Table 5. Clinical Outcomes of Contemporary Trials on BP-DES and DP-DES Designs.
| Trials | Study details | Cardiac death | TLR | TVR | MI | TV-MI | Late ST | ST | Other events |
|---|---|---|---|---|---|---|---|---|---|
| BIOSCIENCE (2-year follow-up) [24] | Orsiro arm: 1,063 patients (1,594 lesions); XIENCE arm: 1,056 patients (1,545 lesions); patients with presence or absence of STEMI | 3.2% vs. 3.2% | 6.4% vs. 5.8 % | 8.1% vs. 7.5% | 6.1% vs. 7.2% | 4.1% vs. 4.5% | - | Definite/probable 3.9% vs. 4.9%; definite 1.1% vs. 0.8% | CI-TVR 7.7% vs. 6.8%; CI-TLR: 6.0% vs. 5.1%; TLF 10.5% vs. 10.4%; TVF 12.2% vs. 12.3% |
| DESSOLVE III (2-year follow-up) [25] | MiSTENT (703/1,398 patients) vs. XIENCE (695/1,398 patients); 20 centers in Europe; all comers | 3.0% vs. 2.0% | 5.1% vs. 6% | 6.9% vs. 8.5% | 3.0% vs. 2.8% | 2.7% vs. 2.3% | Late 0.4% vs. 0.6%; very late ST 0.3% vs. 0.3% | Definite/probable 0.9% vs. 1.3%; definite 0.6% vs. 1% | CI-TVR 5.9% vs. 7.7%; CI-TLR: 4.6% vs. 5.4%; DOCE/TLF: 8.7% vs. 8.6% |
| BIOSTEMI trial (2-year follow-up) [22] | Orsiro (649/1,300 patients/651 lesions) vs. XIENCE (651/1,300 patients/806 lesions); 10 centers in Switzerland; first STEMI | 2.9% vs. 3.2% | 2.8% vs. 5.2% | 3.4% vs. 6.3% | 3.7% vs. 3.1% | 1.5% vs. 2.0% | - | Definite/probable 2.0% vs. 2.3%; definite 1.4% vs. 1.8% | TLF: 5.1% vs. 8.1%; CI-TVR 3.1% vs. 6.1%; CI-TLR: 2.5% vs. 5.1%; TVF 6% vs. 9.4% |
| BIOFLOW-V trial (3-year follow-up) [23] | Orsiro (884/1,334 patients/1,051 lesions) vs. XIENCE (450/1,334 patients/561 lesions); 92 international randomized study centers; non-STEMI/ACS | 1.1% vs. 1.2% | - | - | - | 5% vs. 9.2% | Late and very late ST 0.1% vs. 1.2% | - | ID-TLR: 3.2% vs. 6.7%; MACE: 11.5% vs. 17.5%; TVF: 9.7% vs. 16.2; TLF: 8.2% vs. 13.6% |
| BIOFLOW-II trial (5-year follow-up) [26] | Orsiro (298 patients/332 lesions) vs. XIENCE (154 patients/173 lesions); 24 centers in eight European countries; de novo lesions | 1.7% vs. 2.8% | - | - | 4.5% vs. 6.2% | 3.4% vs. 3.3% | - | Overall ST 0.7% vs. 2.8%; definite 0% vs. 0.7%; probable 0% | CI-TVR 12.6% vs. 10.1%; CI-TLR: 6.3% vs. 6.7%; TLF 10.4% vs. 12.7%; TVF 15.6% vs. 12.7% |
| BIOFLOW-V trial (5-year follow-up) [23] | Orsiro (884 patients) vs. XIENCE (450 patients); 92 randomized study centers; non-STEMI/ACS | 2.6% vs. 1.9% | - | - | 6.6% vs. 10.3% | Late and very late ST 0.3% vs. 1.6% | - | ID-TLR: 5.9% vs. 7.7%; ID-TVR: 9.6% vs. 12.4%; TLF 12.3% vs. 15.3%; TVF 15.2% vs .19%; MACE: 18.3% vs. 21.4% | |
| BIORESORT trial (3-year follow-up) [27] | 1,506/3,514 patients; Orsiro (525) vs. synergy (496) vs. resolute integrity (485); four clinical sites; all-comer trial | 1.3% vs. 1.8% vs. 2.1% | 1.7% vs. 2.5% vs. 4.4% | - | - | 2.7% vs. 2.7% vs. 4.0% | - | Definite or probable ST 0.6% vs. 1.2% vs. 1.5%; definite ST 0.4% vs. 0.6% vs. 1.1% | TLF: 5.2% vs. 6.5% vs. 8.7% |
| SCAAR registry [28] | 4,561 patients implanted with Orsiro and 69,570 n-DES group (XIENCE PRIME, XIENCE Xpedition and XIENCE ProX, PROMUS Element, Plus and Promus PRIMER, Resolute Integrity and Resolute, Onyx, SYNERGY; undergoing PCI | - | 1.6% vs. 2.3% | 6.0% vs. 5.2% | Late ST: 0.5% vs. 0.6%; very late ST: 0.7% vs. 0.8% | Definite ST: 0.7% vs. 0.8% |
Values are n (%). ACS: acute coronary syndrome; BP: biodegradable polymer; CI-TLR: clinically-indicated target lesion revascularization; CI-TVR: clinically-indicated target vessel revascularization; DP: durable polymer; ID-TLR: ischemia-driven target lesion revascularization; ID-TVR: ischemia-driven target vessel revascularization; MACE: major adverse cardiac event; N: number of patients; n-DES: new-generation drug-eluting stent; PCI: percutaneous coronary intervention; ST: stent thrombosis; STEMI: ST elevation myocardial infarction; TLF: target lesion failure; TVF: target vessel failure; TV-MI: target vessel-related myocardial infarction.