

3 327 Table 1 Patient characteristics Age yr, mean 2SD Sex male/female Coronary risk factor Hypertension Hyperlipidemia Diabetes mellitus Smoking Hemodialysis Prior MI Prior CABG Low EF less than 4% Medication Aspirin Ticlopidine Statin ACE-inhibitor/ AT blocker Beta-blocker n 124 n / / sirolimus-eluting stent ; bare metal stent ; MI myocardial infarction ; CABG coronary artery bypass grafting ; EF ejection fraction ; ACE angiotensin converting enzyme ; AT angiotensin. Stable AP Unstable AP SMI AMI RMI Table 2 Diagnosis n n AP angina pectoris ; SMI silent myocardial ischemia ; AMI acute myocardial infarction ; RMI recent myocardial ischemia. Other abbreviations as in Table Table 4 PCI slow flow2 PCI LAD LCX RCA LMT AHA classification Type A/B 1 Type B 2 /C Table 3 Lesion characteristics F value n 13 n LAD left anterior descending artery ; LCX : left circumflex artery ; RCA right coronary artery ; LMT left main trunk ; AHA American Heart Association. Other abbreviations as in Table 1. Table 4 Procedural characteristics n 13 n 146 Direct stenting IVUS guide No. of stent/target lesion Stent diameter mm Stent length mm Max inflation pressure atm Procedural success % Continuous values are mean 2SD. IVUS intravascular ultrasound. Other abbreviations as in Table 1. Table 5 6 %DS late loss Table 6 6 %DS late loss Table 7 6 %DS late loss Table % Table 9 6 J Cardiol 26 Dec; 48 6 :

4 328 Table 5 Quantitative coronary arteriography analysis Pre-RD mm Pre-MLD mm Pre-LL mm Pre-DS % Post-MLD mm Post-DS % n n RD reference diameter ; MLD minimal lumen diameter ; LL lesion length ; DS : diameter stenosis. Other abbreviations as in Table 1. Table 8 Quantitative coronary arteriography analysis acute coronary syndrome lesion Pre-RD mm Pre-MLD mm Pre-LL mm Pre-DS % Post-MLD mm Post-DS % Follow-up MLD mm Follow-up DS % Late loss n n Table 6 Follow-up quantitative coronary arteriography analysis Abbreviations as in Tables 1, 5. Follow-up MLD mm Follow-up DS % Late loss Abbreviations as in Table 1. n 13 n Table 9 Major adverse cardiac event at 3 days Death SAT/TVR n 13 n % SAT subacute thrombosis ; TVR target vessel revascularization. Other abbreviations as in Tables 1, 5. Table 7 Quantitative coronary arteriography analysis stable lesion Pre-RD mm Pre-MLD mm Pre-LL mm Pre-DS % Post-MLD mm Post-DS % Follow-up MLD mm Follow-up DS % Late loss Abbreviations as in Tables 1, 5. n n Table 1 Table Colombo 1 IVUS 25% 22% 23 4 FDA SIRIUS 3 in-segment 8.9% J Cardiol 26 Dec; 48 6 :

5 329 Table 1 Major adverse cardiac event at 6 months Restenosis MACE Death MI TVR ACS n 44 n 13 Stable n ACS acute coronary syndrome. Other abbreviations as in Tables 1, 5, 9. n 146 ACS n 84 Stable n Table 11 Type of restenosis n 4 n 5 In-stent Focal 1 16 Multi focal 2 Diffuse 2 26 Peri-stent Proximal 1 3 Distal 2 Both 1 Abbreviations as in Table 1. Degertekin mm % late loss.13mm 2 8.3% Aoki 5 77 mm 1 5.3% late loss.12mm 18.5% 43 mm 6 late loss.11 6 late loss.15 late loss SIRIUS 3.2% 5.8% 3 E-SIRIUS trial 6 2.1% IVUS SIRIUS RESERCH registry 8% 3,6 2 IVUS Lemos % J Cardiol 26 Dec; 48 6 :

6 33 8 PCI 1 1.7% PCI 9 1.4% 2mm 2.5mm 2.75 mm PCI : 3mm : 3mm : 1.7% % 3.1% 34.2% p.1 3.8% 31.5% p.1 : J Cardiol 26 Dec; 48 6 : J Cardiol 26 Dec; 48 6 :

7 331 1 Colombo A, De Gregorio J, Moussa I, Kobayashi Y, Karvouni E, Di Mario C, Albiero R, Finci L, Moses J : Intravascular ultrasound-guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions. J Am Coll Cardiol 21; 38 : Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O Shaughnessy C, Caputo RP, Kereiakes DJ,Williams DO, Teirstein PS, Jaeger JL, Kuntz RE ; SIRIUS Investigators : Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 23; 349: Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Clark MR, Cohen BM, Ellis SG, Coleman P, Hill C, Shi C, Cutlip DE, Kuntz RE, Moses JW : Two-year outcomes after sirolimus-eluting stent implantation : Results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions SIRIUS trial. J Am Coll Cardiol 26 ; 47 : Degertekin M, Arampatzis CA, Lemos PA, Saia F, Hoye A, Daemen J, Tanabe K, Lee CH, Hofma SJ, Sianos G, McFadden E, van der Giessen W, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW : Very long sirolimus-eluting stent implantation for de novo coronary lesions. Am J Cardiol 24; 93 : Aoki J, Ong AT, Rodriguez Granillo GA, McFadden EP, van Mieghem CA, Valgimigli M, Tsuchida K, Sianos G, Regar E, de Jaegere PP, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW : stented length 64mm using drug-eluting stents for de novo coronary artery lesions. Am Heart J 25 ; 15 : Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G ; E-SIRIUS Investigators : Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries : Doubleblind, randomised controlled trial E-SIRIUS. Lancet 23; 362: Lemos PA, Hoye A, Goedhart D, Arampatzis CA, Saia F, van der Giessen WJ, McFadden E, Sianos G, Smits PC, Hofma SH, de Feyter PJ, van Domburg RT, Serruys PW: Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients: An evaluation from the Rapamycin- Eluting Stent Evaluated At Rotterdam Cardiology Hospital RESEARCH study. Circulation 24; 19: Abreu L, Meireles GC, Forte AA, Sumita M, Hayashi J, Solano J : Coronary artery aneurysm one year and five months after sirolimus-eluting stent placement. Arq Bras Cardiol 25 ; 85 : in Portuguese with Eng abstr 9 Ong AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW : Sirolimus-eluting stents remain superior to bare-metal stents at two years: Medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital RESEARCH registry. J Am Coll Cardiol 26 ; 47 : Ishikawa T, Mutoh M, Fuda Y, Sakamoto H, Okada H, Higashitani M, Nakano Y, Yamaguchi J, Enta K, Satoh T, Imai K, Horie T, Mochizuki S: Documented subacute stent thrombosis within thirty days after stenting with sirolimuseluting stent Cypher for acute myocardial infarction : A Japanese single center retrospective non-randomized study. Circ J 26; 7 : J Cardiol 26 Dec; 48 6 :